Registration Statement No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

MEDICAL INDUSTRIES OF THE AMERICAS, INC.

(Exact name of registrant as specified in its charter)

Delaware	5047	82-4008793
(State or other jurisdiction of incorporation or organization)	(Primary Standard Industrial Classification Code Number)	(I.R.S. Employer Identification Number)

Medical Industries of the Americas, Inc.

9454 Wilshire Blvd., Suite #600

Beverly Hills, CA 90212

(334) 866-0070

(Address and telephone number of registrant’s principal executive offices)

Robby D. Cucher Esq.

9454 Wilshire Blvd., Suite #600

Beverly Hills, CA 90212

(334) 866-0070

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

David Ficksman, Esq. William P. Hubbard, Esq. TroyGould PC 1801 Century Park East, 16^th Floor Los Angeles, CA 90067 Tel.: (310) 553-4441 Joseph M. Lucosky, Esq. Thomas D. Twedt, Esq. Lucosky Brookman LLP 101 Wood Avenue South Woodbridge, NJ 08830 Tel.: (732) 395-4402

Approximate date of commencement of proposed sale to the public:

As soon as practicable after the effective date of this registration statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth 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 to Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

EXPLANATORY NOTE

This Registration Statement contains two prospectuses, as set forth below.

● Public Offering Prospectus. A prospectus to be used for the initial public offering of [●] shares of common stock of the Registrant (the “Public Offering Prospectus”) through the underwriters named in the Underwriting section of the Public Offering Prospectus.

● Resale Prospectus. A prospectus to be used for the potential resale by certain stockholders of the Company (the “Non-IPO Selling Stockholders”) of 811,500 shares of common stock of the Registrant (the “Resale Prospectus”).

The Resale Prospectus is substantively identical to the Public Offering Prospectus, except for the following principal points:

● they contain different front covers;

● all references in the Public Offering Prospectus to “this offering” will be changed to “the IPO,” defined as the underwritten initial public offering of our common stock, in the Resale Prospectus;

● all references in the Public Offering Prospectus to “underwriters” will be changed to “underwriters of the IPO” in the Resale Prospectus;

● they contain different “Use of Proceeds” sections;

● they contain different “Summary — The Offering” sections;

● the “Underwriting” section from the Public Offering Prospectus is deleted from the Resale Prospectus and a “Plan of Distribution” section is inserted in its place;

● the “Legal Matters” section in the Resale Prospectus deletes the reference to counsel for the underwriters; and

● they contain different back covers.

The Registrant has included in this Registration Statement a set of alternate pages after the back cover page of the Public Offering Prospectus (the “Alternate Pages”) to reflect the foregoing differences in the Resale Prospectus as compared to the Public Offering Prospectus. The Public Offering Prospectus will exclude the Alternate Pages and will be used for the public offering by the Registrant. The Resale Prospectus will be substantively identical to the Public Offering Prospectus except for the substitution of the Alternate Pages and disclosures described above and will be used for the resale offering by the Non-IPO Selling Stockholders.

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The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell, nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

Subject to Completion, dated February 14, 2023

PRELIMINARY PROSPECTUS

[●] Shares of Common Stock

MEDICAL INDUSTRIES OF THE AMERICAS, INC.

This is an initial public offering of shares of our common stock, par value $[●] per share. Prior to this offering, there has been no public market for our common stock. It is currently estimated that the initial public offering price per share will be between $[●] and $[●]. We have applied for listing of our common stock on The Nasdaq Capital Market (“Nasdaq”) under the symbol “IAMR”. We will not proceed with this offering in the event our common stock is not approved for listing on Nasdaq.

The actual public offering price per share will be determined between us and the underwriters at the time of pricing. Therefore, the assumed public offering price used throughout this prospectus may not be indicative of the final offering price.

Investing in our securities involves risks. See “Risk Factors” beginning on page 12. You should carefully consider these risk factors, as well as the information contained in this prospectus, before purchasing any of the securities offered by this prospectus.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

	Per Share	Total
Price to the public	$	$
Shares underlying the Representative Warrants	$	$
Underwriting discounts and commissions(1)	$	$
Proceeds to us, before expenses(2)	$	$

(1)	We have also agreed to issue Spartan Capital Securities, LLC warrants to purchase shares of our common stock (the “Representative Warrants”), and to reimburse the underwriters for certain expenses. We refer you to “Underwriting” beginning on page 60 of this prospectus for additional information regarding underwriting compensation.
(2)	The amount of offering proceeds to us presented in this table does not give effect to any exercise of the: (i) underwriters’ over-allotment option we have granted to the underwriters as described below and (ii) the Representative Warrants being issued to the underwriters in this offering.

We have granted the underwriters the option for a period of 45 days to purchase up to an additional [●] shares of common stock at the initial public offering price, less underwriting discounts and commissions, solely to cover over-allotments, if any.

The underwriters expect to deliver the shares against payment to the investors in this offering on or about [●], 2023.

Sole Book Running Manager

Spartan Capital Securities, LLC

Prospectus dated [●], 2023

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TABLE OF CONTENTS

	Page
PROSPECTUS SUMMARY	5
RISK FACTORS	12
INFORMATION REGARDING FORWARD-LOOKING STATEMENTS	22
INDUSTRY AND MARKET DATA	23
USE OF PROCEEDS	24
DIVIDEND POLICY	25
CAPITALIZATION	25
DILUTION	25
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	27
BUSINESS	38
MANAGEMENT	48
EXECUTIVE AND DIRECTOR COMPENSATION	51
CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS	53
PRINCIPAL STOCKHOLDERS	53
DESCRIPTION OF CAPITAL STOCK	55
DESCRIPTION OF SECURITIES WE ARE OFFERING	56
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS OF OUR COMMON STOCK	57
UNDERWRITING	60
LEGAL MATTERS	67
EXPERTS	67
WHERE YOU CAN FIND MORE INFORMATION	67
INDEX TO FINANCIAL STATEMENTS	F-1

We have not, and the underwriters have not, authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectus prepared by or on behalf of us or to which we have referred you. We take no responsibility for and can provide no assurance as to the reliability of, any other information that others may give to you.

You should rely only on the information contained in this prospectus. No dealer, salesperson or other person is authorized to give information that is not contained in this prospectus. This prospectus is not an offer to sell nor is it seeking an offer to buy these securities in any jurisdiction where the offer or sale is not permitted. The selling stockholders are offering to sell and seeking offers to buy our common stock only in jurisdictions where offers and sales are permitted. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of these securities.

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PROSPECTUS SUMMARY

The following summary highlights selected information contained elsewhere in this prospectus and is qualified in its entirety by the more detailed information and financial statements included elsewhere in this prospectus. It does not contain all the information that may be important to you and your investment decision. You should carefully read this entire prospectus, including the matters set forth under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and our financial statements and related notes included elsewhere in this prospectus. In this prospectus, unless context requires otherwise, references to “we,” “us,” “our,” or the “Company” refer to Medical Industries of the Americas, Inc.

Company Overview

Description of Our Operations, Principal Activities and Key Factors

Medical Industries of the Americas, Inc. is a U.S.-based medical supplies company that is in the process of outfitting a production facility for manufacturing dipped latex products, thermal packs, surgical marking products and disposable scalpels. We own a variety of machinery and equipment capable of producing dipped latex products and thermal packs. With this equipment, we are currently producing industrial grade powdered latex gloves and disposable cold packs. Eventually we plan produce additional latex products, such as latex exam and surgical gloves and condoms, additional varieties of thermal packs, and eventually surgical marking products and disposable scalpels.

Our equipment includes four latex dip lines and twelve vertical form, fill and seal machines (“VFFSMs”).

The four latex dip lines are capable of producing lightly powdered industrial natural latex gloves, medical grade latex gloves and condoms. One of the latex dip lines is currently tooled and producing industrial lightly powdered gloves. We are currently in the process of retooling the other three existing condom dip lines to manufacture medical grade powder-free latex gloves. We plan to have these dip lines retooled and producing medical grade latex gloves by approximately the second quarter of 2023.

The VFFSMs are capable of producing different varieties of thermal packs, such as hot or cold thermal packs, disposable or reusable thermal packs, and different sized thermal packs. Ten of the VFFSMs are arranged in pairs, forming five systems used for making disposable cold packs. One of these five VFFSM systems is currently in service and producing disposable cold packs. The two additional VFFSMs are each configured to manufacture reusable cold packs, or gel packs.

We also own additional manufacturing equipment which is currently on-site, including packaging machinery, product test equipment and instrumentation used for quality control.

Once operational, the annual output of each glove line is estimated to be up to approximately 180 million gloves, and the annual output of each thermal pack system, consisting of two VFFSMs each, is estimated to be up to approximately 10 million thermal packs. These estimates are based on the historical output of the equipment.

Our manufacturing facility is located in Eufaula, Alabama. The Eufaula facility has direct rail access to the ports of Savannah, Georgia and Mobile, Alabama.

The primary raw material used in our production process for disposable latex gloves and other latex products is raw natural rubber latex. We purchase such material from third-party brokers operating out of the Port of Savannah, which is the site of a major rubber and latex terminal.

The primary raw materials used in our production process of thermal packs are two-ply laminated polyethylene, magnesium sulphate (for hot packs), and urea, an agricultural grade fertilizer (for cold packs). These materials are purchased from suppliers and commodities chemical brokers located in the United States and shipped to our Eufaula facility via truck. Once we have increased production to full scale, we expect to have the capability to receive shipments by rail, utilizing our private, onsite rail spur.

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Product Portfolio Characteristics

The key characteristics of our current and planned product portfolio are:

Products presently being manufactured and sold:

● Disposable cold packs

● Lightly powdered industrial gloves

Additional products planned to be put into production in 2023:

● Different varieties of thermal packs, including reusable cold packs, disposable heat packs, and reusable heat packs.

● Maternity pads

● Latex medical exam gloves and surgical gloves

● Latex rubber condoms

Potential Future Products (based on the availability of capital):

● Scalpel blades, syringes, razor blades

● Hospital beds, medical textiles

With respect to the additional products we plan to put into production in 2023, in order to reach this production goal, we will need to obtain additional capital and complete the refurbishment and installation of certain machinery and equipment that we own. We currently have machinery in place to produce different varieties of thermal packs, including reusable cold packs, disposable heat packs, and reusable heat packs. This machinery is substantially identical to the machinery currently producing disposable cold packs, and we are in the process of refurbishing such machinery to begin production. We also have machinery onsite to manufacture maternity pads, scalpel blades, syringes and razor blades. We have contracted mechanical, electrical, and control engineers and are in discussions with original equipment manufacturers to procure installation of such machinery.

Target Markets

Our immediate focus is on the United States and other North American markets. Our target customers are primarily distributors and wholesalers, with a secondary focus on end users.

Our Team

Our team consists of capable and experienced professionals from various disciplines and backgrounds.

● Abraham Summers, our founder and current President and Chairman of the Board, has previously served as the Chief Financial Officer of a public reporting company and prior to that as an analyst with a family office.

● David Silver, our Chief Executive Officer, has advised corporations on investor relations, corporate crises, strategic management, and public/private partnerships for nearly three decades.

● Denise Berry, our Chief Financial Officer and co-founder, is a former sergeant and decorated war veteran of the United States Army, and prior to co-founding the Company she led an international team of over 40 financial professionals with Transamerica Corporation.

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Upon the effectiveness of the registration statement of which this prospectus forms a part, our Board of Directors will expand to include:

● Edward Boardwine

● Alan Fogelman

● Bruce Potash

Our Strategy

Once our Eufaula facility becomes fully operational, we plan to be a leading U.S.-based mass-manufacturer of disposable natural rubber latex gloves. We currently have one line operational and in production, and our refurbishing of the second line is approximately 75% complete. As funding for refurbishment allows, we expect to double production capabilities by the second quarter of 2023. We will then refurbish the additional lines and increase staff as needed. Our ability to bring the Eufaula facility fully operational, and to operate as a leading U.S.-based mass-manufacturer of disposable natural rubber latex gloves moving forward, is dependent upon the availability of additional capital and the successful refurbishment of our existing machinery and equipment.

Our strategy involves leveraging our supply-chain and logistical advantage to supply products to customers in the United States and other North American markets. Currently, distributors and wholesalers of latex gloves and other latex products source their products nearly exclusively from overseas. By operating a manufacturing facility domestically, we believe we will be able to deliver the same or higher quality products more quickly and cost effectively than our competitors, thus providing us with a significant competitive advantage.

Our basic strategy for our future products is the same. For products that we can manufacture for a cost approximately the same as that required to produce the product overseas, we will differentiate ourselves by virtue of our domestic location and ability to deliver products efficiently. Cold packs, for example, are costly to ship internationally due to their weight. Once we are able to increase production of cold packs at our Eufaula facility, we believe we will have a distinct advantage over competitors who source their cold packs from overseas.

Risks Associated with Our Business

Our business is subject to a number of risks of which you should be aware of before making an investment decision. These risks are discussed more fully in the “Risk Factors” section of this prospectus immediately following this prospectus summary. Some of the risks involved with the offering include the following:

● We are a development-stage company that has generated very limited revenues to date. Our lack of revenues does not provide a sufficient basis for you to assess our business and prospects.

● As a relative start-up, we do not have experience in how our equipment will operate, including with respect to amounts of product produced and the timing and extent of the need for repairs or refurbishment.

● All of our operations are currently in a single production line so that any operational problems arising from that line will have a material effect on our business.

● We currently do not have any contracts guaranteeing any specific amount of purchases, so our revenues and pricing will depend upon the demand for our products which we may not be able to accurately predict.

● Our operations are currently contained in one physical location which places us at risk for natural disasters, such as tornadoes or hurricanes.

● As with others in the rubber industry, we rely on third parties to supply our raw materials. We purchase such raw materials from brokers operating out of the Port of Savannah, Georgia. Our operations could be adversely affected by global raw material shortages, the volatility of raw material prices and supply chain disruption.

● Supply chain issues, including impediments to freight trucks traveling cross-border or between states lines, may adversely affect our ability to obtain component raw materials and/or ship product to our distributors or customers.

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● If we lose key personnel or are unable to attract and retain qualified personnel, our business could be harmed and our ability to compete could be impaired.

● We expect to experience rapid growth, including from adding additional product lines, which will place a significant strain on our financial and managerial resources.

● If we are unable to effectively manage our growth, our ability to implement our business strategy and our operating results will likely be materially adversely affected.

● We may not be able to adjust our operating expenses in order to offset any unexpected revenue shortfalls.

● If we do not develop and enhance our brand, we will not be able to establish our customer base or build our revenues

● We currently have approximately $10,775,000 in outstanding debt. Substantially all of our debt is secured by our assets so that any action by a debt holder, such as foreclosure, could have a material adverse effect on our business.

● Even with the net proceeds of the Offering, we will be required to raise additional funds to implement our business plan including adding additional product lines. No assurance can be given that such funds will be available or, if available what the terms thereof will be.

● The impact of the military conflict in Ukraine and associated geopolitical tensions and responses, including on inflation, supply chains, commodities, energy, and cyber-security may affect our operations.

● Our industry is characterized by intense competition.

● We do not plan to pay dividends in the foreseeable future, and, as a result, stockholders will need to sell shares to realize a return on their investment.

● If you invest in our stock, your investment may be disadvantaged by future funding, if we are able to obtain it.

● There is no public trading market for our securities, and there can be no assurance that such a market will develop in the future.

● Our offering price has been arbitrarily established and you will incur substantial dilution.

Implications of Being an Emerging Growth Company and a Smaller Reporting Company

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, enacted in April 2012, and we will remain an emerging growth company until the earliest to occur of: the last day of the fiscal year in which we have more than $1.235 billion in annual revenue; the date we qualify as a “large accelerated filer,” with at least $700 million of equity securities held by non-affiliates; the issuance, in any three-year period, by us of more than $1.0 billion in non-convertible debt securities; and the last day of the fiscal year ending after the fifth anniversary of our initial public offering. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. In particular, in this prospectus, we have provided only two years of audited financial statements and have not included all of the executive compensation-related information that would be required if we were not an emerging growth company. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock.

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In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of the extended transition period to comply with new or revised accounting standards and to adopt certain of the reduced disclosure requirements available to emerging growth companies. As a result, we will not be subject to the same implementation timing for new or revised accounting standards as other public companies that are not emerging growth companies which may make comparison of our financial statements to those of other public companies more difficult. As a result of this election, the information that we provide in this prospectus may be different than the information you may receive from other public companies in which you hold equity interests. We intend to take advantage of the extended transition period.

We are also a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantage of these scaled disclosures for so long as (i) the market value of our voting and non-voting common stock held by non-affiliates is less than $250 million measured on the last business day of our second fiscal quarter or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our voting and non-voting common stock held by non-affiliates is less than $700 million measured on the last business day of our second fiscal quarter. Specifically, as a smaller reporting company, we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and have reduced disclosure obligations regarding executive compensation, and, similar to emerging growth companies, if we are a smaller reporting company with less than $100 million in annual revenue, we would not be required to obtain an attestation report on internal control over financial reporting issued by our independent registered public accounting firm.

Corporate Information

We were incorporated as a Delaware corporation in December 2017. Our principal executive offices are located at 954 Wilshire Boulevard, Suite 600, Beverly Hills, California 90212. Our telephone number is (334) 866-0070.

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THE OFFERING

Shares offered by us	[●] shares.
Common stock outstanding prior to this offering	51,503,901 shares
Common stock to be outstanding immediately after this offering (1)	[●] shares ( [●] shares if the underwriters exercise their over-allotment option in full)
Option to purchase additional shares	The underwriters have an option for a period of 45 days to purchase up to an additional 15% of the total number of shares to be offered, solely for the purpose of covering over-allotments.
Use of proceeds	We estimate that the net proceeds from this offering will be approximately $[●] million, or approximately $[●] if the underwriters exercise their over-allotment option in full, at an assumed public offering price of $[●] per share, after deducting the underwriting discounts and commissions, the non-accountable expense allowance payable to the underwriters, and estimated offering expenses payable by us. We intend to use approximately $[●] million for upgrading equipment at our Eufaula facility, approximately $[●] million for working capital, and approximately $[●] million to repay certain of our outstanding debt obligations. See “Use of Proceeds” for a more complete description of the intended use of proceeds from this offering.
Lock-up agreements	Our directors, officers, and certain Stockholders have agreed with the underwriters not to sell, transfer or dispose of any shares or similar securities for a period of 180 days after the date of this prospectus. For additional information regarding our arrangement with the underwriters, please see “Underwriting.”
Risk factors	See “Risk Factors” on page 12 and other information included in this prospectus for a discussion of factors to consider carefully before deciding to invest in shares of our common stock.
Proposed Nasdaq Capital Market symbol	IAMR

(1) The number of shares of common stock outstanding after this offering is based on [●] shares of our common stock outstanding as of December 31, 2021 and gives effect to the issuance of [●] shares of common stock issuable upon conversion of convertible indebtedness owed to Target Capital 6 LLC and HarCal, Inc. immediately prior to the effective date of this offering, assuming an initial public offering price of $ [●] per share, which is the midpoint of the price range set forth on the cover page of this prospectus (the “Debt Conversion”).

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Selected Summary Consolidated Financial Data

The following tables summarize our historical financial data as of and for the periods indicated. We derived the summary statement of operations data for the years ended December 31, 2021 and 2020 and our summary balance sheet data as of December 31, 2021 set forth below from our audited financial statements contained elsewhere in this prospectus. We derived the summary statement of operations data for the nine months ended September 30, 2022 and 2021 and our summary balance sheet data as of September 30, 2022 from our unaudited condensed financial statements contained elsewhere in this prospectus, and such summary information is not necessarily indicative of results to be expected for the full year. The unaudited condensed financial statements have been prepared on the same basis as the audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly our financial position as of September 30, 2022 and the results of operations for the nine months ended September 30, 2022 and 2021. You should read this data together with our financial statements and related notes included elsewhere in this prospectus and the information under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” The summary financial data included in this section are not intended to replace the financial statements and related notes included elsewhere in this prospectus and are qualified in their entirety by those financial statements and related notes. Our historical results are not necessarily indicative of our future results.

Statement of Operations Data:

In the table below, amounts are rounded to nearest thousands, except share and per share amounts.

	Nine Months Ended September 30,						Year Ended December 31,
	2022			2021			2021			2020
Statement of Operations Data:
Net sales	$	—		$	—		$	—		$	70,352
Cost of goods sold		73,869			108,498			—			56,445
Operating expenses		3,480,707			401,477			11,939,362			6,083,488
Change in fair value of convertible debt derivative liability		(836,662	)		—			(416,903	)		7,770
Loss on extinguishment of debt		—			—			(4,983,658	)		—
Interest		(839,073	)		—			(9,269,496	)		(3,457,339	)
Realized and unrealized loss on investment		(85,252	)		—			—			—
Dividend-- & interest		4,180						—
Net loss	$	(5,311,383	)	$	(509,975	)	$	(26,609,419	)	$	(9,519,150	)
Net loss per share, basic and diluted	$	(0.11	)	$	(0.01	)	$	(0.58	)	$	(0.26	)
Weighted--average shares used in computing net loss per share, basic and diluted		50,431,101			45,826,585			45,826,585			35,969,256

Balance Sheet Data
	September 30, 2022			December 31, 2021
Cash	$	10,388		$	5,157
Total assets	$	6,810,388		$	7,434,235
Total liabilities	$	15,377,140		$	10,739,604
Accumulated deficit	$	(53,438,499	)	$	(48,127,116	)
Total stockholders’ deficit	$	(8,566,752	)	$	(3,305,369	)

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RISK FACTORS

An investment in our common stock involves a high degree of risk. Before making an investment decision, you should give careful consideration to the following risk factors, in addition to the other information included in this prospectus, including our financial statements and related notes, before deciding whether to invest in shares of our common stock. The occurrence of any of the adverse developments described in the following risk factors could materially and adversely harm our business, financial condition, results of operations or prospects. In that case, the trading price of our common stock could decline, and you may lose all or part of your investment.

Risks Relating to Our Financial Position and Capital Needs

We are a Development-Stage Company.

We are a development-stage company that has generated very limited revenues to date. Our lack of revenues does not provide a sufficient basis for you to assess our business and prospects.

We have a significant amount of outstanding debt.

We currently have approximately $10,775,000 in outstanding debt all of which is currently overdue. Substantially all of our debt is secured by our assets, so that any action by a debt holder, such as foreclosure, could have a material adverse effect on our business. While management believes that our debt will be converted into equity or restructured, no assurance can be given that we will be successful in this regard. Additionally, the terms of any modification of the debt which includes conversion into equity could be result in substantial dilution in the position of our equity holders.

We will need additional capital.

As of September 30, 2022, we have negative working capital of approximately ($7,540,907). We believe that even with the net proceeds of the Offering we will be required to raise additional funds to implement our business plan including adding additional product lines. No assurance can be given that such funds will be available or, if available what the terms thereof will be.

Risks Related to the Regulatory Approval of our Products

In the United States, healthcare products are subject to regulation by the Food and Drug Administration (“FDA”). FDA classifies both medical examination gloves and thermal packs as a Class I medical device product, and as such, we are required to comply with the Quality System regulation (21 CFR part 820) and general controls under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(a)(1)(A)) with respect to our latex gloves.

FDA reviews medical examination gloves to ensure that performance criteria such as leak resistance, tear resistance and biocompatibility are met. FDA has also implemented extensive labelling requirements for medical examination gloves, including specific requirements for gloves that contain natural rubber latex, as our gloves do. Noncompliance with these FDA standards and regulations can result in administrative enforcement, such as warning letters and administrative detention, or in civil penalties, product bans and recalls. If our gloves fail to meet the FDA requirements and we become subject to FDA penalties, warnings, or recalls, such penalties, warnings, or recalls could have a material adverse effect on our business reputation and financial condition.

If we begin producing new products in addition to latex gloves and thermal packs, consistent with our future plans, such blades and syringes, and/or medical textiles, we may become subject to additional regulation by FDA or other agencies. Failure to comply with such additional regulation could pose similar risks and have a material adverse effect on our business.

Risks Related to Our Dependence on Third Parties

As with others in the rubber industry, we rely on third parties to supply our raw materials. We purchase such raw materials from brokers operating out of the Port of Savannah, Georgia. While the rubber market is historically stable, our operations could be adversely affected by global raw material shortages, the volatility of raw material prices and supply chain disruption.

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Risks Related to our Intellectual Property

We may become subject to claims alleging infringement of third parties’ patents and other intellectual property rights, which may result in costly litigation and could result in us having to pay substantial damages or limit our ability to commercialize our products.

Our current, and any future, products may infringe upon or may be alleged to infringe upon existing patents or patents that may be granted to third parties in the future. Additionally, pending patent applications which have been published can, subject to certain limitations, be later amended in a manner that could cover our technologies or our products. As a result, we may become party to, or threatened with, future adversarial proceedings or litigation regarding patents with respect to our products and technology.

If we are sued for patent infringement, we would need to demonstrate that our products or methods either do not infringe upon the patent claims of the relevant patent or that the patent claims are invalid, and we may not be able to do this. If we are found to infringe upon a third party’s patent, we could be required to obtain a license from such third party to continue commercializing and marketing our products and technology or we may elect to enter into such a license in order to settle litigation or in order to resolve disputes prior to litigation. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we are able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us and could require us to make substantial royalty payments. We could also be forced, including by court order, to cease commercializing the infringing technology or products. A finding of infringement could prevent us from commercializing our products or force us to cease some of our business operations, which could materially harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similarly negative impact on our business. Any such claims are likely to be expensive to defend, and some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. Moreover, even if we are successful in defending any infringement proceedings, we may incur substantial costs and divert management’s time and attention in doing so, which could materially adversely affect our business, results of operations or financial condition.

Risks Related to Our Business Operations

We face certain risks specifically related to our Business.

As a relative start-up, we have limited experience in how our equipment will operate, including with respect to amounts of product produced and the timing and extent of the need for repairs or refurbishment.

All of operations are currently in a limited number of production lines so that any operational problems arising from one or more lines will have a material effect on our business.

We currently do not have any contracts guaranteeing any specific amount of purchases, so our revenues and pricing will depend upon the demand for our products which we may not be able to accurately predict.

Our operations are currently contained in one physical location which places us at risk for natural disasters, such as tornadoes or hurricanes.

As with others in the rubber industry, we rely on third parties to supply our raw materials. We purchase such raw materials from brokers operating out of the Port of Savannah, Georgia. Our operations could be adversely affected by global raw material shortages, the volatility of raw material prices and supply chain disruption.

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If we lose key personnel or are unable to attract and retain qualified personnel, our business could be harmed and our ability to compete could be impaired.

Our success will depend to a significant degree upon the contributions of our management team which we will need to build. If we lose the services of one or more of our key members, we may be unable to achieve our business objectives. Additionally, we may be unable to attract and retain personnel with the advanced technical qualifications or managerial experience necessary for the development of our business and planned expansion into areas and activities requiring additional expertise, due to intense competition for qualified personnel among technology-based businesses.

We face risks related to expanding operations and managing our growth.

We expect to experience rapid growth including from adding additional product lines which will place a significant strain on our financial and managerial resources. In order to achieve and manage growth effectively, we must establish, improve, and expand our operational and financial management capabilities. Moreover, we will need to increase staffing and effectively train, motivate, and manage our employees. Failure to manage growth effectively could harm our business, financial condition, or results of operations.

If we are unable to effectively manage our growth, our ability to implement our business strategy and our operating results will likely be materially adversely affected.

Implementation of our business plan will likely place a significant strain on our management who must develop administrative, operating, and financial infrastructures. To manage our business and planned growth effectively, we must successfully develop, implement, maintain, and enhance our financial and accounting systems and controls, identify, hire, and integrate new personnel and manage expanded operations. Our failure to do so could either limit our growth or cause our business to fail.

We may not be able to adjust our operating expenses in order to offset any unexpected revenue shortfalls.

Our operating expenses will be based on our expectations of our future revenues. We intend to expend significant amounts in the short term, particularly to build brand awareness and build additional product lines. We may be unable to adjust spending quickly enough to offset any unexpected revenue shortfall. If we fail to substantially increase our revenues, then our financial condition and results of operations would be materially adversely affected.

High transportation costs combined with shortages of trucks and qualified drivers could affect our operating costs.

Supply chain issues, in particular challenges with freight trucks, either cross border or between state lines resulting from a rise of fuel prices as well as shortages of qualified drivers, may adversely affect our ability to obtain raw manufacturing materials as well as our ability to ship our products to their final destination. This in turn may limit our ability to provide products to distributors and ultimately our customers causing a decrease in our revenue. We are currently working to mitigate transportation issues by monitoring cost effective transportation alternative venues to mitigate the effects and challenges in connection with freight trucks and labor scarcity.

If we do not develop and enhance our brand, we will not be able to establish our customer base or build our revenues.

The development of our brand is critical to our ability to establish our user base and build our revenues. In order to attract users and advertisers, we intend to expend funds for creating and maintaining brand loyalty. We plan to use a combination of social media, print and Web-based advertising to promote our brand. If we fail to advertise and market our brand effectively, we will lose users and our revenues will decline. Our success in promoting and enhancing our brand will also depend on our success in providing high quality products that are attractive to our customers.

We are subject to competition.

Our industry is characterized by intense competition. Many of our competitors and potential competitors, in comparison to us, have longer operating histories, greater name recognition in some markets, larger customer bases, and/or significantly greater financial, technical, and marketing resources.

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Our industry involves very low barrier to entry with respect to intellectual property.

Our business does not depend on patents or trade secrets, and therefore other companies with the necessary capital and technical capability could enter the marketplace without needing to overcome any barriers regarding intellectual property. Therefore, it is possible new competitors could emerge, and such a competitor could replicate our products or production process, and we would not be able to protect ourselves based on intellectual property claims.

Alternatives to natural rubber latex gloves may threaten the market for our products.

Due to the stigma of latex allergy among health professionals and in the general population, gloves made of non-latex materials such as polyvinyl chloride, nitrile rubber, or neoprene have become widely used. However, we have obtained Section 510(k) approval from the FDA to produce “low protein,” or non-allergenic, gloves. While this capability mitigates any competitive disadvantage we may have with regard to non-latex competitor products, the stigma associated with latex allergy may nonetheless harm our business.

FDA Ban on Powdered Latex Medical Gloves

On January 19, 2017, the FDA issued a final rule banning “powdered” latex medical gloves. The rule was issued in response to evidence that such gloves posed risks to patients, including airway and wound inflammation, post-surgical adhesions and allergic reactions. However, this rule does not apply to powder used during the manufacturing process for non-powdered gloves, so long as only trace amounts (no more than 2mg of powder per glove) make it into the finished product. Additionally, this rule applies only to medical gloves. The rule does not impact powdered latex gloves used in other areas, such as latex gloves for industrial, janitorial or foodservice uses.

We currently produce lightly powdered industrial latex gloves, and are in the process of obtaining equipment called chlorinators that will be added in-line to our dip lines and allow us to produce marketable non-powdered medical gloves. Our ability to produce latex medical exam gloves and surgical gloves, which we plan to put into production in 2023, is dependent upon our ability to successfully obtain and install such equipment. If we are unable to do so, we will not be able to produce and sell latex gloves for medical purposes, which will negatively impact our ability to implement our business plan. We plan to continue producing lightly powdered industrial latex gloves notwithstanding out ability to produce latex medical exam gloves and surgical gloves.

Our business may be adversely affected by the ongoing coronavirus pandemic.

The outbreak of the novel coronavirus (COVID-19) has evolved into a global pandemic. The coronavirus has spread to many regions of the world. The extent to which the coronavirus impacts our business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning the coronavirus and the actions to contain the coronavirus or treat its impact, among others.

As a result of the continuing spread of the coronavirus, our business operations could be delayed or interrupted. For instance, if any third-party in the supply chain for materials used in the production of our products are adversely impacted by restrictions resulting from the coronavirus outbreak, our supply chain may be disrupted, limiting our ability to manufacture our products.

As a result of the shelter-in-place order and other mandated local travel restrictions, our employees engaged in manufacturing or other activities may not be able to access the necessary facilities, which may result in our core activities being significantly limited or curtailed, possibly for an extended period of time.

While the potential economic impact brought by and the duration of the pandemic may be difficult to assess or predict, it has already caused, and is likely to result in further, significant disruption of global financial markets, which may reduce our ability to access capital either at all or on favorable terms. In addition, a recession, depression or other sustained adverse market event resulting from the spread of the coronavirus could materially and adversely affect our business and the value of our common stock.

The ultimate impact of the current pandemic, or other health epidemic, or the current hostilities in Ukraine, is highly uncertain and subject to change. We do not yet know the full extent of new variants, potential delays or impacts on our business, our customers, our competitors, healthcare systems or the global economy as a whole. However, these effects could have a material impact on our operations, and we will continue to monitor the situation closely.

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Current uncertainty in global economic conditions, including, the Russia-Ukraine conflict and inflation, could adversely affect our revenue and business.

Global inflation has increased during 2022. The Russia-Ukraine conflict and other geopolitical tensions, as well as the related international response, have exacerbated inflationary pressures, including causing increases in the price for goods and services and increased global supply chain disruptions, which have resulted in, and may continue to result in, shortages in materials and services and related uncertainties. Such shortages have resulted in, and may continue to result in, cost increases for labor, fuel, materials and services, and could continue to cause costs to increase, and also result in the scarcity of certain materials. We cannot predict any future trends in the rate of inflation or other negative economic factors or associated increases in our operating costs and how that may impact our business. To the extent we are unable to recover higher operating costs resulting from inflation or otherwise mitigate the impact of such costs on our business, our revenues and gross profit could decrease, and our financial condition and results of operations could be adversely affected. Interest rate increases may raise our cost of goods sold and negatively impact our ability to obtain debt financing, which in turn may negatively impact our ability to acquire new machinery and equipment. To date, increased borrowing costs have not impacted our ability to make timely payments on existing debt obligations, but interest rate increases may ultimately have such impact. Supply chain disruptions could represent a challenge for us, which may have a material adverse effect on our operations. In order to mitigate the possible effects of supply chain disruptions, we are continuously monitoring global economic conditions and has taken actions to prevent or minimize the impact resulting from these supply chain disruptions, such as the use of multiple vendors that supply the identical parts, making minor engineering modifications to our products for ease and speed of changing components and increasing our inventory to shorten delivery times to our customers. Our efforts will have no impact on our product quality, reliability or regulatory approvals.

Significant disruptions of information technology systems, computer system failures or breaches of information security could adversely affect our business.

We may rely to an extent upon sophisticated information technology systems to operate our business. The size and complexity of our information technology and information security systems, and those of our third-party vendors with whom we may contract, make such systems potentially vulnerable to service interruptions or to security breaches from inadvertent or intentional actions by our employees or vendors, or from malicious attacks by third parties. Such attacks are of ever-increasing levels of sophistication and are made by groups and individuals with a wide range of motives (including, but not limited to, industrial espionage and market manipulation) and expertise. While we intend to invest in the protection of data and information technology, there can be no assurance that our efforts will prevent service interruptions or security breaches.

Our internal computer systems, and those other business vendors on which we may rely, are vulnerable to damage from computer viruses, unauthorized access, natural disasters, fire, terrorism, war and telecommunication and electrical failures. We exercise little or no control over these third parties, which increases our vulnerability to problems with their systems. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs. Any interruption or breach in our systems could adversely affect our business operations or result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal, business and reputational harm to us or allow third parties to gain material, inside information that they use to trade in our securities. To the extent that any disruption or security breach results in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability, our ability to manufacture products could be impaired and our business could be otherwise adversely affected.

Risks Related to Owning our Common Stock and This Offering

We do not plan to pay dividends in the foreseeable future, and, as a result, stockholders will need to sell shares to realize a return on their investment.

We have not declared or paid any cash dividends on our capital stock since inception. We intend to retain any future earnings to finance the operation and expansion of our business and do not anticipate paying any cash dividends in the foreseeable future. Consequently, you will need to sell your shares of common stock in order to realize a return on your investment and you may not be able to sell your shares at or above the price you paid for them.

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If you invest in our stock, your investment may be disadvantaged by future funding, if we are able to obtain it.

To the extent we obtain funding by issuance of common stock or securities convertible into common stock, you may suffer significant dilution in percentage of ownership and, if such issuances are below the then value of stockholder equity, in stockholder equity per share. In addition, any debt financing we may secure could involve restrictive covenants relating to our capital raising activities and other financial and operational matters, which may make it more difficult for us to obtain additional capital with which to pursue our business plan, and to pay dividends. You have no assurance we will be able to obtain any additional financing on terms favorable to us, if at all.

If we are unable to establish appropriate internal financial reporting controls and procedures, it could cause us to fail to meet our reporting obligations, result in the restatement of our financial statements, harm our operating results, subject us to regulatory scrutiny and sanction, cause investors to lose confidence in our reported financial information and have a negative effect on the market price for shares of our Common Stock.

Effective internal controls are necessary for us to provide reliable financial reports and to effectively prevent fraud. We maintain a system of internal control over financial reporting, which is defined as a process designed by, or under the supervision of, our principal executive officer and principal financial officer, or persons performing similar functions, and effected by our Board of Directors, management and other personnel, 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.

As a public company, we will have significant additional requirements for enhanced financial reporting and internal controls. We will be required to document and test our internal control procedures in order to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act of 2002, which requires annual management assessments of the effectiveness of our internal controls over financial reporting. The process of designing and implementing effective internal controls is a continuous effort that requires us to anticipate and react to changes in our business and the economic and regulatory environments and to expend significant resources to maintain a system of internal controls that is adequate to satisfy our reporting obligations as a public company.

We cannot assure you that we will, in the future, identify areas requiring improvement in our internal control over financial reporting. We cannot assure you that the measures we will take to remediate any areas in need of improvement will be successful or that we will implement and maintain adequate controls over our financial processes and reporting in the future as we continue our growth. If we are unable to establish appropriate internal financial reporting controls and procedures, it could cause us to fail to meet our reporting obligations, result in the restatement of our financial statements, harm our operating results, subject us to regulatory scrutiny and sanction, cause investors to lose confidence in our reported financial information and have a negative effect on the market price for shares of our common stock.

Financial reporting obligations of being a public company in the U.S. are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters.

As a publicly traded company we will incur significant additional legal, accounting and other expenses. The obligations of being a public company in the U.S. will require significant expenditures and will place significant demands on our management and other personnel, including costs resulting from public company reporting obligations under the Exchange Act and the rules and regulations regarding corporate governance practices, including those under the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, and the listing requirements of the stock exchange on which our securities are listed. These rules require the establishment and maintenance of effective disclosure and financial controls and procedures, internal control over financial reporting and changes in corporate governance practices, among many other complex rules that are often difficult to implement, monitor and maintain compliance with. Moreover, despite recent reforms made possible by the JOBS Act, the reporting requirements, rules, and regulations will make some activities more time-consuming and costly, particularly after we are no longer an “emerging growth company.” In addition, we expect these rules and regulations to make it more difficult and more expensive for us to obtain director and officer liability insurance. Our management and other personnel will need to devote a substantial amount of time to ensure that we comply with all of these requirements and to keep pace with new regulations, otherwise we may fall out of compliance and risk becoming subject to litigation or being delisted, among other potential problems.

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The market price of our common stock may be volatile.

The market price of our common stock may be highly volatile. Some of the factors that may materially affect the market price of our common stock are beyond our control, such as changes in financial estimates by industry and securities analysts, conditions or trends in the industry in which we operate or sales of our common stock. These factors may materially adversely affect the market price of our common stock, regardless of our performance. In addition, public stock markets have experienced extreme price and trading volume volatility. This volatility has significantly affected the market prices of securities of many companies for reasons frequently unrelated to the operating performance of the specific companies. These broad market fluctuations may adversely affect the market price of our common stock.

The market prices and trading volume of our shares of Common Stock may experience rapid and substantial price volatility which could cause purchasers of our Common Stock to incur substantial losses.

Recently, the market prices and trading volume of shares of common stock of other small publicly traded with a limited number of shares available to purchasers, have experienced rapid and substantial price volatility unrelated to the financial performance of those companies. Similarly, subsequent to this offering, shares of our Common Stock may experience similar rapid and substantial price volatility unrelated to our financial performance, which could cause purchasers of our Common Stock to incur substantial losses, which may be unpredictable and not bear any relationship to our business and financial performance. Extreme fluctuations in the market price of our Common Stock may occur in response to strong and atypical retail investor interest, including on social media and online forums, the direct access by retail investors to broadly available trading platforms, the amount and status of short interest in our securities, access to margin debt, trading in options and other derivatives on our Common Stock and any related hedging and other trading factors;

If there is extreme market volatility and trading patterns in our Common Stock, it may create several risks for investors, including the following:

● the market price of our Common Stock may experience rapid and substantial increases or decreases unrelated to our operating performance or prospects, or macro or industry fundamentals;

● if our future market capitalization reflects trading dynamics unrelated to our financial performance or prospects, purchasers of our Common Stock could incur substantial losses as prices decline once the level of market volatility has abated;

● if the future market price of our Common Stock declines, purchasers may be unable to resell your shares at or above the price at which you acquired them. We cannot assure you that the market of our Common Stock will not fluctuate or decline significantly in the future, in which case you could incur substantial losses.

Further, we may incur rapid and substantial increases or decreases in our stock price in the foreseeable future that may not coincide in timing with the disclosure of news or developments by or affecting us. Accordingly, the market price of our shares of common stock may fluctuate dramatically, and may decline rapidly, regardless of any developments in our business. Overall, there are various factors, many of which are beyond our control, that could negatively affect the market price of our Common Stock or result in fluctuations in the price or trading volume of our Common Stock, including:

● actual or anticipated variations in our annual or quarterly results of operations, including our earnings estimates and whether we meet market expectations with regard to our earnings;

● our current inability to pay dividends or other distributions;

● changes in market valuations of similar companies;

● market reaction to any additional equity, debt or other securities that we may issue in the future, and which may or may not dilute the holdings of our existing stockholders;

● additions or departures of key personnel;

● actions by institutional or significant stockholders;

● short interest in our stock and the market response to such short interest;

● the dramatic increase in the number of individual holders of our stock and their participation in social media platforms targeted at speculative investing;

● speculation in the press or investment community about our company or industry;

● strategic actions by us or our competitors, such as acquisitions or other investments;

● legislative, administrative, regulatory or other actions affecting our business, our industry, including positions taken by the Internal Revenue Service (“IRS”);

● investigations, proceedings, or litigation that involve or affect us;

● the occurrence of any of the other risk factors included in this Registration Statement on Form S-1; and

● general market and economic conditions.

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We may issue more shares in a future financing or pursuant to existing agreements which will result in substantial dilution.

Our Certificate of Incorporation, as amended, authorizes the issuance of a maximum of 100,000,000 shares of common stock. Any future merger or acquisition effected by us would result in the issuance of additional securities without stockholder approval and the substantial dilution in the percentage of our common stock held by our then existing stockholders. Moreover, the common stock issued in any such merger or acquisition transaction may be valued on an arbitrary or non-arm’s-length basis by our management, resulting in an additional reduction in the percentage of Common Stock held by our then existing stockholders. Additionally, we expect to seek additional financing in order to provide working capital to the operating business. Our Board of Directors has the power to issue any or all of such authorized but unissued shares without stockholder approval. To the extent that additional shares of common stock are issued in connection with and following a business combination or otherwise, dilution to the interests of our stockholders will occur and the rights of the holders of common stock might be materially and adversely affected.

An active trading market for our common stock may not develop, and you may not be able to sell your common stock at or above the public offering price.

Prior to the consummation of this offering, there has been no public market for our common stock. An active trading market for shares of our common stock may never develop or be sustained following this offering. If an active trading market does not develop, you may have difficulty selling your shares of common stock at an attractive price, or at all. The price for our Shares in this offering will be determined by negotiations between us and the underwriters, and it may not be indicative of prices that will prevail in the open market following this offering. Consequently, you may not be able to sell your common stock at or above the public offering price or at any other price or at the time that you would like to sell. An inactive market may also impair our ability to raise capital by selling our common stock, and it may impair our ability to attract and motivate our employees through equity incentive awards and our ability to acquire other companies, products or technologies by using our common stock as consideration.

The price of our common stock may fluctuate substantially.

You should consider an investment in our common stock to be risky, and you should invest in our Shares only if you can withstand a significant loss and wide fluctuations in the market value of your investment. We expect that revenue from sales, if any, will fluctuate significantly and our future annual expenses as a percentage of our revenue may be significantly different from those we have recorded in the past. Our financial results may fluctuate from period to period due to a number of factors, including foreign currency exchange rates.

Other factors that may cause the market price of our common stock to fluctuate, in addition to the other risks mentioned in this “Risk Factors” section and elsewhere in this prospectus, are:

● sale of our common stock by our stockholders, executives, and directors and our stockholders whose shares are being registered in this offering;

● volatility and limitations in trading volumes of our shares of common stock;

● our ability to obtain additional financing to fund operations and other business activities;

● the timing and success of introductions of new products by us or our competitors or any other change in the competitive dynamics of our industry, including consolidation among competitors, customers or strategic partners;

● network outages or security breaches;

● our ability to attract customers;

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● our ability to obtain the raw materials required to manufacture our products;

● any penalties or administrative actions resulting from our failure to comply with FDA regulation;

● unanticipated safety concerns related to the use of our products;

● failures to meet external expectations or management guidance;

● changes in our capital structure or dividend policy, future issuances of securities, or sales of large blocks of common stock by our stockholders;

● our cash position;

● announcements and events surrounding financing efforts, including debt and equity securities;

● our inability to enter into new markets or develop new products;

● reputational issues;

● competition from existing technologies and products or new technologies and products that may emerge;

● announcements of acquisitions, partnerships, collaborations, joint ventures, new products, capital commitments, or other events by us or our competitors;

● changes in general economic, political and market conditions in or any of the regions in which we conduct our business;

● changes in industry conditions or perceptions;

● changes in valuations of similar companies or groups of companies;

● analyst research reports, recommendation and changes in recommendations, price targets, and withdrawals of coverage;

● departures and additions of key personnel;

● disputes and litigations related to intellectual properties, proprietary rights, and contractual obligations;

● changes in applicable laws, rules, regulations, or accounting practices and other dynamics; and

● other events or factors, many of which may be out of our control.

In addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences a loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial condition and results of operations. If any of the foregoing occurs, it could cause our stock price to fall and may expose us to lawsuits that, even if unsuccessful, could be costly to defend and a distraction to management.

A sale or perceived sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.

Our directors, officers, and certain stockholders have agreed not to sell shares of our common stock for a period of 180 days following this offering, subject to extension under specified circumstances. See “Underwriting.” Common stock subject to these lock-up agreements will become eligible for sale in the public market upon expiration of these lock-up agreements, subject to limitations imposed by Rule 144 under the Securities Act of 1933, as amended. If our stockholders sell substantial amounts of our common stock in the public market, the market price of our common stock could fall. Moreover, the perceived risk of this potential dilution could cause stockholders to attempt to sell their shares and investors to short our common stock. These sales also may make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate.

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Market and economic conditions may negatively impact our business, financial condition and share price.

Concerns over medical epidemics, energy costs, geopolitical issues such as the present conflict in Ukraine, the U.S. mortgage market, unstable global credit markets and financial conditions, and volatile oil prices have led to periods of significant economic instability, diminished liquidity and credit availability, declines in consumer confidence and discretionary spending, diminished expectations for the global economy and expectations of slower global economic growth, increased unemployment rates, and increased credit defaults in recent years. Our general business strategy may be adversely affected by any such economic downturns (including the current downturn related to the current COVID-19 pandemic), volatile business environments and continued unstable or unpredictable economic and market conditions. If these conditions continue to deteriorate or do not improve, it may make any necessary debt or equity financing more difficult to complete, more costly, and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance, and share price and could require us to delay or abandon development or commercialization plans.

If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume may decline.

The trading market for our common stock will rely in part on the research and reports that industry or financial analysts publish about us, our business, our markets and our competitors. We do not control these analysts. If securities analysts do not cover our common stock after the closing of this offering, the lack of research coverage may adversely affect the market price of our common stock. Furthermore, if one or more of the analysts who do cover us downgrade our stock or if those analysts issue other unfavorable commentary about us or our business, our stock price would likely decline. If one or more of these analysts cease coverage of us or fails to regularly publish reports on us, we could lose visibility in the market and interest in our stock could decrease, which in turn could cause our stock price or trading volume to decline and may also impair our ability to attract new customers.

Because certain of our stockholders control a significant number of shares of our common stock, they may have effective control over actions requiring stockholder approval.

Following this offering, [●] will directly or indirectly beneficially own approximately [●]% of our outstanding shares of common stock. As a result, [●] would have the ability to control the outcome of matters submitted to our stockholders for approval, including the election of directors and any merger, consolidation or sale of all or substantially all of our assets. Accordingly, this concentration of ownership might harm the market price of our common stock by:

● delaying, deferring or preventing a change in corporate control;

● impeding a merger, consolidation, takeover or other business combination involving us; or

● discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

You will incur immediate dilution as a result of this offering.

If you purchase common stock in this offering, you will pay more for your shares than the net tangible book value of your shares. As a result, you will incur immediate dilution of $[●] per share, representing the difference between the assumed public offering price of $[●] per share and our estimated as adjusted net tangible book value as of September 30, 2022 of $[●] per share. Accordingly, should we be liquidated at our book value, you would not receive the full amount of your investment.

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Our Certificate of Incorporation and our Bylaws, and Delaware law may have anti-takeover effects that could discourage, delay or prevent a change in control, which may cause our stock price to decline.

Our Certificate of Incorporation and our Bylaws, and Delaware law could make it more difficult for a third party to acquire us, even if closing such a transaction would be beneficial to our stockholders.

Provisions of our Certificate of Incorporation and our Bylaws and Delaware law also could have the effect of discouraging potential acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a stockholder might consider favorable. Such provisions may also prevent or frustrate attempts by our stockholders to replace or remove our management. In particular, the certificate of incorporation and bylaws and Delaware law, as applicable, among other things:

● provide the board of directors with the ability to alter the bylaws without stockholder approval;

● place limitations on the removal of directors;

● establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; and

● provide that vacancies on the board of directors may be filled by a majority of directors in office, although less than a quorum.

INFORMATION REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements that involve risks and uncertainties. You should not place undue reliance on these forward-looking statements. All statements other than statements of historical facts contained in this prospectus are forward-looking statements. The forward-looking statements in this prospectus are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. In some cases, you can identify these forward-looking statements by terms such as “anticipate,” “believe,” “continue,” “could,” “depends,” “estimate,” “expects,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms or other similar expressions, although not all forward-looking statements contain those words. We have based these forward-looking statements on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, strategy, short- and long-term business operations and objectives, and financial needs. These forward-looking statements include, but are not limited to, statements concerning the following:

● our projected financial position and estimated cash burn rate;

● our estimates regarding expenses, future revenues and capital requirements;

● our ability to continue as a going concern;

● our need to raise substantial additional capital to fund our operations;

● our ability to obtain the necessary regulatory approvals to market and commercialize our products and planned future products;

● the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our customers, our competitors, healthcare systems or the global economy as a whole;

● the results of market research conducted by us or others;

● our ability to obtain and maintain intellectual property protection for our products and any planned future products;

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● the possibility that a third party may claim we or our third-party licensors have infringed, misappropriated or otherwise violated their intellectual property rights and that we may incur substantial costs and be required to devote substantial time defending against claims against us;

● our reliance on third-party suppliers;

● our ability to expand our organization to accommodate potential growth and our ability to retain and attract key personnel;

● the potential for us to incur substantial costs resulting from product liability lawsuits against us and the potential for these product liability lawsuits to cause us to limit our commercialization of our products;

● our ability to operate our facility effectively and manufacture products; and

● the successful development of our commercialization capabilities, including sales and marketing capabilities.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this prospectus to conform these statements to actual results or to changes in our expectations.

You should read this prospectus and the documents that we reference in this prospectus and have filed with the SEC as exhibits to the registration statement of which this prospectus is a part with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.

INDUSTRY AND MARKET DATA

This prospectus contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. We obtained the industry and market data in this prospectus from our own research as well as from industry and general publications, surveys and studies conducted by third parties. This data involves a number of assumptions and limitations and contains projections and estimates of the future performance of the industries in which we operate that are subject to a high degree of uncertainty, including those discussed in “Risk Factors.” We caution you not to give undue weight to such projections, assumptions and estimates. Further, industry and general publications, studies and surveys generally state that they have been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe that these publications, studies and surveys are reliable, we have not independently verified the data contained in them. In addition, while we believe that the results and estimates from our internal research are reliable, such results and estimates have not been verified by any independent source.

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TRADEMARKS AND TRADE NAMES

We own or have rights to various trademarks, service marks and trade names that we use in connection with the operation of our business. This prospectus may also contain trademarks, service marks and trade names of third parties, which are the property of their respective owners. Our use or display of third parties’ trademarks, service marks, trade names or products in this prospectus is not intended to, and does not imply a relationship with, or endorsement or sponsorship by us. Solely for convenience, the trademarks, service marks and trade names referred to in this prospectus may appear without the ^®, TM or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, service marks and trade names.

USE OF PROCEEDS

We estimate that the net proceeds from our issuance and sale of common stock in this offering will be approximately $[●] million, based on an assumed public offering price of $[●] per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. If the underwriters exercise their over-allotment option to purchase additional shares in full, we estimate that the net proceeds from this offering will be approximately $[●].

We intend to use the net proceeds as follows: We intend to use approximately $[●] million for upgrading equipment at our Eufaula facility, approximately $[●] million for working capital, and approximately $[●] million to repay certain of our outstanding debt obligations, which amount includes accrued and unpaid interest through the date of repayment.

The approximately $[●] million for updating equipment would be used to fund the following:

● Upgrading Line 4 for production of gloves

● Upgrading Line 2 for production of gloves

● Purchase of additional chlorinators for glove production

From the approximately $[●] million allocated to working capital, it is possible that a certain amount may be used to repay certain of our debt obligations, the amount of which will depend upon whether and the extent to which the holders of such debt elect to convert such debt into equity of the Company.

From the approximately $[●] million to repay certain of our outstanding debt obligations, we plan to use approximately $350,000 toward our line of credit with Gnosiis International, LLC, which is controlled by Abe Summers, our president, chairman of the board and a principal stockholder. See “Certain Relationships and Related Person Transactions” for further discussion of the line of credit agreement between us and Gnosiis International, LLC.

A $1.00 increase or decrease in the assumed public offering price of $[●] per share would increase or decrease the net proceeds from this offering by approximately $[●], assuming that the number of shares offered by us, as set forth on the cover page of this prospectus remains the same and after deducting the estimated underwriting discounts and commissions and non-accountable expense allowance payable to the underwriters.

This expected use of the net proceeds from this offering and our existing cash represents our intentions based upon our current plans, financial condition and business conditions. The proceeds of the Offering will be insufficient to fully implement our business plan. We will need to seek additional funds through public or private equity or debt financings or other sources. If we do not successfully raise such monies, we will be unable to implement our business plan. Our management will retain broad discretion over the allocation of the net proceeds from this offering and our existing cash.

In the ordinary course of our business, we expect to from time to time evaluate the acquisition of, investment in or in-license of complementary products, technologies or businesses, and we could use a portion of the net proceeds from this offering for such activities. We currently do not have any agreements, arrangements or commitments with respect to any potential acquisition, investment or license.

Pending our use of the net proceeds from this offering, we intend to also invest a portion of such net proceeds in a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments and government securities.

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DIVIDEND POLICY

We have never paid or declared any cash dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future. We intend to retain all available funds and any future earnings to fund the development and expansion of our business. Any future determination to pay dividends will be at the discretion of our board of directors and will depend upon a number of factors, including our results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors our board of directors deems relevant.

CAPITALIZATION

The following table sets forth our cash and cash equivalents and capitalization as of December 31, 2021, as follows:

● on an actual basis;

● on a pro forma basis to give effect to the Debt Conversion, based on the assumed initial public offering price of $[●] per share, which is the midpoint of the price range set forth on the cover page of this prospectus; and

● on a pro forma as adjusted basis to give further effect to our issuance and sale of shares of our common stock in this offering at an assumed initial public offering price of $[●] per share, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting underwriting discounts and commissions and estimated offering expenses payable by us of $[●] million and therefore providing net proceeds of approximately $[●] million.

The pro forma as adjusted information below is illustrative only, and our capitalization following the closing of this offering will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing. You should read this information in conjunction with our financial statements and the related notes included elsewhere in this prospectus and the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section and other financial information contained in this prospectus.

	As of September 30, 2022
	Actual			Pro forma	Pro Forma as adjusted
Cash and cash equivalents	$	10,388
Stockholders’ (deficit) equity
Common stock, $0.0001 par value, 100,000,000 shares authorized, and 51,018,355 shares issued and outstanding, actual		5,101
Additional paid-in capital		44,866,646
Accumulated deficit		(53,438,499	)
Total stockholders’ (deficit) equity		(8,566,752	)
Total capitalization	$	(3,300,212	)

(1) Each $1.00 increase (decrease) in the assumed initial public offering price of $[●] per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted amount of each of cash and cash equivalents, total equity and total capitalization by $[●] million, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 0.1 million shares in the number of shares offered by us at the assumed initial public offering price per share, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase (decrease) the pro forma as adjusted amount of each of cash and cash equivalents, total equity and total capitalization by approximately $[●] million.

The number of shares of common stock on a pro forma and pro forma as adjusted basis set forth in the table above is based on 51,018,355 shares of our common stock outstanding as of September 30, 2022 after giving effect to the Debt Conversion.

DILUTION

If you invest in our common stock in this offering, your ownership interest will be immediately diluted to the extent of the difference between the assumed initial public offering price of $[●] per share (the mid-point of the range appearing on the front cover of this prospectus) and the pro forma as adjusted net tangible book value per share of our common stock immediately upon the consummation of this offering. Pro forma net tangible book value per share represents the book value of our tangible assets less the book value of our total liabilities divided by the number of shares of common stock then issued and outstanding.

After giving effect to the Debt Conversion, as of December 31, 2021, we had a pro forma historical net tangible book value of $[●], or $[●] per share of common stock, based on [●] shares of common stock deemed outstanding pro forma as of December 31, 2021.

After giving effect to the issuance and sale of [●] shares of our common stock in this offering at an assumed public offering price of $[●] per share, and after deducting estimated underwriting discounts and commissions, the non-accountable expense allowance payable to the underwriters, and estimated offering costs payable by us, our pro forma as adjusted net tangible book value as of [December 31, 2021] would have been $[●], or $[●] per share. This represents an immediate increase in pro forma as adjusted net tangible book value per share of $[●] to existing stockholders and immediate dilution of $[●] in pro forma as adjusted net tangible book value per share to new investors purchasing common stock in this offering. Dilution per share to new investors is determined by subtracting pro forma as adjusted net tangible book value per share after this offering from the assumed public offering price per share paid by new investors. The following table illustrates this dilution on a per share basis:

Assumed public offering price per share		$
Pro forma net tangible book value per share as of December 31, 2021	$
Increase in pro forma net tangible book value per share attributable to new investors purchasing common stock in this offering
Pro forma as adjusted net tangible book value per share after this offering
Dilution per share to new investors purchasing shares in this offering		$

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The dilution information discussed above is illustrative only and will change based on the actual public offering price and other terms of this offering determined at pricing. A $1.00 increase in the assumed public offering price of $[●] per share , which is the midpoint of the price range set forth on the cover page of this prospectus, would increase our pro forma net tangible book value after this offering by approximately $[●] per share and the dilution to new investors purchasing common stock in this offering by approximately $[●] per share, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discount and commissions and the non-accountable expense allowance payable to the underwriters. A $1.00 decrease in the assumed public offering price of $[●] per Share, which is the midpoint of the price range set forth on the cover page of this prospectus, would decrease our pro forma net tangible book value after this offering by approximately $[●] per share and the dilution to new investors purchasing common stock in this offering by approximately $[●] per share, assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting estimated underwriting discount and commissions and the non-accountable expense allowance payable to the underwriters.

An Increase of 500,000 shares in the number of shares offered by us, as set forth on the cover page of this prospectus, would increase our pro forma net tangible book value after this offering by approximately $[●] per share and decrease the dilution to new investors purchasing common stock in this offering by approximately $[●] per share, assuming no change in the assumed public offering price per share and after deducting estimated underwriting discounts and commissions and the non-accountable expense allowance payable to the underwriters. A decrease of 500,000 shares in the number of shares offered by us, as set forth on the cover page of this prospectus, would decrease our pro forma net tangible book value after this offering by approximately $[●] per share and increase the dilution to new investors purchasing common stock in this offering by approximately $[●] per share, assuming no change in the assumed public offering price per share and after deducting estimated underwriting discounts and commissions and the non-accountable expense allowance payable to the underwriters.

If the underwriters exercise their option to purchase additional shares in full, the as adjusted net tangible book value per share after giving effect to the offering would be $[●] per share. This represents an increase in as adjusted net tangible book value of $[●] per share to existing stockholders and dilution in as adjusted net tangible book value of $[●] per share to new investors.

To the extent that stock options are exercised, or we issue additional shares of common stock in the future, there will be further dilution to investors participating in this offering. In addition, if we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This management’s discussion and analysis (“MD&A”) of the financial condition and results of operations of Medical Industries of the Americas, Inc. and its subsidiaries is supplemental to, and should be read in conjunction with, our audited financial statements for the years ended December 31, 2021 and 2020 contained elsewhere in this prospectus. The discussion in this section contains forward-looking statements that reflect our plans, estimates, and beliefs that involve risks and uncertainties. Actual future results could differ materially from those discussed below for many reasons, including those set forth under the “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” sections in this prospectus.

Our financial statements are prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”).

Company Overview

Medical Industries of the Americas, Inc. is a U.S.-based medical supplies company that is in the process of outfitting a production facility for manufacturing dipped latex products, thermal packs, surgical marking products and disposable scalpels. We own a variety of machinery and equipment capable of producing dipped latex products and thermal packs. With this equipment, we are currently producing industrial grade powdered latex gloves and disposable cold packs. Eventually we plan produce additional latex products, such as latex exam and surgical gloves and condoms, additional varieties of thermal packs, and eventually surgical marking products and disposable scalpels.

Our manufacturing facility is located in Eufaula, Alabama. The Eufaula facility has direct rail access to the ports of Savannah, Georgia and Mobile, Alabama.

Key Factors Affecting Our Performance

Upgrading our Eufaula Facility and Equipment

Our ability to generate revenues is dependent on our ability to upgrade the equipment at our Eufaula facility and bring additional equipment online to increase production dipped latex products and thermal packs and to begin producing additional products. We plan to use the proceeds of this offering in part for this purpose.

Third-Party Suppliers

As with others in the rubber industry, we rely on third parties to supply our raw materials. We purchase such raw materials from brokers operating out of the Port of Savannah, Georgia. Our operations could be adversely affected by global raw material shortages, the volatility of raw material prices and supply chain disruption, including our ability to timely and cost effectively ship raw materials to our Eufaula facility.

Public Company Costs

Our common stock will be registered with the SEC and listed on Nasdaq, which will require us to hire additional personnel and implement public company procedures and processes. We expect to incur additional annual expenses as a public company for internal controls compliance and public company reporting obligations, directors’ and officers’ liability insurance, director fees and additional internal and external accounting and legal and administrative resources, including increased audit and legal fees.

Critical Accounting Policies and Estimates

We believe the following accounting policies are most critical in understanding and evaluating this management discussion and analysis:

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Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Estimates are used when accounting for items such as allowance for doubtful debts, valuation of derivative liability, valuation of our common stock and stock-based compensation, income taxes and commitments. Actual results could differ from these estimates.

Cash and Cash Equivalents

We consider highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. There were no cash equivalents as of September 30, 2022 and December 31, 2022.

Marketable Securities

Our portfolio of marketable securities is comprised of investments in money market funds that invest in U.S. government securities and equity securities, which were purchased during 2021. Our marketable securities are classified as trading securities. Trading securities are presented on the balance sheet at fair value at the end of each reporting period. Gains and losses resulting from the change in fair value of trading securities would be included in the accompanying statement of operations, to which there were none during the year ended December 31, 2021. The estimated fair values of marketable securities are determined using inputs such as actual trade data, benchmark yields, quoted market prices from dealers or brokers, and other similar sources. Interest income from securities is recorded on the accrual basis and dividends from securities are recorded on the ex-dividend date.

As of September 30, 2022 and December 31, 2021, we had $66,618 and $1,395,311, respectively, in marketable securities.

Fair Value of Financial Instruments

For purpose of this disclosure, the fair value of a financial instrument is the amount at which the instrument could be exchanged in a current transaction between willing parties, other than in a forced sale or liquidation. The carrying amount of the short-term financial instruments approximate fair value due to the relatively short period to maturity for these instruments. The carrying amounts of cash, accounts receivable, accounts payable and accrued expenses and long-term notes payable approximate their fair values because of the short maturity of these instruments or market interest rate of these terms.

We base the fair value of short-term investments on quoted market prices or other relevant information generated by market transactions involving identical or comparable assets. We measure and record derivative financial instruments at fair value.

We had no items measured at fair value on a nonrecurring basis during the year ended September 30, 2022 and December 31, 2021.

Derivative Debt Liability Financial Instruments

We issued series of convertible secured promissory notes with optional conversion right upon the occurrence of a qualified financing event and automatic conversion right upon the occurrence of change in control.

We evaluated the optional conversion right in accordance with the guidance contained in ASC 815, Derivatives and Hedging and concluded that they meet the derivatives criteria. Thus, they require bifurcation from the host debt instrument and accounted for as a freestanding derivative liability, with subsequent changes in fair value recorded in statements of operations at the end of each reporting period.

Warrants to Purchase Common Stock

Warrants to purchase common stock are accounted for in accordance with the applicable accounting guidance as either derivative liability or as equity instruments depending on the specific terms of the agreement.

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Concentration of Credit Risk

Financial instruments, which potentially subject us to concentrations of credit risk, consist of cash and cash equivalents. We place our cash and temporary cash investments with credit quality financial institutions. At times, such amounts may be in excess of the FDIC $250,000 insurance limit. We do not anticipate incurring any losses related to these credit risks.

Property, Plant and Equipment

Property and equipment are stated at cost less depreciation and depreciated using the straight-line method over their estimated useful lives. Expenditures for maintenance and repairs are charged to operations as incurred while additions and improvements that extend the lives of the assets are capitalized. Gains and losses on disposals are included in the statements of operations.

Property, plant and equipment estimated useful lives are as follows:

Asset Category	Useful lives
Building	40 years
Machinery and equipment	7 -10 years
Furniture and equipment	5 - 7 years

We assess the carrying value of property and equipment whenever events or changes in circumstances indicate that the carrying value may not be recoverable. If there is indication of impairment, we prepare an estimate of future cash flows expected to result from the use of the asset and its eventual disposition. If these cash flows are less than the carrying amount of the asset, an impairment loss is recognized to write down the asset to its estimated fair value. No impairment loss was recorded for the periods ended September 30, 2022 and 2021.

Leases

We account for leases in accordance with the provisions of Accounting Standards Codification (“ASC”) No. 842, Leases. This standard requires lessees to recognize on the balance sheet assets and liabilities for leases with lease terms of more than 12 months. The recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee will depend primarily on its classification as a finance or operating lease.

We determine if an arrangement contains a lease at inception. right of use (“ROU”) assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of lease payments over the lease term. As of September 30, 2022, there was no ROU or lease liability recorded on the balance sheet.

Revenue Recognition

We account for revenue in accordance with ASC 606, Revenue from Contracts with Customers. The underlying principle of ASC 606 is to recognize revenue to depict the transfer of goods or services to customers at the amount expected to be collected.

We recognize revenues when control of the promised goods or services are transferred to a customer, in an amount that reflects the consideration that we expect to receive in exchange for those goods or services. We apply the following five steps in order to determine the appropriate amount of revenue to be recognized as we fulfill our obligations under each of our agreements:

● identify the contract with a customer;

● identify the performance obligations in the contract;

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● determine the transaction price;

● allocate the transaction price to performance obligations in the contract; and

● recognize revenue as the performance obligation is satisfied.

Our performance obligations to deliver products are satisfied at the point in time when control is transferred, and products are received by the customer. This occurs when the customer has legal title to and physical possession of the product, the customer has accepted the product, the significant risks and rewards of ownership have been transferred to the customer, and we have the present right to payment. The transaction price is determined based on the consideration to which we will be entitled in exchange for transferring products to the customer, which is comprised of fixed consideration. To the extent that the transaction price includes variable consideration, we estimate the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method, depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in our judgment, it is probable that a significant future reversal of cumulative revenue recognized will not occur.

We consider ourselves to be the principal in the sale transactions of products produced by third parties and we record revenue and costs of goods sold on a gross basis.

We have elected to adopt the practical expedient in ASC 606-10-25-18(b), for shipping and handling activities performed after a customer obtains control of the product. We elected to account for shipping and handling as activities to fulfill the promise to transfer the product and accrues for the related costs.

The timing of revenue recognition may differ from the timing of invoicing to customers. Accounts receivables are recorded at the invoiced amount, net of an allowance for doubtful accounts. A receivable is recognized in the period we deliver goods or provide services or when our right to consideration is unconditional. Payment terms on invoiced amounts are typically 30 days.

We may receive a payment in excess of revenue recognized to that date. In these circumstances, a contract liability is recorded and classified as Deferred Revenues. Contract liabilities are derecognized when the performance obligations are satisfied, and revenue is recognized.

We have not earned revenues from the manufacture of our products during the periods ended September 30, 2022 and December 31, 2021.

Stock-Based Compensation

We may issue stock options, warrants and restricted stock to employees and non-employees for services rendered. We account for share-based payments under the guidance as set forth in the ASC Topic 718, Share-Based Payment, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees, officers, directors, and consultants, including employee stock options, based on estimated fair values. We estimate the fair value of stock option and warrant awards to employees and directors on the date of grant using an option-pricing model, and the value of the portion of the award that is ultimately expected to vest is recognized as expense over the required service period in our Statements of Operations. We estimate the fair value of restricted stock awards to employees and directors using the market price of our common stock on the date of grant, and the value of the portion of the award that is ultimately expected to vest is recognized as expense over the required service period in our Statements of Operations.

Income Taxes

We follow the asset and liability method of accounting for income taxes under ASC 740, Income Taxes. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred income tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that included the enactment date. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized.

The Company recognizes accrued interest and penalties related to unrecognized tax benefits as income tax expense. No amounts were accrued for the payment of interest and penalties as of September 30, 2022 and December 31, 2021.

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Net Loss Per Common Share

We compute net loss per share under ASC 260-10, Earnings Per Share. Net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the year. Diluted earnings per share includes the number of additional common shares that would have been outstanding if all dilutive potential common shares had been issued, using the treasury stock method. The dilutive effect of potentially dilutive securities is reflected in diluted net income per share if the exercise prices were lower than the average fair market value of common shares during the reporting period. Potential common shares are excluded from the computation when their effect is antidilutive. Basic and diluted net loss per common share is the same for the periods ended September 30, 2022 and December 31, 2021 because we have only incurred losses, and all potentially dilutive securities are anti-dilutive.

Recently Issued Accounting Standards

Fair Value Measurements

In August 2018, the FASB issued Accounting Standards Update (“ASU”) No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement. This standard modifies certain disclosure requirements on fair value measurements. This standard became effective for us on January 1, 2020. The adoption of this standard did not have a material impact on our disclosures.

Recently Issued Accounting Pronouncements

In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. This ASU also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and it simplifies the diluted earnings per share calculation in certain areas.

The new standard will become effective for us beginning January 1, 2024, using either a modified retrospective or a fully retrospective method of transition and early adoption is permitted. Management is currently evaluating the impact of the new standard on our financial statements.

Our management does not believe that any other recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on our financial statements.

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Results of Operations for the Nine Months Ended September 30, 2022 and September 30, 2021

The following table summarizes our results of operations for the nine months ended September 30, 2022 and 2021:

	Nine Months Ended September 30, 2022			Nine Months September 30, 2021			Change			% Change
Revenue	$	—		$	—		$	—			—	%
Cost of sales		73,869			108,498			106,850			32	%
Gross Profit		(73,869	)		(108,498	)		(106,850	)		32	%
Operating expenses:
General and administrative		3,480,707			401,975			3,078,732			766	%
Total operating expenses		3,480,707			509,975			2,970,732			583	%
Loss from operations		(3,554,576	)		(509,975	)		(3,186,080	)		(597	)%
Other(expenses) income:
Interest expense		(839,073	)		—			(839,073	)		100	%
Realized and unrealized loss on investments		(85,252	)		—			(85,252	)		100	%
Dividend & Interest		4,180			—			4,180			100	%
Loss on extinguishment of debt		—			—			—			—
Change in derivative liability		(836,662	)		—			—			100	%
Total other expenses		(1,756,807	)		—						100	%
Net loss	$	(5,311,383	)	$	(509,975	)		(4,942,887	)		(941	)%
Net loss per share, basic and diluted	$	(0.11	)	$	(0.01	)					(808	)%
Weighted average shares outstanding, basic and diluted		50,431,101			50,431,101						—

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General and Administrative

We recognized general and administrative expenses of approximately $3,480,707 and $401,975 for the nine months ended September 30, 2022 and September 30, 2021, respectively, resulting in an increase of approximately $3,078,732 or 766%.

During the nine months ended September 30, 2022, we began staffing and performing maintenance on the production lines. We also began hiring various consultants to assist with getting the plant operational.

Other Expenses

Other expenses are comprised of the following:

● Interest expense of approximately $0.8 million and $0 for the periods ended September 30, 2022 and September 30, 2021, respectively.

● During the nine months ended September 30, 2022, we sold marketable securities which had decreased in value since we purchased them. The recognized loss on this sale was $85,252.

Net Loss

We recorded a net loss of approximately $5.3 million and $0.5 million for the periods ended September 30, 2022 and 2021, respectively, due to the items and explanations detailed above.

Net Loss Per Share

The net loss per share in 2022 increased over 2021 by $0.10 due to the increase in the net loss of approximately $5 million, due to the items and explanations detailed above.

Results of Operations for the Years Ended December 31, 2021 and 2020

The following table summarizes our results of operations for the years ended December 31, 2021 and 2020:

	Year Ended December 31, 2021			Year Ended December 31, 2020			% Change
Revenue	$	—		$	70,352			—100	%
Cost of sales		—			56,445			—100	%
Gross Profit		—			13,907			—100	%
Operating expenses:
Stock based compensation		10,507,476			5,222,388			101	%
General and administrative		1,431,886			861,100			66	%
Total operating expenses		11,939,362			6,083,488			74	%
Loss from operations		(11,939,362	)		(6,069,581	)		97	%
Other(expenses) income:
Interest expense		(9,269,496	)		(3,457,339	)		168	%
Loss on extinguishment of debt		(4,983,658	)		—
Change in derivative liability		(416,903	)		7,770
Total other expenses		(14,670,057	)		(3,449,569	)		325	%
Net loss	$	(26,609,419	)	$	(9,519,150	)		180	%
Net loss per share, basic and diluted	$	(0.58	)	$	(0.26	)		104	%
Weighted average shares outstanding, basic and diluted		45,826,585			35,969,256			26.6	%

Revenues

We did not generate revenues for the year ended December 31, 2021. We sold products that we did not manufacture in the year ended December 31, 2020, recognized revenue of approximately $70,000 and incurred costs of sales of approximately $56,000.

Stock-Based Compensation

We recorded share-based compensation expense of approximately $10.5 million and $5.2 million for the years ended December 31, 2021 and 2020, respectively, an increase of approximately $5.3 million. The expense represents the fair value of 3,166,099 and 2,896,262 restricted shares of common stock issued for consulting and other professional services rendered by independent contractors during the years ended December 31, 2021 and 2020, respectively. Such professional services included financial and business consulting, accounting services, legal services, media consulting and graphic design. These restricted shares of common stock were valued using the common stock fair value at the issuance date which significantly varied year over year. Fair value of consultants’ restricted shares amounted to approximately $10.2 million and $2.4 million in 2021 and 2020, respectively.

Additionally, during 2021 and 2020, we issued 317,961 and 3,395,772 shares of our common stock to a director, officer and a significant shareholder in accordance with anti-dilution adjustments under promissory notes held by such persons. This antidilution right expired on January 31, 2021. The shares were valued at approximately $0.3 million and $2.8 million using the common stock fair value at the issuance date, which significantly varies year over year.

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General and Administrative

We recognized general and administrative expenses of approximately $1,432,000 and $861,000 for the years ended December 31, 2021 and 2020, respectively, resulting in an increase of approximately $571,000 or 74%.

During the year ended December 31, 2021, we produced approximately 20,000 safety gloves in our plant to use as samples for marketing purposes. The manufacturing effort engaged the plant and equipment in actual production activities and provided a proof of production. Expenditures incurred in part for the production line were approximately $305,000, consisting of ingredients and raw materials of $186,000, equipment rental of $13,000 and utilities of $106,000.

Other categories of general and administrative expenses decreased for the year ended December 31, 2021 compared to the prior year of 2020 by approximately $47,000 due to expenses incurred for recording fees, evaluation expenses and other net expenses.

Other Expenses

Other expenses are comprised of the following:

● Interest expense of approximately $9.3 million and $3.5 million for the years ended December 31, 2021 and 2020, respectively. The increase is due to new loans and revised loan agreements entered into in 2021. Included in interest expense is the accretion of debt discount of approximately $8.6 million and $3.2 million for the same comparative periods related to issuance of approximately 3,875,094 and 3,843,644 shares of common stock at no charge to certain noteholders as an origination fee related to the issuance of new promissory notes. These shares were calculated based on a range from 1 to 4 shares of common stock for every $1 financed in the principal amount of the issued promissory notes. The shares were valued using the common stock fair value at the issuance date which significantly varies year over year.

● Change in the fair value of convertible debt derivative liabilities resulted in an expense of approximately $0.4 million and other income of approximately $8,000 for the years ended December 31, 2021 and 2020, respectively.

● We recognized a loss on the extinguishment of debt of approximately $5 million in 2021 compared to $0 for 2020, which represents the losses incurred on the conversion of outstanding convertible notes payable and their accrued interest into shares of common stock. The loss resulted from the difference between the conversion price of $0.45 compared to the fair value of the common stock on the conversion date of $3.60 per common stock.

Net Loss

We recorded a net loss of approximately $26.6 million and $9.5 million for the years ended December 31, 2021 and 2020, respectively, due to the items and explanations detailed above.

Net Loss Per Share

The net loss per share in 2021 increased over 2020 by $0.32 due to the increase in the net loss of approximately $17.1 million, due to the items and explanations detailed above, as well as an increase in weighted average shares outstanding by 9,857,329 shares. Such increase was due to the sale of approximately 449,505 shares of common stock for cash and the conversion of outstanding notes payable and their accrued interest into approximately 1,588,391 shares of common stock. The remaining increased balance of common stock was due to the issuance of more common stock at no charge as origination fees to note holders and consultants in return of employment and other services rendered in 2021.

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Liquidity and Capital Resources

Sources of Liquidity

We have not generated revenue from the manufacture and sale of our own products. We have thus far funded our operations through the sale of equity and the incurrence of debt. As of September 30, 2022, we had cash and cash equivalents of $10,388. We held marketable securities of approximately $66,618 as of September 30, 2022, which can be liquidated into cash within a short time period. In 2022, we generated $0.9 million in investing activities by selling marketable securities. We used cash in investing activities of approximately $1.5 million to acquire machinery for the plant in 2021. Net cash was provided by financing activities of approximately $0.3 million and $3.3 million, mainly attributable to proceeds from notes payable and the sale of common stock, respectively.

Cash, Cash Equivalents and Cash Flows

The following table summarizes our cash flows for the periods indicated (amounts are rounded to nearest thousands):

	Nine Months Ended September 30,						Years Ended December 31,
	2022			2021			2021			2020
	(unaudited)			(unaudited)
Net cash provided by (used in):
Operating activities	$	(1,301,725	)	$	(260,105	)	$	(1,287,132	)	$	(1,168,253	)
Investing activities		939,576			(278,176	)		(1,502,145	)		(160,284
Financing activities		367,380			564,000			2,765,265			1,342,106
Net increase (decrease) in cash	$	5,231		$	25,719		$	(24,012	)	$	13,569

Operating Activities

Net cash used in operating activities was approximately $1.3 million and $0.2 million in operating activities for the periods ended September 30, 2022 and 2021, respectively, which resulted primarily from the net loss incurred in both periods.

We used approximately $1.3 million and $1.2 million in operating activities for the years ended December 31, 2021 and 2020, respectively, which resulted primarily from the net loss incurred in both years, offset by the following changes in noncash items for both years, presented respectively: annual stock-based compensation expense of approximately $10.5 million and $5.2 million; accretion of debt discount of $8.6 million and $3.2 million; loss on the extinguishment of debt of approximately $5.0 million and $0; and the change in the fair value of convertible debt derivative liability of approximately $0.4 million and $(8,000).

Investing Activities

Cash provided by investing activities was approximately $0.9 million in the period ended September 30, 2022 generated from the sale of marketable securities. We used cash in the amount of approximately $0.2 million for investing activities in the nine months ended September 30, 2021 for the acquisition of property, plant and equipment.

We used cash in the amount of approximately $0.1 million and $0.16 million for investing activities in the years ended December 31, 2021 and 2020, respectively for the acquisition of property, plant and equipment. We purchased marketable securities in 2021 with proceeds from the issued notes payable in the amount of approximately $1.4 million compared to $0 in 2020.

Financing Activities

We received proceeds of approximately $0.3 and $0.5 million primarily from the issuance of promissory notes payable.

We received proceeds of approximately $2.6 million and $1.1 million from the issuance of promissory notes payable, received proceeds of $224,753 and $0 from the sale of our common stock, paid a net of approximately $45,000 towards the related party line of credit in 2021 compared to receipt of net proceeds of approximately $0.2 million from the same line of credit in 2020.

Our ability to raise funds through equity or debt is subject to many risks and uncertainties and, even if we are successful, future equity issuances would result in dilution to our existing stockholders, and any future debt or debt securities may contain covenants that may limit our operations or ability to enter into certain transactions.

Working Capital (Deficit)

As of September 30, 2022, we had a working capital deficit of approximately $7.5 million and an accumulated deficit of approximately $52.6 million.

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Operating and Capital Expenditure Requirements

We have not entered into contracts or obligations to purchase capital expenditures. We may deem it necessary to acquire additional capital equipment, upgrade plant and facilities and purchase other equipment in our manufacturing operations.

Quantitative and Qualitative Disclosures About Market Risk

We have not utilized any derivative financial instruments such as futures contracts, options and swaps, forward foreign exchange contracts or interest rate swaps and futures. We believe that adequate controls are in place to monitor any hedging activities. We do not intend to hedge any existing or future borrowings and, consequently, we do not expect to be affected by changes in market interest rates. We do not currently have any sales or own assets and operate facilities in countries outside the United States and, consequently, we are not affected by foreign currency fluctuations or exchange rate changes. Overall, we believe that our exposure to interest rate risk and foreign currency exchange rate changes is not material to our financial condition or results of operations.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements.

Going Concern and Liquidity

We have relied on cash from financing activities to fund substantially all of the cash requirements of our operating activities and have incurred losses and experienced negative cash flows. We had a net loss from operations of $3,554,576 for the nine months ended September 30, 2022. We had an accumulated deficit of $53,438,499 and negative working capital of $7,540,907 as of September 30, 2022. In connection with our assessment of going concern considerations in accordance with FASB ASC 205-40, “Basis of Presentation – Going Concern,” management has determined that the negative working capital and accumulated deficit raise substantial doubt about our ability to continue as a going concern within one year after the date that the accompanying financial statements are issued. The financial statements do not include any adjustment that might be necessary if we are unable to continue as a going concern.

Notwithstanding the forgoing, we believe, based on our current operating plan, that our current capital resources, along with the net proceeds from this offering, will be sufficient for us to fund our operating expenses and capital expenditure requirements for at least the next twelve months. However, our expected use of the net proceeds from this offering described above represents our intentions based upon our current plans and business conditions. We cannot predict with certainty all of the particular uses for the net proceeds to be received upon the completion of this offering or the amounts that we will actually spend on the uses set forth above. The amounts and timing of our actual expenditures will depend on numerous factors, including the time and cost necessary to conduct our planned commercialization activities, the results of our planned field trials and other factors described in the section titled “Risk Factors” in this prospectus, as well as the amount of cash used in our operations and any unforeseen cash needs.

Emerging Growth Company

We are an “emerging growth company” as defined in the JOBS Act. We would cease to be an emerging growth company upon the earliest to occur of: the last day of the fiscal year in which we have more than $1.235 billion in annual revenue; the date we qualify as a “large accelerated filer,” with at least $700 million of equity securities held by non-affiliates; the issuance, in any three-year period, by us of more than $1.0 billion in non-convertible debt securities; and the last day of the fiscal year ending after the fifth anniversary of our initial public offering. An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. We have elected to take advantage of these reduced disclosure obligations and may elect to take advantage of other reduced reporting obligations in the future.

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For so long as we are an emerging growth company, we will not be required to:

● comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (i.e., an auditor discussion and analysis);

● have an auditor report on our internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act;

● submit certain executive compensation matters to Stockholder advisory votes, such as “say-on-pay,” “say-on-frequency” and pay ratio; and

● disclose certain executive compensation-related items such as the correlation between executive compensation and performance and comparisons of the CEO’s compensation to median employee compensation.

In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. As a result, we may adopt new or revised accounting standard by the date private companies are required to comply.

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BUSINESS

Description of Our Operations, Principal Activities and Key Factors

Medical Industries of the Americas, Inc. is a U.S.-based medical supplies company that is in the process of outfitting a production facility for manufacturing dipped latex products, thermal packs, surgical marking products and disposable scalpels. We own a variety of machinery and equipment capable of producing dipped latex products and thermal packs. With this equipment, we are currently producing industrial grade powdered latex gloves and disposable cold packs. Eventually we plan produce additional latex products, such as latex exam and surgical gloves and condoms, additional varieties of thermal packs, and eventually surgical marking products and disposable scalpels.

Our equipment includes four latex dip lines and twelve vertical form, fill and seal machines (“VFFSMs”).

The four latex dip lines are capable of producing lightly powdered industrial natural latex gloves, medical grade latex gloves and condoms. One of the latex dip lines is currently tooled and producing industrial lightly powdered gloves. We are currently in the process of retooling the other three existing condom dip lines to manufacture medical grade powder-free latex gloves. We plan to have these dip lines retooled and producing medical grade latex gloves by approximately the second quarter of 2023.

The VFFSMs are capable of producing different varieties of thermal packs, such as hot or cold thermal packs, disposable or reusable thermal packs, and different sized thermal packs. Ten of the VFFSMs are arranged in pairs, forming five systems used for making disposable cold packs. One of these five VFFSM systems is currently in service and producing disposable cold packs. The two additional VFFSMs are each configured to manufacture reusable cold packs, or gel packs.

We also own additional manufacturing equipment which is currently on-site, including packaging machinery, product test equipment and instrumentation used for quality control.

Once operational, the annual output of each glove line is estimated to be up to approximately 180 million gloves, and the annual output of each thermal pack system, consisting of two VFFSMs each, is estimated to be up to approximately 10 million thermal packs. These estimates are based on the historical output of the equipment.

Our manufacturing facility is located in Eufaula, Alabama. The Eufaula facility has direct rail access to the ports of Savannah, Georgia and Mobile, Alabama.

The primary raw material used in our production process for disposable latex gloves and other latex products is raw natural rubber latex. We purchase such material from third-party brokers operating out of the Port of Savannah, which is the site of a major rubber and latex terminal.

The primary raw materials used in our production process of thermal packs are two-ply laminated polyethylene, magnesium sulphate (for hot packs), and urea, an agricultural grade fertilizer (for cold packs). These materials are purchased from suppliers and commodities chemical brokers located in the United States and shipped to our Eufaula facility via truck. Once we have increased production to full scale, we expect to have the capability to receive shipments by rail, utilizing our private, onsite rail spur.

Markets

Disposable Gloves

Our immediate focus is on the United States and other North American markets. Our target customers are primarily distributors and wholesalers, which, in connection with group purchasing organizations, ultimately supply the products to hospitals. Our secondary focus is on end users.

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The global disposable glove market was valued at $12.31 billion as of 2021, with the United States accounting for over 35% of the revenue generated. The medical and healthcare segment accounted for 75% of the global market as of 2021¹.

The primary markets for single-use disposable gloves are the medical and healthcare industries, although there are several other industries that provide a market for single-use disposable gloves, such as the automotive industry; oil, gas and mining; food and beverage; metal and machinery; chemical and petrochemical; pharmaceutical; cleanroom supplies; and academic and industrial research and development, among others.²

There are significant opportunities in the disposable glove industry. Underlying the high growth numbers are shifting health, demographic, and policy trends that will fuel demand. Aging populations (23.7% of the US population in 2020)³ and increasing awareness of health and hygiene reinforced by the spread of the COVID-19 pandemic across the country are strengthening the consumption of disposable gloves, and governmental policies reflect these public needs. Latex is the preferred material due to its durability and increased sensitivity. We must keep in mind the threat of synthetic alternatives, allergic considerations (less than 1% of the US population, but particularly common among children with spina bifida)⁴, and pricing concerns. However, management believes that the market for natural rubber latex gloves remains sufficiently robust for us to succeed in the marketplace, and that pricing pressures can be expected to shift consumption back to latex from costlier synthetic alternatives.

Thermal Packs

The immediate focus for the sale of disposable cold packs is the United States and North American markets. The target customers are primarily distributors and wholesalers in the United States market, which, in connection with group purchasing organizations, ultimately supply the products to hospitals. Our secondary focus is on end users.

The global thermal packs (hot and cold) market was valued at an estimated $900 million as of 2020, with the United States accounting for approximately 27% of the revenue generated worldwide. It is expected that the global thermal packs market will continue to expand at a CAGR of 6.6%, reaching a size of $1.4 billion in 2027, and having the cold packs (both reusable and disposable) segment represent 35.6% of the global revenue by this year.⁵

Cold packs (both reusable and disposable) are used in a great variety of cases as a convenient, effective, and affordable treatment to relieve pain and swelling in different parts of the body.

Cold therapy or cryotherapy calms down damaged tissues and causes vasoconstriction, which reduces blood circulation and also numbs the nerves decreasing inflammation, pain, and muscle spasm.⁶ Thus, cold packs (both reusable and disposable) are widely preferred by people who practice outdoor activities to treat sports injuries, being also generally used by aging populations, and patients who suffer from orthopedic and neuropathic diseases.⁷

There are significant opportunities for the sale of cold packs (both reusable and disposable) in the United States, among which there can be found the growing geriatric population (around one-third of the country’s overall population in 2020)⁸, the increase in the cases of arthritis (58.5 million people in 2021)⁹ and diabetes (more than 37 million million people in 2021)¹⁰, which are known to cause neuropathic pains to the patients suffering from either of these conditions. Similarly, the increased demand for non-invasive treatments for sports injuries¹¹, and the rise of non-fatal injuries in traffic accidents¹² (20-50 million people worldwide in 2021) may drive the use of cold packs to alleviate various related pains.

¹ Grand View Research, Disposable Gloves Market Size Report, 2022-2030

² Grand View Research, Disposable Gloves Market Size Report, 2022-2030

³ Statista.com, Resident population in the United States in 2020, by generation

⁴ Asthma and Allergy Foundation of America, Latex Allergy

⁵ Research and Markets, Hot and Cold Therapy Packs – Global Market Trajectory & Analytics

⁶ Transparency Market Research, Hot and Cold Therapy Packs Market

⁷ Prescient & Strategic Intelligence, Hot and Cold Therapy Packs Market

⁸ Statista.com, Resident population in the United States in 2020, by generation

⁹ National Center for Chronic Disease Prevention and Health Promotion, Arthritis

¹⁰ Centers for Disease Control and Prevention, Diabetes Basics

¹¹ Prescient & Strategic Intelligence, Hot and Cold Therapy Packs Market

¹² Prescient & Strategic Intelligence, Hot and Cold Therapy Packs Market

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million people in 2021)¹⁰, which are known to cause neuropathic pains to the patients suffering from either of these conditions. Similarly, the increased demand for non-invasive treatments for sports injuries¹¹, and the rise of non-fatal injuries in traffic accidents¹² (20-50 million people worldwide in 2021) may drive the use of cold packs to alleviate various related pains.

Production Process

We own four dip lines capable of producing lightly powdered industrial natural latex gloves, medical grade latex gloves and or condoms. One of the latex dip lines is currently tooled and producing industrial lightly powdered gloves. We are currently in the process of retooling the other three existing condom dip lines to manufacture medical grade powder-free latex gloves. We also own twelve VFFSMs capable of producing different varieties of thermal packs, such as hot or cold thermal packs, disposable or reusable thermal packs, and different sized thermal packs. One system composed of two VFFSMs is currently in service producing disposable cold packs. Once operational, the annual output of each glove line is estimated to be up to approximately 180 million gloves, and the annual output of each thermal pack system, consisting of two VFFSMs each, is estimated to be up to approximately 10 million thermal packs. These estimates are based on the historical output of the equipment.

Disposable Gloves

The manufacture of latex gloves involves the following steps:

1. Latex harvesting and shipping

a.	Initial tapping of raw rubber from rubber trees.
b.	Preserving of latex rubber from deterioration by addition of ammonia.
c.	Centrifuging of raw latex rubber.
d.	Shipping to factory.

2. Latex preparation

a.	Transfer from tanker trucks to factory storage tanks.
b.	Compounding raw latex with array of chemical additives just prior to use on dipping lines.
c.	Pumping of compounded latex to holding tanks adjacent dip tanks.
d.	Continuous filling of dipping tanks.

3. Dipping and vulcanization (curing)

a. The latex glove dip lines are composed of 8,000 glove mold formers attached to a continuous 1,000 foot long chain for transport through the various sections of the dip line machinery, which includes the following process steps:

i.	Immersion in acid bath.
ii.	Brush cleaning.
iii.	Water rinsing.
iv.	Immersion in latex dips and curing in heated chambers.

b. Top edge of latex is rolled down to create cuff.

c. High pressure streams of water peal latex gloves off mold formers.

d. Gloves are transported to powdering cell by water flowing through pipes.

4. Powder application and drying

a. Flow of water and gloves exit into tubs where the gloves are accumulated.

b. Gloves in tubs are dumped sequentially into slurry-filled rotating drum.

c. Gloves are tumbled in a rotating drum that is filled with a slurry of water and cornstarch.

d. Powdered gloves are transferred to heated rotating drum for drying.

e. Dried gloves are dumped into gaylords.

5. Industrial grade gloves in the gaylords are separated in groups of 100, boxed and packaged for shipment.

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6. Medical grade latex glove post processing

a. Gaylords full of gloves are aged for 72 hours.

b. Aged gloves are loaded into a chlorinator for chlorination process.

c. Chlorinated gloves are removed and placed in the tumble dyer for drying and sterilization.

d. The medical grade gloves are placed in the gaylords, separated into groups of 100, boxed and packaged for shipment.

The manufacture of latex gloves is highly mechanized, so that the labor involved is primarily in packaging and warehousing the product.

Thermal Packs¹³

Disposable cold packs consist of a plastic bag that contains water (in a separate inner bag) and a chemical substance. The chemical substances are either ammonium nitrate or urea. We use urea, which is less caustic, less combustible, and safer than ammonium nitrate. The urea and water must be kept in separate containers within the pack. To activate the disposable cold pack, the user presses the pack with both hands in order to break the inner water bag and then shakes the outer bag to mix the urea and water properly. Once the elements are properly blended, an endothermic reaction occurs, which results in the pack’s temperature lowering to 35°F (1.7°C). The pack will remain at this temperature for 10 to 15 minutes and will become obsolete afterwards.¹⁴

Our manufacturing of disposable cold packs involves the following steps:

1. The film is delivered in rolls and is automatically fed into the machine.

2. The films used for the outer pack as well as the water bag are formed into a tubular shape by forming plates located in their respective film paths.

a. The vertical and bottom edges of the films are heat sealed to form tubs simultaneously in different locations on the machine.

b. Water is added to inner water bag, and the water bag is dropped into the outer pack.

c. Powdered urea and the water bag are added to the outer pack.

d. The top of the outer pack is heat sealed and cut into individual sealed packs.

3. The packs are dropped onto an output conveyor and inspected as they exit the machine.

4. The packs are packaged and shipped.

The materials/ingredients that are used for making disposable cold packs are:

1. Plastic film or “roll stock” (two-ply polyethylene).

a. The film arrives at the facility labeled with logo, usage instructions, material information, and lot numbers.

b.

2. Water.

3. Urea.

Raw Material and Suppliers

Disposable Gloves

The primary raw material used in our production process is raw natural rubber latex. We purchase such material from brokers operating out of the Port of Savannah, Georgia, the site of a major rubber and latex terminal.

Natural rubber latex is the protective fluid contained in tissue beneath the bark of the rubber tree, Hevea brasiliensis. It is a cloudy, white liquid collected by cutting a thin strip of bark from the tree and allowing the latex to be secreted into a collection cup over a period of several hours. It consists of approximately 30-40% rubber particles, 55-65% water and small amounts of protein and other substances.

¹³ Skager, K., How Are Hot and Cold Packs Made?

¹⁴ Brain, M., & Elliot, S., How Refrigerators Work

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The price of latex is highly dependent on the price of rubber. Rubber trades on the Tokyo Commodity Exchange, the Malaysian Rubber Exchange and on the Singapore Commodity Exchange Ltd. The expected spot price of an asset can be determined based on the futures price. However, since there is a slightly positive correlation between the commodity price of rubber and the market price, we expect the futures price to slightly understate the expected spot price and follow a normal backwardation. For commodities we adjust for the additional cost of carry. We continuously monitor the price of latex and receive regular reports regarding same.

Today, more than 90% of the world’s supply comes from South and Southeastern Asian nations including Thailand, Malaysia and India. Rubber trees require a hot, damp climate, and grow only in the “Rubber Belt” — an equatorial zone that stretches around the world. Malaysia is the dominant exporter of rubber gloves in the world, with 32.1% of market share. Latex products account for 91.85% of Malaysian rubber product exports, consisting of gloves (88.8%), pneumatic tires, catheters, condoms, among others.¹⁵ More countries with suitable climates are making efforts to meet natural rubber latex demand, including Thailand, Sri Lanka, Indonesia, India, and Vietnam.¹⁶

Thermal Packs

The primary raw materials used in our production process of thermal packs are two-ply laminated polyethylene, magnesium sulphate (for hot packs), and urea, an agricultural grade fertilizer (for cold packs). The materials are purchased from suppliers and commodities chemical brokers located in the United States and shipped to our Eufaula facility via truck.

Product Portfolio Characteristics

The key characteristics of our current and planned

product portfolio are:

¹⁵ Malaysian Rubber Council, Industry Overview

¹⁶ Observatory of Economic Complexity, Rubber surgical gloves

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Products presently being manufactured and sold:

● Disposable cold packs

● Lightly powdered industrial gloves

Additional products planned to be put into production in 2023:

● Different varieties of thermal packs, including reusable cold packs, disposable heat packs, and reusable heat packs.

● Maternity pads

● Latex medical exam gloves and surgical gloves

● Latex rubber condoms

Potential Future Products (based on the availability of capital):

● Scalpel blades, syringes, razor blades

● Hospital beds, medical textiles

With respect to the additional products we plan to put into production in 2023, in order to reach this production goal, we will need to obtain additional capital and complete the refurbishment and installation of certain machinery and equipment that we own. We currently have machinery in place to produce different varieties of thermal packs, including reusable cold packs, disposable heat packs, and reusable heat packs. This machinery is substantially identical to the machinery currently producing disposable cold packs, and we are in the process of refurbishing such machinery to begin production. We also have machinery onsite to manufacture maternity pads, scalpel blades, syringes and razor blades. We have contracted mechanical, electrical, and control engineers and are in discussions with original equipment manufacturers to procure installation of such machinery.

Our Manufacturing Facilities

Our facility is located at 1600 State Docks Road, Eufaula, Alabama 36027. The Eufaula facility includes a rail-spur onsite, providing direct rail access to the ports of Savannah, Georgia and Mobile, Alabama.

Located at the Eufaula facility are four dip lines capable of producing lightly powdered industrial natural latex gloves, medical grade latex gloves and or condoms. One of the latex dip lines is currently tooled and producing industrial lightly powdered gloves. We are currently in the process of retooling the other three existing condom dip lines to manufacture medical grade powder-free latex gloves. We plan to have these dip lines retooled and producing medical grade latex gloves by approximately the second quarter of 2023. Also located at the Eufaula facility are twelve VFFSMs capable of producing different varieties of thermal packs, such as hot or cold thermal packs, disposable or reusable thermal packs, and different sized thermal packs. One system composed of two VFFSMs is currently in service producing disposable cold packs. We also own other machinery which is currently on-site at the Eufaula facility, including packaging and processing machines, which are capable of producing additional products and which we are in the process of installing and bringing on-line.

Our equipment was once used to make salable products and has been in a dormant state prior to being acquired by us. Some of the equipment has already been overhauled and restored to an operational level, and is currently producing industrial grade lightly powered latex gloves and disposable cold packs. Once we have completed upgrading the remaining equipment, such equipment will be placed online and begin producing products. We currently have one line operational and in production, and our refurbishing of the second line is approximately 75% complete. As funding for refurbishment allows, we expect to double production capabilities by the second quarter of 2023. We will then refurbish the additional lines and increase staff as needed.

Once operational, the annual output of each glove line is estimated to be up to approximately 180 million gloves, and the annual output of each thermal pack system, consisting of two VFFSMs each, is estimated to be up to approximately 10 million thermal packs. These estimates are based on the historical output of the equipment.

Important Events

Company Background

We were incorporated as a Delaware corporation in December 2017 in connection with a joint venture between Gnosiis International, LLC, a Wyoming limited liability company, and Brian Hurley, an individual, as described in further detail below.

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On September 5, 2017 Gnosiis entered into a Binding Memorandum of Cooperation (the “Memorandum”) with two entities under Mr. Hurley’s control, Hurley Realty, LLC (a real estate holding company) and HMS Medical, Inc. (formed in 1965 and at one time a substantial medical supplier and manufacturer), both domiciled in Connecticut. Both Hurley Realty and HMS Medical were subject to bankruptcy and civil proceedings at the time. Pursuant to the Memorandum, Gnosiis agreed to assist the entities controlled by Mr. Hurley in attempting to recover certain assets from such bankruptcies. In exchange, the entities controlled by Mr. Hurley agreed to contribute these assets to a yet-to-be-formed corporation controlled by Gnosiis. The Memorandum also provided that Mr. Hurley would be employed by the yet-to-be-formed corporation in the position of Chief Operating Officer, and that the corporation would execute an mployent agreement with Mr. Hurley to that effect.

On October 10, 2017, Gnosiis and Mr. Hurley executed a Joint Venture Agreement providing additional terms to govern the relationship. On November 10, 2017, Mr. Hurley, Hurley Realty, LLC, and HMS Medical, Inc., collectively, assigned to Gnosiis all right, title and interest in and to certain medical manufacturing equipment.

The corporation contemplated by the parties was ultimately formed on December 29, 2017 and named Medical Industries of the Americas, Inc. Upon incorporation, we assumed any and all commitments, obligations, liabilities, arrangements and the general material matters of the Joint Venture.

Material Transactions

On April 20, 2018, we acquired from HarCal, Inc., an Alabama corporation, certain assets including fifteen (15) acres of real estate, over 100,000 square feet of industrial structure, and a private railroad spur, which today comprise our Eufaula, AL facility. Prior to the transaction, HarCal Inc. was the sole owner of Ameritex, LLC, a Delaware limited liability company, which in turn owned the real estate and equipment located at 1600 State Docks Road, Eufaula, AL. We purchased substantially all of the assets held by Ameritex LLC pursuant to an Asset Purchase Agreement, dated April 20, 2018, for a purchase price of $5 million. The note payable bears interest at Libor plus 6% with no payments due and no interest charged until the 25^th month of the term of the note. The purchase price was paid by the issuance of a five-year promissory note from HarCal Inc. to us (the “HarCal Note”). Concurrently with the execution of the Asset Purchase Agreement, we issued to HarCal, Inc. 650,000 shares of our common stock, in consideration for the inclusion of a provision in the HarCal Note providing that no payment would be due, and no interest would accrue, for the first two years of the term of the HarCal Note.

On November 19 2021, we issued to HarCal, Inc. a Replacement Convertible Note (the “HarCal Replacement Note”) in the amount of $5,145,206.00, maturing on November 19, 2026 and bearing annual interest of LIBOR plus 6%, which superseded and replaced the prior HarCal Note, and also issued to HarCal Inc. a Common Stock Purchase Warrant (the “HarCal Warrant”) giving HarCal, Inc. the option to subscribe for and purchase up to 50% of the number of shares of common stock issued upon the full conversion of the HarCal Replacement Note, subject to the terms and conditions of the HarCal Warrant.

Bridge Financing

On November 17, 2021, we issued to Target Capital 6 LLC a 15% Senior Secured Convertible Note in an aggregate principal amount of up to $2,376,500 (the “Target Note”). The Target Note is secured by all of our assets and property and will be convertible into shares of our common stock upon successful completion of this offering. The conversion price will be set at a 35% discount to the IPO price. The Target Note was amended on June 21, 2022 to increase the principal amount to $3.249,147. The Target note was further amended on August 29, 2022 to extend the maturity date from August 23, 2022 to December 31, 2022. In consideration of this extension, we agreed to issue to Target Capital 6 LLC 200,000 shares of our common stock. The Target note was further amended on January 5, 2023 to extend the maturity date from December 31, 2022 to April 30, 2023. In consideration of this extension, we agreed to issue to Target Capital 6 LLC an additional 200,000 shares of our common stock.

At the same time that we issued the original Target Note, we also issued to Target Capital 6 LLC a Common Stock Purchase Warrant (the “Target Warrant”) giving Target Capital 6 LLC the option to subscribe for and purchase up to 50% of the number of shares of common stock issued upon the full conversion of the Target Note, subject to the terms and conditions of the Target Warrant. The Target Warrant was amended on June 13, 2022 to account for the increased principal amount of the Target Note.

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In connection with the issuance of the Target Note and Target Warrant, we also entered into an Intercreditor Agreement with Target Capital 6 LLC and HarCal, Inc. on November 17, 2021. The parties agreed that all sums owed to Target Capital 6 LLC and HarCal, Inc. which are secured by the same collateral will be held on a pari passu and pro-rata basis between the two creditors. The Intercreditor Agreement was amended on June 14, 2022 to account for the increased principal amount of the Target Note.

Environmental Matters

We are subject to a broad range of federal, state and local laws and regulations relating to pollution and the protection of the environment. These laws regulate, among other things, the discharge of materials into the environment, the handling and disposal of wastes, remediation of contaminated sites and other matters relating to worker and consumer health, and safety and to the protection of the environment. Noncompliance with these regulations can result in significant fines or penalties or limitations on our operations. Some of these laws impose strict, and in certain circumstances, joint and several liability for costs to remediate contaminated sites on owners and operators, as well as persons who arrange to send regulated materials to such sites. In addition, in our manufacturing processes we use substances regulated under U.S. and European environmental laws.

Intellectual Property

Patents

We currently hold no patents. In 2020, Abraham Summers and Dov Charney assigned to us an application for United States Design Patent concerning a design for a face mask. We received an Office Action from the United States Patent and Trademark Office (USPTO) with respect to such patent application in December, 2022, which raised a number of rejections and objections. We are currently considering whether to pursue the patent application further. We do not consider the patent application material to our business.

Confidential Information and Trade Secrets

The success of our business does not depend on confidential information and trade secrets, generally referred to as proprietary information. Nonetheless, we have implemented procedures such as requiring employees to enter into confidentiality agreements and including confidentiality provisions in consulting agreements and supplier agreements, where appropriate.

Trademarks

We are the assignee of seven (7) U.S. Trademark Registrations, as identified in the table below. The registrations were assigned to us by Gnosiis International, LLC on May 26, 2022.

	Serial No.	Reg. No.	Word Mark	Renewal Due
1	74/147,560	1,687,743	HMS	May 19, 2032
2	73/784,240	1,614,734	TWIN TIP	September 25, 2030
3	73/782,965	1,568,187	PERI-WARM	November 28, 2029
4	73/782,964	1,568,186	PERI-COLD	November 28, 2029
5	73/782,963	1,603,565	PERI-GEL	June 26, 2030
6	73/782,949	1,598,422	FLEXITONE	May 29, 2030
7	72/343,122	0,920,296	COL-PRESS	September 14, 2031

Some countries require proof of use in order to maintain the associated trademark rights. In other countries, registrations remain valid unless a third party with an interest therein files an action to have the trademark declared lapsed owing to lack of use.

We submitted two additional trademark applications to the USPTO on December 30, 2022, concerning the logo for our company and the logo for our product American Safety Gloves. The serial numbers of such trademark applications are 97737560 and 97737597, respectively. The applications remain under review by the USPTO.

Domain names

We have registered the domain name listed below from GoDaddy. Domain names are generally renewable every year or every two years.

● https://www.miamericas.com/

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Social Media Accounts

We operate the social media accounts listed below.

LinkedIn

● iAmericas (Industries of the Americas) @iamericas

Instagram

● iAmericas (Industries of the Americas) @iamericashq

● iAmericas Safety Gloves @iamericassafetygloves

● iAmericas Medical Gloves @iamericasmd

Twitter

● Industries of the Americas @iamericashq

● iAmericas Safety Gloves @iamericassafety

● iAmericas Medical Gloves @iamericasmd

Facebook

● Profile: MI Americas (Industries of the Americas) @iamericashq

● Page: Industries of the Americas @iamericasusa

● Page: iAmericas Safety Gloves @iamericassafety

● Page: iAmericas Medical Gloves @iamericasmd

YouTube

● Channel: *iAmericas – Industries of the Americas @iamericas

● Channel: *iAmericas Safety Gloves @iamericassafetygloves

Litigation

We are not currently involved in any dispute, or party to any lawsuit, pertaining to our intellectual property rights or otherwise, either as a plaintiff or a defendant.

Government Regulation

In the United States, healthcare products are subject to regulation by the Food and Drug Administration (“FDA”). FDA classifies medical examination gloves and thermal packs as a Class I medical device product, and as such, we are required to comply with the Quality System regulation (21 CFR part 820) and general controls under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(a)(1)(A)) with respect to our latex gloves.

FDA reviews medical examination gloves to ensure that performance criteria such as leak resistance, tear resistance and biocompatibility are met. FDA has also implemented extensive labelling requirements for medical examination gloves, including specific requirements for gloves that contain natural rubber latex, as our gloves do. Noncompliance with these FDA standards and regulations can result in administrative enforcement, such as warning letters and administrative detention, or in civil penalties, product bans and recalls.

If we begin producing new products, consistent with our future plans, such as blades and syringes and/or medical textiles, we may become subject to additional regulation by FDA or other agencies.

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Employees and Human Capital

As of September 1, 2022, we have engaged 58 full-time service providers through a third-party staffing agency. Such service providers are directly employed by the third-party staffing agency, and not by us. We estimate that, once fully operational, the factory will employ approximately 280 persons. We estimate that we will reach this employment capacity in approximately two years following this offering.

We have relied and plan on continuing to rely on independent organizations, advisors and consultants to perform certain services for us, including handling substantially all aspects of manufacturing, marketing, and sales. Such services may not always be available to us on a timely basis or at costs that we can afford. Our future performance will depend in part on our ability to successfully integrate newly hired officers and to engage and retain consultants, as well as our ability to develop an effective working relationship with our management and consultants.

Competition

Disposable Gloves¹⁷¹⁸

Our key competitors operating in the global disposable gloves market are:

Company	Headquarters
Adventa Berhad (Sun Healthcare)	Petaling Jaya, Selangor, Malaysia
Ammex Corporation	Bellevue, Washington
Ansell Ltd.	Richmond, Victoria, Australia
Cardinal Health, Inc.	Dublin, Ohio
Dynarex Corporation	Orangeburg, New York
Hartalega Holdings Berhad	Sepang, Selangor, Malaysia
Kimberly-Clark Corporation	Irving, Texas
Kossan Rubber Industries Bhd	Klang, Selangor, Malaysia
Rubberex Corporation (M) Berhad	Ipoh, Perak, Malaysia
Semperit Holding AG	Vienna, Austria
Supermax Corporation Berhad	Sungai Buloh, Selangor, Malaysia
Top Glove Corporation Bhd	Shah Alam, Selangor, Malaysia

Other businesses operating in the value chain are Unigloves (UK) Limited, Smart Glove Corporation Sdn Bhd, Cypress Medical Products LLC, Microflex Corporation, Mlnlycke Health Care and YTY Industry Holdings Berhad.

Once our Eufaula facility becomes fully operational, we plan to be a leading latex glove manufacturer located in the United States. We currently have one line operational and in production, and our refurbishing of the second line is approximately 75% complete. As funding for refurbishment allows, we expect to double production capabilities by the second quarter of 2023. We will then refurbish the additional lines and increase staff as needed. Our ability to bring the Eufaula facility fully operational, and to operate as a leading U.S.-based mass-manufacturer of disposable natural rubber latex gloves moving forward, is dependent upon the availability of additional capital and the successful refurbishment of our existing machinery and equipment. Additionally, we note that other companies have produced latex gloves in the United State in the past, and we expect that our competitors may have plans to begin or resume producing latex gloves domestically in the future.

Thermal Packs¹⁹

Below are companies which are involved in the manufacturing of thermal packs (both reusable and disposable):

Company	Headquarters
3M Company	Saint Paul, Minnesota
Beiersdorf AG	Hamburg, Germany
BREG, Inc.	Carlsbad, California
Bruder Healthcare Company	Alpharetta, Georgia
Caldera International, Inc.	Canby, Oregon

¹⁷ Grand View Research, Disposable Gloves Market Size Report, 2022-2030

¹⁸ Allied Market Research, Disposable Gloves Market

¹⁹ Research and Markets, Hot and Cold Therapy Packs – Global Market Trajectory & Analytics

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Cardinal Health, Inc.	Dublin, Ohio
Carex Health Brands	Irving, Texas
Core Products International, Inc.	Osceola, Wisconsin
DJO Global, Inc.	Carlsbad, California
Halyard Health, Inc.	Alpharetta, Georgia
Kobayashi Pharmaceutical Co., Ltd.	Chuo-ku, Osaka, Japan
Koolpak Ltd.	Poole, Dorset, United Kingdom
Life Wear Technologies, Inc.	Pompano Beach, Florida
McKesson	Irving, Texas
Medichill	Osborne Park, Western Australia, Australia
Medline Industries, Inc.	Northfield, Illinois
Medtronic plc	Minneapolis, Minnesota
Pfizer Inc.	Brooklyn, New York
Rohto Pharmaceutical Co.	Ikuno-ku, Osaka, Japan

Customers

As a new business in a competitive industry, we presently have few customers. We currently sell latex gloves on Amazon.com and Walmart.com. In October, 2022, we executed a Distributor/Representative Agreement with FirstLight, Inc., whereby FirstLight, Inc. has agreed assist us in selling our products wholesale to a number of prominent retailers.

Moving forward, as a leading domestic producer of latex gloves, we plan to use our logistical advantage to separate ourselves from competitors and attract new customers. Our target customers are primarily distributors and wholesalers, with a secondary focus on end users.

Inventory

Our current inventory includes the following products:

● 14,400 Cold-Press Instant Ice Cold Compress bags in inventory as of September 30, 2022 (24 gaylords with 600 bags in each gaylord).

● 2,202,000 Industrial Lightly Powdered Latex gloves (2,202 cases of 1,000 gloves each).

● Raw materials consisting of 7,591 gallons of raw latex and other chemicals

MANAGEMENT

The following table and biographical summaries set forth information, including principal occupation and business experience, about our directors and executive officers as of the date of this prospectus:

Name	Age	Position
Abraham Summers	37	Chairman of the Board, President
David Silver	69	Chief Executive Officer
Denise Berry	36	Chief Financial Officer, Director Nominee
Edward Boardwine	76	Director Nominee
Alan Fogelman	74	Director Nominee
Bruce Potash	69	Director Nominee

Abraham Summers, Chairman of the Board and President

Mr. Summers is the co-founder of Medical Industries of the Americas in 2018. He has also founded Gnosiis International LLC, a boutique economics and urban planning advisory firm, in 2011, where he continues to serve as Managing Partner. He has worked in real estate management and within a Family Office environment specializing in multifamily, commercial and high-rise construction and project development. He has served in a Chief Financial Officer capacity for both private and publicly traded companies and has been a guest lecturer at Columbia Law School on the topics of entrepreneurship and finance. He has advised or been an entrepreneur on deals and projects exceeding $100 million in capital including assembling the capital for us. He is an urban planner by training and a Cum Laude graduate of the University of Southern California and their Price School where he graduated on the Dean’s List with a Bachelor’s of Science the Policy, Management, and Planning Program and certificate in Real Estate Development.

David Silver, Chief Executive Officer

Mr. Silver has served as our Chief Executive Officer since 2019, after joining as a consultant in 2018. Prior to joining us as a consultant, Mr. Silver had been retired and attending law school since 2016. Mr. Silver is a Swedish-born executive skilled at working with global public and private companies. Mr. Silver has 27 years of experience advising corporations on investor relations, corporate crises, strategic management, and public/private partnerships. In 2018, Mr. Silver earned his Master of Law in Legal Studies from one of the top law schools in the U.S., Washington University in St. Louis. His confluence of business, finance and law makes him a leading corporate dealmaker, leader, and negotiator. Mr. Silver is also a renowned book author on groupthink in global corporate boardrooms.

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Denise Berry, Chief Financial Officer and Director Nominee

Ms. Berry is a co-founder of Medical Industries of the Americas where she has served as the Chief Financial Officer since 2018. Prior to joining us full-time, Ms. Berry served as a Financial Professional/Consultant for Transamerica from 2017-2021. She has guided us from inception including attracting Stockholders, recruiting key personnel, and overseeing the various important duties and evolving entrepreneurial needs throughout the development cycles including practical plant operations, marketing, and financial leadership. At Transamerica, she built a team of over 40 financial professionals across the U.S., Canada, and Puerto Rico and held a life, accident, and health insurance license and series 65 financial license. She co-founded a technology company based in Greece where the company secured over one million dollars in Seed Round investment and a successful exit. She had prior co-founded a military technology company in Santa Cruz, CA focused on 3D weapons printing where she oversaw fundraising, team management and project development. Ms. Berry is a former sergeant and decorated war veteran of the United States Army. She served as a 68W combat medic in the 328th CSH unit and a squad leader where she was responsible for the training and instruction of LifeSaver Courses of over 200 soldiers. She was deployed to Iraq providing health care to the detainees of Baghdad and Taji, Iraq and was involved with hospital construction. Ms. Berry graduated with a Bachelor of Science in International Business while in the military and received a Master’s in Business Administration from California State University, Monterey Bay.

Edward Boardwine, Director Nominee

Mr. Boardwine is a businessman and executive manager with decades of high-level managerial experience, who brings a wealth of knowledge and success with respect to corporate turnarounds and new venture startups. Trained and educated as an engineer, Mr. Boardwine has served as president and chief executive officer of Elkem Chemicals, Inc. and president of SIMCALA, Inc., among other positions. From 2010-2018, Mr., Boardwine consulted on silicon production and design with several different projects in North America, Australia, and Iceland. Prior to joining our board of directors, Mr. Boardwine had been retired. Mr. Boardwine holds a Bachelor of Science in Electrical Engineering from West Virginia University and studied Systems Engineering at Ohio University and Marketing at the University of Pittsburgh. He also distinguished himself by serving eight years in the Army National Guard in West Virginia.

Alan Fogelman, Director Nominee

Alan Fogelman, CPA and CFP, brings a wealth of knowledge with over four decades of experience in public accounting, auditing and tax. He has worked for top companies such as BDO Seidman, Ernst & Young and Drexel Burnham, where his audits focused on public companies and helped to finalize shareholder reports. Since 2001, Mr. Fogelman has been self-employed, providing accounting, tax, auditing and financial planning services for his client base.

Bruce Potash, Director Nominee

Bruce Potash is the founder of Outdoor Unlimited, an outdoor billboard advertising business, where he served as an executive for more than 40 years and helped build the business into a major concern. After this success, Mr. Potash worked for Aflac, Inc., where he developed a successful insurance business. Mr. Potash has been retired since 2018.

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Director Terms; Qualifications

Members of our board of directors serve until the next annual meeting of stockholders, or until their successors have been duly elected.

When considering whether directors and nominees have the experience, qualifications, attributes and skills to enable the board of directors to satisfy its oversight responsibilities effectively in light of our business and structure, the board of directors focuses primarily on the industry and transactional experience, and other background, in addition to any unique skills or attributes associated with a director.

Family Relationships

None.

Board of Directors and Corporate Governance

Concurrently with the closing of this offering, our Board of Directors will consist of Abraham Summers, Denise Berry, Edward Boardwine, Alan Fogelman and Bruce Potash

Board Committees

Our Board of Directors has appointed an audit committee, governance committee and compensation committee.

Audit Committee

The audit committee is responsible for overseeing: (i) our accounting and reporting practices and compliance with legal and regulatory requirements regarding such accounting and reporting practices; (ii) the quality and integrity of our financial statements; (iii) our internal control and compliance programs; (iv) our independent auditors’ qualifications and independence and (v) the performance of our independent auditors and our internal audit function. In so doing, the audit committee maintains free and open means of communication between our directors, internal auditors and management.

Concurrently with the closing of this offering, the Audit Committee will consist of Alan Fogelman, Edward Boardwine and Bruce Potash, with Alan Fogelman acting as Chairman.

Compensation Committee

The compensation committee is responsible for reviewing and approving the compensation of our executive officers and directors and our performance plans and other compensation plans. The compensation committee makes recommendations to our Board of Directors in connection with such compensation and performance plans.

Concurrently with the closing of this offering, the Compensation Committee will consist of Alan Fogelman, Edward Boardwine and Bruce Potash, with [ ] acting as Chairman.

Nominating and Corporate Governance Committee

The nominating and corporate governance committee is responsible for (i) identifying, screening and reviewing individuals qualified to serve as directors (consistent with criteria approved by our Board of Directors) and recommending to our Board candidates for nomination for election at the annual meeting of Stockholders or to fill board vacancies or newly created directorships; (ii) developing and recommending to our Board of Directors and overseeing the implementation of our corporate governance guidelines (if any); (iii) overseeing evaluations of our Board of Directors and (iv) recommending to our Board of Directors candidates for appointment to board committees.

Concurrently with the closing of this offering, the Nominating and Corporate Governance Committee will consist of Alan Fogelman, Edward Boardwine and Bruce Potash, with [  ] acting as Chairman.

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Code of Ethics

We have adopted a formal code of ethics within the meaning of Item 406 of Regulation S-K promulgated under the Securities Act, that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions and that that establishes, among other things, procedures for handling actual or apparent conflicts of interest. Our Code of Ethics is available at our website [INSERT URL].

Indemnification Agreements

We have entered into indemnification agreements for our directors and executive officers (“Indemnification Agreement”). The Indemnification Agreement provides for indemnification against expenses, judgments, fines and penalties actually and reasonably incurred by an indemnitee in connection with threatened, pending or completed actions, suits or other proceedings, subject to certain limitations. The Indemnification Agreement also provides for the advancement of expenses in connection with a proceeding prior to a final, non-appealable judgment or other adjudication, provided that the indemnitee provides an undertaking to repay to us any amounts advanced if the indemnitee is ultimately found not to be entitled to indemnification by us. The Indemnification Agreement sets forth procedures for making and responding to a request for indemnification or advancement of expenses, as well as dispute resolution procedures that will apply to any dispute between us and an indemnitee arising under the Indemnification Agreement.

EXECUTIVE AND DIRECTOR COMPENSATION

Executive Compensation

The table below summarizes the compensation earned for services rendered to us in all capacities, for the years indicated, by our named executive officers:

Name and Principal Position(2)	Fiscal Year Ended		Salary ($)			Bonus ($)		Stock awards ($)			Option awards ($)		All other compensation ($)			Total ($)
Abraham Summers		2021	$	—			—		320,677	(1)		—		119,940	(7)	$	440,617
Chairman of the Board, President		2020	$	—			—		2,818,491	(2)		—		119, 940	(8)		2,937,891
David Silver		2021	$	—			—		2,113,976	(3)		—	$	33,000	(9)	$	2,146,976
Chief Executive Officer		2020	$	—			—		585,977	(4)		—	$	30,000	(10)	$	615,977
Denise Berry		2021	$	5,000	(3)		—		1,906,899	(5)		—		43,564	(11)	$	1,955,463
Chief Financial Officer		2020	$	—			—		528,577	(6)		—		—		$	528,577

(1) Represents the fair value of common stock issued to Gnosiis International, LLC, with respect to which Mr. Summers is the sole manager and majority holder.

(2) Represents the fair value of common stock issued to Gnosiis International, LLC, with respect to which Mr. Summers is the sole manager and majority holder.

(3) Represents the fair value of common stock issued for services to the Ruth Israel Trust controlled by Mr. Silver.

(4) Represents the fair value of common stock issued for services to the Ruth Israel Trust controlled by Mr. Silver.

(5) Represents the fair value of common stock issued for services to Luciano Equities controlled by Ms. Berry.

(6) Represents the fair value of common stock issued for services to Luciano Equities controlled by Ms. Berry.

(7) Represents management paid to Gnosiis International, LLC, with respect to which Mr. Summers is the sole manager and majority holder.

(8) Represents management paid to Gnosiis International, LLC, with respect to which Mr. Summers is the sole manager and majority holder.

(9) Represents expense allowance for 2021.

(10) Represents expense allowance for 2020.

(11) Represents expense allowance for 2021.

(12) Represents expense allowance for 2021.

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Director Compensation

The Board adopted a Director Compensation Policy (the “Director Compensation Policy”) as set forth below.

Cash Compensation

Each Director will receive ten thousand dollars ($10,000) in cash payable from the anticipated net proceeds of this offering. Each Director will further receive an additional ten thousand dollars ($10,000) for participation as a member of the Audit Committee, and five thousand dollars ($5,000) as a member of the Compensation Committee or Nominating and Corporate Governance Committee, payable upon appointment out of net proceeds from this offering. Additional cash compensation for each Director on an ongoing basis shall be determined by the Board and the Compensation Committee.

Equity Compensation

Each Director will receive one-hundred thousand (100,000) restricted shares vesting upon the closing of this offering and subject to a lock-up restriction for one-hundred and eighty (180) days from the date of this offering or as required by our underwriter and followed by a one (1) year leak -out restriction period. Each Director will further receive an additional twenty thousand (20,000) restricted shares for participation as a member of the Audit Committee and/or five thousand (5,000) restricted shares for participation as a member of the Compensation Committee or Nominating and Corporate Governance Committee, subject to the same restrictions. Lastly, each Director will receive an additional twenty-five thousand (25,000) restricted shares to serve as Chair of the Audit Committee and ten thousand (10,000) restricted shares to serve as Chair of the Compensation Committee or the Nominating and Corporate Governance Committee. Additional equity compensation for each Director on an ongoing basis shall be determined by the Board and the Compensation Committee.

Reimbursement

Each Director will be entitled to reimbursement or pre-payment of all expenses incurred (such as travel for board meetings to the extent that the meetings will not be via remote calls) with business-class accommodations.

Director Independence

As of the closing of this offering, our Board of Directors will consist of [TBD]. Our Board of Directors undertook a review of the composition of our Board of Directors and the independence of each director. Based upon information requested from and provided by each director concerning their background, employment and affiliations, including family relationships, our Board of Directors has determined that each of [  ], [  ], with [  ] qualify as “independent” as that term is defined by Nasdaq Listing Rule 5605(a)(2).

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CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS

Except for employment arrangements which are described under “executive compensation,” and certain related party loans, which are described below, since January 1, 2020, there has not been, nor is there currently proposed, any transaction in which we are or were a participant, the amount involved exceeds the lesser of $120,000 or 1% of the average of the total assets at December 31, 2021 and 2020, and any of our directors, executive officers, holders of more than 5% of our common stock or any immediate family member of any of the foregoing had or will have a direct or indirect material interest.

On May 7, 2018, we engaged Gnosiis to provide management and consulting services in exchange for one-time fee of $37,000. On the same date, we entered into an unsecured line of credit agreement with Gnosiis for a maximum loan amount of $100,000, to finance the services provided to us by Gnosiis. The interest rate of the line of credit is the Wells Fargo Prime Rate plus 8%. Certain payments were required on weekly basis during the first 24 months, after which Gnosiis received the right to call the loan at any time, upon which the balance outstanding would be amortized over 36 months flat line with interest accruing monthly. If we terminate the services of Abraham Summers, the outstanding principal and accrued interest will be due immediately. Upon default of payment, the outstanding principal and accrued interest will be due immediately.

On January 1, 2019, the management services agreement and line of credit agreement were amended by expanding the scope of management services to be provided by Gnosiis, in exchange for a flat fee of $9,950 per month and increasing the maximum loan amount under the line of credit to $500,000. For the years ended December 31, 2021 and 2020, we included in our General and Administrative expense $119,940 as management fees, which were paid in cash in 2020 and fully accrued in 2021 and included in the accounts payable and accrued expenses.

As of December 31, 2021, we defaulted on payment and Gnosiis elected to increase the maximum loan amount to $800,000 and not enforce the payment of the outstanding principal and accrued interest immediately.

As of September 30, 2022 and December 31, 2021, $124,714 and $315,256 of interest was accrued, respectively. The loan compounds on a monthly basis at the end of every month and the interest accrued is added to the balance of the loan. The balance outstanding on the line of credit was $804,605 and $936,980 as of September 30, 2022 and December 31, 2021, respectively.

The management services agreement states that Gnosiis will receive a flat fee of $375,000, which will be added to the line of credit balance, for its efforts to have our common stock listed on a national securities exchange. The fee will be immediately accrued and billed upon submission of the registration statement of which this prospectus forms a part.

Review, Approval or Ratification of Transactions with Related Persons

Due to the small size of our Company, we do not at this time have a formal written policy regarding the review of related party transactions and rely on our full Board of Directors to review, approve or ratify such transactions and identify and prevent conflicts of interest. Our Board of Directors reviews any such transaction in light of the particular affiliation and interest of any involved director, officer or other employee or stockholder and, if applicable, any such person’s affiliates or immediate family members. Management aims to present transactions to our Board of Directors for approval before they are entered into or, if that is not possible, for ratification after the transaction has occurred. If our Board of Directors finds that a conflict of interest exists, then it will determine the appropriate action or remedial action, if any. Our Board of Directors approves or ratifies a transaction if it determines that the transaction is consistent with our best interests and the best interest of our stockholders.

PRINCIPAL STOCKHOLDERS

The following table sets forth certain information regarding beneficial ownership of our common stock as of December 31, 2022 by (i) each person (or group of affiliated persons) who is known by us to own more than five percent (5%) of the outstanding shares of our common stock, (ii) each director and executive officer, and (iii) all of our directors, executive officers and director nominees as a group. As of the date of this prospectus, there were 51,503,901 shares of our common stock issued and outstanding.

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Except as otherwise indicated, the persons listed below have sole voting and investment power with respect to all shares of our common stock owned by them, except to the extent that power may be shared with a spouse.

Percentage ownership of our common stock before this offering is based on 51,503,901 shares of common stock outstanding as of December 31, 2022, after giving effect to the Debt Conversion. Beneficial ownership is determined in accordance with SEC rules and generally includes voting or investment power with respect to securities. For purposes of this table, a person or group of persons is deemed to have “beneficial ownership” of any shares of common stock that such person currently owns or has the right to acquire within 60 days of the date of this prospectus. With respect to options and warrants, this would include options and warrants that are currently exercisable within 60 days. With respect to convertible securities, this would include securities that are currently convertible within 60 days.

Except as indicated in footnotes to this table, we believe that the stockholders named in this table have sole voting and investment power with respect to all shares of common stock shown to be beneficially owned by them, based on information provided to us by such stockholders. Unless otherwise indicated, the address for each director and executive officer listed is c/o Medical Industries of the Americas, Inc., 9454 Wilshire Blvd., Suite 600, Beverly Hills, CA 90212.

Name of Beneficial Owner or Identity of Group	Title of Class	Shares			Percentage			Post Offering Shares	Post Offering Percentage
5% or greater stockholders:
Gnosiis International, LLC 1712 Pioneer Ave., Ste. 5648A Cheyenne, WY 82001	Common Stock		16,057,222			31.18	%
HarCal, Inc. 4155 Lomac St., Ste. G Montgomery, AL 36106	Common Stock		3,250,000			6.31	%
2036 Investments, Inc. 493 Langley Ave, West Hempstead NY, 11552	Common Stock		2,625,000			5.09	%
Executive Officers and Directors:
Abraham Summers Chairman of the Board, President	Common Stock		16,057,222	(1)		31.18	%
Denise Berry Chief Financial Officer, Director Nominee	Common Stock		1,750,000	(2)		3.40	%
David Silver, Chief Executive Officer	Common Stock		1,993,000	(3)		3.87	%
Edward Boardwine, Director Nominee	Common Stock		25,000			0.04	%
Alan Fogelman, Director Nominee	Common Stock		72,000			0.14	%
Bruce Potash, Director Nominee	Common Stock		1,900,000			3.69	%
Executive Officers and Directors as a Group (5 persons)			21,797,222			42.32	%

(1) The shares consist of 16,057,222 shares owned by Gnosiis International, LLC, with respect to which Mr. Summers is the sole manager and majority holder.

(2) The shares consist of 1,750,000 shares owned by Luciano Equities, Inc., with respect to which Ms. Berry is the sole Stockholder and a director.

(3) The shares consist of 1,993,000 shares owned by Ruth Israel LLC, with respect to which Mr. Silver is the sole manager and majority holder.

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DESCRIPTION OF CAPITAL STOCK

General

Upon completion of this offering, our authorized capital stock will consist of 100,000,000 shares of common stock, par value $0.001 per share.

As of December 31, 2022, there were 141 holders of record of our common stock, 51,503,901 shares of common stock issued and outstanding and no shares of preferred stock issued and outstanding.

The following description of our capital stock and provisions of our Certificate of Incorporation and Bylaws to be effective upon the completion of this offering is only a summary. You should also refer to our Certificate of Incorporation, a copy of which is filed as an exhibit to the registration statement of which this prospectus is a part, and our Bylaws, a copy of which is filed as an exhibit to the registration statement of which this prospectus is a part.

Common Stock

We are authorized to issue up to a total of 100,000,000 shares of common stock, par value $0.001 per share. Holders of our common stock are entitled to one vote for each share held on all matters submitted to a vote of our stockholders. Holders of our common stock have no cumulative voting rights.

Further, holders of our common stock have no pre-emptive or conversion rights or other subscription rights. Upon our liquidation, dissolution or winding-up, holders of our common stock are entitled to share in all assets remaining after payment of all liabilities. Holders of our common stock are entitled to receive dividends, if any, as may be declared from time to time by our board of directors out of our assets which are legally available. Each outstanding share of our common stock is, and all shares of common stock to be issued in this offering when they are paid for will be, fully paid and non-assessable.

The holders of a majority of the shares of our capital stock, represented in person or by proxy, are necessary to constitute a quorum for the transaction of business at any meeting. If a quorum is present, an action by stockholders entitled to vote on a matter is approved if the number of votes cast in favor of the action exceeds the number of votes cast in opposition to the action, with the exception of the election of directors, which requires a plurality of the votes cast.

Options

We intend to sell or issue restricted shares of common stock or to grant incentive stock options or non-qualified stock options, stock appreciation rights, and restricted stock unit awards for the purchase of shares of common stock to employees, members of the Board of Directors and under an equity incentive plan that will be offered in early 2022. As of December 31, 2021, there were no compensatory options outstanding to purchase shares of our common stock. All options to our officers, directors and other employees will be issued pursuant to the 2022 Equity Incentive Plan.

Anti-Takeover Provisions of Delaware Law, our Certificate of Incorporation and our Amended and Restated Bylaws

Delaware Law

We are governed by the provisions of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits a publicly traded Delaware corporation from engaging in a business combination with an interested stockholder for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. A business combination includes mergers, asset sales or other transactions resulting in a financial benefit to the stockholder. An interested stockholder is a person who, together with affiliates and associates, owns (or within three years, did own) 15% or more of the corporation’s voting stock, subject to certain exceptions. The statute could have the effect of delaying, deferring or preventing a change in control of our Company.

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Board of Directors Vacancies

Our Certificate of Incorporation and Bylaws authorize only our board of directors to fill vacant directorships. In addition, the number of directors constituting our board of directors may be set only by resolution of the majority of the incumbent directors.

Stockholder Action; Special Meeting of Stockholders

Our Certificate of Incorporation and Bylaws provide that our stockholders may take action by written consent. Our Certificate of Incorporation and Bylaws further provide that special meetings of our stockholders may be called by a majority of the board of directors, the Chief Executive Officer, or the Chairman of the board of directors.

Advance Notice Requirements for Stockholder Proposals and Director Nominations

Our Bylaws provide that stockholders seeking to bring business before our annual meeting of stockholders, or to nominate candidates for election as directors at our annual meeting of stockholders, must provide timely notice of their intent in writing. To be timely, a stockholder’s notice must be delivered to the secretary at our principal executive offices not later than the close of business on the 90^th day nor earlier than the close of business on the 120^th day prior to the first anniversary of the preceding year’s annual meeting; provided, however, that in the event the date of the annual meeting is more than 30 days before or more than 60 days after such anniversary date, or if no annual meeting was held in the preceding year, notice by the stockholder to be timely must be so delivered not earlier than the close of business on the 120^th day prior to such annual meeting and not later than the close of business on the later of the 90^th day prior to such annual meeting or the 10^th day following the day on which a public announcement of the date of such meeting is first made by us. These provisions may preclude our stockholders from bringing matters before our annual meeting of stockholders or from making nominations for directors at our annual meeting of stockholders.

Authorized but Unissued Shares

Our authorized but unissued shares of common stock are available for future issuance without stockholder approval and may be utilized for a variety of corporate purposes, including future public offerings to raise additional capital, corporate acquisitions and employee benefit plans. The existence of authorized but unissued and unreserved common stock could render more difficult or discourage an attempt to obtain control of us by means of a proxy contest, tender offer, merger or otherwise. If we issue such shares without stockholder approval and in violation of limitations imposed by Nasdaq or any stock exchange on which our stock may then be trading, our stock could be delisted.