10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2020 OR
☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____ to _____

Commission File Number: 001-33718

U.S. STEM CELL, INC.

(Exact name of registrant as specified in its charter)

Florida	65-0945967
(State or other jurisdiction of incorporation or organization	(I.R.S. Employer Identification No.)

1560 Sawgrass Corporate Pkwy 4th Floor, Sunrise, FL 33323

(Address of principal executive offices) (Zip Code)

(954) 835-1500

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-Accelerated filer	☐	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	USRM	OTC

As of July 15, 2021, there were 452,413,153 outstanding shares of the Registrant’s common stock, par value $0.001 per share.

Transitional Small Business Disclosure Format Yes ☐ No ☒ 

TABLE OF CONTENTS

PART I.	FINANCIAL INFORMATION	Page No.
Item 1.	Financial Statements
	Condensed Balance Sheets as of September 30, 2020 (Unaudited) and December 31, 2019	3
	Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2020 and 2019 (Unaudited)	4
	Condensed Statements of Stockholders' Deficit for the Three and Nine Months Ended September 30, 2020 and 2019 (Unaudited)	5
	Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2020 and 2019 (Unaudited)	7
	Notes to Condensed Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	28
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	37
Item 4.	Controls and Procedures	37
PART II.	OTHER INFORMATION
Item 1.	Legal Proceedings	38
Item 1A.	Risk Factors	39
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	39
Item 3.	Defaults Upon Senior Securities	39
Item 4.	Mine Safety Disclosures	39
Item 5.	Other Information	39
Item 6.	Exhibits	39
	Signatures	42

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

U.S. STEM CELL, INC.

CONDENSED BALANCE SHEETS

	September 30,			December 31,
	2020			2019
	(unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	81,228		$	-
Accounts receivable, net		21,469			48,208
Inventories		5,418			8,096
Prepaid expenses and other current assets		10,000			10,000
Total current assets		118,115			66,304
Investments		-			23,539
Total assets	$	118,115		$	89,843
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Bank overdraft	$	-		$	1,520
Accounts payable		1,231,623			1,187,989
Accrued expenses		1,379,821			1,115,526
Advances - related parties		797,040			511,744
Deferred revenue, current portion		23,000			23,800
Deferred gain on sale of equipment, current portion		-			21,474
Deposits		465,286			465,286
Notes payable - related parties		3,733,404			2,757,442
Notes payable, current portion, net of debt discount of $9,501 and $9,057, respectively		1,400,910			1,297,477
Promissory note payable, net of debt discount of $0 and $29,296, respectively		1,397,762			1,368,467
Convertible notes payable, net of debt discount of $6,221 and $0, respectively		38,779			-
Total current liabilities		10,467,625			8,750,725
Long-term liabilities:
Deferred revenue		60,250			62,500
Notes payable, net of debt discount of $34,091 and $41,391, respectively		769,741			756,014
Total long-term liabilities		829,991			818,514
Total liabilities		11,297,616			9,569,239
Commitments and contingencies (See Note 13)
Stockholders' deficit:
Preferred stock, par value $0.001; 20,000,000 shares authorized, -0- issued and outstanding		-			-
Common stock, par value $0.001; 2,000,000,000 shares authorized, 429,702,662 and 417,724,767 shares issued and outstanding, respectively		429,703			417,725
Additional paid-in capital		124,315,620			123,726,894
Accumulated deficit		(135,924,824	)		(133,624,015	)
Total stockholders' deficit		(11,179,501	)		(9,479,396	)
Total liabilities and stockholders' deficit	$	118,115		$	89,843

The accompanying notes are an integral part of these unaudited condensed financial statements.

3

U.S. STEM CELL, INC.

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

	For Three Months Ended September 30,						For the Nine Months Ended September 30,
	2020			2019			2020			2019
Revenue:
Products	$	44,970		$	28,160		$	116,347		$	299,826
Services		19,677			127,456			45,446			2,412,808
Management fees - related party		-			975			-			50,751
Total revenue		64,647			156,591			161,793			2,763,385
Cost of sales		18,576			137,366			53,550			1,165,459
Gross profit		46,071			19,225			108,243			1,597,926
Operating expenses:
Research and development		-			-			-			263
Selling, general and administrative		1,039,352			1,616,970			2,068,245			3,628,652
Pre-litigation settlement		-			-			-			500,000
Total operating expenses		1,039,352			1,616,970			2,068,245			4,128,915
Loss from operations		(993,281	)		(1,597,745	)		(1,960,002	)		(2,530,989	)
Other income (expenses):
Gain (loss) on settlement of accounts payable and accrued interest, net		(204	)		33,203			277			21,892
Gain on sale of equipment		-			32,211			21,474			96,634
Miscellaneous income		-			11,000			-			11,069
Income (loss) from equity investments		(9,718	)		(33,478	)		(23,539	)		93,778
Interest expense		(152,572	)		(91,140	)		(339,019	)		(850,677	)
Total other income (expenses)		(162,494	)		(48,204	)		(340,807	)		(627,304	)
Net loss before income taxes		(1,155,775	)		(1,645,949	)		(2,300,809	)		(3,158,293	)
Income taxes (benefit)		-			-			-			-
NET LOSS	$	(1,155,775	)	$	(1,645,949	)	$	(2,300,809	)	$	(3,158,293	)
Net loss per common share, basic and diluted	$	(0.00	)	$	(0.00	)	$	(0.01	)	$	(0.01	)
Weighted average number of common shares outstanding, basic and diluted		429,684,176			396,637,920			427,207,208			392,029,562

The accompanying notes are an integral part of these unaudited condensed financial statements.

4

U.S. STEM CELL, INC.

CONDENSED STATEMENT OF STOCKHOLDERS' DEFICIT

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020

									Additional
	Preferred Stock				Common Stock				Paid-in		Accumulated
	Shares		Amount		Shares		Amount		Capital		Deficit			Total
Balance, June 30, 2020		-	$	-		428,001,981	$	428,002	$	124,132,196	$	(134,769,049	)	$	(10,208,851	)
Common stock issued in settlement of accounts payable		-		-		1,700,681		1,701		8,504		-			10,205
Stock-based compensation		-		-		-		-		174,920		-			174,920
Net loss		-		-		-		-		-		(1,155,775	)		(1,155,775	)
Balance, September 30, 2020 (unaudited)		-	$	-		429,702,662	$	429,703	$	124,315,620	$	(135,924,824	)	$	(11,179,501	)

									Additional
	Preferred Stock				Common Stock				Paid-in		Accumulated
	Shares		Amount		Shares		Amount		Capital		Deficit			Total
Balance, December 31, 2019		-	$	-		417,724,767	$	417,725	$	123,726,894	$	(133,624,015	)	$	(9,479,396	)
Common stock issued in settlement of accounts payable and accrued interest		-		-		7,977,895		7,978		36,390		-			44,368
Common stock issued for services		-		-		4,000,000		4,000		12,000		-			16,000
Beneficial conversion feature recognized on convertible note		-		-		-		-		15,000		-			15,000
Stock-based compensation		-		-		-		-		525,336		-			525,336
Net loss		-		-		-		-		-		(2,300,809	)		(2,300,809	)
Balance, September 30, 2020 (unaudited)		-	$	-		429,702,662	$	429,703	$	124,315,620	$	(135,924,824	)	$	(11,179,501	)

The accompanying notes are an integral part of these unaudited condensed financial statements.

5

U.S. STEM CELL, INC.

CONDENSED STATEMENT OF STOCKHOLDERS' DEFICIT

FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2019

									Additional
	Preferred Stock				Common Stock				Paid-in		Accumulated
	Shares		Amount		Shares		Amount		Capital		Deficit			Total
Balance, June 30, 2019		-	$	-		393,694,820	$	393,695	$	123,231,001	$	(131,301,022	)	$	(7,676,326	)
Common stock issued in settlement of accounts payable		-		-		4,049,140		4,049		29,964		-			34,013
Stock-based compensation		-		-		-		-		174,450		-			174,450
Net loss		-		-		-		-		-		(1,645,949	)		(1,645,949	)
Balance, September 30, 2019 (unaudited)		-	$	-		397,743,960	$	397,744	$	123,435,415	$	(132,946,971	)	$	(9,113,812	)

	Preferred Stock				Common Stock				Paid-in		Accumulated
	Shares		Amount		Shares		Amount		Capital		Deficit			Total
Balance, December 31, 2018		-	$	-		378,076,976	$	378,077	$	122,528,391	$	(129,788,678	)	$	(6,882,210	)
Common stock issued in settlement of accounts payable and accrued interest		-		-		16,166,984		16,167		296,027		-			312,194
Common stock issued for services		-		-		3,500,000		3,500		82,850		-			86,350
Contribution to equity investment		-		-		-		-		15,265		-			15,265
Stock-based compensation		-		-		-		-		512,882		-			512,882
Net loss		-		-		-		-		-		(3,158,293	)		(3,158,293	)
Balance, September 30, 2019 (unaudited)		-	$	-		397,743,960	$	397,744	$	123,435,415	$	(132,946,971	)	$	(9,113,812	)

The accompanying notes are an integral part of these unaudited condensed financial statements.

6

U.S. STEM CELL, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

	For the Nine Months Ended September 30,
	2020			2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(2,300,809	)	$	(3,158,293	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		-			154,956
Bad debt (recoveries)		-			30,869
Interest and amortization of debt discount		309,219			141,296
(Gain) loss on settlement of accounts payable and accrued interest		(277	)		(21,892	)
Gain on sale of equipment		(21,474	)		(96,634	)
Related party notes payable issued for services rendered		975,962			800,000
Loss (income) on equity investments		23,539			(93,778	)
Note payable issued in pre-trial settlement		-			500,000
Stock-based compensation		541,336			586,382
Changes in operating assets and liabilities:
Accounts receivable		26,739			(33,079	)
Inventories		2,678			46,864
Accounts payable		79,134			269,070
Accrued expenses		9,152			(4,507	)
Deferred revenue		(3,050	)		(112,390	)
Net cash used in operating activities		(357,851	)		(991,136	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from equity investments		-			166,833
Net cash provided by investing activities		-			166,833
CASH FLOWS FROM FINANCING ACTIVITIES:
Repayments for overdraft protection		(1,520	)		-
Proceeds from related party advances		285,296			140,000
Repayments of related party notes		-			(213,739	)
Proceeds from notes payable		150,000			-
Repayments of notes payable		(39,697	)		(381,000	)
Proceeds from convertible note payable		45,000			-
Net cash provided by (used in) financing activities		439,079			(454,739	)
Net increase (decrease) in cash and cash equivalents		81,228			(1,279,042	)
Cash and cash equivalents, beginning of period		-			1,357,146
Cash and cash equivalents, end of period	$	81,228		$	78,104
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Interest paid	$	29,800		$	633,859
Income taxes paid	$	-		$	-
SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES:
Common shares issued in settlement of accounts payable and accrued interest	$	44,368		$	312,194
Beneficial conversion feature recognized on convertible note	$	15,000		$	-
Equity contributed to investment	$	-		$	15,265
Record right-to-use assets and related lease liability	$	-		$	383,351

The accompanying notes are an integral part of these unaudited condensed financial statements.

7

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

NOTE 1 — NATURE OF OPERATIONS

Overview

U.S. Stem Cell, Inc. was incorporated under the laws of the State of Florida in August 1999. The Company is in the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. The business includes the development of proprietary cell therapy products as well as revenue generating physician and patient-based regenerative medicine/cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of cell therapy clinics. To date, the Company has not generated significant revenues in that they remain less than their total operating expenses, has incurred expenses, and has sustained losses. Consequently, its operations are subject to all the risks inherent in the establishment of a research and development business enterprise.

Basis of Presentation

The interim unaudited condensed financial statements included herein reflect all material adjustments (consisting of normal recurring adjustments and reclassifications and non-recurring adjustments) which, in the opinion of the Company’s management, are ordinary and necessary for a fair presentation of results for the interim periods. Certain information and footnote disclosures required under generally accepted accounting principles in the United States of America (“GAAP”) have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The Company’s management believes the disclosures are adequate to make the information presented not misleading.

The condensed balance sheet information as of December 31, 2019 was derived from the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2019 (“2019 Annual Report”), filed with the SEC pursuant to Section 13 or 15(d) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), on July 15, 2021. These interim unaudited condensed financial statements should be read in conjunction with the 2019 Annual Report. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the results to be expected for the entire fiscal year or for any other period.

NOTE 2 – GOING CONCERN AND MANAGEMENT’S LIQUIDITY PLANS

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

As shown in the accompanying financial statements, as of September 30, 2020, the Company had cash on hand of $81,228 and a working capital deficit (current liabilities in excess of current assets) of $10,349,510. During the nine months ended September 30, 2020, the net loss was $2,300,809 and net cash used in operating activities was $357,851. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of the unaudited condensed financial statements.

The Company’s primary source of operating funds has been from revenue generated from sales with additional cash proceeds from the sale of common stock and the issuances of promissory notes and other debt. The Company has experienced net losses from operations since inception, but it expects these conditions to improve in the future as it develops its business model. The Company had a stockholders’ deficit of 11,179,501 at September 30, 2020 and requires additional financing to fund future operations.

The Company’s existence is dependent upon management’s ability to develop profitable operations and to obtain additional funding sources. There can be no assurance that the Company’s financing efforts will result in profitable operations or the resolution of the Company’s liquidity problems. The accompanying statements do not include any adjustments that might result should the Company be unable to continue as a going concern. Along with diversifying the portfolio of products distributed by the Company, including equipment and biologics, it is the intention of the Company management to both continue to adhere to the Court Order (see Note 13) as well as re-establish its good standing with the Agency (FDA). These points are not mutually exclusive nor negotiable and management believes that there are still  business and patient goodness opportunities while still abiding by all legal requirements  As a result, management shall be continuing with the development of  US Stem Cell Training, Inc., an operating division of the Company, that  is a content developer of regenerative medicine/cell therapy informational and training materials for physicians and patients and complies with both requirements--as well as Vetbiologics, an operating division of the Company, that  is a veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the highest quality regenerative medicine therapies to dogs, cats and horses.

8

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

NOTE 3 – SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from these estimates.

Fair Value

Accounting Standards Codification subtopic 825-10, Financial Instruments (“ASC 825-10”) requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable, accrued liabilities, and short-term borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments. All other significant financial assets, financial liabilities and equity instruments of the Company are either recognized or disclosed in the financial statements together with other information relevant for making a reasonable assessment of future cash flows, interest rate risk and credit risk. Where practicable the fair values of financial assets and financial liabilities have been determined and disclosed; otherwise only available information pertinent to fair value has been disclosed.

The Company follows Accounting Standards Codification subtopic 820-10, Fair Value Measurements and Disclosures (“ASC 820-10”) and Accounting Standards Codification subtopic 825-10, Financial Instruments (“ASC 825-10”), which permits entities to choose to measure many financial instruments and certain other items at fair value.

Cash

The Company considers cash to consist of cash on hand and temporary investments having an original maturity of 90 days or less that are readily convertible into cash.

Accounts Receivable and Allowance for Doubtful Accounts

Accounts receivable are non-interest bearing and are stated at gross invoice amounts less an allowance for doubtful accounts. Credit is extended to customers based on an evaluation of their financial condition, industry reputation, and other judgmental factors considered by the Company’s management. The Company generally does not require collateral or other security interest to support accounts receivable. Based on trends and specific factors, the customer’s credit terms may be modified, including required payment upon delivery.

The Company performs regular on-going credit evaluations of its customers as deemed relevant. As events, trends, and circumstance warrant, the Company’s management estimates the amounts that are more likely than not to be uncollectible. These amounts are recognized as bad debt expense and are reflected within selling, general, administrative and other expenses on the Company’s accompanying statement of operations.

Any charges to the allowance for doubtful accounts on accounts receivable are charged to operations in amounts sufficient to maintain the allowance for uncollectible accounts at a level management believes is adequate to cover any probable losses. Management determines the adequacy of the allowance based on historical write-off percentages and the current status of accounts receivable. Accounts receivable are charged off against the allowance when collectability is determined to be permanently impaired. As of September 30, 2020 and December 31, 2019, the allowance for doubtful accounts was $13,203.

Inventories

Inventories are stated at the lower of cost or market with cost being determined on a first-in, first-out (FIFO) basis. The Company writes down its inventory for estimated obsolescence or unmarketable inventory equal to the difference between the cost of inventory and the estimated market value based upon assumptions about future demand and market conditions. If actual market conditions are less favorable than those projected by management, additional inventory write-downs may be required. During the periods presented, there were no inventory write-downs.

9

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

Investments

The Company follows Accounting Standards Codification subtopic 323-10, Investments-Equity Methods and Joint Ventures (“ASC 323-10) which requires the accounting for investments where the Company can exert significant influence, but not control of a joint venture or equity investment. The Company accounted for its 49.9% member interest ownerships of U.S. Stem Cell Clinic, LLC and Regenerative Wellness Clinic, LLC, respectively, and its 49% member interest ownership of U.S. Stem Cell Clinic of the Villages utilizing the equity method of accounting (See Note 5).

Revenue Recognition

Effective January 1, 2018, the Company recognizes revenue in accordance with Accounting Standards Codification 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific revenue recognition guidance throughout the Industry Topics of the Accounting Standards Codification. The updated guidance states that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The guidance also provides for additional disclosures with respect to revenues and cash flows arising from contracts with customers.

At the time of each transaction, management assesses whether the fee associated with the transaction is fixed or determinable and whether or not collection is reasonably assured. The assessment of whether the fee is fixed or determinable is based upon the payment terms of the transaction. Collectability is assessed based on a number of factors, including past transaction history with the client and the creditworthiness of the client.

The Company’s primary sources of revenue are from the sale of test kits and equipment, training services, patient treatments, laboratory services and cell banking. 

Revenues for kits and equipment sold are not recorded until kits and equipment are received by the customer. Revenues from in-person trainings are recognized when the training occurs and revenues from on demand online trainings are recognized when the customer purchases the rights to the training course. Any cash received as a deposit for trainings are recorded by the Company as a liability.

Patient treatments and laboratory services revenue are recognized when those services have been completed or satisfied.

Revenues for cell banking are accounted for as multiple performance obligations as described in ASC 606 and addresses accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets. Because the Company sells its services separately, on more than a limited basis and at a price within a narrow range, the Company was able to allocate revenue based on stand-alone pricing. The multiple performance obligations include stem cell banking, dose retrieval and yearly storage fees. Revenues for stem cell banking and dose retrieval is recognized at the point of service and revenues for the yearly storage fees is recognized over the term of the banking contract, which is typically one year with annual renewals.

At September 30, 2020 and December 31, 2019, the Company had deferred revenues of $83,250 and $86,300, respectively, which includes $63,250 and $65,500, respectively, for the Intellectual Property Licensing Agreement.

Research and Development

The Company accounts for research and development costs in accordance with Accounting Standards Codification subtopic 730-10, Research and Development (“ASC 730-10”). Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved as defined under the applicable agreement. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred. The Company incurred research and development expenses of $0 for the three and nine months ended September 30, 2020, respectively; and $0 and $263 for the three and nine months ended September 30, 2019, respectively.

10

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

Stock-Based Compensation

Stock-based compensation expense is measured at the grant date fair value of the award and is expensed over the requisite service period. For stock-based awards to employees, non-employees and directors, the Company calculates the fair value of the award on the date of grant using the Black-Scholes option pricing model. Determining the fair value of stock-based awards at the grant date under this model requires judgment, including estimating volatility, employee stock option exercise behaviors and forfeiture rates. The assumptions used in calculating the fair value of stock-based awards represent the Company’s best estimates, but these estimates involve inherent uncertainties and the application of management’s judgment.

Income Taxes

The Company follows Accounting Standards Codification subtopic 740-10, Income Taxes (“ASC 740-10”) for recording the provision for income taxes. Deferred tax assets and liabilities are computed based upon the difference between the financial statement and income tax basis of assets and liabilities using the enacted marginal tax rate applicable when the related asset or liability is expected to be realized or settled. Deferred income tax expenses or benefits are based on the changes in the asset or liability during each period. If available evidence suggests that it is more likely than not that some portion or all of the deferred tax assets will not be realized, a valuation allowance is required to reduce the deferred tax assets to the amount that is more likely than not to be realized. Future changes in such valuation allowance are included in the provision for deferred income taxes in the period of change. Deferred income taxes may arise from temporary differences resulting from income and expense items reported for financial accounting and tax purposes in different periods.

Deferred taxes are classified as current or non-current, depending on the classification of assets and liabilities to which they relate.  Deferred taxes arising from temporary differences that are not related to an asset or liability are classified as current or non-current depending on the periods in which the temporary differences are expected to reverse and are considered immaterial.

Net Loss per Common Share

The Company computes earnings (loss) per share under Accounting Standards Codification subtopic 260-10, Earnings Per Share (“ASC 260-10”). Net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the year.  Diluted earnings per share, if presented, would include the dilution that would occur upon the exercise or conversion of all potentially dilutive securities into common stock using the “treasury stock” and/or “if converted” methods as applicable.

The computation of basic and diluted income (loss) per share as of September 30, 2020 and 2019 excludes potentially dilutive securities when their inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during the period.

Potentially dilutive securities excluded from the computation of basic and diluted net loss per share are as follows:

	September 30,
	2020		2019
Options		111,119,914		121,038,655
Warrants		1,110,468		1,112,251
Convertible note		11,260,433		-
Total potentially dilutive shares		123,490,815		122,150,906

Recent Accounting Pronouncements

FASB Accounting Standards Updates (“ASU”) 2017-04 (Topic 350), “Intangibles – Goodwill and Others” – Issued in January 2017, ASU 2017-04 simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. This guidance was effective for the Company in the first fiscal quarter of 2020. The adoption of this standard did not have a material impact on the Company’s financial statements and related disclosures.

11

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

In February 2016, the FASB established ASC Topic 842, Leases (Topic 842), by issuing ASU No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new standard establishes a right-of-use (ROU) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company adopted the new standard on January 1, 2019. The new standard provides a number of optional practical expedients in transition. The Company has elected the ‘package of practical expedients’, which permit it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter is not applicable to the Company. The new standard had a material effect on the Company’s financial statements. The most significant effects of adoption relate to (1) the recognition of new ROU assets and lease liabilities on its balance sheet for real estate operating leases; and (2) providing significant new disclosures about its leasing activities. Upon adoption, the Company recognized additional operating lease liabilities, net of deferred rent, of approximately $57,000 based on the present value of the remaining minimum rental payments under current leasing standards for existing operating leases. The Company also recognized corresponding ROU assets of approximately $57,000. On October 24, 2019, the Company entered into an Assignment and Assumption of Lease by and between the Company, American Cell Technology, LLC, and Sawgrass Business Plaza, LLC. Subsequently, the Company relocated to a new location within the same city and entered into a month-to-month lease. Accordingly, the right of use assets and lease liabilities were eliminated. The new standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, the Company will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. Beginning in 2019, the Company changed to its disclosed lease recognition policies and practices, as well as to other related financial statement disclosures due to the adoption of this standard.

FASB ASU No. 2018-07 (Topic 718), “Compensation – Stock Compensation: Improvements to Nonemployee Share-Based Payment Accounting” – Issued in June 2018, ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. The amendments also clarify that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606. The Company adopted the new standard on January 1, 2019. The adoption of this guidance did not have a material impact on the Company’s financial condition or results of operations.

In August 2020, the FASB issued ASU 2020-06, which simplifies the guidance on accounting for convertible debt instruments by removing the separation models for: (1) convertible debt with a cash conversion feature; and (2) convertible instruments with a beneficial conversion feature. As a result, the Company will not separately present in equity an embedded conversion feature in such debt. Instead, we will account for a convertible debt instrument wholly as debt, unless certain other conditions are met. We expect the elimination of these models will reduce reported interest expense and increase reported net income for the Company’s convertible instruments falling under the scope of those models before the adoption of ASU 2020-06. Also, ASU 2020-06 requires the application of the if-converted method for calculating diluted earnings per share and the treasury stock method will be no longer available. The provisions of ASU 2020-06 are applicable for fiscal years beginning after December 15, 2021, with early adoption permitted no earlier than fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its financial statements.

In August 2018, the FASB issued Accounting Standards Update (“ASU”) 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement” (“ASU 2018-13”). ASU 2018-13 removes certain disclosure requirements, including the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, the policy for timing of transfers between levels, and the valuation processes for Level 3 fair value measurements. ASU 2018-13 also adds disclosure requirements, including changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements, and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The amendments on changes in unrealized gains and losses, and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. This guidance was effective for the Company in the first fiscal quarter of 2020. The adoption of this standard did not have a material impact on the Company’s financial statements and related disclosures.

There are various other updates recently issued, most of which represented technical corrections to the accounting literature or application to specific industries and are not expected to a have a material impact on the Company’s financial position, results of operations or cash flows.

12

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

NOTE 4 — PROPERTY AND EQUIPMENT

Property and equipment as of September 30, 2020 and December 31, 2019 is summarized as follows:

	September 30, 2020			December 31, 2019
Furniture, fixtures and equipment	$	5,598		$	5,598
Computer equipment		1,809			1,809
Property and equipment, cost		7,407			7,407
Less: accumulated depreciation and amortization		(7,407	)		(7,407	)
Property and equipment, net	$	-		$	-

As a consequence of the Court Order (see Note 13 “Government Claim”), the Company resolved to divest itself of certain equipment and other assets (the “Equipment Assets”) used in connection with the Company’s human tissue banking business, but consistent however with the requirements of the Court Order, and to adjust the business plan and operations to accommodate this potential divesture. To facilitate the above, the Company entered into a Termination and Release Agreement and a Letter Agreement intended to divest itself of certain equipment and other assets underlying the related equipment lease transaction. In addition, on October 24, 2019, the Company entered into an Assignment and Assumption of Lease by and between the Company, American Cell Technology, LLC, and Sawgrass Business Plaza, LLC. Subsequently, the Company relocated to a new location within the same city and entered into a month-to-month lease. As part of the termination of the operating lease, the Company left certain property and equipment (all of which had been fully depreciated) at the old location.

In connection with the sale of the lab, medical and other equipment, the Company realized a gain on sale of equipment of $386,535.  The gain is recognized ratably over the term of the lease to operations. During the three and nine months ended September 30, 2020, the Company recognized $0 and $21,474, respectively; and $32,211 and $96,634 during the three and nine months ended September 30, 2019, respectively, as gain on sale of equipment.  As of September 30, 2020 and December 31, 2019, deferred gain on sale of equipment was $0 and $21,474, respectively.

Depreciation expense was $0 for the three and nine months ended September 30, 2020, respectively. Depreciation expense was $51,652 and $154,956, of which $51,652 and $154,956 was included in cost of sales, for the three and nine months ended September 30, 2019, respectively.

NOTE 5 — INVESTMENTS

U.S. Stem Cell Clinic, LLC

The investment in U.S. Stem Cell Clinic, LLC is comprised of a 49.9% (increased from 33.3% on January 29, 2019) member interest ownership and is accounted for using the equity method of accounting. The Company’s income (loss) earned by U.S. Stem Cell Clinic, LLC member interest was ($9,718) and ($23,539) for the three and nine months ended September 30, 2020, respectively; and ($51,514) and $51,514 for the three and nine months ended September 30, 2019, respectively (inception to date income of $599,921) and is included in other income (expense) in the accompanying Statements of Operations.  In addition, during the nine months ended September 30, 2020 and 2019, the Company received distributions totaling $0 and $64,870, respectively, from U.S. Stem Cell Clinic, LLC (inception to date of $663,870).  The carrying value of the investment at September 30, 2020 and December 31, 2019 is $0 and $23,539, respectively (See also Note 16; In March, 2021, the Company divested its entire interest in U.S. Stem Cell Clinic, LLC).

At September 30, 2020 and December 31, 2019, accounts receivable for sales of product and services to U.S. Stem Cell Clinic, LLC was $28,763. Revenues earned from sales to U.S. Stem Clinic, LLC for the three and nine months ended September 30, 2020 were $0 and $1,441, respectively; and $33,614 and $329,003 for the three and nine months ended September 30, 2019, respectively.

In January 2019, a member of U.S. Stem Cell Clinic, LLC contributed 16.6% of his ownership interest to the Company increasing the Company’s member interest from 33.3% to 49.9%. The Company recorded the contribution to equity of $4,435.

An affiliate of one of the Company’s officers is a minority investor in the U.S. Stem Cell Clinic, LLC.

13

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

Regenerative Wellness Clinic, LLC

The investment in Regenerative Wellness Clinic, LLC is comprised of a 49.9% (increased from 33.3% on January 29, 2019) member interest ownership and is accounted for using the equity method of accounting. The Company has provided technical expertise, but no cash investment with Regenerative Wellness Clinic, LLC’s startup in 2017. The Company’s income earned by Regenerative Wellness Clinic, LLC member interest was $0 for the three and nine months ended September 30, 2020; and ($2,910) and $69,345 for the three and nine months ended September 30, 2019, respectively (inception to date income of $113,047) and is included in other income (expense) in the accompanying Statements of Operations. In addition, during the nine months ended September 30, 2020 and 2019, the Company received distributions totaling $0 and $101,963, respectively, from Regenerative Wellness Clinic, LLC (inception to date of $101,963). The carrying value of the investment at September 30, 2020 and December 31, 2019 is $0. In October 2019, the Company divested its entire interest in U.S. Stem Cell Clinic, LLC.

At December 31, 2019, accounts receivable for sales of products and services to Regenerative Wellness Clinic, LLC was $0. Revenues earned from sales to Regenerative Wellness Clinic, LLC for the three and nine months ended September 30, 2019 was $16,637 and $132,984, respectively.

In January 2019, a member of Regenerative Wellness Clinic, LLC contributed 16.6% of his ownership interest to the Company increasing the Company’s member interest from 33.3% to 49.9%. The Company recorded the contribution to equity of $10,830.

An affiliate of one of the Company’s officers is an investor in the Regenerative Wellness Clinic, LLC.

U.S. Stem Cell of the Villages LLC

On January 30, 2018, Greg Knutson, a director of the Company (“Knutson”) and the Company agreed to open and operate a regenerative medicine/cell therapy clinic providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases in Florida.  To that end, U.S. Stem Cell Clinic of The Villages LLC (the “LLC”) was formed January 30, 2018. Knutson provided the Company with the sum of Three Hundred Thousand Dollars ($300,000) (the “Investment”) to be utilized for the formation and initial operation of the LLC.  Currently, Knutson holds a 51% member interest in the LLC and the Company holds a 49% member interest. The Company will provide operating assistance as well as management services, the latter to be compensated at fee of five percent (5%) of the LLC gross revenues.

As of December 31, 2018, upon completion of U.S. Stem Cell of the Villages LLC, the Company received $189,909 from Greg Knutson, the holder of the 51% member interest. Accordingly, this was recognized as additional paid-in capital. Subsequently, the Company contributed $86,750 as its initial investment in the U.S. Stem Cell of the Villages, LLC. The Company’s 49% income (loss) incurred by U.S. Stem Cell of the Villages LLC member interest was $0 for the three and nine months ended September 30, 2020; and ($9,931) and ($27,081) for the three and nine months ended September 30, 2019, respectively (inception to date loss of $23,050) and is included in other income (expense) in the accompanying Statements of Operations. In addition, during the nine months ended September 30, 2020 and 2019, the Company received distributions totaling $0 from U.S. Stem Cell of the Villages LLC. The carrying value of the investment at September 30, 2020 and December 31, 2019 was $0.

At September 30, 2020 and December 31, 2019, accounts receivable for sales of products and services to U.S. Stem Cell of the Villages LLC was $0. Revenues earned from sales to U.S. Stem Cell of the Villages LLC for the three and nine months ended September 30, 2020 was $0, respectively; and $9,975 and $140,328 for the three and nine months ended September 30, 2019, respectively.

During the three and nine months ended September 30, 2020, the Company received $0; and $975 and $50,751 for the three and nine months ended September 30, 2019, respectively, in management fees from the LLC.

As of the date of this filing, US Stem Cell Clinic of the Villages, LLC is currently dormant.

NOTE 6 — RIGHT TO USE ASSETS AND LEASE LIABILITY

The Company leased its headquarters in Sunrise, Florida which consisted of 4,860 square feet of space at a rate of approximately $82,620 per year. On February 4, 2016, the Company extended its facility lease to extend the term of the lease until August 31, 2019 at a monthly base rent of $7,306 plus a pro rata share of landlord’s operating expenses. Effective September 1, 2019, the Company entered into a second amendment to extend the lease through August 31, 2024 with base rent beginning at $87,674 per year and escalating to $98,678 per year plus a pro rata share of the landlord’s operating expenses.

14

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

On September 1, 2019, the lease commencement date, the Company estimated the lease liability and the right of use assets at present value using the Company’s estimated incremental borrowing rate of 8% and determined their initial present values, at inception, of $383,351. In determining the length of the lease term to its long-term lease, the Company determined there was not an option to extend the lease.

In determining the length of the lease term for this long-term lease, the Company determined there was not an option to extend the lease. At lease commencement date, the Company estimated the lease liability and the right of use assets at present value using the Company’s estimated incremental borrowing rate of 8% and determined the initial present value, at inception, of $274,180. On January 1, 2019, upon adoption of ASC Topic 842, the Company recorded right to use assets of $56,734 and lease liability of $56,734.

On October 24, 2019, the Company entered into an Assignment and Assumption of Lease by and between the Company, American Cell Technology, LLC, and Sawgrass Business Plaza, LLC. Subsequently, the Company relocated to a new location within the same city and entered into a month-to-month lease. Accordingly, the right of use assets and lease liabilities were eliminated.

During the three and nine months ended September 30, 2020 and 2019, lease expense was comprised of the following:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2020		2019		2020		2019
Operating lease expense	$	1,689	$	34,560	$	3,891	$	105,200
Variable lease expense		-		-		-		685
Total lease expense	$	1,689	$	34,560	$	3,891	$	105,885

NOTE 7 — ACCRUED EXPENSES

Accrued expenses consisted of the following as of September 30, 2020 and December 31, 2019:   

	September 30, 2020		December 31, 2019
Interest and fees payable to the Guarantors of the Company’s loan agreement with Seaside Bank	$	522,746	$	456,190
Accrued interest payable		777,937		580,204
Vendor accruals and other		79,138		79,132
Accrued expenses and other current liabilities	$	1,379,821	$	1,115,526

During the nine months ended September 30, 2020, the Company issued 1,445,647 shares of its common stock, having a fair value of $11,565, in lieu of payment in cash of accrued and unpaid interest of $9,145, resulting in a loss on settlement of $2,420.

NOTE 8 — NOTES PAYABLE

Notes payable were comprised of the following as of September 30, 2020 and December 31, 2019:

	September 30, 2020			December 31, 2019
Seaside Bank note payable	$	980,000		$	980,000
Hunton & Williams note payable		387,500			391,000
Weider note payable		453,493			482,939
Mallard note payable		243,250			250,000
EIDL note payable		150,000			-
Total notes payable		2,214,243			2,103,939
Less unamortized debt discount		(43,592	)		(50,448	)
Total notes payable net of unamortized debt discount		2,170,651			2,053,491
Less current portion		(1,400,910	)		(1,297,477	)
Long-term portion	$	769,741		$	756,014

15

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

Seaside Bank

On October 25, 2010, the Company entered into a Loan Agreement with Seaside National Bank and Trust for a $980,000 loan at 4.25% per annum interest that was used to refinance the Company’s loan with Bank of America. The obligation is guaranteed by certain stockholders of the Company. The Company renewed the loan with Seaside National Bank and Trust during the first quarter of 2018 to extend the maturity date to May 18, 2020. The Company renewed the loan with Seaside National Bank and Trust during the first quarter of 2020 to extend the maturity date to May 18, 2022.

Hunton & Williams

At December 31, 2016, the Company has two outstanding notes payable with interest at 8% per annum due at maturity. The two notes, $61,150 and $323,822, are payable in one balloon payment upon the date the Noteholder provides written demand, however the Company is not obligated to make payments until the Northstar Biotech Group, LLC (or successor) Loan is paid off.

On August 31, 2017, the Company and the noteholder entered into a Note Forbearance, Modification and Repayment Agreement (“Agreement”). The two notes, $61,150 and $323,822, were payable in one balloon payment upon the date of a written demand and upon certain triggering events occurring. The sum of unpaid principal and accumulated interest for both notes as of August 31, 2017 of $747,680 and an account payable of $40,596 result in an aggregate balance due of $788,276.

The noteholder agreed to accept full payment of their obligation over a four (4) year period in 48 monthly installments on an adjusted debt obligation in aggregate of $624,000 (reducing the outstanding balance), with such payments staggered in amounts such that the Company will pay $10,000 monthly the first year, $12,000 monthly the second year, $14,000 monthly the third year, and $16,000 monthly the final year.  In addition, the noteholder agreed to suspend accrual interest on the notes commencing September 1, 2017.

The Agreement remains in full force and effect provided the Company continues to make the monthly payments, there is no event of default as defined in the notes and an agreement to a subordination agreement by Northstar Biotech Group, LLC, which has been provided. In May 2019, the Company did not make the required scheduled payment. In September 2010, the noteholder agreed to waive their default rights under the agreement provided a minimum of $5,000 was paid by the end of 2019 and to reduce the required monthly payment to $500 per month commencing in January 2020. The Company satisfied the $5,000 payment requirement by the end of 2019 and commenced making the required $500 monthly payments in January 2020.

The Company imputed an interest rate of 5% and discounted the note accordingly. The imputed debt discount of $69,700 was amortized to interest expense using the effective interest method. For the three and nine months ended September 30, 2020, the Company amortized $0 debt discount; and $24,205 and $34,945 for the three and nine months ended September 30, 2019, respectively, of debt discount to interest expense. At September 30, 2020, the Company was in default and was renegotiating the payment structure. Thus, the remaining unamortized debt discount was charged to interest expense at September 30, 2020. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $387,500 and $391,000, respectively.

Weider

The Company, as one of the parties entered into a Settlement Agreement and General Release (the “Agreement”) dated June 3, 2019 related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year 5.25% unsecured promissory note, dated June 15, 2019, in the principal amount of $500,000, payable in monthly increments of $5,000 per month, with a final balloon payment due on June 15, 2024. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $453,493 and $482,939, respectively.

Mallard

The Company, as one of the parties entered into a Settlement Agreement and General Release (the “Agreement”) dated December 6, 2019 related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year non-interest bearing unsecured promissory note, dated December 6, 2019, in the principal amount of $250,000, payable in monthly increments of $750 per month, with a final balloon payment of $205,000 due on January 1, 2025. The Company imputed an interest rate of 5% and discounted the note accordingly. The imputed debt discount of $51,063 is being amortized to interest expense using the effective interest method. For the three and nine months ended September 30, 2020, the Company amortized $2,328 and $6,857, respectively, of debt discount to interest expense. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $199,658 and $199,551, net of debt discount of $43,592 and $50,448, respectively.

16

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

Economic Injury Disaster Loan (EIDL)

On June 20, 2020, the Company executed the standard loan documents for an EIDL from the U.S. Small Business Administration in light of the impact of the COVID-19 pandemic on our business. Pursuant to that certain Loan Authorization and Agreement (the “SBA Loan Agreement”), the principal amount of the EIDL received was $150,000, with proceeds to be used for working capital purposes. Interest accrues at the rate of 3.75% per annum. Installment payments, including principal and interest, are due monthly beginning June 20, 2021 (twelve months from the date of the SBA Loan Agreement) in the amount of $731. The balance of principal and interest is payable thirty years from the date of the SBA Loan Agreement. As of September 30, 2020, the remaining carrying value of the note was $150,000. At September 30, 2020, accrued interest on the note was $1,572, and is included in accrued expenses on the accompanying balance sheet.

NOTE 9 — PROMISSORY NOTE PAYABLE

On June 1, 2015, the Company issued an amended and restated promissory note of $1,697,762 in settlement of the $1,500,000 outstanding subordinated debt, related accrued interest of $373,469 and accumulated and unpaid guarantor fees of $624,737.

The note is unsecured and non-interest bearing and requires four semi-annual payments of $75,000 beginning on December 31, 2015 with the remaining unpaid balance due June 1, 2020.  On June 1, 2020, the Company defaulted on the promissory note. Upon default, the note became due in full and the Company began accruing interest at the default interest rate of 18%.

The Company imputed an interest rate of 5% and discounted the promissory note accordingly. The imputed debt discount of $368,615 was amortized to interest expense using the effective interest method. For the three and nine months ended September 30, 2020, the Company amortized $0 and $29,295, respectively of debt discount; and $17,616 and $52,273 for the three and nine months ended September 30, 2019, respectively, of debt discount to interest expense.  As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $1,397,762 and $1,368,467, net of debt discount of $0 and $29,296, respectively.

NOTE 10 — CONVERTIBLE NOTE PAYABLE

On February 5, 2020, the Company issued an unsecured convertible promissory note in the principal amount of $35,000 that matures on February 5, 2021 and bears interest at a rate of 5% per annum. The investor has the right to convert the outstanding balance of the note at any time into shares of common stock of the Company at a conversion price equal to a thirty percent (30%) discount of the average closing price of the Company’s common stock on the OTC Markets electronic exchange for the prior thirty (30) trading days prior to conversion, subject to adjustment. Upon the occurrence of an event of default, the investor may accelerate the note pursuant to which the outstanding balance will become, at the noteholder’s election, immediately due and payable. As a result of the beneficial conversion feature of the note, debt discount of $15,000 was recognized with a corresponding increase in additional paid-in capital. The debt discount is being amortized to interest expense using the effective interest method. For the three and nine months ended September 30, 2020, the Company amortized $3,777 and $8,779, respectively, of debt discount to interest expense.  As of September 30, 2020, the remaining carrying value of the note was $28,779, net of debt discount of $6,221. At September 30, 2020, accrued interest on the note was $1,141, and is included in accrued expenses on the accompanying balance sheet.

On September 8, 2020, the Company issued an unsecured convertible promissory note in the principal amount of $10,000 that is due on demand and bears interest at a rate of 5% per annum. The investor has the right to convert the outstanding balance of the note at any time into shares of common stock of the Company at a conversion price of $0.0467. Upon the occurrence of an event of default, the remaining principal and accrued interest become immediately due and payable, with interest accruing at 18% per annum on any unpaid amounts.  As of September 30, 2020, the remaining carrying value of the note was $10,000. At September 30, 2020, accrued interest on the note was $30, and is included in accrued expenses on the accompanying balance sheet.

NOTE 11 — RELATED PARTY TRANSACTIONS

Advances – Related Parties

As of September 30, 2020 and December 31, 2019, the Company’s officers and directors have provided advances that are unsecured, non-interest bearing and due on demand. During the nine months ended September 30, 2020 and 2019, the Company received aggregate proceeds from advances of $285,296 and $140,000, respectively. As of September 30, 2020 and December 31, 2019, the Company owed $797,040 and $511,744, respectively, for advances.

17

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

Notes Payable – Related Parties

Northstar Biotechnology Group, LLC

On February 29, 2012, a promissory note issued to BlueCrest Master Fund Limited (“BlueCrest”) was assigned to Northstar Biotechnology Group, LLC (“Northstar”), owned partly by certain directors and existing shareholders of the Company at the time, including Dr. William P. Murphy Jr., Dr. Samuel Ahn and Charles Hart. At the date of the assignment, the principal amount of the BlueCrest note was $544,267 (the “Note”).

On March 30, 2012, the Company and Northstar agreed to extend until May 1, 2012 the initial payment date for any and all required monthly under the Note, such that the first of the four monthly payments required under the Note will be due and payable on May 1, 2012 and all subsequent payments will be due on a monthly basis thereafter commencing on June 1, 2012, and to waive any and all defaults and/or events of default under the Note with respect to such payments. The Company did not make the required payment, and as a result, was in default of the revised agreement. The Company renegotiated the terms of the Note and Northstar agreed to suspend the requirement of principal payments by the Company and allow payment of interest-only in common stock.

On September 21, 2012, the Company issued 5,000 common stock purchase warrants to Northstar that was treated as additional interest expense upon issuance.

On October 1, 2012, the Company and Northstar entered into a limited waiver and forbearance agreement providing a recapitalized new note balance comprised of all sums due Northstar with a maturity date extended perpetually. The Company agreed to issue 5,000,000 shares of Series A Convertible Preferred Stock and 10,000 shares of common stock in exchange for $210,000 as payment towards outstanding debt, default interest, penalties, professional fees outstanding and due Northstar. In addition, the Company executed a security agreement granting Northstar a lien on all patents, patent applications, trademarks, service marks, copyrights and intellectual property rights of any nature, as well as the results of all clinical trials, know-how for preparing Myoblasts, old and new clinical data, existing approved trials, all right and title to Myoblasts, clinical trial protocols and other property rights.

In addition, the Company granted Northstar a perpetual license on products as described for resale, relicensing, and commercialization outside the United States. In connection with the granted license, Northstar shall pay the Company a royalty of up to 8% on revenues generated.

Effective October 1, 2012, the interest rate was 12.85% per annum. The parties agreed, as of February 28, 2013, to reduce the interest rate to 7% per annum.

In connection with the consideration paid, Northstar waived, from the effective date through the earlier of termination or expiration of the agreement, satisfaction of the obligations as described in the forbearance agreement.

In 2012, 5,000,000 shares of Series A Convertible Preferred Stock were approved to be issued, which was subsequently increased to 20,000,000 shares of preferred stock as Series A Convertible Preferred Stock. In addition, the Company was obligated to issue additional preferred stock equal in lieu of payment of cash of accrued and unpaid interest on each six-month anniversary of the effective date (October 1, 2012). In lieu of the initial two payments in preferred stock, the parties agreed to modify the voting rights of the subsequently cancelled Series A Convertible Preferred Stock from 20 votes per share on matters to be voted on by the common stockholders to 25 votes per share on matters to be voted on by the common stockholders and all prior and subsequent payments of interest will be in common stock. The Company is required to issue additional shares of its common stock (as amended), in lieu of cash, each six-month anniversary of the effective date for any accrued and unpaid interest.

On September 30, 2013, the Company issued 8,772 shares of its common stock as payment of $100,000 towards principal.

On December 24, 2013, the Company issued 3,916 shares of its common stock as payment of accrued interest through June 30, 2013 of $85,447.

On April 2, 2014, the Company issued 275 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,635 due April 1, 2014 per the forbearance agreement.

On September 17, 2014, the limited waiver and forbearance agreement entered into on October 1, 2012 to provide that the perpetual license on products as described for resale, relicensing and commercialization outside the United States was amended as such on the condition that Northstar provide certain financing, which financing the Company, in its sole discretion, could decline and retain the license.

18

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

On October 3, 2014, the Company issued 515 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2014 per the forbearance agreement.

On April 3, 2015, the Company issued 1,363 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,635 due April 1, 2015 per the forbearance agreement.

On October 2, 2015, the Company issued 4,156 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2015 per the forbearance agreement.

On October 7, 2015, the Company issued 34,522 shares of its common stock in settlement of $100,000 principal payment towards the outstanding debt.

On April 7, 2016, the Company issued 57,778 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due April 1, 2016 per the forbearance agreement.

On October 6, 2016, the Company issued 848,490 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2016 per the forbearance agreement.

On March 1, 2017, Northstar and the Company entered into a settlement agreement (“Settlement Agreement “) related to then pending litigation. Pursuant to the terms and conditions of the Settlement Agreement, Northstar converted its outstanding Series A Convertible preferred stock, into twenty million (20,000,000) shares of common stock according to the original conversion terms. In addition, and separate and apart from the conversion, Northstar received eleven million (11,000,000) shares of the Company’s common stock. Northstar will receive ten percent (10%) of all Company international sales (based on a gross sales basis). There was no effect of the 10% obligation as there were no international sales in 2017 or through 2019. Furthermore, a Northstar designee, Greg Knutson, was appointed as a member of the Board of Directors of the Company and two Company directors, Michael Tomas and Kristin Comella, each exercised their prior Northstar options to each receive a five percent (5%) member interest in Northstar.  The parties agreed to a mutual release and Northstar agreed to terminate any UCC lien on the Company assets previously filed for the benefit of Northstar. On March 9, 2017 and April 1, 2017, the Company issued 30,000,000 and 1,000,000 shares of its common stock, respectively, as described above. In connection with the settlement, the Company recorded a loss on litigation settlement of $316,800.

On April 1, 2017, the Company issued 286,315 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,703.

On October 2, 2017, the Company issued 559,187 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705.

On October 19, 2018, the Company issued 164,523 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $9,195.

On April 19, 2019, the Company issued 379,141 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $9,145.

On October 1, 2019, the Company issued 1,692,353 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $9,195.

On April 1, 2020, the Company issued 1,445,647 shares of its common stock, having a fair value of $11,565, in lieu of payment in cash of accrued and unpaid interest of $9,145, resulting in a loss on settlement of $2,420.

As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $262,000. At September 30, 2020 and December 31, 2019, accrued interest on the note was $13,323 and $8,700, respectively, and is included in accrued expenses on the accompanying balance sheet.

19

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

Notes Payable - Mr. Tomas, President and Chief Executive Officer

On August 7, 2017, the Company issued a $500,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due one year from date of issuance. During the nine months ended September 30, 2020 and 2019, the Company paid principal of $0 and $321,607, respectively, of this note. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $161,786.

On May 7, 2018, the Company issued a $500,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due six months from date of issuance. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $500,000.

On July 1, 2019, the Company issued a $500,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due November 7, 2019. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $500,000.

On December 31, 2019, the Company issued a $178,077 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due on demand. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $178,077.

On March 31, 2020, the Company issued a $187,500 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due on demand. As of September 30, 2020, the remaining carrying value of the note was $187,500.

On June 30, 2020, the Company issued a $187,500 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due on demand. As of September 30, 2020, the remaining carrying value of the note was $187,500.

On July 1, 2020, the Company issued a $500,000 promissory note as payment of an annual bonus awarded. The promissory note bears interest of 5% per annum and is due on demand. As of September 30, 2020, the remaining carrying value of the note was $500,000.

On September 30, 2020, the Company issued a $100,962 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due on demand. As of September 30, 2020, the remaining carrying value of the note was $100,962.

At September 30, 2020 and December 31, 2019, accrued interest on the notes was $453,282 and $389,695, respectively, and is included in accrued expenses on the accompanying balance sheet.

Notes Payable - Dr. Comella, former Chief Science Officer as of September 30, 2020.

On September 6, 2016, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due upon demand. During the nine months ended September 30, 2019, the Company received back $107,868 of principal amounts previously paid for this note. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $255,579.

On August 7, 2017, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due one year from date of issuance. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $300,000.

On May 7, 2018, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due six months from date of issuance. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $300,000.

On July 1, 2019, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due November 7, 2019. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $300,000.

20

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

At September 30, 2020 and December 31, 2019, accrued interest on the notes was $194,081 and $150,708, respectively, and is included in accrued expenses on the accompanying balance sheet.

Dr. Comella is no longer a member of the Board of Directors after September 1, 2019.

	September 30, 2020		December 31, 2019
Northstar	$	262,000	$	262,000
Note payable, Mr. Tomas		161,786		161,786
Note payable, Mr. Tomas		500,000		500,000
Note payable, Mr. Tomas		500,000		500,000
Note payable, Mr. Tomas		178,077		178,077
Note payable, Mr. Tomas		187,500		-
Note payable, Mr. Tomas		187,500		-
Note payable, Mr. Tomas		500,000		-
Note payable, Mr. Tomas		100,962		-
Note payable, Dr. Comella*		255,579		255,579
Note payable, Dr. Comella*		300,000		300,000
Note payable, Dr. Comella*		300,000		300,000
Note payable, Dr. Comella*		300,000		300,000
Total officer and director notes	$	3,733,404	$	2,757,442
* Dr. Comella is no longer a member of the Board of Directors effective September 1, 2019.

Other Transactions – Related Parties

Transactions with GACP

On March 3, 2017, the Company entered into an asset sale and lease agreement (sale/leaseback transaction, the “Asset Sale and Lease Agreement”) with General American Capital Partners (GACP), whereby the Company sold certain lab, medical and other equipment relating to the cell banking business for $400,000 and leased back the sold equipment over a three-year term. The Company determined that the transaction was a capitalized lease and accordingly recorded the leased assets and liabilities based on the estimated present value of the minimum lease payments. In connection with the Asset Sale and Lease Agreement, the Company is obligated to accrue 10% of cell-banking revenue as for marketing, offset by any incurred costs of the Company.  At September 30, 2020 and December 31, 2019, the outstanding accrued marketing obligation is $0.

On March 3, 2017, the Company also entered into a customer purchase agreement with GACP whereby the Company received a deposit $50,000 (included in long-term liabilities at December 31, 2018) in exchange for the sale of the first 5,000 future customers of the cell-banking business after the effective date of the agreement; GACP also had the right to purchase additional customers at a price of $20 per customer.  There is no reduction in the selling price should the new customers be fewer than 5,000.  The effective date of the sale is upon the expiry or early termination of the aforementioned Asset Sale and Lease Agreement.

March 3, 2017, the Company also entered into an asset purchase agreement of intellectual property with GACP whereby the Company received a deposit of $50,000 (included in long-term liabilities at December 31, 2018) for the sale of all of the Company’s worldwide rights, title or interest in certain intellectual and other property (as defined) associated with the cell-banking business. The effective date of the sale is upon the expiry or early termination of the aforementioned Asset Sale and Lease Agreement.

Effective May 9, 2018, pursuant to an Amendment to the Asset Sale and Lease Agreement, GACP suspended their obligation to open additional clinics (tolling such obligation to a mutually agreeable date in the future) and it has suspended the monthly aggregate number of stem cell kits set forth for purchase in a given month arising from such clinics.

21

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

As a consequence of the Court Order dated June 4, 2019 (see Note 13 “Government Claim”), the Company resolved to divest itself of certain equipment and other assets (the “Equipment Assets”) used in connection with the Company’s human tissue banking business, but consistent however with the requirements of the Court Order, and to adjust the business plan and operations to accommodate this potential divesture. To facilitate the above, the Company entered into the following agreements:

● Termination and Release Agreement by and between GACP, the Company, and Michael Tomas and Kristin Comella dated September 24, 2019 (terminating the Non-Competition and Non-Solicitation Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017).

● Letter Agreement on Stem Cell Processing and Storage by and between the Company and American Cell Technology, LLC

Effective October 9, 2019, the Company terminated the Asset Sale and Lease Agreement by and between the Company and GACP. Accordingly, the long-term deposit liabilities were written off, resulting in a gain on debt settlement of $100,000. In addition, the right of use assets and lease liabilities were also written off.

NOTE 12 — FAIR VALUE MEASUREMENT

The Company adopted the provisions of ASC 825-10. ASC 825-10 defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required or permitted to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and considers assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of non-performance. ASC 825-10 establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 825-10 establishes three levels of inputs that may be used to measure fair value:

● Level 1 – Quoted prices in active markets for identical assets or liabilities.

● Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities.

● Level 3 – Unobservable inputs to the valuation methodology that are significant to the measurement of fair value of assets or liabilities.

All items required to be recorded or measured on a recurring basis are based upon Level 3 inputs.

To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is disclosed and is determined based on the lowest level input that is significant to the fair value measurement.

As of September 30, 2020 and December 31, 2019, the Company did not have any items that would be classified as level 1, 2 or 3 disclosures.

As of September 30, 2020 and December 31, 2019, the Company did not have any derivative instruments that were designated as hedges.

22

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

NOTE 13 — COMMITMENTS AND CONTINGENCIES

Royalty Agreement / Middle East

On November 9, 2016, the Company entered into an Intellectual Property License Agreement whereby the Company granted High Rise Group Company the exclusive right to the Company’s intellectual property (as defined) for the licensed use and development in Kuwait and other GCC/Middle East countries for 25 years in exchange for a payment of $75,000 and a 5% royalty generated under the agreement.  The licensing agreement is recorded as deferred revenue and amortized over the term of the agreement.  The carrying balance as of September 30, 2020 and December 31, 2019 was $63,250 and $65,500, respectively.

The intent is for U.S. Stem Cell Middle East to offer regenerative treatment options to patients, based on U.S. Stem Cell, Inc. products and technologies like MyoCell™. To date, the first clinic in Kuwait City has been completed but has not begun operations as High Rising Group has not yet been able to secure regulatory approvals to operate.

Litigation

On December 12, 2017, a product liability lawsuit was filed in Broward County, specifically Jeannine Mallard v. U.S. Stem Cell, Inc., US Stem Cell Clinics LLC., Regenestem, LLC., Regenestem Network, LLC., and Kristin C. Comella. The Company will continue to defend it vigorously. On December 6, 2019, the Company was one of the parties to a Settlement Agreement and General Release (the “Agreement”) related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year non-interest bearing unsecured promissory note, dated December 6, 2019, in the principal amount of $250,000, payable in monthly increments of $750 per month, with a final balloon payment of $205,000 due on January 1, 2025 (see Note 8, “Mallard”).

On September 17, 2015, a product liability lawsuit was filed in Broward County, specifically Patsy Bade v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D., and on November 30, 2015, a product liability lawsuit was filed in Broward County, specifically Elizabeth Noble v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D. During the year ended December 31, 2016, both matters settled by the Company’s insurance policy with no additional cost to the Company, except for the obligation to pay the insurance company deductible of $100,000, of which $11,000 was paid in fiscal 2017. The remaining amount due under this settlement is $28,850 and $30,050 as of September 30, 2020 and December 31, 2019, respectively, and is included in accounts payable.

On June 3, 2019, the Company was one of the parties to a Settlement Agreement and General Release (the “Agreement”) related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year 5.25% Promissory Note, dated June 15, 2019, in the principal amount of Five Hundred Thousand Dollars ($500,000), payable in monthly increments of Five Thousand ($5,000) per month (see Note 8, “Weider”).

The Company is subject at times to other legal proceedings and claims, which arise in the ordinary course of its business.  Although occasional adverse decisions or settlements may occur, the Company believes that the final disposition of such matters should not have a material adverse effect on its financial position, results of operations or liquidity.  There was no outstanding litigation as of September 30, 2020 other than that described above.

Government Claim

On May 9, 2018, the U.S. Department of Justice filed an injunctive action, specifically United States of America v. U.S. Stem Clinic, LLC, U.S. Stem Cell, Inc., Kristin C. Comella, and Theodore Gradel. The Complaint alleges, among other matters that the defendants manufacture “stromal vascular fraction” (SVF) products from patient adipose (fat) tissue, which the companies then market as stem cell-based treatments, and which U.S. Stem Cell Clinic, LLC administers to patients, without first obtaining what the government alleges are necessary FDA approvals. Although Theodore Gradel was initially listed as a defendant, he subsequently entered into a consent agreement and is no longer party to this case.

23

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

The U.S. and the defendants filed cross motions for summary judgment, each asking for a ruling in its favor. On June 3, 2019, the Court entered an order granting Summary Judgment for the government and denying the defendants’ motion for summary judgment. The order focused on the defendants’ actions in providing and marketing SVF therapy. In an order dated June 4, 2019, the Court granted the defendants’ request to allow it the opportunity to work out the language of the form of injunction with the government, and if unsuccessful, to provide a status report to the Court by June 14, 2019, outlining areas of disagreement. The Court further ordered that the defendants (U.S. Stem Clinic, LLC, U.S. Stem Cell, Inc., and Kristin C. Comella) ‘not sell, provide or otherwise engage in any SVF therapy or any other activities to be regulated by the FDA as explained in the Court’s Order on the Parties’ Motions for Summary Judgment.” On June 25, 2019, the Court entered an Order of Permanent Injunction, generally enjoining the defendants with respect to the SVF Product and requiring other actions. The Company filed an appeal on August 23, 2019 and attended oral argument on January 13, 2021.  On June 2, 2021, the Eleventh Circuit Court ruled to affirm lower courts’ judgement. The Company did not challenge the district court’s judgment upon any other ground.

The Company, in divesting certain equipment and other assets and assigning its lease, has and will continue to experience a decrease in revenues as the Company both maintains the remainder of the business and transitions into similar or unrelated business opportunities as determined by management. However, management is not able to predict the duration, scope, results, or consequences of the  summary judgment and any transition of the business plan.

Since the Court’s issuance of the Order of Permanent Injunction, the Company has received demand letters for compensation from persons who store their SVF Product and/or other tissue product with the tissue bank (several of the persons have requested refunds of the monies paid to the tissue bank and one person has requested a full refund of monies paid to an altogether separate company due to her not receiving the full amount of treatments she requested; such requests for compensation, to date, have not been material) and requests that the Company preserve cells in the Company’s possession.  The Company sought guidance from the Court, which entered an order generally staying the requirement to destroy any SVF Product, pending a decision on the Company’s appeal. 

NOTE 14 — STOCKHOLDERS’ DEFICIT

Common Stock

During the nine months ended September 30, 2020, the Company issued an aggregate of 6,532,248 shares of its common stock, having a fair value of $32,803, in settlement of outstanding accounts payable. In connection with the issuances, the Company incurred a $2,697 net gain on settlement.

During the nine months ended September 30, 2020, the Company issued 1,445,647 shares of its common stock, having a fair value of $11,565, in lieu of payment in cash of accrued and unpaid interest of $9,145, resulting in a loss on settlement of $2,420.

During the nine months ended September 30, 2020, the Company issued an aggregate of 4,000,000 shares of its common stock, having a fair value of $16,000, for services.

Stock Options

On April 1, 2013, the Board of Directors approved, subject to subsequently received stockholder approval, the establishment of the Bioheart 2013 Omnibus Equity Compensation Plan, or the “2013 Omnibus Plan” (replacing the 1999 Officers and Employees Stock Option Plan, or the Employee Plan, and the 1999 Directors and Consultants Stock Option Plan). The 2013 Omnibus Plan initially reserved up to fifty thousand (50,000) shares of common stock for issuance. On August 4, 2014, the Board of Directors approved to set the reserve to one hundred thousand (100,000) shares of common stock for issuance and to close the 1999 Officers and Employees Stock Option Plan. On February 2, 2015, at the annual meeting of stockholders, the 2013 Omnibus Equity Compensation Plan was approved.

On November 2, 2015, the Company increased the shares reserved under the 2013 Omnibus Plan to five hundred million (500,000,000) shares of common stock for issuance. Effective September 16, 2016, the Company approved an additional twenty five million (25,000,000) shares of common stock to the reserve; effective April 21, 2017, the Company approved an additional twenty five million (25,000,000) shares of common stock to the reserve; effective August 7, 2017, the Company approved an additional thirty million (30,000,000) shares of common stock to the reserve; and effective May 7, 2018, the Company approved an addition of one hundred million (100,000,000) shares of common stock to reserve.

24

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

A summary of the stock option activity for the nine months ended September 30, 2020 is as follows:

				Weighted		Weighted
				Average		Average
	Number of			Exercise		Remaining Life		Intrinsic
	Options			Price		In Years		Value
Outstanding, December 31, 2019		111,120,474		$	0.0247		8.3	$	-
Granted		-
Exercised		-
Forfeited/Expired		(560	)	$	0.1540
Outstanding, September 30, 2020		111,119,914		$	0.0247		7.8	$	-
Exercisable, September 30, 2020		75,737,414		$	0.0255		7.2	$	-

Options Outstanding							Options Exercisable
			Weighted		Weighted				Weighted
	Outstanding		Average		Average		Exercisable		Average
Exercise	Number of		Exercise		Remaining Life		Number of		Exercise
Price	Options		Price		In Years		Options		Price
$0.004 to $0.010		41,900,000	$	0.0051		8.3		21,650,000	$	0.0049
$0.011 to $0.020		16,300,000	$	0.0196		6.0		16,300,000	$	0.0196
$0.021 to $0.030		9,710,000	$	0.0253		8.1		8,605,000	$	0.0252
$0.0363		22,735,000	$	0.0363		6.9		18,707,500	$	0.0363
$0.0536		20,000,000	$	0.0536		7.6		10,000,000	$	0.0536
$0.1540		474,914	$	0.1540		5.0		474,914	$	0.1540
		111,119,914	$	0.0247		7.5		75,737,414	$	0.0255

The aggregate intrinsic value of outstanding stock options was $0, based on options with an exercise price less than the Company’s stock price of $0.0043 as of September 30, 2020, which would have been received by the option holders had those option holders exercised their options as of that date.

The fair value of all options that vested during the nine months ended September 30, 2020 and 2019 was $525,336 and $512,882, respectively. As of September 30, 2020, the Company had $890,216 of total unrecognized compensation cost related to non-vested awards granted under the 2013 Omnibus Plan, which the Company expects to recognize over a weighted average period of 0.92 years.

Warrants

A summary of the warrant activity for the nine months ended September 30, 2020 is as follows:

					Weighted
			Weighted		Average
			Average		Remaining
	Number of		Exercise		Life		Intrinsic
	Warrants		Price		In Years		Value
Outstanding, December 31, 2019		1,110,468	$	12.8400		8.2	$	-
Granted		-
Exercised		-
Expired		-
Outstanding, September 30, 2020		1,110,468	$	12.84		7.4	$	-
Exercisable, September 30, 2020		1,108,923	$	2.14		7.4	$	-

25

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

Warrants Outstanding							Warrants Exercisable
			Weighted		Weighted				Weighted
	Outstanding		Average		Average		Exercisable		Average
Exercise	Number of		Exercise		Remaining Life		Number of		Exercise
Price	Warrants		Price		In Years		Warants		Price
$0.03 to $20.00		1,086,536	$	1.27		7.5		1,086,536	$	1.27
$20.01 to $30.00		19,543	$	25.06		3.4		19,543	$	25.06
$40.01 to $50.00		2,253	$	48.83		2.0		2,253	$	48.83
$50.01 to $60.00		543	$	60.00		0.8		543	$	60.00
>$60.00		1,593	$	7,690.00		6.1		48	$	7,690.00
		1,110,468	$	12.84		7.4		1,108,923	$	2.14

The aggregate intrinsic value of the issued and exercisable warrants of $0 represents the total pretax intrinsic value, based on warrants with an exercise price less than the Company’s stock price of $0.0043 as of September 30, 2020, which would have been received by the warrant holders had those warrants holders exercised their warrants as of that date.

NOTE 15 — CONCENTRATIONS

Concentrations of Credit Risk

The Company’s financial instruments that are exposed to a concentration of credit risk are cash and accounts receivable. Generally, the Company’s cash and cash equivalents in interest-bearing accounts does not exceed FDIC insurance limits. The financial stability of these institutions is periodically reviewed by senior management.

Concentrations of Revenues

For the three and nine months ended September 30, 2020 and 2019, the following customers accounted for more than 10% of the Company’s net revenues:

	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2020			2019			2020			2019
Customer 1		24	%		-			15	%		-
Customer 2		15	%		-			-			-
Customer 3		14	%		-			-			-
Customer 4		-			-			13	%		-
Customer 5		-			27	%		-			12	%
Customer 6		-			22	%		-			-
Totals		53	%		49	%		28	%		12	%

Customer 5 is U.S. Stem Cell Clinic, LLC, a related party, a partly owned investment in which the Company holds a 49.9% member interest.

Concentrations of Accounts Receivable

As of September 30, 2020 and December 31, 2019, the following customers represented more than 10% of the Company’s accounts receivable:

	September 30, 2020			December 31, 2019
Customer 1		83	%		47	%
Customer 2		-			47	%
Totals		83	%		94	%

26

U.S. STEM CELL, INC.

NOTES TO FINANCIAL STATEMENTS

SEPTEMBER 30, 2020

Customer 1 is U.S. Stem Cell Clinic, LLC, a related party, a partly owned investment in which the Company holds a 49.9% member interest.

NOTE 16 — SUBSEQUENT EVENTS

In March 2021, the Company divested its entire interest in U.S. Stem Cell Clinic, LLC.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Unless otherwise indicated, references in this Quarterly Report on Form 10-Q to “we,” “us,” and “our” are to the Company, unless the context requires otherwise. The following discussion and analysis by our management of our financial condition and results of operations should be read in conjunction with our unaudited condensed interim financial statements and the accompanying related notes included in this quarterly report and our audited financial statements and related notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission.

Cautionary Statement Regarding Forward-Looking Statements

This report may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we intend that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors.” Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities and the effects of regulation. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions.

This report may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we intend that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors.” Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities and the effects of regulation. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We discuss many of these risks in greater detail in “Risk Factors.” Risk factors include, but are not limited to, the economic effects of the pandemic, the promptness of distribution of vaccines, domestically and internationally to limit the impact of COVID-19, and the short and long term economic impact of COVID-19 on the marketplace. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this report. You should read this report and the documents that we reference in this report and have filed as exhibits to the report completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

Additional information concerning these, and other risks and uncertainties is contained in our filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2019.

Unless otherwise indicated or the context otherwise requires, all references in this Form 10-Q to “we,” “us,” “our,” “our company,” “U. S. Stem Cell, Inc.” or the “Company” refer to U.S. Stem Cell, Inc. and its subsidiaries.

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Our Ability to Continue as a Going Concern

Our independent registered public accounting firm has issued its report dated March 13, 2020, in connection with the audit of our annual financial statements as of December 31, 2019, that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern and Note 2 to the unaudited financial statements for the period ended September 30, 2020 also describes the existence of conditions that raise substantial doubt about our ability to continue as a going concern.

Overview

We are an enterprise in the regenerative medicine/cellular therapy industry. Our prior focus was on the discovery, development, and commercialization of cell based therapeutics. Our business included the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine/cell therapy training services,

US Stem Cell Training, Inc. (“SCT”), an operating division of our company, is a content developer of regenerative medicine/cell therapy informational and training materials for physicians and patients. SCT also provides in-person and online training courses which are delivered through in-person presentations at SCT’s state of the art facilities and globally at university, hospital and physician’s office locations as well as through online webinars. Additionally, SCT provides hands-on clinical application training for physicians and health care professionals interested in providing regenerative medicine / cell therapy procedures.

Vet biologics, (“VBI”), an operating division of our company, is a veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the highest quality regenerative medicine therapies to dogs, cats and horses. VBI provides veterinarians with extensive regenerative medicine capabilities including the ability to isolate regenerative stem cells from a patient’s own adipose (fat) tissue directly on-site within their own clinic or stall-side.

During fiscal 2019, we had interests in US Stem Cell Clinic, LLC, (“SCC”), Regenerative Wellness Clinic, LLC, and US Stem Cell Clinic of the Villages, LLC as partially owned investments of our company (in which we had a 49.9%, 49.9% and 49% respectively member interests), which were physician run regenerative medicine/cell therapy clinics providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases. During the last quarter of 2019 (and in early 2021 in the case of SCC), we divested ourselves of our Member Interests in SCC and Regenerative Wellness Clinic, LLC, while US Stem Cell Clinic of the Villages, LLC is currently dormant.

Our comprehensive map of products and services:

As of September 30, 2020:

As of the date of this filing:

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Our mission is to advance to market novel regenerative medicine and cellular therapy products that substantially benefit humankind. Our business strategy is, to the extent possible, finance our clinical development pipeline through revenue (cash in-flows) generated through the marketing and sales of unique educational and training services, animal health products and personalized cellular therapeutic treatments.. Accordingly, we have developed a multifaceted portfolio of revenue generating products and services in our US Stem Cell Training, Vetbiologics, operating divisions that will, if successful, financially support its clinical development programs. Our goal is to maximize shareholder value through the generation of short-term profits that increase cash in-flows and decrease the need for venture financings – a modern biotechnology company development strategy.

Today, our company is a combination of opportunistic business enterprises. What we are establishing is a foundation of value in the products and services we are and plan to sell from US Stem Cell Training and Vetbiologics. Our strategy is to expand the revenues generated from each of these operating divisions and to reinvest the profits we generate into our clinical development pipeline.

On November 9, 2016, we executed a Commercial Agency Agreement with High Rising Group Company (General Trading and Construction) and subsequently, on February 10,  2017, we authorized High Rising Group Company as an independent contractor and Licensee for our company for the territories of Kuwait and the Middle East (expressly excluding prohibited countries pursuant to the Patriot Act and The Iran Threat Reduction and Syria Human Rights Act of 2012). The intent of the agreement is for High Rising Group Company to establish clinics specializing in regenerative medicine, stem cell treatment and therapy, including stem cell bank, training, and all related stem cell machines and equipment.  To date, the first clinic in Kuwait City has been completed but has not begun operations as High Rising Group has not yet been able to secure regulatory approvals to operate. With the ongoing construction of the The Sheikha Salwa Sabah Al-Ahmad Center for Stem Cell and Umbilical Cord, a public/private partnership with the government of Kuwait, (see http://news.kuwaittimes.net/website/stem-cell-center-epitomizes-ppp which is expressly not incorporated by reference to this filing), management hopes (but cannot guarantee) that private sector stem cell centers, as described above, will get regulatory approval.

On March 3, 2017, we entered into an asset sale and lease agreement (sale/leaseback transaction; “Asset Sale and Lease Agreement”), with GACP (General American Capital Partners) Stem Cell Bank LLC, a Florida limited liability company (“GACP) whereby we sold certain lab, medical and other equipment relating to the cell banking business for $400,000 and leased back the sold equipment over a three year term.  The lease includes a base monthly rental payment of $20,000, due the first day of each calendar month.  In addition, we are required to pay 2.3%, 22.5% and 31.6% of revenues collected on deposits arising from cell banking business for years 1, 2 and 3, respectively.  At the expiration of the lease, we returned all leased equipment and along with any maintenance records, logs, etc. in our  possession to the lessor with no right of repurchase. Further, as a consequence of the Court Order , the Company resolved to divest itself of certain equipment and other assets (the “Equipment Assets”) used in connection with the Company’s human tissue banking business, but consistent however with the requirements of the Court Order, and to adjust the business plan and operations to accommodate this potential divesture. The divestiture became effective October 10^th, 2019.

We will continue to evaluate and act upon opportunities to increase our top line revenue position and that correspondingly increase cash in-flows. These opportunities include but are not limited to the development and marketing of new products and services, mergers and acquisitions, joint ventures, licensing deals and more.

Further, if the opportunity presents itself whereby we can raise additional capital at a reasonable fair market value, our management will do so. Accordingly, we plan to continue in our efforts to restructure, equitize or eliminate legacy balance sheet issues that are obstacles to market capitalization appreciation and capital fund raising.

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Results of Operations Overview

We are a research and development company and our product candidates have not received regulatory approval or generated any material revenues and is not expected generate revenues until commercialization, if ever. We have generated substantial net losses and negative cash flow from operations since inception and anticipate incurring significant net losses and negative cash flows from operations for the foreseeable future as we continue clinical trials, undertake new clinical trials, apply for regulatory approvals, make capital expenditures, add information systems and personnel, make payments pursuant to our license agreements upon our achievement of certain milestones, continue development of additional product candidates using our technology, establish sales and marketing capabilities and incur the additional cost of operating as a public company. In addition, and as a result of the Court Order (see Note 13), we resolved to divest our company of certain equipment and other assets which will substantially reduce our ability to generate revenues until such time as alternative revenue producing materialize as well as assign our lease.

Three Months Ended September 30, 2020 as compared to the Three Months Ended September 30, 2019

Revenues

We recognized revenues of $64,647 for the three months ended September 30, 2020. These revenues were generated from the sales of laboratory supplies and equipment, and services. We recognized revenues of $156,591 for the three months ended September 30, 2019 from the sale of MyoCath catheters, physician training, patient studies and laboratory services. Due to the Injunction, as described in our Note 13 to our financial statements, our revenue for 2020 has been severely reduced.

Cost of Sales

Cost of sales consists of the costs associated with the production of MyoCath, laboratory supplies necessary for laboratory services, and physician course materials.

Cost of sales were $18,576 and $137,366 in in the three-month periods ended September 30, 2020 and 2019, respectively. Associated gross margins were $46,071 (28.7%) and $19,225 (87.2%) for the three months periods ended September 30, 2020 and 2019, respectively.

Research and Development

Our research and development expenses consist of costs incurred in identifying, developing, and testing, our products and services. Research and development expenses were $0 in the three-month period ended September 30, 2020, no change from the research and development expenses of $0 in the three-month period ended September 30, 2019. Current management focus is towards on sales in addition to research and development and its corresponding ongoing costs. The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing.

Marketing, General and Administrative

Our marketing, general and administrative costs were $1,039,352 for the three-month period ended September 30, 2020 compared to $1,616,970 for the three-month period ended September 30, 2019, an decrease of $577,618. The decrease in costs are primarily due to reduction in operations due to the Court Order.

Our marketing, general and administrative expenses primarily consist of the costs associated with our general management and product and service marketing programs, including, but not limited to, salaries and related expenses for executive, administrative and marketing personnel, rent, insurance, legal and accounting fees, consulting fees, travel and entertainment expenses, conference costs and other clinical marketing and trade program expenses.

(Gain) Loss on settlement of debt

During the three months ended September 30, 2020, we incurred a net loss of $204 primarily related to accounts payable and debt restructured during the current period as compared to a net aggregate gain of $33,203 for the same period last year.

Gain on sale of equipment

In March 2017, we entered a sale/leaseback transaction whereby we sold our lab and other medical equipment and re-leased the equipment back for 36 months.  In connection with the sale/leaseback, we realized a gain on sale of equipment of $386,535, which we will recognize to operations over the term of the lease (36 months). During the three months ended September 30, 2020 and 2019, we recognized $0 and $32,211 in current period operations.

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Income from equity investment

Our investment of a 49.9% (33.3% in 2018) member interest ownership of U.S. Stem Cell Clinic, LLC and Regenerative Wellness Clinic as well as a 49% interest in U.S. Stem Cell Clinic of the Villages LLC are accounted for using the equity method of accounting.  As such, we report our pro rata share of income (loss) from equity investments for the period.  For the three months ended September 30, 2020 and 2019 our pro rata share of income (loss) was $(9,718) and $(33,478), respectively. We divested ourselves of our member interests in Regenerative Wellness Clinic, LLC and U.S. Stem Cell Clinic, LLC in October 2019 and March 2021, respectively. U.S. Stem Cell Clinic of the Villages, LLC is currently dormant.

Interest Expense

Interest expenses during the three months ended September 30, 2020 were $152,572 compared to $91,140 for the three months ended September 30, 2019. Interest expenses primarily consists of interest incurred on the principal amount of the Northstar loan, our former Bank of America loan, the Seaside National Bank loan, accrued fees and interest payable to the Guarantors, our capital lease and the amortization of debt discounts and non-cash interest incurred relating to our issued convertible notes payable.

Nine Months Ended September 30, 2020 as compared to the Nine Months Ended September 30, 2019

Revenues

We recognized revenues of $161,793 for the nine months ended September 30, 2020. These revenues were generated from the sales of laboratory supplies and equipment, and services. We recognized revenues of $2,763,385 for the nine months ended September 30, 2019 from the sale of MyoCath catheters, physician training, patient studies and laboratory services. Due to the Injunction, as described in our Note 13 to our financial statements, our revenue for 2020 has been severely reduced.

Cost of Sales

Cost of sales consists of the costs associated with the production of MyoCath, laboratory supplies necessary for laboratory services, and physician course materials.

Cost of sales were $53,550 and $1,165,459 in in the nine-month periods ended September 30, 2020 and 2019, respectively. Associated gross margins were $108,243 (66.9%) and $1,597,923 (57.8%) for the three months periods ended September 30, 2020 and 2019, respectively.

Research and Development

Our research and development expenses consist of costs incurred in identifying, developing, and testing, our products and services. Research and development expenses were $0 in the nine-month period ended September 30, 2020, a decrease of $263 from the research and development expenses of $263 in the nine-month period ended September 30, 2019. Current management focus is towards on sales in addition to research and development and its corresponding ongoing costs. The timing and amount of our planned research and development expenditures is dependent on our ability to obtain additional financing.

Marketing, General and Administrative

Our marketing, general and administrative costs were $2,068,245 for the nine-month period ended September 30, 2020 compared to $3,628,652 for the three-month period ended September 30, 2019, an decrease of $ 1,560,407. The decrease in costs are primarily due to reduction in operations due to the Court Order.

Our marketing, general and administrative expenses primarily consist of the costs associated with our general management and product and service marketing programs, including, but not limited to, salaries and related expenses for executive, administrative and marketing personnel, rent, insurance, legal and accounting fees, consulting fees, travel and entertainment expenses, conference costs and other clinical marketing and trade program expenses.

(Gain) Loss on settlement of debt

During the three months ended September 30, 2020, we incurred a net gain of $277 primarily related to accounts payable and debt restructured during the current period as compared to a net aggregate gain of $21,892 for the same period last year.

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Gain on sale of equipment

In March 2017, we entered a sale/leaseback transaction whereby we sold our lab and other medical equipment and re-leased the equipment back for 36 months.  In connection with the sale/leaseback, we realized a gain on sale of equipment of $386,535, which we will recognize to operations over the term of the lease (36 months). During the nine months ended September 30, 2020 and 2019, we recognized $21,474 and $96,634 in current period operations.

Income from equity investment

Our investment of a 49.9% (33.3% in 2018) member interest ownership of U.S. Stem Cell Clinic, LLC and Regenerative Wellness Clinic as well as a 49% interest in U.S. Stem Cell Clinic of the Villages LLC are accounted for using the equity method of accounting.  As such, we report our pro rata share of income (loss) from equity investments for the period.  For the nine months ended September 30, 2020 and 2019 our pro rata share of income (loss) was $(23,539) and $93,778, respectively. We divested ourselves of our member interests in Regenerative Wellness Clinic, LLC and U.S. Stem Cell Clinic, LLC in October 2019 and March 2021, respectively. U.S. Stem Cell Clinic of the Villages, LLC is currently dormant.

Interest Expense

Interest expenses during the nine months ended September 30, 2020 were $339,019 compared to $850,677 for the nine months ended September 30, 2019. Interest expenses primarily consists of interest incurred on the principal amount of the Northstar loan, our former Bank of America loan, the Seaside National Bank loan, accrued fees and interest payable to the Guarantors, our capital lease and the amortization of debt discounts and non-cash interest incurred relating to our issued convertible notes payable.

Stock-Based Compensation

Stock-based compensation reflects our recognition as an expense of the value of stock options and other equity instruments issued to our employees and non-employees over the vesting period of the options and other equity instruments. We have granted to our employee’s options to purchase shares of common stock at exercise prices equal to the fair market value of the underlying shares of common stock at the time of each grant, as determined by our Board of Directors, with input from management.

We follow Accounting Standards Codification subtopic 718-10. Compensation (“ASC 718-10”) which requires that all share-based payments to both employee and non-employees be recognized in the income statement based on their fair values.

In awarding our common stock, our Board of Directors considered a number of factors, including, but not limited to:

● our financial position and historical financial performance;

● arm’s length sales of our common stock;

● the development status of our product candidates;

● the business risks we face;

● vesting restrictions imposed upon the equity awards; and

● an evaluation and benchmark of our competitors; and

● prospects of a liquidity event.

On April 1, 2013, the Board of Directors approved, subject to subsequently received shareholder approval, the establishment of the Bioheart 2013 Omnibus Equity Compensation Plan, or the “2013 Omnibus Plan”. The 2013 Omnibus Plan initially reserved up to fifty thousand (50,000) shares of common stock for issuance. On August 4, 2014, the Board of Directors approved to set the reserve to one hundred thousand (100,000) shares of common stock for issuance and to close the 1999 Officers and Employees Stock Option Plan. On February 2, 2015, at the annual meeting of shareholders, the majority of shareholders approved the 2013 Omnibus Equity Compensation Plan. On November 2, 2015, the Board of Directors approved the increase of the reserve under the 2013 Omnibus Plan to five hundred million (500,000,000) shares of common stock for issuance, effective September 16, 2016, approved an addition of twenty five million (25,000,000) shares of common stock to the reserve, effective April 21, 2017, approved an addition of twenty five million (25,000,000) shares of common stock to the reserve, effective August 7, 2017, approved an addition of thirty million (30,000,000) shares of common stock to the reserve and effective May 7, 2018, approved an addition of one hundred million (100,000,000) shares of common stock to reserve.

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Critical Accounting Policies

Our discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

Actual results may differ from these estimates under different assumptions or conditions. While our critical accounting policies are described in Note 1 to our financial statements appearing elsewhere in this report, we believe the following policies are important to understanding and evaluating our reported financial results:

Revenue Recognition

Effective January 1, 2018, the Company recognizes revenue in accordance with Accounting Standards Codification 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific revenue recognition guidance throughout the Industry Topics of the Accounting Standards Codification. The updated guidance states that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The guidance also provides for additional disclosures with respect to revenues and cash flows arising from contracts with customers.

At the time of each transaction, management assesses whether the fee associated with the transaction is fixed or determinable and whether or not collection is reasonably assured. The assessment of whether the fee is fixed or determinable is based upon the payment terms of the transaction. Collectability is assessed based on a number of factors, including past transaction history with the client and the creditworthiness of the client.

The Company’s primary sources of revenue are from the sale of test kits and equipment, training services, patient treatments, laboratory services and cell banking. 

Revenues for kits and equipment sold are not recorded until kits and equipment are received by the customer. Revenues from in-person trainings are recognized when the training occurs and revenues from on demand online trainings are recognized when the customer purchases the rights to the training course. Any cash received as a deposit for trainings are recorded by the Company as a liability.

Patient treatments and laboratory services revenue are recognized when those services have been completed or satisfied.

Revenues for cell banking sales are accounted for as multiple performance obligations as described in ASC 606 and addresses accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets. Because the Company sells its services separately, on more than a limited basis and at a price within a narrow range, the Company was able to allocate revenue based on stand-alone pricing. The multiple performance obligations include stem cell banking, dose retrieval and yearly storage fees. Revenues for stem cell banking and dose retrieval is recognized at the point of service and revenues for the yearly storage fees is recognized over the term of the banking contract, which is typically one year with annual renewals.

Research and Development Activities

We account for research and development costs in accordance with Accounting Standards Codification subtopic 730-10, Research and Development (“ASC 730-10”). Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved as defined under the applicable agreement. Our company-sponsored research and development costs related to both present and future products are expensed in the period incurred.

Inflation

Our opinion is that inflation has not had, and is not expected to have, a material effect on our operations.

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Climate Change

Our opinion is that neither climate change, nor governmental regulations related to climate change, have had, or are expected to have, any material effect on our operations.

Concentrations of Credit Risk

As of September 30, 2020, one customer, a related party (US Stem Cell Clinic LLC, a partly owned investment in which the Company holds a 49.9% interest), represented 83% of the Company’s accounts receivable. As of December 31, 2019, two customers, of which one customer is a related party (US Stem Cell Clinic LLC, a partly owned investment in which the Company holds a 49.9% interest), represented 47% and 47%, respectively, representing an aggregate of 94% of the Company’s accounts receivable.

For the three months ended September 30, 2020, three customers represented 24%, 15% and 14%, respectively, of the Company’s revenues.  For the three months ended September 30, 2019, two customers, of which the first one is a related party (US Stem Cell Clinic LLC, a partly owned investment in which the Company holds a 49.9% interest), represented 27% and 22%, respectively, of the Company’s revenues.

For the nine months ended September 30, 2020, two customers represented 15% and 13%, respectively, of the Company’s revenues.  For the nine months ended September 30, 2019, one customer, a related party (US Stem Cell Clinic LLC, a partly owned investment in which the Company holds a 49.9% interest), represented 12% of the Company’s revenues.

Recent Accounting Policies 

There are various other updates recently issued, most of which represented technical corrections to the accounting literature or application to specific industries and are not expected to a have a material impact on our  financial position, results of operations or cash flows.

Liquidity and Capital Resources

In the three months ended September 30, 2020, we incurred negative cash flow from operations of $94,659 and will continue to finance our considerable operational cash needs with cash generated from financing activities and revenues.

Investing Activities

Net cash provided by investing activities was $0 for the nine-months ended September 30, 2020 represented proceeds from our equity investment as compared to cash provided by investing activities of $166,833 from our equity investments for the same period last year.

Financing Activities

Net cash provided in financing activities was an aggregate of $439,079 in the nine-month period ended September 30, 2020 as compared to cash used of $454,739 in the three-month period ended in September 30, 2019.

Existing Capital Resources and Future Capital Requirements and Plan of Operations

We have generated substantial net losses and negative cash flow from operations since inception and anticipate incurring significant net losses and negative cash flows from operations for the foreseeable future. Historically, we have relied on proceeds from the sale of our common stock and our incurrence of debt to provide the funds necessary to conduct our research and development activities and to meet our other cash needs.

At September 30, 2020, we had cash and cash equivalents totaling $81,228. However, our working capital deficit as of such date was approximately $10.3 million.

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Along with diversifying the portfolio of products distributed by our company, including equipment and biologics, it is the intention of our Company to both continue to adhere to the Court Order (see Note 13 of the Financial Statements) as well as re -establish its good standing with the Agency (FDA). These points are not mutually exclusive nor negotiable and we believe that there are still  business and patient goodness opportunities while still abiding by all legal requirements  As a result, management shall be continuing with the development of  US Stem Cell Training, Inc. , an operating division of our company, that  is a content developer of regenerative medicine/cell therapy informational and training materials for physicians and patients and complies with both requirements--as well as Vetbiologics, an operating division of our company, that  is a veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the highest quality regenerative medicine therapies to dogs, cats and horses. In addition, our company is transitioning the current clinics to a more diversified regenerative medicine platform, while complying with recent court rulings. While not providing legal advice, our company may also engage in managing third-party clinics to ensure they too abide by recent regulatory requirements

Economic Injury Disaster Loan (EIDL)

On June 20, 2020, the Company executed the standard loan documents for an EIDL from the U.S. Small Business Administration in light of the impact of the COVID-19 pandemic on our business. Pursuant to that certain Loan Authorization and Agreement (the “SBA Loan Agreement”), the principal amount of the EIDL received was $150,000, with proceeds to be used for working capital purposes. Interest accrues at the rate of 3.75% per annum. Installment payments, including principal and interest, are due monthly beginning June 20, 2021 (twelve months from the date of the SBA Loan Agreement) in the amount of $731. The balance of principal and interest is payable thirty years from the date of the SBA Loan Agreement. As of September 30, 2020, the remaining carrying value of the note was $150,000. At September 30, 2020, accrued interest on the note was $1,572, and is included in accrued expenses on the accompanying balance sheet.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

Not required under Regulation S-K for “smaller reporting companies.”

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

As required under Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we carried out an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Accounting Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, 2020. Based upon that evaluation, the Chief Executive Officer and Chief Accounting Officer concluded that our disclosure controls and procedures as of September 30, 2020 were not effective, for the same reasons as previously disclosed under Item 9A. “Controls and Procedures” in our Annual Report on Form 10-K for our fiscal year ended December 31, 2019. 

Changes in Internal Controls over Financial Reporting

There have been no changes in our internal controls over financial reporting (as defined in Rule 13a-15(f) and 15d-(f) of the Exchange Act) that occurred during our last fiscal quarter to which this report relates that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PAR II — OTHER INFORMATION

Item 1. Legal Proceedings

On September 17, 2015, a product liability lawsuit was filed in Broward County, specifically Patsy Bade v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D., and on November 30, 2015, a product liability lawsuit was filed in Broward County, specifically Elizabeth Noble v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D. During the year ended December 31, 2016, both matters settled by the Company’s insurance policy with no additional cost to the Company, excluding the Company payment of the $100,000 insurance company deductible of which $11,000 was paid in fiscal 2017. As a result of the final settlement and determination of insurance coverage, the Company recognized $100,000 of expense due to litigation for the year ended December 31, 2017. The remaining amount due under this settlement was $28,850 as of September 30, 2020.

On December 12, 2017, a product liability lawsuit was filed in Broward County, specifically Jeannine Mallard v. U.S. Stem Cell, Inc., US Stem Cell Clinics LLC., Regenestem, LLC., Regenestem Network, LLC., and Kristin C. Comella. The Company will continue to defend it vigorously. On December 6, 2019, the Company was one of the parties to a Settlement Agreement and General Release (the “Agreement”) related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year non-interest bearing unsecured promissory note, dated December 6, 2019, in the principal amount of $250,000, payable in monthly increments of $750 per month, with a final balloon payment of $205,000 due on January 1, 2025.

On June 3, 2019, the Company was one of the parties to a Settlement Agreement and General Release (the “Agreement”) related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year 5.25% Promissory Note, dated June 15, 2019, in the principal amount of Five Hundred Thousand Dollars ($500,000), payable in monthly increments of Five Thousand ($5,000) per month. The remaining amount due under this settlement was $453,493as of September 30, 2020.

The Company is subject at times to other legal proceedings and claims, which arise in the ordinary course of its business.  Although occasional adverse decisions or settlements may occur, the Company believes that the final disposition of such matters should not have a material adverse effect on its financial position, results of operations or liquidity.  There was no outstanding litigation as of September 30, 2020 other than that described above.

Government Claim

On May 9, 2018, the U.S. Department of Justice filed an injunctive action, specifically United States of America v. U.S. Stem Clinic, LLC, U.S. Stem Cell, Inc., Kristin C. Comella, and Theodore Gradel. The Complaint alleges, among other matters that the defendants manufacture “stromal vascular fraction” (SVF) products from patient adipose (fat) tissue, which the companies then market as stem cell-based treatments, and which U.S. Stem Cell Clinic, LLC administers to patients, without first obtaining what the government alleges are necessary FDA approvals. Although Theodore Gradel was initially listed as a defendant, he subsequently entered into a consent agreement and is no longer a party to this case.

The U.S. and the defendants filed cross motions for summary judgment, each asking for a ruling in its favor. On June 3, 2019, the Court entered an order granting Summary Judgment for the government and denying the defendants’ motion for summary judgment. The order focused on the defendants’ actions in providing and marketing SVF therapy. In an order dated June 4, 2019, the Court granted the defendants’ request to allow it the opportunity to work out the language of the form of injunction with the government, and if unsuccessful, to provide a status report to the Court by June 14, 2019, outlining areas of disagreement. The Court further ordered that the defendants (U.S. Stem Clinic, LLC, U.S. Stem Cell, Inc., and Kristin C. Comella) ‘not sell, provide or otherwise engage in any SVF therapy or any other activities to be regulated by the FDA as explained in the Court’s Order on the Parties’ Motions for Summary Judgment.” On June 25, 2019, the Court entered an Order of Permanent Injunction, generally enjoining the defendants with respect to the SVF Product and requiring other actions. The Company filed an appeal on August 23, 2019 and its counsel attended appellate oral argument on January 13, 2021. On June 2, 2021, the Eleventh Circuit Court ruled to affirm lower courts’ judgement. The Company did not challenge the district court’s judgment upon any other ground. The Company is not able to predict the duration, scope, results, or consequences of the U.S. Department of Justice actions and final rulings and management is assessing its options on a going forward basis. 

The Company, in divesting certain equipment and other assets and assigning its lease, has and will continue to experience a decrease in revenues as the Company both maintains the remainder of the business and transitions into similar or unrelated business opportunities as determined by management; However, management is not able to predict the duration, scope, results, or consequences of the summary judgment and any transition of the business plan. There can be no assurance that the Company will prevail on its appeal and obtain a reversal of the final judgment.

38

After the Court’s issuance of the Order of Permanent Injunction, the Company has received demand letters for compensation from persons who store their SVF Product and/or other tissue product with the tissue bank (several of the persons have requested refunds of the monies paid to the tissue bank and one person has requested a full refund of monies paid to an altogether separate company due to her not receiving the full amount of treatments she requested; such requests for compensation, to date, have not been material) and requests that the Company preserve cells in the Company’s possession.  The Company sought guidance from the Court, which entered an order generally staying the requirement to destroy any SVF Product, pending a decision on the Company’s appeal.  Many of the tissue bank depositors attempted to intervene in the FDA action, and filed an appeal when their intervention was denied. Their appeal was dismissed. It is anticipated that these depositors will present their position on tissue/SVF preservation to the trial court now that the appeal has been decided. As disclosed by the Company previously, the Company entered into a transaction in 2019 in which it divested itself of the operation of the tissue bank.

Item 1A. Risk Factors

Not required under Regulation S-K for “smaller reporting companies.”

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None

Item 3. Defaults Upon Senior Securities

There were no defaults upon senior securities during the period ended September 30, 2020

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None

Item 6. Exhibits

Exhibit No.	Exhibit Description
2.1(20)	Asset Sale and Lease Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017.
2.2(20)	Asset Purchase Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017.
2.3(20)	Customer Purchase Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017.
3.1 (1)	Articles of Incorporation
3.2(5)	Amended and Restated Articles of Incorporation
3.3(8)	Articles of Amendment to the Articles of Incorporation
3.4(17)	Articles of Amendment to the Articles of Incorporation
3.5 (7)	Amended and Restated Bylaws
3.6(19)	Amendment to Bylaws
4.1(4)	Loan and Security Agreement, dated as of May 31, 2007 by and between BlueCrest Capital Finance, L.P. and the Registrant
4.2(9)	Amendment to Loan and Security Agreement, between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009
4.3(9)	Grant of Security Interest (Patents), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009
4.4(9)	Security Agreement (Intellectual Property), between the Company and BlueCrest Venture Finance Master Fund Limited, dated as of April 2, 2009
4.5(9)	Subordination Agreement, by Hunton & Williams, LLP in favor of BlueCrest Venture Finance Master Fund Limited, entered into and effective April 2, 2009

39

4.6(9)	Amended and Restated Promissory Note, dated April 2, 2009, by the Company to BlueCrest Venture Finance Master Fund Limited
4.7(9)	Warrant to purchase shares of the Registrant’s common stock, dated April 2, 2009, issued to BlueCrest Venture Finance Master Fund Limited
4.8(10)	Warrant to purchase shares of the Registrant’s common stock, dated April 2, 2009, issued to Rogers Telecommunications Limited
4.9(10)	Warrant to purchase shares of the Registrant’s common stock, dated April 2, 2009, issued to Hunton & Williams, LLP
4.10 (15)	Series A Convertible Preferred Stock
10.1(1)	Lease Agreement between the Registrant and Sawgrass Business Plaza, LLC, as amended, dated November 14, 2006.
10.2(3)	Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the Registrant, Howard J. Leonhardt and Brenda Leonhardt
10.3(3)	Loan Guarantee, Payment and Security Agreement, dated as of June 1, 2007, by and between the Registrant and William P. Murphy Jr., M.D.
10.4(3)	Loan Agreement, dated as of June 1, 2007, by and between the Registrant and Bank of America, N.A.
10.5(5)	Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the Registrant and Samuel S. Ahn, M.D.
10.6(5)	Loan Guarantee, Payment and Security Agreement, dated as of September 12, 2007, by and between the Registrant and Dan Marino
10.7(5)	Loan Guarantee, Payment and Security Agreement, dated as of September 19, 2007, by and between the Registrant and Jason Taylor
10.8(6)	Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the Registrant and Howard and Brenda Leonhardt
10.9(6)	Second Amendment to Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the Registrant and Howard and Brenda Leonhardt
10.10(6)	Second Amendment to Loan Guarantee, Payment and Security Agreement, dated as of October 10, 2007, by and between the Registrant and William P. Murphy, Jr., M.D.
10.11(11)	Loan Agreement with Seaside National Bank and Trust, dated October 25, 2010.
10.12(11)	Promissory Note with Seaside National Bank and Trust, dated October 25, 2010.
10.13(11)	Amended and Restated Loan and Security Agreement with BlueCrest Venture Finance Master Fund Limited, dated October 25, 2010.
10.14(12)	Unsecured Convertible Promissory Note for $25,000, with Magna Group, LLC, dated January 3, 2011.
10.15(12)	Promissory Note for $139,728.82 with Magna Group, LLC, dated January 3, 2011.
10.16(13)	Unsecured Convertible Promissory Note for $34,750, with Magna Group, LLC, dated May 16, 2011.
10.17(13)	Promissory Note for $139,728.82 with Magna Group, LLC, dated May 16, 2011.
10.18**(14)	2013 U.S. Stem Cell, Inc. Omnibus Equity Compensation Plan
10.19(16)	Senior Convertible Note with Magna Equities II, LLC, dated October 1, 2015
10.20(16)	Securities Purchase Agreement, dated as of October 1, 2015, by and between Magna Equities II, LLC and U.S. Stem Cell, Inc.
10.21(16)	Registration Rights Agreement, dated as of October 1, 2015, by and between Magna Holdings I, LLC and U.S. Stem Cell, Inc.
10.22(18)	Senior Convertible Note Magna Equities II, LLC, dated December 3, 2015
10.23(18)	Amended and Restated Senior Convertible Note, dated December 3, 2015.
10.24(18)	Securities Purchase Agreement, dated as of December 3, 2015, by and between Magna Equities II, LLC and U.S. Stem Cell, Inc.
10.25(18)	Registration Rights Agreement, dated as of December 3, 2015, by and between Magna Holdings I, LLC and U.S. Stem Cell, Inc.
10.26(20)	Non-Competition and Non-Solicitation Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017.
10.27(21)	First Amendment to Lease Agreement between the Registrant and Sawgrass Business Plaza, LLC, as amended, dated November 17, 2017.
10.28(22)	Second Amendment to Lease Agreement between the Registrant and Sawgrass Business Plaza, LLC, as amended, dated November 17, 2017.
10.29(23)	Termination and Release Agreement by and between GACP, the Company, and Michael Tomas and Kristin Comella dated September 24, 2019.

40

10.30(23)	Letter Agreement on Stem Cell Processing and Storage by and between the Company and American Cell Technology, LLC, dated September 24, 2019
10.31(24)	Assignment and Assumption of Lease by and between the Company, American Cell Technology, LLC, and Sawgrass Business Plaza, LLC, dated October 24, 2019.
14.1(2)	Code of Business Conduct and Ethics
31.1*	Certification of Chief Executive Officer and Chief Financial Officer (Principal Accounting Officer) pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*	Certifications of Chief Executive Officer and Chief Financial Officer (Principal Accounting Officer) pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101 INS	XBRL Instance Document
101 SCH	XBRL Taxonomy Extension Schema Document
101 CAL	XBRL Taxonomy Calculation Linkbase Document
101 DEF	XBRL Taxonomy Extension Definition Linkbase Document
101 LAB	XBRL Taxonomy Labels Linkbase Document
101 PRE	XBRL Taxonomy Presentation Linkbase Document
*	Filed herewith
**	Indicates management contract or compensatory plan.
(1)	Incorporated by reference to the Company’s Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on February 13, 2007.
(2)	Incorporated by reference to Amendment No. 1 to the Company’s Form S-1 filed with the SEC on June 5, 2007.
(3)	Incorporated by reference to Amendment No. 3 to the Company’s Form S-1 filed with the SEC on August 9, 2007.
(4)	Incorporated by reference to Amendment No. 4 to the Company’s Form S-1 filed with the SEC on September 6, 2007.
(5)	Incorporated by reference to Amendment No. 5 to the Company’s Form S-1 filed with the SEC on October 1, 2007.
(6)	Incorporated by reference to Post-effective Amendment No. 1 to the Company’s Form S-1 filed with the SEC on October 11, 2007.
(7)	Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on July 3, 2008.
(8)	Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on August 8, 2008.
(9)	Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on April 8, 2009.
(10)	Incorporated by reference to the Company’s Annual Report on Form 10-K filed with the SEC on April 15, 2009.
(11)	Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on October 29, 2010.
(12)	Incorporated by reference to the Company’s Current Report on Form 8-K filed with the SEC on January 12, 2011.
(13)	Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on May 25, 2011.
(14)	Incorporated by reference to the Company Quarterly Report on Form 10-Q filed with the SEC on May 9, 2013.
(15)	Incorporated by reference to the Company’s Definitive Proxy Statement on Schedule 14A filed with the SEC on April 28, 2014.
(16)	Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on October 2, 2015.
(17)	Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on November 4, 2015.
(18)	Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on December 4, 2015.
(19)	Incorporated by reference to the text of the Company Current Report on Form 8-K filed with the SEC on August 3, 2016.
(20)	Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on March 8, 2017.
(21)	Incorporated by reference to the Company Annual Report on Form 10-K filed with the SEC on April 16, 2018.
(22)	Incorporated by reference to the Company’s Quarterly Report on Form 10-Q filed with the SEC on May 7, 2019.
(23)	Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on September 27, 2019.
(24)	Incorporated by reference to the Company Current Report on Form 8-K filed with the SEC on October 24, 2019.

41

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

		U.S. Stem Cell, Inc.
Date: July 15, 2021	By:	/s/ Mike Tomas
		Mike Tomas
		Chief Executive Officer &
		President and Principal Financial
		and Accounting Officer

42

EX-31.1

Exhibit 31.1

Certification of Chief Executive Officer and Principal Accounting Officer

I, Mike Tomas, certify that:

1.	I have reviewed this report on Form 10-Q of U.S Stem Cell, Inc.;
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.	The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
	a.	designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
	b.	designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
	c.	evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
	d.	disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.	The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
	a.	all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
	b.	any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: July 15, 2021
		/s/ Mike Tomas
	Name:	Mike Tomas
		President and Chief Executive Officer
		Chief Financial Officer and Principal
		Accounting Officer

EX-32.1

Exhibit 32.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

I, Mike Tomas, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge, U.S. Stem Cell, Inc.’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and that

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

(2)  The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.

Date: July 15, 2021
		/s/ Mike Tomas
	Name:	Mike Tomas
		President and Chief Executive Officer, Chief
		Financial Officer and Principal Accounting
		Officer

XML

Document And Entity Information - shares	9 Months Ended
	Sep. 30, 2020	Jul. 15, 2021
Document Information Line Items
Entity Registrant Name	U.S. STEM CELL, INC.
Document Type	10-Q
Current Fiscal Year End Date	--12-31
Entity Common Stock, Shares Outstanding		452,413,153
Amendment Flag	false
Entity Central Index Key	0001388319
Entity Current Reporting Status	No
Entity Filer Category	Non-accelerated Filer
Document Period End Date	Sep. 30, 2020
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q3
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Interactive Data Current	Yes

XML

CONDENSED BALANCE SHEETS - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Current assets:
Cash and cash equivalents	$ 81,228	$ 0
Accounts receivable, net	21,469	48,208
Inventories	5,418	8,096
Prepaid expenses and other current assets	10,000	10,000
Total current assets	118,115	66,304
Investments	0	23,539
Total assets	118,115	89,843
Current liabilities:
Bank overdraft	0	1,520
Accounts payable	1,231,623	1,187,989
Accrued expenses	1,379,821	1,115,526
Advances - related parties	797,040	511,744
Deferred revenue, current portion	23,000	23,800
Deferred gain on sale of equipment, current portion	0	21,474
Deposits	465,286	465,286
Notes payable - related parties	3,733,404	2,757,442
Notes payable, current portion, net of debt discount of $9,501 and $9,057, respectively	1,400,910	1,297,477
Promissory note payable, net of debt discount of $0 and $29,296, respectively	1,397,762	1,368,467
Convertible notes payable, net of debt discount of $6,221 and $0, respectively	38,779	0
Total current liabilities	10,467,625	8,750,725
Long-term liabilities:
Deferred revenue	60,250	62,500
Notes payable, net of debt discount of $34,091 and $41,391, respectively	769,741	756,014
Total long-term liabilities	829,991	818,514
Total liabilities	11,297,616	9,569,239
Commitments and contingencies (See Note 13)
Stockholders' deficit:
Preferred stock, par value $0.001; 20,000,000 shares authorized, -0- issued and outstanding	0	0
Common stock, par value $0.001; 2,000,000,000 shares authorized, 429,702,662 and 417,724,767 shares issued and outstanding, respectively	429,703	417,725
Additional paid-in capital	124,315,620	123,726,894
Accumulated deficit	(135,924,824)	(133,624,015)
Total stockholders' deficit	(11,179,501)	(9,479,396)
Total liabilities and stockholders' deficit	$ 118,115	$ 89,843

XML

CONDENSED BALANCE SHEETS (Parentheticals) - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Debt discount (in Dollars)	$ 43,592	$ 50,448
Preferred stock, par value (in Dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized	20,000,000	20,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value (in Dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized	2,000,000,000	2,000,000,000
Common stock, shares issued	429,702,662	417,724,767
Common stock, shares outstanding	429,702,662	417,724,767
Notes Payable, Other Payables [Member]
Debt discount (in Dollars)	$ 34,091	$ 41,391
Notes Payable, Other Payables [Member]
Debt discount (in Dollars)	9,501	9,057
Promissory Note [Member]
Debt discount (in Dollars)	0	29,296
Convertible Notes Payable [Member]
Debt discount (in Dollars)	$ 6,221	$ 0

XML

CONDENSED STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Revenue:
Revenue	$ 64,647	$ 156,591	$ 161,793	$ 2,763,385
Cost of sales	18,576	137,366	53,550	1,165,459
Gross profit	46,071	19,225	108,243	1,597,926
Operating expenses:
Research and development	0	0	0	263
Selling, general and administrative	1,039,352	1,616,970	2,068,245	3,628,652
Pre-litigation settlement	0	0	0	500,000
Total operating expenses	1,039,352	1,616,970	2,068,245	4,128,915
Loss from operations	(993,281)	(1,597,745)	(1,960,002)	(2,530,989)
Other income (expenses):
Gain (loss) on settlement of accounts payable and accrued interest, net	(204)	33,203	277	21,892
Gain on sale of equipment	0	32,211	21,474	96,634
Miscellaneous income	0	11,000	0	11,069
Income (loss) from equity investments	(9,718)	(33,478)	(23,539)	93,778
Interest expense	(152,572)	(91,140)	(339,019)	(850,677)
Total other income (expenses)	(162,494)	(48,204)	(340,807)	(627,304)
Net loss before income taxes	(1,155,775)	(1,645,949)	(2,300,809)	(3,158,293)
Income taxes (benefit)	0	0	0	0
NET LOSS	$ (1,155,775)	$ (1,645,949)	$ (2,300,809)	$ (3,158,293)
Net loss per common share, basic and diluted (in Dollars per share)	$ 0.00	$ 0.00	$ (0.01)	$ (0.01)
Weighted average number of common shares outstanding, basic and diluted (in Shares)	429,684,176	396,637,920	427,207,208	392,029,562
Product [Member]
Revenue:
Revenue	$ 44,970	$ 28,160	$ 116,347	$ 299,826
Service [Member]
Revenue:
Revenue	19,677	127,456	45,446	2,412,808
Management Fees-related Party [Member]
Revenue:
Revenue	$ 0	$ 975	$ 0	$ 50,751

XML

CONDENSED STATEMENT OF STOCKHOLDERS' DEFICIT - USD ($)	Preferred Stock [Member]	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	Total
Balance at Dec. 31, 2018		$ 378,077	$ 122,528,391	$ (129,788,678)	$ (6,882,210)
Balance (in Shares) at Dec. 31, 2018		378,076,976
Common stock issued in settlement		$ 16,167	296,027		312,194
Common stock issued in settlement (in Shares)		16,166,984
Common stock issued for services		$ 3,500	82,850		86,350
Common stock issued for services (in Shares)		3,500,000
Contribution to equity investment			15,265		15,265
Stock based compensation			512,882		512,882
Net loss				(3,158,293)	(3,158,293)
Balance at Sep. 30, 2019		$ 397,744	123,435,415	(132,946,971)	(9,113,812)
Balance (in Shares) at Sep. 30, 2019		397,743,960
Balance at Jun. 30, 2019		$ 393,695	123,231,001	(131,301,022)	(7,676,326)
Balance (in Shares) at Jun. 30, 2019		393,694,820
Common stock issued in settlement		$ 4,049	29,964		34,013
Common stock issued in settlement (in Shares)		4,049,140
Stock based compensation			174,450		174,450
Net loss				(1,645,949)	(1,645,949)
Balance at Sep. 30, 2019		$ 397,744	123,435,415	(132,946,971)	(9,113,812)
Balance (in Shares) at Sep. 30, 2019		397,743,960
Balance at Dec. 31, 2019	$ 0	$ 417,725	123,726,894	(133,624,015)	(9,479,396)
Balance (in Shares) at Dec. 31, 2019	0	417,724,767
Common stock issued in settlement		$ 7,978	36,390		44,368
Common stock issued in settlement (in Shares)		7,977,895
Common stock issued for services		$ 4,000	12,000		$ 16,000
Common stock issued for services (in Shares)		4,000,000			4,000,000
Beneficial conversion feature recognized on convertible note			15,000		$ 15,000
Stock based compensation			525,336		525,336
Net loss				(2,300,809)	(2,300,809)
Balance at Sep. 30, 2020	$ 0	$ 429,703	124,315,620	(135,924,824)	(11,179,501)
Balance (in Shares) at Sep. 30, 2020	0	429,702,662
Balance at Jun. 30, 2020	$ 0	$ 428,002	124,132,196	(134,769,049)	(10,208,851)
Balance (in Shares) at Jun. 30, 2020	0	428,001,981
Common stock issued in settlement		$ 1,701	8,504		10,205
Common stock issued in settlement (in Shares)		1,700,681
Stock based compensation			174,920		174,920
Net loss				(1,155,775)	(1,155,775)
Balance at Sep. 30, 2020	$ 0	$ 429,703	$ 124,315,620	$ (135,924,824)	$ (11,179,501)
Balance (in Shares) at Sep. 30, 2020	0	429,702,662

XML

CONDENSED STATEMENTS OF CASH FLOWS - USD ($)	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (2,300,809)	$ (3,158,293)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	0	154,956
Bad debt (recoveries)	0	30,869
Interest and amortization of debt discount	309,219	141,296
(Gain) loss on settlement of accounts payable and accrued interest	(277)	(21,892)
Gain on sale of equipment	(21,474)	(96,634)
Related party notes payable issued for services rendered	975,962	800,000
Loss (income) on equity investments	23,539	(93,778)
Note payable issued in pre-trial settlement	0	500,000
Stock-based compensation	541,336	586,382
Changes in operating assets and liabilities:
Accounts receivable	26,739	(33,079)
Inventories	2,678	46,864
Accounts payable	79,134	269,070
Accrued expenses	9,152	(4,507)
Deferred revenue	(3,050)	(112,390)
Net cash used in operating activities	(357,851)	(991,136)
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from equity investments	0	166,833
Net cash provided by investing activities	0	166,833
CASH FLOWS FROM FINANCING ACTIVITIES:
Repayments for overdraft protection	(1,520)	0
Proceeds from related party advances	285,296	140,000
Repayments of related party notes	0	(213,739)
Proceeds from notes payable	150,000	0
Repayments of notes payable	(39,697)	(381,000)
Proceeds from convertible note payable	45,000	0
Net cash provided by (used in) financing activities	439,079	(454,739)
Net increase (decrease) in cash and cash equivalents	81,228	(1,279,042)
Cash and cash equivalents, beginning of period	0	1,357,146
Cash and cash equivalents, end of period	81,228	78,104
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Interest paid	29,800	633,859
Income taxes paid	0	0
SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES:
Common stock issued in settlement of notes payable	44,368	312,194
Beneficial conversion feature recognized on convertible note	15,000	0
Equity contributed to investment	0	15,265
Record right-to-use assets and related lease liability	$ 0	$ 383,351

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NATURE OF OPERATIONS

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Nature of Operations [Text Block]

NOTE 1 — NATURE OF OPERATIONS

Overview

U.S. Stem Cell, Inc. was incorporated under the laws of the State of Florida in August 1999. The Company is in the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. The business includes the development of proprietary cell therapy products as well as revenue generating physician and patient-based regenerative medicine/cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of cell therapy clinics. To date, the Company has not generated significant revenues in that they remain less than their total operating expenses, has incurred expenses, and has sustained losses. Consequently, its operations are subject to all the risks inherent in the establishment of a research and development business enterprise.

Basis of Presentation

The interim unaudited condensed financial statements included herein reflect all material adjustments (consisting of normal recurring adjustments and reclassifications and non-recurring adjustments) which, in the opinion of the Company’s management, are ordinary and necessary for a fair presentation of results for the interim periods. Certain information and footnote disclosures required under generally accepted accounting principles in the United States of America (“GAAP”) have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The Company’s management believes the disclosures are adequate to make the information presented not misleading.

The condensed balance sheet information as of December 31, 2019 was derived from the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2019 (“2019 Annual Report”), filed with the SEC pursuant to Section 13 or 15(d) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), on July 15, 2021. These interim unaudited condensed financial statements should be read in conjunction with the 2019 Annual Report. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the results to be expected for the entire fiscal year or for any other period.

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GOING CONCERN AND MANAGEMENT'S LIQUIDITY PLANS

9 Months Ended

Sep. 30, 2020

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Substantial Doubt about Going Concern [Text Block]

NOTE 2 – GOING CONCERN AND MANAGEMENT’S LIQUIDITY PLANS

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

As shown in the accompanying financial statements, as of September 30, 2020, the Company had cash on hand of $81,228 and a working capital deficit (current liabilities in excess of current assets) of $10,349,510. During the nine months ended September 30, 2020, the net loss was $2,300,809 and net cash used in operating activities was $357,851. These conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year from the issuance of the unaudited condensed financial statements.

The Company’s primary source of operating funds has been from revenue generated from sales with additional cash proceeds from the sale of common stock and the issuances of promissory notes and other debt. The Company has experienced net losses from operations since inception, but it expects these conditions to improve in the future as it develops its business model. The Company had a stockholders’ deficit of 11,179,501 at September 30, 2020 and requires additional financing to fund future operations.

The Company’s existence is dependent upon management’s ability to develop profitable operations and to obtain additional funding sources. There can be no assurance that the Company’s financing efforts will result in profitable operations or the resolution of the Company’s liquidity problems. The accompanying statements do not include any adjustments that might result should the Company be unable to continue as a going concern. Along with diversifying the portfolio of products distributed by the Company, including equipment and biologics, it is the intention of the Company management to both continue to adhere to the Court Order (see Note 13) as well as re-establish its good standing with the Agency (FDA). These points are not mutually exclusive nor negotiable and management believes that there are still  business and patient goodness opportunities while still abiding by all legal requirements  As a result, management shall be continuing with the development of  US Stem Cell Training, Inc., an operating division of the Company, that  is a content developer of regenerative medicine/cell therapy informational and training materials for physicians and patients and complies with both requirements--as well as Vetbiologics, an operating division of the Company, that  is a veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the highest quality regenerative medicine therapies to dogs, cats and horses.

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SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Organization, Consolidation, Basis of Presentation, Business Description and Accounting Policies [Text Block]

NOTE 3 – SIGNIFICANT ACCOUNTING POLICIES

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from these estimates.

Fair Value

Accounting Standards Codification subtopic 825-10, Financial Instruments (“ASC 825-10”) requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable, accrued liabilities, and short-term borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments. All other significant financial assets, financial liabilities and equity instruments of the Company are either recognized or disclosed in the financial statements together with other information relevant for making a reasonable assessment of future cash flows, interest rate risk and credit risk. Where practicable the fair values of financial assets and financial liabilities have been determined and disclosed; otherwise only available information pertinent to fair value has been disclosed.

The Company follows Accounting Standards Codification subtopic 820-10, Fair Value Measurements and Disclosures (“ASC 820-10”) and Accounting Standards Codification subtopic 825-10, Financial Instruments (“ASC 825-10”), which permits entities to choose to measure many financial instruments and certain other items at fair value.

Cash

The Company considers cash to consist of cash on hand and temporary investments having an original maturity of 90 days or less that are readily convertible into cash.

Accounts Receivable and Allowance for Doubtful Accounts

Accounts receivable are non-interest bearing and are stated at gross invoice amounts less an allowance for doubtful accounts. Credit is extended to customers based on an evaluation of their financial condition, industry reputation, and other judgmental factors considered by the Company’s management. The Company generally does not require collateral or other security interest to support accounts receivable. Based on trends and specific factors, the customer’s credit terms may be modified, including required payment upon delivery.

The Company performs regular on-going credit evaluations of its customers as deemed relevant. As events, trends, and circumstance warrant, the Company’s management estimates the amounts that are more likely than not to be uncollectible. These amounts are recognized as bad debt expense and are reflected within selling, general, administrative and other expenses on the Company’s accompanying statement of operations.

Any charges to the allowance for doubtful accounts on accounts receivable are charged to operations in amounts sufficient to maintain the allowance for uncollectible accounts at a level management believes is adequate to cover any probable losses. Management determines the adequacy of the allowance based on historical write-off percentages and the current status of accounts receivable. Accounts receivable are charged off against the allowance when collectability is determined to be permanently impaired. As of September 30, 2020 and December 31, 2019, the allowance for doubtful accounts was $13,203.

Inventories

Inventories are stated at the lower of cost or market with cost being determined on a first-in, first-out (FIFO) basis. The Company writes down its inventory for estimated obsolescence or unmarketable inventory equal to the difference between the cost of inventory and the estimated market value based upon assumptions about future demand and market conditions. If actual market conditions are less favorable than those projected by management, additional inventory write-downs may be required. During the periods presented, there were no inventory write-downs.

Investments

The Company follows Accounting Standards Codification subtopic 323-10, Investments-Equity Methods and Joint Ventures (“ASC 323-10) which requires the accounting for investments where the Company can exert significant influence, but not control of a joint venture or equity investment. The Company accounted for its 49.9% member interest ownerships of U.S. Stem Cell Clinic, LLC and Regenerative Wellness Clinic, LLC, respectively, and its 49% member interest ownership of U.S. Stem Cell Clinic of the Villages utilizing the equity method of accounting (See Note 5).

Revenue Recognition

Effective January 1, 2018, the Company recognizes revenue in accordance with Accounting Standards Codification 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific revenue recognition guidance throughout the Industry Topics of the Accounting Standards Codification. The updated guidance states that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The guidance also provides for additional disclosures with respect to revenues and cash flows arising from contracts with customers.

At the time of each transaction, management assesses whether the fee associated with the transaction is fixed or determinable and whether or not collection is reasonably assured. The assessment of whether the fee is fixed or determinable is based upon the payment terms of the transaction. Collectability is assessed based on a number of factors, including past transaction history with the client and the creditworthiness of the client.

The Company’s primary sources of revenue are from the sale of test kits and equipment, training services, patient treatments, laboratory services and cell banking. 

Revenues for kits and equipment sold are not recorded until kits and equipment are received by the customer. Revenues from in-person trainings are recognized when the training occurs and revenues from on demand online trainings are recognized when the customer purchases the rights to the training course. Any cash received as a deposit for trainings are recorded by the Company as a liability.

Patient treatments and laboratory services revenue are recognized when those services have been completed or satisfied.

Revenues for cell banking are accounted for as multiple performance obligations as described in ASC 606 and addresses accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets. Because the Company sells its services separately, on more than a limited basis and at a price within a narrow range, the Company was able to allocate revenue based on stand-alone pricing. The multiple performance obligations include stem cell banking, dose retrieval and yearly storage fees. Revenues for stem cell banking and dose retrieval is recognized at the point of service and revenues for the yearly storage fees is recognized over the term of the banking contract, which is typically one year with annual renewals.

At September 30, 2020 and December 31, 2019, the Company had deferred revenues of $83,250 and $86,300, respectively, which includes $63,250 and $65,500, respectively, for the Intellectual Property Licensing Agreement.

Research and Development

The Company accounts for research and development costs in accordance with Accounting Standards Codification subtopic 730-10, Research and Development (“ASC 730-10”). Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved as defined under the applicable agreement. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred. The Company incurred research and development expenses of $0 for the three and nine months ended September 30, 2020, respectively; and $0 and $263 for the three and nine months ended September 30, 2019, respectively.

Stock-Based Compensation

Stock-based compensation expense is measured at the grant date fair value of the award and is expensed over the requisite service period. For stock-based awards to employees, non-employees and directors, the Company calculates the fair value of the award on the date of grant using the Black-Scholes option pricing model. Determining the fair value of stock-based awards at the grant date under this model requires judgment, including estimating volatility, employee stock option exercise behaviors and forfeiture rates. The assumptions used in calculating the fair value of stock-based awards represent the Company’s best estimates, but these estimates involve inherent uncertainties and the application of management’s judgment.

Income Taxes

The Company follows Accounting Standards Codification subtopic 740-10, Income Taxes (“ASC 740-10”) for recording the provision for income taxes. Deferred tax assets and liabilities are computed based upon the difference between the financial statement and income tax basis of assets and liabilities using the enacted marginal tax rate applicable when the related asset or liability is expected to be realized or settled. Deferred income tax expenses or benefits are based on the changes in the asset or liability during each period. If available evidence suggests that it is more likely than not that some portion or all of the deferred tax assets will not be realized, a valuation allowance is required to reduce the deferred tax assets to the amount that is more likely than not to be realized. Future changes in such valuation allowance are included in the provision for deferred income taxes in the period of change. Deferred income taxes may arise from temporary differences resulting from income and expense items reported for financial accounting and tax purposes in different periods.

Deferred taxes are classified as current or non-current, depending on the classification of assets and liabilities to which they relate.  Deferred taxes arising from temporary differences that are not related to an asset or liability are classified as current or non-current depending on the periods in which the temporary differences are expected to reverse and are considered immaterial.

Net Loss per Common Share

The Company computes earnings (loss) per share under Accounting Standards Codification subtopic 260-10, Earnings Per Share (“ASC 260-10”). Net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the year.  Diluted earnings per share, if presented, would include the dilution that would occur upon the exercise or conversion of all potentially dilutive securities into common stock using the “treasury stock” and/or “if converted” methods as applicable.

The computation of basic and diluted income (loss) per share as of September 30, 2020 and 2019 excludes potentially dilutive securities when their inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during the period.

Potentially dilutive securities excluded from the computation of basic and diluted net loss per share are as follows:

	September 30,
	2020		2019
Options		111,119,914		121,038,655
Warrants		1,110,468		1,112,251
Convertible note		11,260,433		-
Total potentially dilutive shares		123,490,815		122,150,906

Recent Accounting Pronouncements

FASB Accounting Standards Updates (“ASU”) 2017-04 (Topic 350), “Intangibles – Goodwill and Others” – Issued in January 2017, ASU 2017-04 simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. This guidance was effective for the Company in the first fiscal quarter of 2020. The adoption of this standard did not have a material impact on the Company’s financial statements and related disclosures.

In February 2016, the FASB established ASC Topic 842, Leases (Topic 842), by issuing ASU No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new standard establishes a right-of-use (ROU) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company adopted the new standard on January 1, 2019. The new standard provides a number of optional practical expedients in transition. The Company has elected the ‘package of practical expedients’, which permit it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter is not applicable to the Company. The new standard had a material effect on the Company’s financial statements. The most significant effects of adoption relate to (1) the recognition of new ROU assets and lease liabilities on its balance sheet for real estate operating leases; and (2) providing significant new disclosures about its leasing activities. Upon adoption, the Company recognized additional operating lease liabilities, net of deferred rent, of approximately $57,000 based on the present value of the remaining minimum rental payments under current leasing standards for existing operating leases. The Company also recognized corresponding ROU assets of approximately $57,000. On October 24, 2019, the Company entered into an Assignment and Assumption of Lease by and between the Company, American Cell Technology, LLC, and Sawgrass Business Plaza, LLC. Subsequently, the Company relocated to a new location within the same city and entered into a month-to-month lease. Accordingly, the right of use assets and lease liabilities were eliminated. The new standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, the Company will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. Beginning in 2019, the Company changed to its disclosed lease recognition policies and practices, as well as to other related financial statement disclosures due to the adoption of this standard.

FASB ASU No. 2018-07 (Topic 718), “Compensation – Stock Compensation: Improvements to Nonemployee Share-Based Payment Accounting” – Issued in June 2018, ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. The amendments also clarify that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606. The Company adopted the new standard on January 1, 2019. The adoption of this guidance did not have a material impact on the Company’s financial condition or results of operations.

In August 2020, the FASB issued ASU 2020-06, which simplifies the guidance on accounting for convertible debt instruments by removing the separation models for: (1) convertible debt with a cash conversion feature; and (2) convertible instruments with a beneficial conversion feature. As a result, the Company will not separately present in equity an embedded conversion feature in such debt. Instead, we will account for a convertible debt instrument wholly as debt, unless certain other conditions are met. We expect the elimination of these models will reduce reported interest expense and increase reported net income for the Company’s convertible instruments falling under the scope of those models before the adoption of ASU 2020-06. Also, ASU 2020-06 requires the application of the if-converted method for calculating diluted earnings per share and the treasury stock method will be no longer available. The provisions of ASU 2020-06 are applicable for fiscal years beginning after December 15, 2021, with early adoption permitted no earlier than fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its financial statements.

In August 2018, the FASB issued Accounting Standards Update (“ASU”) 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement” (“ASU 2018-13”). ASU 2018-13 removes certain disclosure requirements, including the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, the policy for timing of transfers between levels, and the valuation processes for Level 3 fair value measurements. ASU 2018-13 also adds disclosure requirements, including changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements, and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The amendments on changes in unrealized gains and losses, and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. This guidance was effective for the Company in the first fiscal quarter of 2020. The adoption of this standard did not have a material impact on the Company’s financial statements and related disclosures.

There are various other updates recently issued, most of which represented technical corrections to the accounting literature or application to specific industries and are not expected to a have a material impact on the Company’s financial position, results of operations or cash flows.

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PROPERTY AND EQUIPMENT

9 Months Ended

Sep. 30, 2020

Property, Plant and Equipment [Abstract]

Property, Plant and Equipment Disclosure [Text Block]

NOTE 4 — PROPERTY AND EQUIPMENT

Property and equipment as of September 30, 2020 and December 31, 2019 is summarized as follows:

	September 30, 2020			December 31, 2019
Furniture, fixtures and equipment	$	5,598		$	5,598
Computer equipment		1,809			1,809
Property and equipment, cost		7,407			7,407
Less: accumulated depreciation and amortization		(7,407	)		(7,407	)
Property and equipment, net	$	-		$	-

As a consequence of the Court Order (see Note 13 “Government Claim”), the Company resolved to divest itself of certain equipment and other assets (the “Equipment Assets”) used in connection with the Company’s human tissue banking business, but consistent however with the requirements of the Court Order, and to adjust the business plan and operations to accommodate this potential divesture. To facilitate the above, the Company entered into a Termination and Release Agreement and a Letter Agreement intended to divest itself of certain equipment and other assets underlying the related equipment lease transaction. In addition, on October 24, 2019, the Company entered into an Assignment and Assumption of Lease by and between the Company, American Cell Technology, LLC, and Sawgrass Business Plaza, LLC. Subsequently, the Company relocated to a new location within the same city and entered into a month-to-month lease. As part of the termination of the operating lease, the Company left certain property and equipment (all of which had been fully depreciated) at the old location.

In connection with the sale of the lab, medical and other equipment, the Company realized a gain on sale of equipment of $386,535.  The gain is recognized ratably over the term of the lease to operations. During the three and nine months ended September 30, 2020, the Company recognized $0 and $21,474, respectively; and $32,211 and $96,634 during the three and nine months ended September 30, 2019, respectively, as gain on sale of equipment.  As of September 30, 2020 and December 31, 2019, deferred gain on sale of equipment was $0 and $21,474, respectively.

Depreciation expense was $0 for the three and nine months ended September 30, 2020, respectively. Depreciation expense was $51,652 and $154,956, of which $51,652 and $154,956 was included in cost of sales, for the three and nine months ended September 30, 2019, respectively.

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INVESTMENTS

9 Months Ended

Sep. 30, 2020

Equity Method Investments and Joint Ventures [Abstract]

Equity Method Investments and Joint Ventures Disclosure [Text Block]

NOTE 5 — INVESTMENTS

U.S. Stem Cell Clinic, LLC

The investment in U.S. Stem Cell Clinic, LLC is comprised of a 49.9% (increased from 33.3% on January 29, 2019) member interest ownership and is accounted for using the equity method of accounting. The Company’s income (loss) earned by U.S. Stem Cell Clinic, LLC member interest was ($9,718) and ($23,539) for the three and nine months ended September 30, 2020, respectively; and ($51,514) and $51,514 for the three and nine months ended September 30, 2019, respectively (inception to date income of $599,921) and is included in other income (expense) in the accompanying Statements of Operations.  In addition, during the nine months ended September 30, 2020 and 2019, the Company received distributions totaling $0 and $64,870, respectively, from U.S. Stem Cell Clinic, LLC (inception to date of $663,870).  The carrying value of the investment at September 30, 2020 and December 31, 2019 is $0 and $23,539, respectively (See also Note 16; In March, 2021, the Company divested its entire interest in U.S. Stem Cell Clinic, LLC).

At September 30, 2020 and December 31, 2019, accounts receivable for sales of product and services to U.S. Stem Cell Clinic, LLC was $28,763. Revenues earned from sales to U.S. Stem Clinic, LLC for the three and nine months ended September 30, 2020 were $0 and $1,441, respectively; and $33,614 and $329,003 for the three and nine months ended September 30, 2019, respectively.

In January 2019, a member of U.S. Stem Cell Clinic, LLC contributed 16.6% of his ownership interest to the Company increasing the Company’s member interest from 33.3% to 49.9%. The Company recorded the contribution to equity of $4,435.

An affiliate of one of the Company’s officers is a minority investor in the U.S. Stem Cell Clinic, LLC.

Regenerative Wellness Clinic, LLC

The investment in Regenerative Wellness Clinic, LLC is comprised of a 49.9% (increased from 33.3% on January 29, 2019) member interest ownership and is accounted for using the equity method of accounting. The Company has provided technical expertise, but no cash investment with Regenerative Wellness Clinic, LLC’s startup in 2017. The Company’s income earned by Regenerative Wellness Clinic, LLC member interest was $0 for the three and nine months ended September 30, 2020; and ($2,910) and $69,345 for the three and nine months ended September 30, 2019, respectively (inception to date income of $113,047) and is included in other income (expense) in the accompanying Statements of Operations. In addition, during the nine months ended September 30, 2020 and 2019, the Company received distributions totaling $0 and $101,963, respectively, from Regenerative Wellness Clinic, LLC (inception to date of $101,963). The carrying value of the investment at September 30, 2020 and December 31, 2019 is $0. In October 2019, the Company divested its entire interest in U.S. Stem Cell Clinic, LLC.

At December 31, 2019, accounts receivable for sales of products and services to Regenerative Wellness Clinic, LLC was $0. Revenues earned from sales to Regenerative Wellness Clinic, LLC for the three and nine months ended September 30, 2019 was $16,637 and $132,984, respectively.

In January 2019, a member of Regenerative Wellness Clinic, LLC contributed 16.6% of his ownership interest to the Company increasing the Company’s member interest from 33.3% to 49.9%. The Company recorded the contribution to equity of $10,830.

An affiliate of one of the Company’s officers is an investor in the Regenerative Wellness Clinic, LLC.

U.S. Stem Cell of the Villages LLC

On January 30, 2018, Greg Knutson, a director of the Company (“Knutson”) and the Company agreed to open and operate a regenerative medicine/cell therapy clinic providing cellular treatments for patients afflicted with neurological, autoimmune, orthopedic and degenerative diseases in Florida.  To that end, U.S. Stem Cell Clinic of The Villages LLC (the “LLC”) was formed January 30, 2018. Knutson provided the Company with the sum of Three Hundred Thousand Dollars ($300,000) (the “Investment”) to be utilized for the formation and initial operation of the LLC.  Currently, Knutson holds a 51% member interest in the LLC and the Company holds a 49% member interest. The Company will provide operating assistance as well as management services, the latter to be compensated at fee of five percent (5%) of the LLC gross revenues.

As of December 31, 2018, upon completion of U.S. Stem Cell of the Villages LLC, the Company received $189,909 from Greg Knutson, the holder of the 51% member interest. Accordingly, this was recognized as additional paid-in capital. Subsequently, the Company contributed $86,750 as its initial investment in the U.S. Stem Cell of the Villages, LLC. The Company’s 49% income (loss) incurred by U.S. Stem Cell of the Villages LLC member interest was $0 for the three and nine months ended September 30, 2020; and ($9,931) and ($27,081) for the three and nine months ended September 30, 2019, respectively (inception to date loss of $23,050) and is included in other income (expense) in the accompanying Statements of Operations. In addition, during the nine months ended September 30, 2020 and 2019, the Company received distributions totaling $0 from U.S. Stem Cell of the Villages LLC. The carrying value of the investment at September 30, 2020 and December 31, 2019 was $0.

At September 30, 2020 and December 31, 2019, accounts receivable for sales of products and services to U.S. Stem Cell of the Villages LLC was $0. Revenues earned from sales to U.S. Stem Cell of the Villages LLC for the three and nine months ended September 30, 2020 was $0, respectively; and $9,975 and $140,328 for the three and nine months ended September 30, 2019, respectively.

During the three and nine months ended September 30, 2020, the Company received $0; and $975 and $50,751 for the three and nine months ended September 30, 2019, respectively, in management fees from the LLC.

As of the date of this filing, US Stem Cell Clinic of the Villages, LLC is currently dormant.

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RIGHT TO USE ASSETS AND LEASE LIABILITY

9 Months Ended

Sep. 30, 2020

Disclosure Text Block [Abstract]

Lessee, Operating Leases [Text Block]

NOTE 6 — RIGHT TO USE ASSETS AND LEASE LIABILITY

The Company leased its headquarters in Sunrise, Florida which consisted of 4,860 square feet of space at a rate of approximately $82,620 per year. On February 4, 2016, the Company extended its facility lease to extend the term of the lease until August 31, 2019 at a monthly base rent of $7,306 plus a pro rata share of landlord’s operating expenses. Effective September 1, 2019, the Company entered into a second amendment to extend the lease through August 31, 2024 with base rent beginning at $87,674 per year and escalating to $98,678 per year plus a pro rata share of the landlord’s operating expenses.

On September 1, 2019, the lease commencement date, the Company estimated the lease liability and the right of use assets at present value using the Company’s estimated incremental borrowing rate of 8% and determined their initial present values, at inception, of $383,351. In determining the length of the lease term to its long-term lease, the Company determined there was not an option to extend the lease.

In determining the length of the lease term for this long-term lease, the Company determined there was not an option to extend the lease. At lease commencement date, the Company estimated the lease liability and the right of use assets at present value using the Company’s estimated incremental borrowing rate of 8% and determined the initial present value, at inception, of $274,180. On January 1, 2019, upon adoption of ASC Topic 842, the Company recorded right to use assets of $56,734 and lease liability of $56,734.

On October 24, 2019, the Company entered into an Assignment and Assumption of Lease by and between the Company, American Cell Technology, LLC, and Sawgrass Business Plaza, LLC. Subsequently, the Company relocated to a new location within the same city and entered into a month-to-month lease. Accordingly, the right of use assets and lease liabilities were eliminated.

During the three and nine months ended September 30, 2020 and 2019, lease expense was comprised of the following:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2020		2019		2020		2019
Operating lease expense	$	1,689	$	34,560	$	3,891	$	105,200
Variable lease expense		-		-		-		685
Total lease expense	$	1,689	$	34,560	$	3,891	$	105,885

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ACCRUED EXPENSES

9 Months Ended

Sep. 30, 2020

Payables and Accruals [Abstract]

Accounts Payable and Accrued Liabilities Disclosure [Text Block]

NOTE 7 — ACCRUED EXPENSES

Accrued expenses consisted of the following as of September 30, 2020 and December 31, 2019:   

	September 30, 2020		December 31, 2019
Interest and fees payable to the Guarantors of the Company’s loan agreement with Seaside Bank	$	522,746	$	456,190
Accrued interest payable		777,937		580,204
Vendor accruals and other		79,138		79,132
Accrued expenses and other current liabilities	$	1,379,821	$	1,115,526

During the nine months ended September 30, 2020, the Company issued 1,445,647 shares of its common stock, having a fair value of $11,565, in lieu of payment in cash of accrued and unpaid interest of $9,145, resulting in a loss on settlement of $2,420.

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NOTES PAYABLE

9 Months Ended

Sep. 30, 2020

Disclosure Text Block [Abstract]

Debt and Capital Leases Disclosures [Text Block]

NOTE 8 — NOTES PAYABLE

Notes payable were comprised of the following as of September 30, 2020 and December 31, 2019:

	September 30, 2020			December 31, 2019
Seaside Bank note payable	$	980,000		$	980,000
Hunton & Williams note payable		387,500			391,000
Weider note payable		453,493			482,939
Mallard note payable		243,250			250,000
EIDL note payable		150,000			-
Total notes payable		2,214,243			2,103,939
Less unamortized debt discount		(43,592	)		(50,448	)
Total notes payable net of unamortized debt discount		2,170,651			2,053,491
Less current portion		(1,400,910	)		(1,297,477	)
Long-term portion	$	769,741		$	756,014

Seaside Bank

On October 25, 2010, the Company entered into a Loan Agreement with Seaside National Bank and Trust for a $980,000 loan at 4.25% per annum interest that was used to refinance the Company’s loan with Bank of America. The obligation is guaranteed by certain stockholders of the Company. The Company renewed the loan with Seaside National Bank and Trust during the first quarter of 2018 to extend the maturity date to May 18, 2020. The Company renewed the loan with Seaside National Bank and Trust during the first quarter of 2020 to extend the maturity date to May 18, 2022.

Hunton & Williams

At December 31, 2016, the Company has two outstanding notes payable with interest at 8% per annum due at maturity. The two notes, $61,150 and $323,822, are payable in one balloon payment upon the date the Noteholder provides written demand, however the Company is not obligated to make payments until the Northstar Biotech Group, LLC (or successor) Loan is paid off.

On August 31, 2017, the Company and the noteholder entered into a Note Forbearance, Modification and Repayment Agreement (“Agreement”). The two notes, $61,150 and $323,822, were payable in one balloon payment upon the date of a written demand and upon certain triggering events occurring. The sum of unpaid principal and accumulated interest for both notes as of August 31, 2017 of $747,680 and an account payable of $40,596 result in an aggregate balance due of $788,276.

The noteholder agreed to accept full payment of their obligation over a four (4) year period in 48 monthly installments on an adjusted debt obligation in aggregate of $624,000 (reducing the outstanding balance), with such payments staggered in amounts such that the Company will pay $10,000 monthly the first year, $12,000 monthly the second year, $14,000 monthly the third year, and $16,000 monthly the final year.  In addition, the noteholder agreed to suspend accrual interest on the notes commencing September 1, 2017.

The Agreement remains in full force and effect provided the Company continues to make the monthly payments, there is no event of default as defined in the notes and an agreement to a subordination agreement by Northstar Biotech Group, LLC, which has been provided. In May 2019, the Company did not make the required scheduled payment. In September 2010, the noteholder agreed to waive their default rights under the agreement provided a minimum of $5,000 was paid by the end of 2019 and to reduce the required monthly payment to $500 per month commencing in January 2020. The Company satisfied the $5,000 payment requirement by the end of 2019 and commenced making the required $500 monthly payments in January 2020.

The Company imputed an interest rate of 5% and discounted the note accordingly. The imputed debt discount of $69,700 was amortized to interest expense using the effective interest method. For the three and nine months ended September 30, 2020, the Company amortized $0 debt discount; and $24,205 and $34,945 for the three and nine months ended September 30, 2019, respectively, of debt discount to interest expense. At September 30, 2020, the Company was in default and was renegotiating the payment structure. Thus, the remaining unamortized debt discount was charged to interest expense at September 30, 2020. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $387,500 and $391,000, respectively.

Weider

The Company, as one of the parties entered into a Settlement Agreement and General Release (the “Agreement”) dated June 3, 2019 related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year 5.25% unsecured promissory note, dated June 15, 2019, in the principal amount of $500,000, payable in monthly increments of $5,000 per month, with a final balloon payment due on June 15, 2024. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $453,493 and $482,939, respectively.

Mallard

The Company, as one of the parties entered into a Settlement Agreement and General Release (the “Agreement”) dated December 6, 2019 related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year non-interest bearing unsecured promissory note, dated December 6, 2019, in the principal amount of $250,000, payable in monthly increments of $750 per month, with a final balloon payment of $205,000 due on January 1, 2025. The Company imputed an interest rate of 5% and discounted the note accordingly. The imputed debt discount of $51,063 is being amortized to interest expense using the effective interest method. For the three and nine months ended September 30, 2020, the Company amortized $2,328 and $6,857, respectively, of debt discount to interest expense. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $199,658 and $199,551, net of debt discount of $43,592 and $50,448, respectively.

Economic Injury Disaster Loan (EIDL)

On June 20, 2020, the Company executed the standard loan documents for an EIDL from the U.S. Small Business Administration in light of the impact of the COVID-19 pandemic on our business. Pursuant to that certain Loan Authorization and Agreement (the “SBA Loan Agreement”), the principal amount of the EIDL received was $150,000, with proceeds to be used for working capital purposes. Interest accrues at the rate of 3.75% per annum. Installment payments, including principal and interest, are due monthly beginning June 20, 2021 (twelve months from the date of the SBA Loan Agreement) in the amount of $731. The balance of principal and interest is payable thirty years from the date of the SBA Loan Agreement. As of September 30, 2020, the remaining carrying value of the note was $150,000. At September 30, 2020, accrued interest on the note was $1,572, and is included in accrued expenses on the accompanying balance sheet.

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PROMISSORY NOTE PAYABLE

9 Months Ended

Sep. 30, 2020

Debt Disclosure [Abstract]

Debt Disclosure [Text Block]

NOTE 9 — PROMISSORY NOTE PAYABLE

On June 1, 2015, the Company issued an amended and restated promissory note of $1,697,762 in settlement of the $1,500,000 outstanding subordinated debt, related accrued interest of $373,469 and accumulated and unpaid guarantor fees of $624,737.

The note is unsecured and non-interest bearing and requires four semi-annual payments of $75,000 beginning on December 31, 2015 with the remaining unpaid balance due June 1, 2020.  On June 1, 2020, the Company defaulted on the promissory note. Upon default, the note became due in full and the Company began accruing interest at the default interest rate of 18%.

The Company imputed an interest rate of 5% and discounted the promissory note accordingly. The imputed debt discount of $368,615 was amortized to interest expense using the effective interest method. For the three and nine months ended September 30, 2020, the Company amortized $0 and $29,295, respectively of debt discount; and $17,616 and $52,273 for the three and nine months ended September 30, 2019, respectively, of debt discount to interest expense.  As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $1,397,762 and $1,368,467, net of debt discount of $0 and $29,296, respectively.

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CONVERTIBLE NOTE PAYABLE

9 Months Ended

Sep. 30, 2020

Debt Disclosure [Abstract]

Short-term Debt [Text Block]

NOTE 10 — CONVERTIBLE NOTE PAYABLE

On February 5, 2020, the Company issued an unsecured convertible promissory note in the principal amount of $35,000 that matures on February 5, 2021 and bears interest at a rate of 5% per annum. The investor has the right to convert the outstanding balance of the note at any time into shares of common stock of the Company at a conversion price equal to a thirty percent (30%) discount of the average closing price of the Company’s common stock on the OTC Markets electronic exchange for the prior thirty (30) trading days prior to conversion, subject to adjustment. Upon the occurrence of an event of default, the investor may accelerate the note pursuant to which the outstanding balance will become, at the noteholder’s election, immediately due and payable. As a result of the beneficial conversion feature of the note, debt discount of $15,000 was recognized with a corresponding increase in additional paid-in capital. The debt discount is being amortized to interest expense using the effective interest method. For the three and nine months ended September 30, 2020, the Company amortized $3,777 and $8,779, respectively, of debt discount to interest expense.  As of September 30, 2020, the remaining carrying value of the note was $28,779, net of debt discount of $6,221. At September 30, 2020, accrued interest on the note was $1,141, and is included in accrued expenses on the accompanying balance sheet.

On September 8, 2020, the Company issued an unsecured convertible promissory note in the principal amount of $10,000 that is due on demand and bears interest at a rate of 5% per annum. The investor has the right to convert the outstanding balance of the note at any time into shares of common stock of the Company at a conversion price of $0.0467. Upon the occurrence of an event of default, the remaining principal and accrued interest become immediately due and payable, with interest accruing at 18% per annum on any unpaid amounts.  As of September 30, 2020, the remaining carrying value of the note was $10,000. At September 30, 2020, accrued interest on the note was $30, and is included in accrued expenses on the accompanying balance sheet.

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RELATED PARTY TRANSACTIONS

9 Months Ended

Sep. 30, 2020

Related Party Transactions [Abstract]

Related Party Transactions Disclosure [Text Block]

NOTE 11 — RELATED PARTY TRANSACTIONS

Advances – Related Parties

As of September 30, 2020 and December 31, 2019, the Company’s officers and directors have provided advances that are unsecured, non-interest bearing and due on demand. During the nine months ended September 30, 2020 and 2019, the Company received aggregate proceeds from advances of $285,296 and $140,000, respectively. As of September 30, 2020 and December 31, 2019, the Company owed $797,040 and $511,744, respectively, for advances.

Notes Payable – Related Parties

Northstar Biotechnology Group, LLC

On February 29, 2012, a promissory note issued to BlueCrest Master Fund Limited (“BlueCrest”) was assigned to Northstar Biotechnology Group, LLC (“Northstar”), owned partly by certain directors and existing shareholders of the Company at the time, including Dr. William P. Murphy Jr., Dr. Samuel Ahn and Charles Hart. At the date of the assignment, the principal amount of the BlueCrest note was $544,267 (the “Note”).

On March 30, 2012, the Company and Northstar agreed to extend until May 1, 2012 the initial payment date for any and all required monthly under the Note, such that the first of the four monthly payments required under the Note will be due and payable on May 1, 2012 and all subsequent payments will be due on a monthly basis thereafter commencing on June 1, 2012, and to waive any and all defaults and/or events of default under the Note with respect to such payments. The Company did not make the required payment, and as a result, was in default of the revised agreement. The Company renegotiated the terms of the Note and Northstar agreed to suspend the requirement of principal payments by the Company and allow payment of interest-only in common stock.

On September 21, 2012, the Company issued 5,000 common stock purchase warrants to Northstar that was treated as additional interest expense upon issuance.

On October 1, 2012, the Company and Northstar entered into a limited waiver and forbearance agreement providing a recapitalized new note balance comprised of all sums due Northstar with a maturity date extended perpetually. The Company agreed to issue 5,000,000 shares of Series A Convertible Preferred Stock and 10,000 shares of common stock in exchange for $210,000 as payment towards outstanding debt, default interest, penalties, professional fees outstanding and due Northstar. In addition, the Company executed a security agreement granting Northstar a lien on all patents, patent applications, trademarks, service marks, copyrights and intellectual property rights of any nature, as well as the results of all clinical trials, know-how for preparing Myoblasts, old and new clinical data, existing approved trials, all right and title to Myoblasts, clinical trial protocols and other property rights.

In addition, the Company granted Northstar a perpetual license on products as described for resale, relicensing, and commercialization outside the United States. In connection with the granted license, Northstar shall pay the Company a royalty of up to 8% on revenues generated.

Effective October 1, 2012, the interest rate was 12.85% per annum. The parties agreed, as of February 28, 2013, to reduce the interest rate to 7% per annum.

In connection with the consideration paid, Northstar waived, from the effective date through the earlier of termination or expiration of the agreement, satisfaction of the obligations as described in the forbearance agreement.

In 2012, 5,000,000 shares of Series A Convertible Preferred Stock were approved to be issued, which was subsequently increased to 20,000,000 shares of preferred stock as Series A Convertible Preferred Stock. In addition, the Company was obligated to issue additional preferred stock equal in lieu of payment of cash of accrued and unpaid interest on each six-month anniversary of the effective date (October 1, 2012). In lieu of the initial two payments in preferred stock, the parties agreed to modify the voting rights of the subsequently cancelled Series A Convertible Preferred Stock from 20 votes per share on matters to be voted on by the common stockholders to 25 votes per share on matters to be voted on by the common stockholders and all prior and subsequent payments of interest will be in common stock. The Company is required to issue additional shares of its common stock (as amended), in lieu of cash, each six-month anniversary of the effective date for any accrued and unpaid interest.

On September 30, 2013, the Company issued 8,772 shares of its common stock as payment of $100,000 towards principal.

On December 24, 2013, the Company issued 3,916 shares of its common stock as payment of accrued interest through June 30, 2013 of $85,447.

On April 2, 2014, the Company issued 275 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,635 due April 1, 2014 per the forbearance agreement.

On September 17, 2014, the limited waiver and forbearance agreement entered into on October 1, 2012 to provide that the perpetual license on products as described for resale, relicensing and commercialization outside the United States was amended as such on the condition that Northstar provide certain financing, which financing the Company, in its sole discretion, could decline and retain the license.

On October 3, 2014, the Company issued 515 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2014 per the forbearance agreement.

On April 3, 2015, the Company issued 1,363 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,635 due April 1, 2015 per the forbearance agreement.

On October 2, 2015, the Company issued 4,156 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2015 per the forbearance agreement.

On October 7, 2015, the Company issued 34,522 shares of its common stock in settlement of $100,000 principal payment towards the outstanding debt.

On April 7, 2016, the Company issued 57,778 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due April 1, 2016 per the forbearance agreement.

On October 6, 2016, the Company issued 848,490 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705 due October 1, 2016 per the forbearance agreement.

On March 1, 2017, Northstar and the Company entered into a settlement agreement (“Settlement Agreement “) related to then pending litigation. Pursuant to the terms and conditions of the Settlement Agreement, Northstar converted its outstanding Series A Convertible preferred stock, into twenty million (20,000,000) shares of common stock according to the original conversion terms. In addition, and separate and apart from the conversion, Northstar received eleven million (11,000,000) shares of the Company’s common stock. Northstar will receive ten percent (10%) of all Company international sales (based on a gross sales basis). There was no effect of the 10% obligation as there were no international sales in 2017 or through 2019. Furthermore, a Northstar designee, Greg Knutson, was appointed as a member of the Board of Directors of the Company and two Company directors, Michael Tomas and Kristin Comella, each exercised their prior Northstar options to each receive a five percent (5%) member interest in Northstar.  The parties agreed to a mutual release and Northstar agreed to terminate any UCC lien on the Company assets previously filed for the benefit of Northstar. On March 9, 2017 and April 1, 2017, the Company issued 30,000,000 and 1,000,000 shares of its common stock, respectively, as described above. In connection with the settlement, the Company recorded a loss on litigation settlement of $316,800.

On April 1, 2017, the Company issued 286,315 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,703.

On October 2, 2017, the Company issued 559,187 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $12,705.

On October 19, 2018, the Company issued 164,523 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $9,195.

On April 19, 2019, the Company issued 379,141 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $9,145.

On October 1, 2019, the Company issued 1,692,353 shares of its common stock in lieu of payment in cash of accrued and unpaid interest of $9,195.

On April 1, 2020, the Company issued 1,445,647 shares of its common stock, having a fair value of $11,565, in lieu of payment in cash of accrued and unpaid interest of $9,145, resulting in a loss on settlement of $2,420.

As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $262,000. At September 30, 2020 and December 31, 2019, accrued interest on the note was $13,323 and $8,700, respectively, and is included in accrued expenses on the accompanying balance sheet.

Notes Payable - Mr. Tomas, President and Chief Executive Officer

On August 7, 2017, the Company issued a $500,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due one year from date of issuance. During the nine months ended September 30, 2020 and 2019, the Company paid principal of $0 and $321,607, respectively, of this note. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $161,786.

On May 7, 2018, the Company issued a $500,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due six months from date of issuance. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $500,000.

On July 1, 2019, the Company issued a $500,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due November 7, 2019. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $500,000.

On December 31, 2019, the Company issued a $178,077 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due on demand. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $178,077.

On March 31, 2020, the Company issued a $187,500 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due on demand. As of September 30, 2020, the remaining carrying value of the note was $187,500.

On June 30, 2020, the Company issued a $187,500 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due on demand. As of September 30, 2020, the remaining carrying value of the note was $187,500.

On July 1, 2020, the Company issued a $500,000 promissory note as payment of an annual bonus awarded. The promissory note bears interest of 5% per annum and is due on demand. As of September 30, 2020, the remaining carrying value of the note was $500,000.

On September 30, 2020, the Company issued a $100,962 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due on demand. As of September 30, 2020, the remaining carrying value of the note was $100,962.

At September 30, 2020 and December 31, 2019, accrued interest on the notes was $453,282 and $389,695, respectively, and is included in accrued expenses on the accompanying balance sheet.

Notes Payable - Dr. Comella, former Chief Science Officer as of September 30, 2020.

On September 6, 2016, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due upon demand. During the nine months ended September 30, 2019, the Company received back $107,868 of principal amounts previously paid for this note. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $255,579.

On August 7, 2017, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due one year from date of issuance. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $300,000.

On May 7, 2018, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due six months from date of issuance. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $300,000.

On July 1, 2019, the Company issued a $300,000 promissory note in exchange for compensation earned. The promissory note bears interest of 5% per annum and is due November 7, 2019. As of September 30, 2020 and December 31, 2019, the remaining carrying value of the note was $300,000.

At September 30, 2020 and December 31, 2019, accrued interest on the notes was $194,081 and $150,708, respectively, and is included in accrued expenses on the accompanying balance sheet.

Dr. Comella is no longer a member of the Board of Directors after September 1, 2019.

	September 30, 2020		December 31, 2019
Northstar	$	262,000	$	262,000
Note payable, Mr. Tomas		161,786		161,786
Note payable, Mr. Tomas		500,000		500,000
Note payable, Mr. Tomas		500,000		500,000
Note payable, Mr. Tomas		178,077		178,077
Note payable, Mr. Tomas		187,500		-
Note payable, Mr. Tomas		187,500		-
Note payable, Mr. Tomas		500,000		-
Note payable, Mr. Tomas		100,962		-
Note payable, Dr. Comella*		255,579		255,579
Note payable, Dr. Comella*		300,000		300,000
Note payable, Dr. Comella*		300,000		300,000
Note payable, Dr. Comella*		300,000		300,000
Total officer and director notes	$	3,733,404	$	2,757,442
* Dr. Comella is no longer a member of the Board of Directors effective September 1, 2019.

Other Transactions – Related Parties

Transactions with GACP

On March 3, 2017, the Company entered into an asset sale and lease agreement (sale/leaseback transaction, the “Asset Sale and Lease Agreement”) with General American Capital Partners (GACP), whereby the Company sold certain lab, medical and other equipment relating to the cell banking business for $400,000 and leased back the sold equipment over a three-year term. The Company determined that the transaction was a capitalized lease and accordingly recorded the leased assets and liabilities based on the estimated present value of the minimum lease payments. In connection with the Asset Sale and Lease Agreement, the Company is obligated to accrue 10% of cell-banking revenue as for marketing, offset by any incurred costs of the Company.  At September 30, 2020 and December 31, 2019, the outstanding accrued marketing obligation is $0.

On March 3, 2017, the Company also entered into a customer purchase agreement with GACP whereby the Company received a deposit $50,000 (included in long-term liabilities at December 31, 2018) in exchange for the sale of the first 5,000 future customers of the cell-banking business after the effective date of the agreement; GACP also had the right to purchase additional customers at a price of $20 per customer.  There is no reduction in the selling price should the new customers be fewer than 5,000.  The effective date of the sale is upon the expiry or early termination of the aforementioned Asset Sale and Lease Agreement.

March 3, 2017, the Company also entered into an asset purchase agreement of intellectual property with GACP whereby the Company received a deposit of $50,000 (included in long-term liabilities at December 31, 2018) for the sale of all of the Company’s worldwide rights, title or interest in certain intellectual and other property (as defined) associated with the cell-banking business. The effective date of the sale is upon the expiry or early termination of the aforementioned Asset Sale and Lease Agreement.

Effective May 9, 2018, pursuant to an Amendment to the Asset Sale and Lease Agreement, GACP suspended their obligation to open additional clinics (tolling such obligation to a mutually agreeable date in the future) and it has suspended the monthly aggregate number of stem cell kits set forth for purchase in a given month arising from such clinics.

As a consequence of the Court Order dated June 4, 2019 (see Note 13 “Government Claim”), the Company resolved to divest itself of certain equipment and other assets (the “Equipment Assets”) used in connection with the Company’s human tissue banking business, but consistent however with the requirements of the Court Order, and to adjust the business plan and operations to accommodate this potential divesture. To facilitate the above, the Company entered into the following agreements:

● Termination and Release Agreement by and between GACP, the Company, and Michael Tomas and Kristin Comella dated September 24, 2019 (terminating the Non-Competition and Non-Solicitation Agreement between U.S. Stem Cell, Inc. and GACP Stem Cell Bank LLC., dated March 3, 2017).

● Letter Agreement on Stem Cell Processing and Storage by and between the Company and American Cell Technology, LLC

Effective October 9, 2019, the Company terminated the Asset Sale and Lease Agreement by and between the Company and GACP. Accordingly, the long-term deposit liabilities were written off, resulting in a gain on debt settlement of $100,000. In addition, the right of use assets and lease liabilities were also written off.

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FAIR VALUE MEASUREMENT

9 Months Ended

Sep. 30, 2020

Fair Value Disclosures [Abstract]

Fair Value Disclosures [Text Block]

NOTE 12 — FAIR VALUE MEASUREMENT

The Company adopted the provisions of ASC 825-10. ASC 825-10 defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities required or permitted to be recorded at fair value, the Company considers the principal or most advantageous market in which it would transact and considers assumptions that market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of non-performance. ASC 825-10 establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 825-10 establishes three levels of inputs that may be used to measure fair value:

● Level 1 – Quoted prices in active markets for identical assets or liabilities.

● Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities.

● Level 3 – Unobservable inputs to the valuation methodology that are significant to the measurement of fair value of assets or liabilities.

All items required to be recorded or measured on a recurring basis are based upon Level 3 inputs.

To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is disclosed and is determined based on the lowest level input that is significant to the fair value measurement.

As of September 30, 2020 and December 31, 2019, the Company did not have any items that would be classified as level 1, 2 or 3 disclosures.

As of September 30, 2020 and December 31, 2019, the Company did not have any derivative instruments that were designated as hedges.

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COMMITMENTS AND CONTINGENCIES

9 Months Ended

Sep. 30, 2020

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies Disclosure [Text Block]

NOTE 13 — COMMITMENTS AND CONTINGENCIES

Royalty Agreement / Middle East

On November 9, 2016, the Company entered into an Intellectual Property License Agreement whereby the Company granted High Rise Group Company the exclusive right to the Company’s intellectual property (as defined) for the licensed use and development in Kuwait and other GCC/Middle East countries for 25 years in exchange for a payment of $75,000 and a 5% royalty generated under the agreement.  The licensing agreement is recorded as deferred revenue and amortized over the term of the agreement.  The carrying balance as of September 30, 2020 and December 31, 2019 was $63,250 and $65,500, respectively.

The intent is for U.S. Stem Cell Middle East to offer regenerative treatment options to patients, based on U.S. Stem Cell, Inc. products and technologies like MyoCell™. To date, the first clinic in Kuwait City has been completed but has not begun operations as High Rising Group has not yet been able to secure regulatory approvals to operate.

Litigation

On December 12, 2017, a product liability lawsuit was filed in Broward County, specifically Jeannine Mallard v. U.S. Stem Cell, Inc., US Stem Cell Clinics LLC., Regenestem, LLC., Regenestem Network, LLC., and Kristin C. Comella. The Company will continue to defend it vigorously. On December 6, 2019, the Company was one of the parties to a Settlement Agreement and General Release (the “Agreement”) related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year non-interest bearing unsecured promissory note, dated December 6, 2019, in the principal amount of $250,000, payable in monthly increments of $750 per month, with a final balloon payment of $205,000 due on January 1, 2025 (see Note 8, “Mallard”).

On September 17, 2015, a product liability lawsuit was filed in Broward County, specifically Patsy Bade v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D., and on November 30, 2015, a product liability lawsuit was filed in Broward County, specifically Elizabeth Noble v. Bioheart, Inc. US Stem Cell Clinics LLC, Alejandro Perez, ARNP, and Shareen Greenbaum, M.D. During the year ended December 31, 2016, both matters settled by the Company’s insurance policy with no additional cost to the Company, except for the obligation to pay the insurance company deductible of $100,000, of which $11,000 was paid in fiscal 2017. The remaining amount due under this settlement is $28,850 and $30,050 as of September 30, 2020 and December 31, 2019, respectively, and is included in accounts payable.

On June 3, 2019, the Company was one of the parties to a Settlement Agreement and General Release (the “Agreement”) related to certain medical procedures. Without admitting any liability, and as part of that Agreement, the Company agreed to provide a five-year 5.25% Promissory Note, dated June 15, 2019, in the principal amount of Five Hundred Thousand Dollars ($500,000), payable in monthly increments of Five Thousand ($5,000) per month (see Note 8, “Weider”).

The Company is subject at times to other legal proceedings and claims, which arise in the ordinary course of its business.  Although occasional adverse decisions or settlements may occur, the Company believes that the final disposition of such matters should not have a material adverse effect on its financial position, results of operations or liquidity.  There was no outstanding litigation as of September 30, 2020 other than that described above.

Government Claim

On May 9, 2018, the U.S. Department of Justice filed an injunctive action, specifically United States of America v. U.S. Stem Clinic, LLC, U.S. Stem Cell, Inc., Kristin C. Comella, and Theodore Gradel. The Complaint alleges, among other matters that the defendants manufacture “stromal vascular fraction” (SVF) products from patient adipose (fat) tissue, which the companies then market as stem cell-based treatments, and which U.S. Stem Cell Clinic, LLC administers to patients, without first obtaining what the government alleges are necessary FDA approvals. Although Theodore Gradel was initially listed as a defendant, he subsequently entered into a consent agreement and is no longer party to this case.

The U.S. and the defendants filed cross motions for summary judgment, each asking for a ruling in its favor. On June 3, 2019, the Court entered an order granting Summary Judgment for the government and denying the defendants’ motion for summary judgment. The order focused on the defendants’ actions in providing and marketing SVF therapy. In an order dated June 4, 2019, the Court granted the defendants’ request to allow it the opportunity to work out the language of the form of injunction with the government, and if unsuccessful, to provide a status report to the Court by June 14, 2019, outlining areas of disagreement. The Court further ordered that the defendants (U.S. Stem Clinic, LLC, U.S. Stem Cell, Inc., and Kristin C. Comella) ‘not sell, provide or otherwise engage in any SVF therapy or any other activities to be regulated by the FDA as explained in the Court’s Order on the Parties’ Motions for Summary Judgment.” On June 25, 2019, the Court entered an Order of Permanent Injunction, generally enjoining the defendants with respect to the SVF Product and requiring other actions. The Company filed an appeal on August 23, 2019 and attended oral argument on January 13, 2021.  On June 2, 2021, the Eleventh Circuit Court ruled to affirm lower courts’ judgement. The Company did not challenge the district court’s judgment upon any other ground.

The Company, in divesting certain equipment and other assets and assigning its lease, has and will continue to experience a decrease in revenues as the Company both maintains the remainder of the business and transitions into similar or unrelated business opportunities as determined by management. However, management is not able to predict the duration, scope, results, or consequences of the  summary judgment and any transition of the business plan.

Since the Court’s issuance of the Order of Permanent Injunction, the Company has received demand letters for compensation from persons who store their SVF Product and/or other tissue product with the tissue bank (several of the persons have requested refunds of the monies paid to the tissue bank and one person has requested a full refund of monies paid to an altogether separate company due to her not receiving the full amount of treatments she requested; such requests for compensation, to date, have not been material) and requests that the Company preserve cells in the Company’s possession.  The Company sought guidance from the Court, which entered an order generally staying the requirement to destroy any SVF Product, pending a decision on the Company’s appeal. 

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STOCKHOLDERS' DEFICIT

9 Months Ended

Sep. 30, 2020

Stockholders' Equity Note [Abstract]

Stockholders' Equity Note Disclosure [Text Block]

NOTE 14 — STOCKHOLDERS’ DEFICIT

Common Stock

During the nine months ended September 30, 2020, the Company issued an aggregate of 6,532,248 shares of its common stock, having a fair value of $32,803, in settlement of outstanding accounts payable. In connection with the issuances, the Company incurred a $2,697 net gain on settlement.

During the nine months ended September 30, 2020, the Company issued 1,445,647 shares of its common stock, having a fair value of $11,565, in lieu of payment in cash of accrued and unpaid interest of $9,145, resulting in a loss on settlement of $2,420.

During the nine months ended September 30, 2020, the Company issued an aggregate of 4,000,000 shares of its common stock, having a fair value of $16,000, for services.

Stock Options

On April 1, 2013, the Board of Directors approved, subject to subsequently received stockholder approval, the establishment of the Bioheart 2013 Omnibus Equity Compensation Plan, or the “2013 Omnibus Plan” (replacing the 1999 Officers and Employees Stock Option Plan, or the Employee Plan, and the 1999 Directors and Consultants Stock Option Plan). The 2013 Omnibus Plan initially reserved up to fifty thousand (50,000) shares of common stock for issuance. On August 4, 2014, the Board of Directors approved to set the reserve to one hundred thousand (100,000) shares of common stock for issuance and to close the 1999 Officers and Employees Stock Option Plan. On February 2, 2015, at the annual meeting of stockholders, the 2013 Omnibus Equity Compensation Plan was approved.

On November 2, 2015, the Company increased the shares reserved under the 2013 Omnibus Plan to five hundred million (500,000,000) shares of common stock for issuance. Effective September 16, 2016, the Company approved an additional twenty five million (25,000,000) shares of common stock to the reserve; effective April 21, 2017, the Company approved an additional twenty five million (25,000,000) shares of common stock to the reserve; effective August 7, 2017, the Company approved an additional thirty million (30,000,000) shares of common stock to the reserve; and effective May 7, 2018, the Company approved an addition of one hundred million (100,000,000) shares of common stock to reserve.

A summary of the stock option activity for the nine months ended September 30, 2020 is as follows:

				Weighted		Weighted
				Average		Average
	Number of			Exercise		Remaining Life		Intrinsic
	Options			Price		In Years		Value
Outstanding, December 31, 2019		111,120,474		$	0.0247		8.3	$	-
Granted		-
Exercised		-
Forfeited/Expired		(560	)	$	0.1540
Outstanding, September 30, 2020		111,119,914		$	0.0247		7.8	$	-
Exercisable, September 30, 2020		75,737,414		$	0.0255		7.2	$	-

Options Outstanding							Options Exercisable
			Weighted		Weighted				Weighted
	Outstanding		Average		Average		Exercisable		Average
Exercise	Number of		Exercise		Remaining Life		Number of		Exercise
Price	Options		Price		In Years		Options		Price
$0.004 to $0.010		41,900,000	$	0.0051		8.3		21,650,000	$	0.0049
$0.011 to $0.020		16,300,000	$	0.0196		6.0		16,300,000	$	0.0196
$0.021 to $0.030		9,710,000	$	0.0253		8.1		8,605,000	$	0.0252
$0.0363		22,735,000	$	0.0363		6.9		18,707,500	$	0.0363
$0.0536		20,000,000	$	0.0536		7.6		10,000,000	$	0.0536
$0.1540		474,914	$	0.1540		5.0		474,914	$	0.1540
		111,119,914	$	0.0247		7.5		75,737,414	$	0.0255

The aggregate intrinsic value of outstanding stock options was $0, based on options with an exercise price less than the Company’s stock price of $0.0043 as of September 30, 2020, which would have been received by the option holders had those option holders exercised their options as of that date.

The fair value of all options that vested during the nine months ended September 30, 2020 and 2019 was $525,336 and $512,882, respectively. As of September 30, 2020, the Company had $890,216 of total unrecognized compensation cost related to non-vested awards granted under the 2013 Omnibus Plan, which the Company expects to recognize over a weighted average period of 0.92 years.

Warrants

A summary of the warrant activity for the nine months ended September 30, 2020 is as follows:

					Weighted
			Weighted		Average
			Average		Remaining
	Number of		Exercise		Life		Intrinsic
	Warrants		Price		In Years		Value
Outstanding, December 31, 2019		1,110,468	$	12.8400		8.2	$	-
Granted		-
Exercised		-
Expired		-
Outstanding, September 30, 2020		1,110,468	$	12.84		7.4	$	-
Exercisable, September 30, 2020		1,108,923	$	2.14		7.4	$	-

Warrants Outstanding							Warrants Exercisable
			Weighted		Weighted				Weighted
	Outstanding		Average		Average		Exercisable		Average
Exercise	Number of		Exercise		Remaining Life		Number of		Exercise
Price	Warrants		Price		In Years		Warants		Price
$0.03 to $20.00		1,086,536	$	1.27		7.5		1,086,536	$	1.27
$20.01 to $30.00		19,543	$	25.06		3.4		19,543	$	25.06
$40.01 to $50.00		2,253	$	48.83		2.0		2,253	$	48.83
$50.01 to $60.00		543	$	60.00		0.8		543	$	60.00
>$60.00		1,593	$	7,690.00		6.1		48	$	7,690.00
		1,110,468	$	12.84		7.4		1,108,923	$	2.14

The aggregate intrinsic value of the issued and exercisable warrants of $0 represents the total pretax intrinsic value, based on warrants with an exercise price less than the Company’s stock price of $0.0043 as of September 30, 2020, which would have been received by the warrant holders had those warrants holders exercised their warrants as of that date.

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CONCENTRATIONS

9 Months Ended

Sep. 30, 2020

Risks and Uncertainties [Abstract]

Concentration Risk Disclosure [Text Block]

NOTE 15 — CONCENTRATIONS

Concentrations of Credit Risk

The Company’s financial instruments that are exposed to a concentration of credit risk are cash and accounts receivable. Generally, the Company’s cash and cash equivalents in interest-bearing accounts does not exceed FDIC insurance limits. The financial stability of these institutions is periodically reviewed by senior management.

Concentrations of Revenues

For the three and nine months ended September 30, 2020 and 2019, the following customers accounted for more than 10% of the Company’s net revenues:

	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2020			2019			2020			2019
Customer 1		24	%		-			15	%		-
Customer 2		15	%		-			-			-
Customer 3		14	%		-			-			-
Customer 4		-			-			13	%		-
Customer 5		-			27	%		-			12	%
Customer 6		-			22	%		-			-
Totals		53	%		49	%		28	%		12	%

Customer 5 is U.S. Stem Cell Clinic, LLC, a related party, a partly owned investment in which the Company holds a 49.9% member interest.

Concentrations of Accounts Receivable

As of September 30, 2020 and December 31, 2019, the following customers represented more than 10% of the Company’s accounts receivable:

	September 30, 2020			December 31, 2019
Customer 1		83	%		47	%
Customer 2		-			47	%
Totals		83	%		94	%

Customer 1 is U.S. Stem Cell Clinic, LLC, a related party, a partly owned investment in which the Company holds a 49.9% member interest.

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SUBSEQUENT EVENTS

9 Months Ended

Sep. 30, 2020

Subsequent Events [Abstract]

Subsequent Events [Text Block]

NOTE 16 — SUBSEQUENT EVENTS

In March 2021, the Company divested its entire interest in U.S. Stem Cell Clinic, LLC.

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Accounting Policies, by Policy (Policies)

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Fair Value of Financial Instruments, Policy [Policy Text Block]

Fair Value

Accounting Standards Codification subtopic 825-10, Financial Instruments (“ASC 825-10”) requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable, accrued liabilities, and short-term borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments. All other significant financial assets, financial liabilities and equity instruments of the Company are either recognized or disclosed in the financial statements together with other information relevant for making a reasonable assessment of future cash flows, interest rate risk and credit risk. Where practicable the fair values of financial assets and financial liabilities have been determined and disclosed; otherwise only available information pertinent to fair value has been disclosed.

The Company follows Accounting Standards Codification subtopic 820-10, Fair Value Measurements and Disclosures (“ASC 820-10”) and Accounting Standards Codification subtopic 825-10, Financial Instruments (“ASC 825-10”), which permits entities to choose to measure many financial instruments and certain other items at fair value.

Cash and Cash Equivalents, Policy [Policy Text Block]

Cash

The Company considers cash to consist of cash on hand and temporary investments having an original maturity of 90 days or less that are readily convertible into cash.

Inventory, Policy [Policy Text Block]

Inventories

Inventories are stated at the lower of cost or market with cost being determined on a first-in, first-out (FIFO) basis. The Company writes down its inventory for estimated obsolescence or unmarketable inventory equal to the difference between the cost of inventory and the estimated market value based upon assumptions about future demand and market conditions. If actual market conditions are less favorable than those projected by management, additional inventory write-downs may be required. During the periods presented, there were no inventory write-downs.

Equity Method Investments [Policy Text Block]

Investments

The Company follows Accounting Standards Codification subtopic 323-10, Investments-Equity Methods and Joint Ventures (“ASC 323-10) which requires the accounting for investments where the Company can exert significant influence, but not control of a joint venture or equity investment. The Company accounted for its 49.9% member interest ownerships of U.S. Stem Cell Clinic, LLC and Regenerative Wellness Clinic, LLC, respectively, and its 49% member interest ownership of U.S. Stem Cell Clinic of the Villages utilizing the equity method of accounting (See Note 5).

Revenue [Policy Text Block]

Revenue Recognition

Effective January 1, 2018, the Company recognizes revenue in accordance with Accounting Standards Codification 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific revenue recognition guidance throughout the Industry Topics of the Accounting Standards Codification. The updated guidance states that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The guidance also provides for additional disclosures with respect to revenues and cash flows arising from contracts with customers.

At the time of each transaction, management assesses whether the fee associated with the transaction is fixed or determinable and whether or not collection is reasonably assured. The assessment of whether the fee is fixed or determinable is based upon the payment terms of the transaction. Collectability is assessed based on a number of factors, including past transaction history with the client and the creditworthiness of the client.

The Company’s primary sources of revenue are from the sale of test kits and equipment, training services, patient treatments, laboratory services and cell banking. 

Revenues for kits and equipment sold are not recorded until kits and equipment are received by the customer. Revenues from in-person trainings are recognized when the training occurs and revenues from on demand online trainings are recognized when the customer purchases the rights to the training course. Any cash received as a deposit for trainings are recorded by the Company as a liability.

Patient treatments and laboratory services revenue are recognized when those services have been completed or satisfied.

Revenues for cell banking are accounted for as multiple performance obligations as described in ASC 606 and addresses accounting for arrangements that may involve the delivery or performance of multiple products, services and/or rights to use assets. Because the Company sells its services separately, on more than a limited basis and at a price within a narrow range, the Company was able to allocate revenue based on stand-alone pricing. The multiple performance obligations include stem cell banking, dose retrieval and yearly storage fees. Revenues for stem cell banking and dose retrieval is recognized at the point of service and revenues for the yearly storage fees is recognized over the term of the banking contract, which is typically one year with annual renewals.

At September 30, 2020 and December 31, 2019, the Company had deferred revenues of $83,250 and $86,300, respectively, which includes $63,250 and $65,500, respectively, for the Intellectual Property Licensing Agreement.

Research and Development Expense, Policy [Policy Text Block]

Research and Development

The Company accounts for research and development costs in accordance with Accounting Standards Codification subtopic 730-10, Research and Development (“ASC 730-10”). Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved as defined under the applicable agreement. Company-sponsored research and development costs related to both present and future products are expensed in the period incurred. The Company incurred research and development expenses of $0 for the three and nine months ended September 30, 2020, respectively; and $0 and $263 for the three and nine months ended September 30, 2019, respectively.

Share-based Payment Arrangement [Policy Text Block]

Stock-Based Compensation

Stock-based compensation expense is measured at the grant date fair value of the award and is expensed over the requisite service period. For stock-based awards to employees, non-employees and directors, the Company calculates the fair value of the award on the date of grant using the Black-Scholes option pricing model. Determining the fair value of stock-based awards at the grant date under this model requires judgment, including estimating volatility, employee stock option exercise behaviors and forfeiture rates. The assumptions used in calculating the fair value of stock-based awards represent the Company’s best estimates, but these estimates involve inherent uncertainties and the application of management’s judgment.

Income Tax, Policy [Policy Text Block]

Income Taxes

The Company follows Accounting Standards Codification subtopic 740-10, Income Taxes (“ASC 740-10”) for recording the provision for income taxes. Deferred tax assets and liabilities are computed based upon the difference between the financial statement and income tax basis of assets and liabilities using the enacted marginal tax rate applicable when the related asset or liability is expected to be realized or settled. Deferred income tax expenses or benefits are based on the changes in the asset or liability during each period. If available evidence suggests that it is more likely than not that some portion or all of the deferred tax assets will not be realized, a valuation allowance is required to reduce the deferred tax assets to the amount that is more likely than not to be realized. Future changes in such valuation allowance are included in the provision for deferred income taxes in the period of change. Deferred income taxes may arise from temporary differences resulting from income and expense items reported for financial accounting and tax purposes in different periods.

Deferred taxes are classified as current or non-current, depending on the classification of assets and liabilities to which they relate.  Deferred taxes arising from temporary differences that are not related to an asset or liability are classified as current or non-current depending on the periods in which the temporary differences are expected to reverse and are considered immaterial.

Earnings Per Share, Policy [Policy Text Block]

Net Loss per Common Share

The Company computes earnings (loss) per share under Accounting Standards Codification subtopic 260-10, Earnings Per Share (“ASC 260-10”). Net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the year.  Diluted earnings per share, if presented, would include the dilution that would occur upon the exercise or conversion of all potentially dilutive securities into common stock using the “treasury stock” and/or “if converted” methods as applicable.

The computation of basic and diluted income (loss) per share as of September 30, 2020 and 2019 excludes potentially dilutive securities when their inclusion would be anti-dilutive, or if their exercise prices were greater than the average market price of the common stock during the period.

Potentially dilutive securities excluded from the computation of basic and diluted net loss per share are as follows:

	September 30,
	2020		2019
Options		111,119,914		121,038,655
Warrants		1,110,468		1,112,251
Convertible note		11,260,433		-
Total potentially dilutive shares		123,490,815		122,150,906

New Accounting Pronouncements, Policy [Policy Text Block]

Recent Accounting Pronouncements

FASB Accounting Standards Updates (“ASU”) 2017-04 (Topic 350), “Intangibles – Goodwill and Others” – Issued in January 2017, ASU 2017-04 simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. This guidance was effective for the Company in the first fiscal quarter of 2020. The adoption of this standard did not have a material impact on the Company’s financial statements and related disclosures.

In February 2016, the FASB established ASC Topic 842, Leases (Topic 842), by issuing ASU No. 2016-02, which requires lessees to recognize leases on-balance sheet and disclose key information about leasing arrangements. Topic 842 was subsequently amended by ASU No. 2018-01, Land Easement Practical Expedient for Transition to Topic 842; ASU No. 2018-10, Codification Improvements to Topic 842, Leases; and ASU No. 2018-11, Targeted Improvements. The new standard establishes a right-of-use (ROU) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet. Leases will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company adopted the new standard on January 1, 2019. The new standard provides a number of optional practical expedients in transition. The Company has elected the ‘package of practical expedients’, which permit it not to reassess under the new standard its prior conclusions about lease identification, lease classification and initial direct costs. The Company did not elect the use-of-hindsight or the practical expedient pertaining to land easements; the latter is not applicable to the Company. The new standard had a material effect on the Company’s financial statements. The most significant effects of adoption relate to (1) the recognition of new ROU assets and lease liabilities on its balance sheet for real estate operating leases; and (2) providing significant new disclosures about its leasing activities. Upon adoption, the Company recognized additional operating lease liabilities, net of deferred rent, of approximately $57,000 based on the present value of the remaining minimum rental payments under current leasing standards for existing operating leases. The Company also recognized corresponding ROU assets of approximately $57,000. On October 24, 2019, the Company entered into an Assignment and Assumption of Lease by and between the Company, American Cell Technology, LLC, and Sawgrass Business Plaza, LLC. Subsequently, the Company relocated to a new location within the same city and entered into a month-to-month lease. Accordingly, the right of use assets and lease liabilities were eliminated. The new standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, the Company will not recognize ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. Beginning in 2019, the Company changed to its disclosed lease recognition policies and practices, as well as to other related financial statement disclosures due to the adoption of this standard.

FASB ASU No. 2018-07 (Topic 718), “Compensation – Stock Compensation: Improvements to Nonemployee Share-Based Payment Accounting” – Issued in June 2018, ASU 2018-07 expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from non-employees. The amendments also clarify that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606. The Company adopted the new standard on January 1, 2019. The adoption of this guidance did not have a material impact on the Company’s financial condition or results of operations.

In August 2020, the FASB issued ASU 2020-06, which simplifies the guidance on accounting for convertible debt instruments by removing the separation models for: (1) convertible debt with a cash conversion feature; and (2) convertible instruments with a beneficial conversion feature. As a result, the Company will not separately present in equity an embedded conversion feature in such debt. Instead, we will account for a convertible debt instrument wholly as debt, unless certain other conditions are met. We expect the elimination of these models will reduce reported interest expense and increase reported net income for the Company’s convertible instruments falling under the scope of those models before the adoption of ASU 2020-06. Also, ASU 2020-06 requires the application of the if-converted method for calculating diluted earnings per share and the treasury stock method will be no longer available. The provisions of ASU 2020-06 are applicable for fiscal years beginning after December 15, 2021, with early adoption permitted no earlier than fiscal years beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its financial statements.

In August 2018, the FASB issued Accounting Standards Update (“ASU”) 2018-13, “Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement” (“ASU 2018-13”). ASU 2018-13 removes certain disclosure requirements, including the amount of and reasons for transfers between Level 1 and Level 2 of the fair value hierarchy, the policy for timing of transfers between levels, and the valuation processes for Level 3 fair value measurements. ASU 2018-13 also adds disclosure requirements, including changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level 3 fair value measurements, and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. The amendments on changes in unrealized gains and losses, and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. This guidance was effective for the Company in the first fiscal quarter of 2020. The adoption of this standard did not have a material impact on the Company’s financial statements and related disclosures.

There are various other updates recently issued, most of which represented technical corrections to the accounting literature or application to specific industries and are not expected to a have a material impact on the Company’s financial position, results of operations or cash flows.

Use of Estimates, Policy [Policy Text Block]

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from these estimates.

Receivables, Trade and Other Accounts Receivable, Allowance for Doubtful Accounts, Policy [Policy Text Block]

Accounts Receivable and Allowance for Doubtful Accounts

Accounts receivable are non-interest bearing and are stated at gross invoice amounts less an allowance for doubtful accounts. Credit is extended to customers based on an evaluation of their financial condition, industry reputation, and other judgmental factors considered by the Company’s management. The Company generally does not require collateral or other security interest to support accounts receivable. Based on trends and specific factors, the customer’s credit terms may be modified, including required payment upon delivery.

The Company performs regular on-going credit evaluations of its customers as deemed relevant. As events, trends, and circumstance warrant, the Company’s management estimates the amounts that are more likely than not to be uncollectible. These amounts are recognized as bad debt expense and are reflected within selling, general, administrative and other expenses on the Company’s accompanying statement of operations.

Any charges to the allowance for doubtful accounts on accounts receivable are charged to operations in amounts sufficient to maintain the allowance for uncollectible accounts at a level management believes is adequate to cover any probable losses. Management determines the adequacy of the allowance based on historical write-off percentages and the current status of accounts receivable. Accounts receivable are charged off against the allowance when collectability is determined to be permanently impaired. As of September 30, 2020 and December 31, 2019, the allowance for doubtful accounts was $13,203.

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SIGNIFICANT ACCOUNTING POLICIES (Tables)

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block]

Potentially dilutive securities excluded from the computation of basic and diluted net loss per share are as follows:

	September 30,
	2020		2019
Options		111,119,914		121,038,655
Warrants		1,110,468		1,112,251
Convertible note		11,260,433		-
Total potentially dilutive shares		123,490,815		122,150,906

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PROPERTY AND EQUIPMENT (Tables)

9 Months Ended

Sep. 30, 2020

Property, Plant and Equipment [Abstract]

Property, Plant and Equipment [Table Text Block]

Property and equipment as of September 30, 2020 and December 31, 2019 is summarized as follows:

	September 30, 2020			December 31, 2019
Furniture, fixtures and equipment	$	5,598		$	5,598
Computer equipment		1,809			1,809
Property and equipment, cost		7,407			7,407
Less: accumulated depreciation and amortization		(7,407	)		(7,407	)
Property and equipment, net	$	-		$	-

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RIGHT TO USE ASSETS AND LEASE LIABILITY (Tables)

9 Months Ended

Sep. 30, 2020

Disclosure Text Block [Abstract]

Lease, Cost [Table Text Block]

During the three and nine months ended September 30, 2020 and 2019, lease expense was comprised of the following:

	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2020		2019		2020		2019
Operating lease expense	$	1,689	$	34,560	$	3,891	$	105,200
Variable lease expense		-		-		-		685
Total lease expense	$	1,689	$	34,560	$	3,891	$	105,885

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ACCRUED EXPENSES (Tables)

9 Months Ended

Sep. 30, 2020

Payables and Accruals [Abstract]

Schedule of Accrued Liabilities [Table Text Block]

Accrued expenses consisted of the following as of September 30, 2020 and December 31, 2019:

	September 30, 2020		December 31, 2019
Interest and fees payable to the Guarantors of the Company’s loan agreement with Seaside Bank	$	522,746	$	456,190
Accrued interest payable		777,937		580,204
Vendor accruals and other		79,138		79,132
Accrued expenses and other current liabilities	$	1,379,821	$	1,115,526

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NOTES PAYABLE (Tables)

9 Months Ended

Sep. 30, 2020

Disclosure Text Block [Abstract]

Schedule of Debt [Table Text Block]

Notes payable were comprised of the following as of September 30, 2020 and December 31, 2019:

	September 30, 2020			December 31, 2019
Seaside Bank note payable	$	980,000		$	980,000
Hunton & Williams note payable		387,500			391,000
Weider note payable		453,493			482,939
Mallard note payable		243,250			250,000
EIDL note payable		150,000			-
Total notes payable		2,214,243			2,103,939
Less unamortized debt discount		(43,592	)		(50,448	)
Total notes payable net of unamortized debt discount		2,170,651			2,053,491
Less current portion		(1,400,910	)		(1,297,477	)
Long-term portion	$	769,741		$	756,014

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RELATED PARTY TRANSACTIONS (Tables)

9 Months Ended

Sep. 30, 2020

Related Party Transactions [Abstract]

Schedule of Related Party Transactions [Table Text Block]

Officer and Director Notes

	September 30, 2020		December 31, 2019
Northstar	$	262,000	$	262,000
Note payable, Mr. Tomas		161,786		161,786
Note payable, Mr. Tomas		500,000		500,000
Note payable, Mr. Tomas		500,000		500,000
Note payable, Mr. Tomas		178,077		178,077
Note payable, Mr. Tomas		187,500		-
Note payable, Mr. Tomas		187,500		-
Note payable, Mr. Tomas		500,000		-
Note payable, Mr. Tomas		100,962		-
Note payable, Dr. Comella*		255,579		255,579
Note payable, Dr. Comella*		300,000		300,000
Note payable, Dr. Comella*		300,000		300,000
Note payable, Dr. Comella*		300,000		300,000
Total officer and director notes	$	3,733,404	$	2,757,442
* Dr. Comella is no longer a member of the Board of Directors effective September 1, 2019.

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STOCKHOLDERS' DEFICIT (Tables)

9 Months Ended

Sep. 30, 2020

Stockholders' Equity Note [Abstract]

Share-based Payment Arrangement, Option, Activity [Table Text Block]

A summary of the stock option activity for the nine months ended September 30, 2020 is as follows:

				Weighted		Weighted
				Average		Average
	Number of			Exercise		Remaining Life		Intrinsic
	Options			Price		In Years		Value
Outstanding, December 31, 2019		111,120,474		$	0.0247		8.3	$	-
Granted		-
Exercised		-
Forfeited/Expired		(560	)	$	0.1540
Outstanding, September 30, 2020		111,119,914		$	0.0247		7.8	$	-
Exercisable, September 30, 2020		75,737,414		$	0.0255		7.2	$	-

Share-based Payment Arrangement, Option, Exercise Price Range [Table Text Block]

Options Outstanding							Options Exercisable
			Weighted		Weighted				Weighted
	Outstanding		Average		Average		Exercisable		Average
Exercise	Number of		Exercise		Remaining Life		Number of		Exercise
Price	Options		Price		In Years		Options		Price
$0.004 to $0.010		41,900,000	$	0.0051		8.3		21,650,000	$	0.0049
$0.011 to $0.020		16,300,000	$	0.0196		6.0		16,300,000	$	0.0196
$0.021 to $0.030		9,710,000	$	0.0253		8.1		8,605,000	$	0.0252
$0.0363		22,735,000	$	0.0363		6.9		18,707,500	$	0.0363
$0.0536		20,000,000	$	0.0536		7.6		10,000,000	$	0.0536
$0.1540		474,914	$	0.1540		5.0		474,914	$	0.1540
		111,119,914	$	0.0247		7.5		75,737,414	$	0.0255

Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block]

A summary of the warrant activity for the nine months ended September 30, 2020 is as follows:

					Weighted
			Weighted		Average
			Average		Remaining
	Number of		Exercise		Life		Intrinsic
	Warrants		Price		In Years		Value
Outstanding, December 31, 2019		1,110,468	$	12.8400		8.2	$	-
Granted		-
Exercised		-
Expired		-
Outstanding, September 30, 2020		1,110,468	$	12.84		7.4	$	-
Exercisable, September 30, 2020		1,108,923	$	2.14		7.4	$	-

Schedule of Warrants or Rights, Shares Authorized, by Exercise Price Range [Table Text Block]

Warrants Outstanding							Warrants Exercisable
			Weighted		Weighted				Weighted
	Outstanding		Average		Average		Exercisable		Average
Exercise	Number of		Exercise		Remaining Life		Number of		Exercise
Price	Warrants		Price		In Years		Warants		Price
$0.03 to $20.00		1,086,536	$	1.27		7.5		1,086,536	$	1.27
$20.01 to $30.00		19,543	$	25.06		3.4		19,543	$	25.06
$40.01 to $50.00		2,253	$	48.83		2.0		2,253	$	48.83
$50.01 to $60.00		543	$	60.00		0.8		543	$	60.00
>$60.00		1,593	$	7,690.00		6.1		48	$	7,690.00
		1,110,468	$	12.84		7.4		1,108,923	$	2.14

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CONCENTRATIONS (Tables)

9 Months Ended

Sep. 30, 2020

Customer Concentration Risk [Member]

CONCENTRATIONS (Tables) [Line Items]

Schedules of Concentration of Risk, by Risk Factor [Table Text Block]

For the three and nine months ended September 30, 2020 and 2019, the following customers accounted for more than 10% of the Company’s net revenues:

	For the Three Months Ended September 30,						For the Nine Months Ended September 30,
	2020			2019			2020			2019
Customer 1		24	%		-			15	%		-
Customer 2		15	%		-			-			-
Customer 3		14	%		-			-			-
Customer 4		-			-			13	%		-
Customer 5		-			27	%		-			12	%
Customer 6		-			22	%		-			-
Totals		53	%		49	%		28	%		12	%

Credit Concentration Risk [Member]

CONCENTRATIONS (Tables) [Line Items]

Schedules of Concentration of Risk, by Risk Factor [Table Text Block]

As of September 30, 2020 and December 31, 2019, the following customers represented more than 10% of the Company’s accounts receivable:

	September 30, 2020			December 31, 2019
Customer 1		83	%		47	%
Customer 2		-			47	%
Totals		83	%		94	%

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GOING CONCERN AND MANAGEMENT'S LIQUIDITY PLANS (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Jun. 30, 2020	Dec. 31, 2019	Jun. 30, 2019	Dec. 31, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Cash and Cash Equivalents, at Carrying Value	$ 81,228	$ 78,104	$ 81,228	$ 78,104		$ 0		$ 1,357,146
Working Capital (Deficit)	(10,349,510)		(10,349,510)
Net Income (Loss) Attributable to Parent	(1,155,775)	(1,645,949)	(2,300,809)	(3,158,293)
Net Cash Provided by (Used in) Operating Activities			(357,851)	(991,136)
Stockholders' Equity Attributable to Parent	$ (11,179,501)	$ (9,113,812)	$ (11,179,501)	$ (9,113,812)	$ (10,208,851)	$ (9,479,396)	$ (7,676,326)	$ (6,882,210)

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SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Sep. 01, 2019	Jan. 01, 2019	Jan. 30, 2018
SIGNIFICANT ACCOUNTING POLICIES (Details) [Line Items]
Accounts Receivable, Allowance for Credit Loss, Current	$ 13,203		$ 13,203
Deferred Revenue	83,250		83,250		$ 86,300
Research and Development Expense	$ 0	$ 0	$ 0	$ 263
Sunrise, Florida [Member]
SIGNIFICANT ACCOUNTING POLICIES (Details) [Line Items]
Operating Lease, Liability						$ 383,351	$ 57,000
Operating Lease, Right-of-Use Asset							$ 57,000
U.S. Stem Cell Clinic, LLC [Member]
SIGNIFICANT ACCOUNTING POLICIES (Details) [Line Items]
Equity Method Investment, Ownership Percentage	49.90%		49.90%
U.S. Stem Cell Clinic of The Village LLC (the "LLC") [Member]
SIGNIFICANT ACCOUNTING POLICIES (Details) [Line Items]
Equity Method Investment, Ownership Percentage	49.00%		49.00%					49.00%
Royalty Arrangement [Member]
SIGNIFICANT ACCOUNTING POLICIES (Details) [Line Items]
Deferred Revenue	$ 63,250		$ 63,250		$ 65,500

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SIGNIFICANT ACCOUNTING POLICIES (Details) - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share - shares	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	123,490,815	122,150,906
Share-based Payment Arrangement, Option [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	111,119,914	121,038,655
Warrant [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	1,110,468	1,112,251
Convertible Debt Securities [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	11,260,433	0

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PROPERTY AND EQUIPMENT (Details) - USD ($)		3 Months Ended		9 Months Ended
	Mar. 03, 2017	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
Property, Plant and Equipment [Abstract]
Sale Leaseback Transaction, Lease Terms	Termination and Release Agreement and a Letter Agreement intended to divest itself of certain equipment and other assets underlying the related equipment lease transaction
Sale Leaseback Transaction, Deferred Gain, Gross	$ 386,535
Sale Leaseback Transaction, Current Period Gain Recognized		$ 0	$ 32,211	$ 21,474	$ 96,634
Sale Leaseback Transaction, Deferred Gain, Net		$ 0		0		$ 21,474
Depreciation			51,652	$ 0	154,956
Cost, Depreciation			$ 51,652		$ 154,956

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PROPERTY AND EQUIPMENT (Details) - Schedule of Property and Equipment - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Schedule of Property and Equipment [Abstract]
Furniture, fixtures and equipment	$ 5,598	$ 5,598
Computer equipment	1,809	1,809
Property and equipment, gross	7,407	7,407
Less accumulated depreciation and amortization	(7,407)	(7,407)
Property and equipment, net	$ 0	$ 0

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INVESTMENTS (Details) - USD ($)		1 Months Ended	3 Months Ended		9 Months Ended		12 Months Ended		254 Months Ended
	Jan. 30, 2018	Jan. 31, 2019	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Dec. 31, 2018	Sep. 30, 2020	Jan. 29, 2019
INVESTMENTS (Details) [Line Items]
Income (Loss) from Equity Method Investments			$ (9,718)	$ (33,478)	$ (23,539)	$ 93,778
Equity Method Investments			0		0		$ 23,539		$ 0
Revenues			$ 64,647	156,591	$ 161,793	2,763,385
U.S. Stem Cell Clinic, LLC [Member]
INVESTMENTS (Details) [Line Items]
Equity Method Investment, Ownership Percentage			49.90%		49.90%				49.90%
Income (Loss) from Equity Method Investments			$ (9,718)	(51,514)	$ (23,539)	51,514			$ 599,921
Proceeds from Equity Method Investment, Distribution					0	64,870			663,870
Accounts Receivable, after Allowance for Credit Loss			28,763		28,763		28,763		28,763
Revenues			0	33,614	1,441	329,003
Investment Company, Contributed Capital, Percent		16.60%
Contribution to Equity		$ 4,435
Regenerative Wellness Clinic, LLC [Member]
INVESTMENTS (Details) [Line Items]
Equity Method Investment, Ownership Percentage										33.30%
Income (Loss) from Equity Method Investments				(2,910)	0	69,345			113,047
Proceeds from Equity Method Investment, Distribution					0	101,963			101,963
Equity Method Investments			$ 0		$ 0		0		$ 0
Accounts Receivable, after Allowance for Credit Loss							0
Revenues				16,637		132,984
Investment Company, Contributed Capital, Percent		16.60%
Contribution to Equity		$ 10,830
U.S. Stem Cell Clinic of The Village LLC (the "LLC") [Member]
INVESTMENTS (Details) [Line Items]
Equity Method Investment, Ownership Percentage	49.00%		49.00%		49.00%				49.00%
Income (Loss) from Equity Method Investments				(9,931)	$ 0	(27,081)			$ 23,050
Proceeds from Equity Method Investment, Distribution					0
Equity Method Investments			$ 0		0				0
Revenues				9,975	0	140,328
Related Party Transaction, Description of Transaction	To that end, U.S. Stem Cell Clinic of The Villages LLC (the “LLC”) was formed January 30, 2018. Knutson provided the Company with the sum of Three Hundred Thousand Dollars ($300,000) (the “Investment”) to be utilized for the formation and initial operation of the LLC. Currently, Knutson holds a 51% member interest in the LLC and the Company holds a 49% member interest. The Company will provide operating assistance as well as management services, the latter to be compensated at fee of five percent (5%) of the LLC gross revenues
Ownership Percentage by Knutson	51.00%
Proceeds from Contributed Capital							$ 86,750	$ 189,909
Accounts Receivable, before Allowance for Credit Loss			$ 0		0				$ 0
Proceeds from Fees Received				$ 975	$ 0	$ 50,751
U.S. Stem Cell Clinic of The Village LLC (the "LLC") [Member] | Utilized for Fromation of LLC [Member]
INVESTMENTS (Details) [Line Items]
Related Party Transaction, Amounts of Transaction	$ 300,000

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RIGHT TO USE ASSETS AND LEASE LIABILITY (Details)		9 Months Ended	12 Months Ended
	Sep. 01, 2019 USD ($)	Sep. 30, 2020 USD ($) ft²	Dec. 31, 2019	Jan. 01, 2019 USD ($)
RIGHT TO USE ASSETS AND LEASE LIABILITY (Details) [Line Items]
Estimated Incremental Borrowing Rate			8.00%
Sunrise, Florida [Member]
RIGHT TO USE ASSETS AND LEASE LIABILITY (Details) [Line Items]
Area of Land (in Square Feet) | ft²		4,860
Operating Leases, Annual Rent Amount	$ 87,674	$ 82,620
Operating Leases, Monthly Base Rent Amount		$ 7,306
Estimated Incremental Borrowing Rate	8.00%
Operating Lease, Liability	$ 383,351			$ 57,000
Operating Lease Right of Use Asset, Gross				274,180
Operating Lease, Right-of-Use Asset				57,000
Sunrise, Florida [Member] | Lease Escalation [Member]
RIGHT TO USE ASSETS AND LEASE LIABILITY (Details) [Line Items]
Operating Leases, Annual Rent Amount	$ 98,678
Accounting Standards Update 2016-02 [Member] | Sunrise, Florida [Member]
RIGHT TO USE ASSETS AND LEASE LIABILITY (Details) [Line Items]
Operating Lease, Liability				56,734
Operating Lease, Right-of-Use Asset				$ 56,734

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RIGHT TO USE ASSETS AND LEASE LIABILITY (Details) - Lease, Cost - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Lease, Cost [Abstract]
Operating lease expense	$ 1,689	$ 34,560	$ 3,891	$ 105,200
Variable lease expense	0	0	0	685
Total lease expense	$ 1,689	$ 34,560	$ 3,891	$ 105,885

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ACCRUED EXPENSES (Details) - USD ($)		3 Months Ended		9 Months Ended
	Oct. 07, 2015	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
ACCRUED EXPENSES (Details) [Line Items]
Debt Conversion, Converted Instrument, Shares Issued (in Shares)	34,522			1,445,647
Debt Conversion, Converted Instrument, Amount				$ 11,565
Debt Conversion, Original Debt, Amount	$ 100,000			9,145
Gain (Loss) on Extinguishment of Debt		$ (204)	$ 33,203	277	$ 21,892
Notes Payable, Other Payables [Member]
ACCRUED EXPENSES (Details) [Line Items]
Gain (Loss) on Extinguishment of Debt				$ 2,420

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ACCRUED EXPENSES (Details) - Schedule of Accrued Liabilities - USD ($)	Sep. 30, 2020	Dec. 31, 2019
Schedule of Accrued Liabilities [Abstract]
Interest and fees payable to the Guarantors of the Company’s loan agreement with Seaside Bank	$ 522,746	$ 456,190
Accrued interest payable	777,937	580,204
Vendor accruals and other	79,138	79,132
Accrued expenses and other current liabilities	$ 1,379,821	$ 1,115,526

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NOTES PAYABLE (Details)						3 Months Ended			9 Months Ended		12 Months Ended
	Jun. 20, 2020 USD ($)	Dec. 06, 2019 USD ($)	Jun. 03, 2019 USD ($)	Aug. 31, 2017 USD ($)	Jun. 01, 2015	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Mar. 31, 2018	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Dec. 31, 2016 USD ($)	Dec. 31, 2019 USD ($)	Oct. 25, 2010
Seaside National Bank and Trust [Member] | Notes Payable to Banks [Member]
NOTES PAYABLE (Details) [Line Items]
Debt Instrument, Interest Rate, Stated Percentage													4.25%
Debt Instrument, Maturity Date								May 18, 2020
Hunton & Williams Notes [Member] | Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) [Line Items]
Debt Instrument, Interest Rate, Stated Percentage											8.00%
Number of Outstanding Notes Payable											2
Notes Payable						$ 387,500			$ 387,500			$ 391,000
Debt Instrument, Payment Terms				payable in one balloon payment upon the date of a written demand and upon certain triggering events occurring							payable in one balloon payment upon the date the Noteholder provides written demand, however the Company is not obligated to make payments until the Northstar Biotech Group, LLC (or successor) Loan is paid off.
Other Notes Payable				$ 747,680
Accounts Payable, Other, Current				40,596
Notes and Loans Payable				$ 788,276
Debt Instrument, Description				The noteholder agreed to accept full payment of their obligation over a four (4) year period in 48 monthly installments on an adjusted debt obligation in aggregate of $624,000 (reducing the outstanding balance), with such payments staggered in amounts such that the Company will pay $10,000 monthly the first year, $12,000 monthly the second year, $14,000 monthly the third year, and $16,000 monthly the final year. In addition, the noteholder agreed to suspend accrual interest on the notes commencing September 1, 2017. The Agreement remains in full force and effect provided the Company continues to make the monthly payments, there is no event of default as defined in the notes and an agreement to a subordination agreement by Northstar Biotech Group, LLC, which has been provided. In May 2019, the Company did not make the required scheduled payment. In September 2010, the noteholder agreed to waive their default rights under the agreement provided a minimum of $5,000 was paid by the end of 2019 and to reduce the required monthly payment to $500 per month commencing in January 2020. The Company satisfied the $5,000 payment requirement by the end of 2019 and commenced making the required $500 monthly payments in January 2020.
Imputed Interest, Rate				5.00%
Debt Instrument, Unamortized Discount				$ 69,700
Amortization of Debt Discount (Premium)							$ 24,205		0	$ 34,945
Hunton & Williams Note #1 [Member] | Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) [Line Items]
Notes Payable											$ 61,150
Hunton & Williams Note #2 [Member] | Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) [Line Items]
Notes Payable											$ 323,822
Weider promissory note [Member] | Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) [Line Items]
Debt Instrument, Interest Rate, Stated Percentage			5.25%
Notes Payable						453,493			453,493			482,939
Debt Instrument, Face Amount			$ 500,000
Debt Instrument, Periodic Payment			$ 5,000
Note Payable, Settlement of Subordinated Debt, Accrued Interest and Guarantor Fees [Member] | Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) [Line Items]
Debt Instrument, Interest Rate Terms					non-interest bearing
Mallard Note Payable [Member] | Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) [Line Items]
Debt Instrument, Interest Rate, Stated Percentage		5.00%
Notes Payable						199,658			199,658			199,551
Debt Instrument, Payment Terms		payable in monthly increments of $750 per month, with a final balloon payment of $205,000 due on January 1, 2025
Debt Instrument, Unamortized Discount		$ 51,063				43,592			43,592			$ 50,448
Amortization of Debt Discount (Premium)						2,328			6,857
Debt Instrument, Face Amount		$ 250,000
EIDL Note Payable [Member] | Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) [Line Items]
Debt Instrument, Interest Rate, Stated Percentage	3.75%
Notes Payable						150,000			150,000
Debt Instrument, Payment Terms	monthly beginning June 20, 2021 (twelve months from the date of the SBA Loan Agreement) in the amount of $731. The balance of principal and interest is payable thirty years from the date of the SBA Loan Agreement
Debt Instrument, Face Amount	$ 150,000
Debt Instrument, Periodic Payment	$ 731
Interest Payable						$ 1,572			$ 1,572

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NOTES PAYABLE (Details) - Schedule of Debt - USD ($)	Sep. 30, 2020	Dec. 31, 2019	Dec. 06, 2019	Aug. 31, 2017
NOTES PAYABLE (Details) - Schedule of Debt [Line Items]
Notes Payable, Gross	$ 2,214,243	$ 2,103,939
Less unamortized debt discount	(43,592)	(50,448)
Total notes payable net of unamortized debt discount	2,170,651	2,053,491
Less current portion	(1,400,910)	(1,297,477)
Long term portion	769,741	756,014
Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) - Schedule of Debt [Line Items]
Less unamortized debt discount	(34,091)	(41,391)
Seaside National Bank and Trust [Member] | Notes Payable to Banks [Member]
NOTES PAYABLE (Details) - Schedule of Debt [Line Items]
Notes Payable, Gross	980,000	980,000
Hunton & Williams Notes [Member] | Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) - Schedule of Debt [Line Items]
Notes Payable, Gross	387,500	391,000
Less unamortized debt discount				$ (69,700)
Weider promissory note [Member] | Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) - Schedule of Debt [Line Items]
Notes Payable, Gross	453,493	482,939
Mallard Note Payable [Member] | Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) - Schedule of Debt [Line Items]
Notes Payable, Gross	243,250	250,000
Less unamortized debt discount	(43,592)	(50,448)	$ (51,063)
EIDL Note Payable [Member] | Notes Payable, Other Payables [Member]
NOTES PAYABLE (Details) - Schedule of Debt [Line Items]
Notes Payable, Gross	$ 150,000	$ 0

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PROMISSORY NOTE PAYABLE (Details) - Promissory Note [Member] - USD ($)			3 Months Ended		9 Months Ended
	Jun. 01, 2020	Jun. 01, 2015	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
PROMISSORY NOTE PAYABLE (Details) [Line Items]
Debt Instrument, Face Amount		$ 1,697,762
Debt Instrument, Periodic Payment		$ 75,000
Default Interest Rate	18.00%
Imputed Interest, Rate		5.00%
Debt Instrument, Unamortized Discount		$ 368,615	$ 0		$ 0		$ 29,296
Amortization of Debt Discount (Premium)			0	$ 17,616	29,295	$ 52,273
Notes Payable			$ 1,397,762		$ 1,397,762		$ 1,368,467
Unpaid Guarantor Fees [Member]
PROMISSORY NOTE PAYABLE (Details) [Line Items]
Debt Conversion, Original Debt, Amount		624,737
Principal [Member]
PROMISSORY NOTE PAYABLE (Details) [Line Items]
Debt Conversion, Original Debt, Amount		1,500,000
Interest [Member]
PROMISSORY NOTE PAYABLE (Details) [Line Items]
Debt Conversion, Original Debt, Amount		$ 373,469

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CONVERTIBLE NOTE PAYABLE (Details) - USD ($)			3 Months Ended	9 Months Ended
	Sep. 08, 2020	Feb. 05, 2020	Sep. 30, 2020	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Jun. 15, 2019
CONVERTIBLE NOTE PAYABLE (Details) [Line Items]
Debt Instrument, Face Amount	$ 10,000	$ 35,000					$ 500,000
Debt Instrument, Maturity Date		Feb. 05, 2021
Debt Instrument, Interest Rate, Stated Percentage	5.00%	5.00%					5.25%
Debt Instrument, Convertible, Terms of Conversion Feature		right to convert the outstanding balance of the note at any time into shares of common stock of the Company at a conversion price equal to a thirty percent (30%) discount of the average closing price of the Company’s common stock on the OTC Markets electronic exchange for the prior thirty (30) trading days prior to conversion
Debt Instrument, Unamortized Discount			$ 43,592	$ 43,592		$ 50,448
Amortization of Debt Discount (Premium)				309,219	$ 141,296
Convertible Notes Payable	$ 10,000		28,779	28,779
Debt Instrument, Convertible, Conversion Price (in Dollars per share)	$ 0.0467
Default Interest Rate	18.00%
Convertible Notes Payable [Member]
CONVERTIBLE NOTE PAYABLE (Details) [Line Items]
Debt Instrument, Unamortized Discount		$ 15,000	6,221	6,221
Amortization of Debt Discount (Premium)			3,777	8,779
Interest Payable			1,141	1,141
Convertible Debt [Member]
CONVERTIBLE NOTE PAYABLE (Details) [Line Items]
Interest Payable			$ 30	$ 30

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RELATED PARTY TRANSACTIONS (Details) - USD ($)																												3 Months Ended		9 Months Ended		12 Months Ended
		Apr. 01, 2020	Feb. 05, 2020	Oct. 09, 2019	Oct. 01, 2019	Jul. 01, 2019	Oct. 19, 2018	May 07, 2018	Apr. 19, 2018	Oct. 02, 2017	Aug. 07, 2017	Apr. 01, 2017	Mar. 09, 2017	Mar. 03, 2017	Nov. 09, 2016	Oct. 06, 2016	Apr. 07, 2016	Oct. 07, 2015	Oct. 02, 2015	Apr. 03, 2015	Oct. 03, 2014	Apr. 02, 2014	Dec. 24, 2013	Sep. 30, 2013	Oct. 01, 2012	Sep. 21, 2012	Mar. 30, 2012	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2013	Sep. 08, 2020	Jul. 01, 2020	Jun. 30, 2020	Mar. 31, 2020	Dec. 31, 2019	Jun. 15, 2019	Sep. 06, 2016	Dec. 31, 2015	Feb. 28, 2013	Feb. 29, 2012
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Due to Related Parties, Current																												$ 797,040		$ 797,040							$ 511,744
Debt Instrument, Face Amount			$ 35,000																														$ 10,000					$ 500,000
Class of Warrant or Rights, Granted (in Shares)																														0
Percentage of Revenues to be Received as Royalty															5.00%
Debt Instrument, Interest Rate, Stated Percentage			5.00%																														5.00%					5.25%
Preferred Stock, Shares Authorized (in Shares)																												20,000,000		20,000,000							20,000,000			20,000,000
Debt Conversion, Converted Instrument, Shares Issued (in Shares)																		34,522												1,445,647
Debt Conversion, Original Debt, Amount																		$ 100,000												$ 9,145
Debt Conversion, Converted Instrument, Amount																														11,565
Stock Issued During Period, Value, Other																												$ 10,205	$ 34,013	44,368	$ 312,194
Gain (Loss) on Extinguishment of Debt																												(204)	$ 33,203	277	21,892
Notes Payable, Related Parties																												3,733,404		3,733,404							$ 2,757,442
Repayments of Notes Payable																														39,697	381,000
Repayments of Related Party Debt																														0	213,739
Debt Instrument, Maturity Date			Feb. 05, 2021
Sale Leaseback Transaction, Lease Terms														Termination and Release Agreement and a Letter Agreement intended to divest itself of certain equipment and other assets underlying the related equipment lease transaction
Accrued Marketing Costs, Current																												0		0
Proceeds from Sale of Machinery and Equipment														$ 50,000
Officers and Directors [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Proceeds from Related Party Debt																														285,296	140,000
Due to Related Parties, Current																												797,040		797,040							511,744
Series A Preferred Stock [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Preferred Stock, Voting Rights																									modify the voting rights of the subsequently cancelled Series A Convertible Preferred Stock from 20 votes per share on matters to be voted on by the common stockholders to 25 votes per share on matters to be voted on by the common stockholders and all prior and subsequent payments of interest will be in common stock
Notes Payable, Other Payables [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Gain (Loss) on Extinguishment of Debt																														2,420
Notes Payable, Other Payables [Member] | Affiliated Entity [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Face Amount																																										$ 544,267
Debt Instrument, Payment Terms																									Company was obligated to issue additional preferred stock equal in lieu of payment of cash of accrued and unpaid interest on each six-month anniversary of the effective date (October 1, 2012).		agreed to extend until May 1, 2012 the initial payment date for any and all required monthly under the Note, such that the first of the four monthly payments required under the Note will be due and payable on May 1, 2012 and all subsequent payments will be due on a monthly basis thereafter commencing on June 1, 2012, and to waive any and all defaults and/or events of default under the Note with respect to such payments. The Company did not make the required payment, and as a result, was in default of the revised agreement. The Company renegotiated the terms of the Note and Northstar agreed to suspend the requirement of principal payments by the Company and allow payment of interest-only in common stock.
Class of Warrant or Rights, Granted (in Shares)																										5,000
Debt Instrument, Debt Default, Description of Violation or Event of Default																									entered into a limited waiver and forbearance agreement providing a recapitalized new note balance comprised of all sums due Northstar with a maturity date extended perpetually. The Company agreed to issue 5,000,000 shares of Series A Convertible Preferred Stock and 10,000 shares of common stock in exchange for $210,000 as payment towards outstanding debt, default interest, penalties, professional fees outstanding and due Northstar. In addition, the Company executed a security agreement granting Northstar a lien on all patents, patent applications, trademarks, service marks, copyrights and intellectual property rights of any nature, as well as the results of all clinical trials, know-how for preparing Myoblasts, old and new clinical data, existing approved trials, all right and title to Myoblasts, clinical trial protocols and other property rights. In addition, the Company granted Northstar a perpetual license on products as described for resale, relicensing, and commercialization outside the United States. In connection with the granted license, Northstar shall pay the Company a royalty of up to 8% on revenues generated.
Percentage of Revenues to be Received as Royalty																									8.00%
Debt Instrument, Interest Rate, Stated Percentage																									12.85%																7.00%
Debt Conversion, Converted Instrument, Shares Issued (in Shares)		1,445,647			1,692,353		164,523		379,141	559,187		286,315											3,916	8,772
Debt Conversion, Original Debt, Amount		$ 9,145			$ 9,195		$ 9,195		$ 9,145	$ 12,705		$ 12,703											$ 85,447	$ 100,000
Debt Conversion, Converted Instrument, Amount		11,565
Gain (Loss) on Extinguishment of Debt		$ 2,420
Notes Payable, Related Parties																												262,000		262,000
Interest Expense, Related Party																														13,323
Interest Payable																																					8,700
Notes Payable, Other Payables [Member] | Chief Executive Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Interest Payable																												453,282		453,282							389,695
Notes Payable, Other Payables [Member] | Chief Scientific Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Interest Payable																												194,081		194,081							150,708
Notes Payable, Other Payables [Member] | Series A Preferred Stock [Member] | Affiliated Entity [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Stock Issued During Period, Value, Other																																$ 316,800
Interest [Member] | Notes Payable, Other Payables [Member] | Affiliated Entity [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Conversion, Converted Instrument, Shares Issued (in Shares)																848,490	57,778		4,156	1,363	515	275
Debt Conversion, Original Debt, Amount																$ 12,705			$ 12,705	$ 12,635	$ 12,705	$ 12,635
Debt Conversion, Converted Instrument, Amount																	$ 12,705
Note Payable #5 [Member] | Notes Payable, Other Payables [Member] | Chief Executive Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Face Amount											$ 500,000
Debt Instrument, Interest Rate, Stated Percentage											5.00%
Notes Payable, Related Parties																												161,786		161,786							161,786
Repayments of Notes Payable																														0	321,607
Note Payable #5 [Member] | Notes Payable, Other Payables [Member] | Chief Scientific Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Interest Rate, Stated Percentage						5.00%
Notes Payable, Related Parties	[1]																											300,000		300,000							300,000
Notes Payable, Related Parties, Noncurrent						$ 300,000
Debt Instrument, Maturity Date						Nov. 07, 2019
Notes Receivable, Related Parties																												300,000		300,000
Note Payable #6 [Member] | Notes Payable, Other Payables [Member] | Chief Executive Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Face Amount								$ 500,000
Debt Instrument, Interest Rate, Stated Percentage								5.00%
Notes Payable, Related Parties																												500,000		500,000							500,000
Debt Instrument, Term								6 months
Note Payable #7 [Member] | Notes Payable, Other Payables [Member] | Chief Executive Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Face Amount						$ 500,000
Debt Instrument, Interest Rate, Stated Percentage						5.00%
Notes Payable, Related Parties																												500,000		500,000							$ 500,000
Note Payable #8 [Member] | Notes Payable, Other Payables [Member] | Chief Executive Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Interest Rate, Stated Percentage																																					5.00%
Notes Payable, Related Parties																												178,077		178,077							$ 178,077
Note Payable #9 [Member] | Notes Payable, Other Payables [Member] | Chief Executive Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Face Amount																																				$ 187,500
Debt Instrument, Interest Rate, Stated Percentage																																				5.00%
Notes Payable, Related Parties																												187,500		187,500							0
Note Payable #10 [Member] | Notes Payable, Other Payables [Member] | Chief Executive Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Face Amount																																			$ 187,500
Debt Instrument, Interest Rate, Stated Percentage																																			5.00%
Notes Payable, Related Parties																												187,500		187,500							0
Note Payable #11 [Member] | Notes Payable, Other Payables [Member] | Chief Executive Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Face Amount																																		$ 500,000
Debt Instrument, Interest Rate, Stated Percentage																																		5.00%
Notes Payable, Related Parties																												500,000		500,000							0
Note Payable #12 [Member] | Notes Payable, Other Payables [Member] | Chief Executive Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Face Amount																												$ 100,962		$ 100,962
Debt Instrument, Interest Rate, Stated Percentage																												5.00%		5.00%
Notes Payable, Related Parties																												$ 100,962		$ 100,962							0
Note Payable #2 [Member] | Notes Payable, Other Payables [Member] | Chief Scientific Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Face Amount																																							$ 300,000
Debt Instrument, Interest Rate, Stated Percentage																																							5.00%
Notes Payable, Related Parties	[1]																											255,579		255,579							255,579
Repayments of Related Party Debt																															$ 107,868
Note Payable #3 [Member] | Notes Payable, Other Payables [Member] | Chief Scientific Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Face Amount											$ 300,000
Debt Instrument, Interest Rate, Stated Percentage											5.00%
Notes Payable, Related Parties	[1]																											300,000		300,000							300,000
Debt Instrument, Term											1 year
Note Payable #4 [Member] | Notes Payable, Other Payables [Member] | Chief Scientific Officer [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Debt Instrument, Face Amount								$ 300,000
Debt Instrument, Interest Rate, Stated Percentage								5.00%
Notes Payable, Related Parties	[1]																											$ 300,000		$ 300,000							$ 300,000
Debt Instrument, Term								6 months
GACP Stem Cell Bank, LLC [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Gain (Loss) on Extinguishment of Debt				$ 100,000
Sale Leaseback Transaction, Net Book Value														$ 400,000
Sale Leaseback Transaction, Lease Terms														leased back the sold equipment over a three-year term
Percentage of Renenue Accrued for Marketing														10.00%
Sale Leaseback Transaction, Description														Company also entered into a customer purchase agreement with GACP whereby the Company received a deposit $50,000 (included in long-term liabilities at December 31, 2018) in exchange for the sale of the first 5,000 future customers of the cell-banking business after the effective date of the agreement; GACP also had the right to purchase additional customers at a price of $20 per customer. There is no reduction in the selling price should the new customers be fewer than 5,000
Proceeds from Sale of Intangible Assets														$ 50,000
Northstar Claims [Member] | Stock Issued for Conversion of Series A Preferred Stock and Litigation Case [Member]
RELATED PARTY TRANSACTIONS (Details) [Line Items]
Stock Issued During Period, Shares, Other (in Shares)												1,000,000	30,000,000

[1] Dr. Comella is no longer a member of the Board of Directors effective September 1, 2019.

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RELATED PARTY TRANSACTIONS (Details) - Schedule of Related Party Transactions - USD ($)		Sep. 30, 2020	Dec. 31, 2019
Related Party Transaction [Line Items]
Notes Payable, Related Party		$ 3,733,404	$ 2,757,442
Northstar Claims [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party		262,000	262,000
Note Payable #5 [Member] | Chief Executive Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party		161,786	161,786
Note Payable #5 [Member] | Chief Scientific Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party	[1]	300,000	300,000
Note Payable #6 [Member] | Chief Executive Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party		500,000	500,000
Note Payable #7 [Member] | Chief Executive Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party		500,000	500,000
Note Payable #8 [Member] | Chief Executive Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party		178,077	178,077
Note Payable #9 [Member] | Chief Executive Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party		187,500	0
Note Payable #10 [Member] | Chief Executive Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party		187,500	0
Note Payable #11 [Member] | Chief Executive Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party		500,000	0
Note Payable #12 [Member] | Chief Executive Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party		100,962	0
Note Payable #2 [Member] | Chief Scientific Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party	[1]	255,579	255,579
Note Payable #3 [Member] | Chief Scientific Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party	[1]	300,000	300,000
Note Payable #4 [Member] | Chief Scientific Officer [Member] | Notes Payable, Other Payables [Member]
Related Party Transaction [Line Items]
Notes Payable, Related Party	[1]	$ 300,000	$ 300,000

[1] Dr. Comella is no longer a member of the Board of Directors effective September 1, 2019.

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COMMITMENTS AND CONTINGENCIES (Details) - USD ($)					12 Months Ended
	Dec. 06, 2019	Jun. 15, 2019	Jul. 01, 2018	Nov. 09, 2016	Dec. 31, 2017	Dec. 31, 2016	Sep. 30, 2020	Sep. 08, 2020	Feb. 05, 2020	Dec. 31, 2019
COMMITMENTS AND CONTINGENCIES (Details) [Line Items]
Royalty Agreement, Term				25 years
Revenue from Contract with Customer, Including Assessed Tax				$ 75,000
Percentage of Revenues to be Received as Royalty				5.00%
Deferred Revenue							$ 83,250			$ 86,300
Debt Instrument, Face Amount		$ 500,000						$ 10,000	$ 35,000
General Insurance Expense					$ 11,000	$ 100,000
Settlement Liabilities, Current							28,850			30,050
Debt Instrument, Interest Rate, Stated Percentage		5.25%						5.00%	5.00%
Debt Instrument, Periodic Payment		$ 5,000
Mallard Note Payable [Member]
COMMITMENTS AND CONTINGENCIES (Details) [Line Items]
Debt Instrument, Face Amount	$ 250,000
Debt Instrument, Payment Terms	payable in monthly increments of $750 per month, with a final balloon payment of $205,000 due on January 1, 2025
Bonus [Member] | Chief Executive Officer [Member]
COMMITMENTS AND CONTINGENCIES (Details) [Line Items]
Deferred Compensation Arrangement with Individual, Description			any liability, and as part of that Agreement, the Company agreed to provide a five-year 5.25% Promissory Note, dated June 15, 2019, in the principal amount of Five Hundred Thousand Dollars ($500,000), payable in monthly increments of Five Thousand ($5,000) per month
Royalty Arrangement [Member]
COMMITMENTS AND CONTINGENCIES (Details) [Line Items]
Deferred Revenue							$ 63,250			$ 65,500

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STOCKHOLDERS' DEFICIT (Details) - USD ($)						3 Months Ended		9 Months Ended
	May 07, 2018	Aug. 07, 2017	Apr. 21, 2017	Sep. 16, 2016	Oct. 07, 2015	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Nov. 02, 2015	Aug. 04, 2014	Apr. 01, 2013
STOCKHOLDERS' DEFICIT (Details) [Line Items]
Stock Issued During Period, Value, Other						$ 10,205	$ 34,013	$ 44,368	$ 312,194
Gain (Loss) on Extinguishment of Debt						(204)	$ 33,203	$ 277	21,892
Debt Conversion, Converted Instrument, Shares Issued (in Shares)					34,522			1,445,647
Debt Conversion, Converted Instrument, Amount								$ 11,565
Debt Conversion, Original Debt, Amount					$ 100,000			$ 9,145
Stock Issued During Period, Shares, Issued for Services (in Shares)								4,000,000
Stock Issued During Period, Value, Issued for Services								$ 16,000	86,350
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value										$ 0
Share-based Payment Arrangement, Noncash Expense								541,336	586,382
Aggregate Intrinsic Value of the Issued and Exercisable Warrants								0
Notes Payable, Other Payables [Member]
STOCKHOLDERS' DEFICIT (Details) [Line Items]
Gain (Loss) on Extinguishment of Debt								$ 2,420
Accounts Payable [Member]
STOCKHOLDERS' DEFICIT (Details) [Line Items]
Stock Issued During Period, Shares, Other (in Shares)								6,532,248
Stock Issued During Period, Value, Other								$ 32,803
Common Stock Issued in Settlement of Accounts Payable, Accrued Expenses and Accrued Interest [Member]
STOCKHOLDERS' DEFICIT (Details) [Line Items]
Gain (Loss) on Extinguishment of Debt								2,697
Share-based Payment Arrangement, Option [Member]
STOCKHOLDERS' DEFICIT (Details) [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value						$ 0		$ 0
Share Price (in Dollars per share)						$ 0.0043		$ 0.0043
Share-based Payment Arrangement, Noncash Expense								$ 525,336	$ 512,882
Share-based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount						$ 890,216		$ 890,216
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition								335 days
Bioheart 2013 Omnibus Equity Compensation Plan [Member]
STOCKHOLDERS' DEFICIT (Details) [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in Shares)											500,000,000	100,000	50,000
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in Shares)	100,000,000	30,000,000	25,000,000	25,000,000

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STOCKHOLDERS' DEFICIT (Details) - Share-based Payment Arrangement, Option, Activity - USD ($)		9 Months Ended
	Dec. 31, 2019	Sep. 30, 2020
Share-based Payment Arrangement, Option, Activity [Abstract]
Options Outstanding	111,120,474
Options Outstanding, Weighted-Average Exercise Price (in Dollars per share)	$ 0.0247
Options Outstanding, Weighted-Average Remaining Contractual Term	8 years 109 days	7 years 292 days
Options Outstanding, Intrinsic Value (in Dollars)	$ 0
Options exercisable		75,737,414
Options exercisable, Weighted-Average Exercise Price (in Dollars per share)		$ 0.0255
Options exercisable, Weighted-Average Remaining Contractual Term		7 years 73 days
Options Granted		0
Options Exercised		0
Options Forfeited/Expired		(560)
Options Forfeited/Expired, Weighted-Average Exercise Price (in Dollars per share)		$ 0.1540
Options Outstanding		111,119,914
Options Outstanding, Weighted-Average Exercise Price (in Dollars per share)		$ 0.0247

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STOCKHOLDERS' DEFICIT (Details) - Share-based Payment Arrangement, Option, Exercise Price Range	9 Months Ended
	Sep. 30, 2020 $ / shares shares
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Weighted-Average Exercise Price	$ 0.0247
Options Outstanding, Weighted-Average Remaining Contractual Term	7 years 6 months
Options Outstanding (in Shares) | shares	111,119,914
Options Exercisable (in Shares) | shares	75,737,414
Options Exercisable, Weighted-Average Exercise Price	$ 0.0255
Options $0.000 to $0.010 [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Weighted-Average Exercise Price	$ 0.0051
Options Outstanding, Weighted-Average Remaining Contractual Term	8 years 109 days
Options Outstanding (in Shares) | shares	41,900,000
Options Exercisable (in Shares) | shares	21,650,000
Options Exercisable, Weighted-Average Exercise Price	$ 0.0049
Options $0.000 to $0.010 [Member] | Minimum [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Exercise Price	0.004
Options $0.000 to $0.010 [Member] | Maximum [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Exercise Price	0.010
Options $0.011 to $0.020 [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Weighted-Average Exercise Price	$ 0.0196
Options Outstanding, Weighted-Average Remaining Contractual Term	6 years
Options Outstanding (in Shares) | shares	16,300,000
Options Exercisable (in Shares) | shares	16,300,000
Options Exercisable, Weighted-Average Exercise Price	$ 0.0196
Options $0.011 to $0.020 [Member] | Minimum [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Exercise Price	0.011
Options $0.011 to $0.020 [Member] | Maximum [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Exercise Price	0.020
Options $0.021 to $0.030 [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Weighted-Average Exercise Price	$ 0.0253
Options Outstanding, Weighted-Average Remaining Contractual Term	8 years 36 days
Options Outstanding (in Shares) | shares	9,710,000
Options Exercisable (in Shares) | shares	8,605,000
Options Exercisable, Weighted-Average Exercise Price	$ 0.0252
Options $0.021 to $0.030 [Member] | Minimum [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Exercise Price	0.021
Options $0.021 to $0.030 [Member] | Maximum [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Exercise Price	0.030
Options $0.0363 [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Exercise Price	0.0363
Options Outstanding, Weighted-Average Exercise Price	$ 0.0363
Options Outstanding, Weighted-Average Remaining Contractual Term	6 years 328 days
Options Outstanding (in Shares) | shares	22,735,000
Options Exercisable (in Shares) | shares	18,707,500
Options Exercisable, Weighted-Average Exercise Price	$ 0.0363
Options, $0.0536 Exercise Price [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Exercise Price	0.0536
Options Outstanding, Weighted-Average Exercise Price	$ 0.0536
Options Outstanding, Weighted-Average Remaining Contractual Term	7 years 219 days
Options Outstanding (in Shares) | shares	20,000,000
Options Exercisable (in Shares) | shares	10,000,000
Options Exercisable, Weighted-Average Exercise Price	$ 0.0536
Options $0.1540 [Member]
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items]
Options Outstanding, Exercise Price	0.1540
Options Outstanding, Weighted-Average Exercise Price	$ 0.1540
Options Outstanding, Weighted-Average Remaining Contractual Term	5 years
Options Outstanding (in Shares) | shares	474,914
Options Exercisable (in Shares) | shares	474,914
Options Exercisable, Weighted-Average Exercise Price	$ 0.1540

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STOCKHOLDERS' DEFICIT (Details) - Schedule of Stockholders' Equity Note, Warrants or Rights - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Schedule of Stockholders' Equity Note, Warrants or Rights [Abstract]
Warrants Outstanding		1,110,468
Warrants Outstanding, Weighted-Average Exercise Price (in Dollars per share)		$ 12.8400
Warrants Outstanding, Weighted-Average Remaining Contractual Term	7 years 146 days	8 years 73 days
Warrants Exercisable	1,108,923
Warrants Exercisable, Weighted-Average Exercise Price (in Dollars per share)	$ 2.14
Warrants Exercisable, Weighted-Average Remaining Contractual Term	7 years 146 days
Warrants Issued	0
Warrants Exercised	0
Warrants Expired	0
Warrants Outstanding	1,110,468
Warrants Outstanding, Weighted-Average Exercise Price (in Dollars per share)	$ 12.84

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STOCKHOLDERS' DEFICIT (Details) - Schedule of Warrants Outstanding and Exercisable by Exercise Price Range - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019	Dec. 31, 2018
STOCKHOLDERS' DEFICIT (Details) - Schedule of Warrants Outstanding and Exercisable by Exercise Price Range [Line Items]
Warrants Outstanding, Shares	1,110,468		1,110,468
Warrants Outstanding, Weighted- Average Exercise Price	$ 12.84
Warrants Outstanding, Weighted- Average Remaining Contractual Term	7 years 146 days	8 years 73 days
Warrants Exercisable, Shares	1,108,923
Warrants Exercisable, Weighted- Average Exercise Price	$ 2.14
Class of Warrants or Rights, Exercise Price Range, $0.01-$20.00 [Member]
STOCKHOLDERS' DEFICIT (Details) - Schedule of Warrants Outstanding and Exercisable by Exercise Price Range [Line Items]
Warrants Outstanding, Shares	1,086,536
Warrants Outstanding, Weighted- Average Exercise Price	$ 1.27
Warrants Outstanding, Weighted- Average Remaining Contractual Term	7 years 6 months
Warrants Exercisable, Shares	1,086,536
Warrants Exercisable, Weighted- Average Exercise Price	$ 1.27
Class of Warrants or Rights, Exercise Price Range, $20.01-$30.00 [Member]
STOCKHOLDERS' DEFICIT (Details) - Schedule of Warrants Outstanding and Exercisable by Exercise Price Range [Line Items]
Warrants Outstanding, Shares	19,543
Warrants Outstanding, Weighted- Average Exercise Price	$ 25.06
Warrants Outstanding, Weighted- Average Remaining Contractual Term	3 years 146 days
Warrants Exercisable, Shares	19,543
Warrants Exercisable, Weighted- Average Exercise Price	$ 25.06
Class of Warrants or Rights, Exercise Price Range, $40.01-$50.00 [Member]
STOCKHOLDERS' DEFICIT (Details) - Schedule of Warrants Outstanding and Exercisable by Exercise Price Range [Line Items]
Warrants Outstanding, Shares	2,253
Warrants Outstanding, Weighted- Average Exercise Price	$ 48.83
Warrants Outstanding, Weighted- Average Remaining Contractual Term	2 years
Warrants Exercisable, Shares	2,253
Warrants Exercisable, Weighted- Average Exercise Price	$ 48.83
Class of Warrants or Rights, Exercise Price Range, $50.01-$60.00 [Member]
STOCKHOLDERS' DEFICIT (Details) - Schedule of Warrants Outstanding and Exercisable by Exercise Price Range [Line Items]
Warrants Outstanding, Shares	543
Warrants Outstanding, Weighted- Average Exercise Price	$ 60.00
Warrants Outstanding, Weighted- Average Remaining Contractual Term	292 days
Warrants Exercisable, Shares	543
Warrants Exercisable, Weighted- Average Exercise Price	$ 60.00
Class of Warrants or Rights, Exercise Price Range, Greater than $60.00 [Member]
STOCKHOLDERS' DEFICIT (Details) - Schedule of Warrants Outstanding and Exercisable by Exercise Price Range [Line Items]
Warrants Outstanding, Shares	1,593
Warrants Outstanding, Weighted- Average Exercise Price	$ 7,690.00
Warrants Outstanding, Weighted- Average Remaining Contractual Term	6 years 36 days
Warrants Exercisable, Shares	48
Warrants Exercisable, Weighted- Average Exercise Price	$ 7,690.00

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CONCENTRATIONS (Details)	Sep. 30, 2020
Customer Concentration Risk [Member] | Customer Five [Member] | Revenue Benchmark [Member]
CONCENTRATIONS (Details) [Line Items]
Equity Method Investment, Ownership Percentage	49.90%
Credit Concentration Risk [Member] | Customer One [Member] | Accounts Receivable [Member]
CONCENTRATIONS (Details) [Line Items]
Equity Method Investment, Ownership Percentage	49.90%

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CONCENTRATIONS (Details) - Schedules of Customer Concentration Risk - Customer Concentration Risk [Member] - Revenue Benchmark [Member]	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Concentration Risk [Line Items]
Customer Concentration Risk, Percentage	53.00%	49.00%	28.00%	12.00%
Customer One [Member]
Concentration Risk [Line Items]
Customer Concentration Risk, Percentage	24.00%	0.00%	15.00%	0.00%
Customer Two [Member]
Concentration Risk [Line Items]
Customer Concentration Risk, Percentage	15.00%	0.00%	0.00%	0.00%
Customer Three [Member]
Concentration Risk [Line Items]
Customer Concentration Risk, Percentage	14.00%	0.00%	0.00%	0.00%
Customer Four [Member]
Concentration Risk [Line Items]
Customer Concentration Risk, Percentage	0.00%	0.00%	13.00%	0.00%
Customer Five [Member]
Concentration Risk [Line Items]
Customer Concentration Risk, Percentage	0.00%	27.00%	0.00%	12.00%
Customer Six [Member]
Concentration Risk [Line Items]
Customer Concentration Risk, Percentage	0.00%	22.00%	0.00%	0.00%

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CONCENTRATIONS (Details) - Schedules of Credit Concentration Risk - Credit Concentration Risk [Member] - Accounts Receivable [Member]	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Concentration Risk [Line Items]
Credit Concentration Risk, Percentage	83.00%	94.00%
Customer One [Member]
Concentration Risk [Line Items]
Credit Concentration Risk, Percentage	83.00%	47.00%
Customer Two [Member]
Concentration Risk [Line Items]
Credit Concentration Risk, Percentage	0.00%	47.00%