0001654954-23-010765.txt : 20230814 0001654954-23-010765.hdr.sgml : 20230814 20230814161352 ACCESSION NUMBER: 0001654954-23-010765 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20230814 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230814 DATE AS OF CHANGE: 20230814 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ENDRA Life Sciences Inc. CENTRAL INDEX KEY: 0001681682 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 260579295 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37969 FILM NUMBER: 231170291 BUSINESS ADDRESS: STREET 1: 3600 GREEN COURT STREET 2: SUITE 350 CITY: ANN ARBOR STATE: MI ZIP: 48105 BUSINESS PHONE: 734-335-0468 MAIL ADDRESS: STREET 1: 3600 GREEN COURT STREET 2: SUITE 350 CITY: ANN ARBOR STATE: MI ZIP: 48105 FORMER COMPANY: FORMER CONFORMED NAME: Endra Inc. DATE OF NAME CHANGE: 20160805 8-K 1 ndra_8k.htm FORM 8-K ndra_8k.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported) August 14, 2023

 

ENDRA Life Sciences Inc.

(Exact name of registrant as specified in its charter)

 

Delaware 

 

001-37969

 

26-0579295

(State or other jurisdiction of incorporation)

 

(Commission File Number)

 

(IRS Employer Identification No.)

 

3600 Green Court, Suite 350 Ann Arbor, MI

 

48105

(Address of principal executive offices)

 

(Zip Code)

 

 

 

Registrant's telephone number, including area code

 

(734) 335-0468

 

______________________________________________

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock, par value $0.0001 per share

NDRA

The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  

 

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

 

 

 

 

Item 2.02 Results of Operations and Financial Condition

 

On August 14, 2023, ENDRA Life Sciences Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2023. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 (the “Securities Act”) or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 7.01. Regulation FD Disclosure.

 

On August 14, 2023, the Company issued a press release announcing submission of a de novo application for the Company’s Thermo-Acoustic Enhanced Ultrasound technology to the United States Food and Drug Administration. A copy of the press release is being furnished as Exhibit 99.2 to this Current Report on Form 8-K.

 

The information in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.2 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.

 

Description

99.1

 

Press Release dated August 14, 2023, furnished herewith.

99.2

 

Press Release dated August 14, 2023, furnished herewith.

 

 

2

 

 

SIGNATURE

 

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

 

 

ENDRA Life Sciences Inc.

 

August 14, 2023

 

 

 

By:

/s/ Francois Michelon

 

 

Name:

Francois Michelon

 

 

Title:

President and Chief Executive Officer

 

 

 

3

EX-99.1 2 ndra_ex991.htm PRESS RELEASE ndra_ex991.htm

EXHIBIT 99.1

 

ENDRA Life Sciences Reports Second Quarter 2023 Financial Results and

Provides a Business Update

 

Conference call begins at 4:30 p.m. Eastern time today

 

ANN ARBOR, Mich. (August 14, 2023) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three and six months ended June 30, 2023 and provided a business update. Highlights from the second quarter of 2023 and recent weeks include:

 

 

·

Submitted a De Novo Request to the U.S. Food and Drug Administration (FDA) for the TAEUS liver system. The TAEUS system is ENDRA’s proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease (NAFLD). The submission included patient scans from established clinical study sites comparing TAEUS liver fat fraction estimates to MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction), which is the gold standard for clinical measurement of liver fat fraction. The study data yielded a sensitivity of 90%. TAEUS estimates of liver fat fraction were strongly correlated to MRI-PDFF scores with a Pearson correlation coefficient of r=0.78.

 

 

 

 

·

Showcased the TAEUS liver system's capabilities at two European clinical conferences. ENDRA participated in the German Diabetes Association’s 57th DDG Annual Meeting in Berlin, which underscored the role of liver health in managing type 2 diabetes. Additionally, the company shared study findings in a peer-reviewed clinical abstract titled "Thermoacoustic assessment of fatty liver disease - an early clinical feasibility study” at the esteemed European Association for the Study of the Liver (EASL) Congress in Vienna. This presentation served to elevate TAEUS' profile among potential clinical users to support commercial adoption.

 

 

 

 

·

Continued the expansion of its intellectual property portfolio to 64 issued patents globally. During the second quarter, ENDRA secured four additional patents, including one in the U.S. and three in China. These newly issued patents not only reinforce ENDRA's unique position in assessing liver fat, but also open the doors for other potential applications. The company is actively exploring licensing opportunities in non-core indications to augment the value of its growing IP portfolio.

 

 

 

 

·

Raised approximately $4.7 million and extended the cash runway. In May, the company raised approximately $4.7 million in net proceeds from the sale of common stock and warrants in a public offering. Management believes ENDRA has sufficient cash to fund operations through several important milestones expected in 2023, including supporting commercial activities in Europe.

 

"Our De Novo submission for the TAEUS system marks a pivotal milestone for ENDRA. It's the culmination of remarkable commitment by the ENDRA team and our clinical partners to address a significant unmet clinical need by providing a non-invasive tool to assess liver fat, at a fraction of the cost of MRI. We believe the De Novo process holds the potential to set the regulatory bar for an entirely new product classification, showcasing TAEUS' unique and innovative capabilities," said Francois Michelon, Chairman and Chief Executive Officer of ENDRA. "We believe our submission is robust and we look forward to working with the FDA as they proceed with their review.”

 

 

 

 

Second Quarter 2023 Financial Results

 

Operating expenses in the second quarter of 2023 were $3.0 million, compared with $3.6 million in the second quarter in 2022. The decrease was mainly due to a decrease in research and development and sales and marketing expenses.

 

Net loss in the second quarter of 2023 was $2.6 million, or $0.43 per share, compared with a net loss of $3.6 million, or $1.17 per share, in the second quarter of 2022.

 

Cash and cash equivalents were $4.8 million as of June 30, 2023. In May, the company raised approximately $4.7 million in net proceeds through an underwritten public offering.

 

Conference Call and Webcast

 

Management will host a conference call and webcast today at 4:30 p.m. Eastern time to discuss these results, provide an update on recent corporate developments and answer questions.

 

Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (844) 868-8846 (U.S.) or (412) 317-5465 (International). A webcast of the call can also be accessed at ENDRA’s Investor Relations page and here.

 

A telephone replay will be available until August 21, 2023 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 3299822. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

 

About ENDRA Life Sciences Inc.

ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology being developed to visualize tissue like MRI, but at 1/50th the cost and at the point of patient care. TAEUS® is designed to work in concert with the more than 700,000 ultrasound systems in use globally today. TAEUS® is initially focused on the measurement of fat in the liver as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH), chronic liver conditions that affect over one billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS®, including visualization of tissue temperature during energy-based surgical procedures. For more information, please visit www.endrainc.com.

 

 

 

 

Forward-Looking Statements

All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of terms such as “approximate,” "anticipate," “attempt,” "believe," "could," "estimate," "expect," “forecast,” “future,” "goal," “hope,” "intend," "may," "plan," “possible,” “potential,” “project,” "seek," "should," "will," “would,” or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Examples of forward-looking statements for ENDRA include, among others: estimates of the timing of future events and anticipated results of our development efforts, including the timing of submission for and receipt of required regulatory approvals and product launches; statements relating to future financial position and projected costs and revenue; expectations concerning ENDRA's business strategy; and statements regarding ENDRA’s ability to find and maintain development partners. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements as a result of various factors including, among others: the ability to raise additional capital in order to continue as a going concern; the ability to obtain regulatory approvals necessary to sell ENDRA medical devices in certain markets in a timely manner, or at all; the ability to develop a commercially feasible technology and its dependence on third parties to design and manufacture its products; the impact of COVID-19 on ENDRA’s business plans; the ability to find and maintain development partners; market acceptance of ENDRA’s technology and the amount and nature of competition in its industry; ENDRA’s ability to protect its intellectual property; and the other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recent Annual Report on Form 10-K and in subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this press release speak only as of the date of issuance, and ENDRA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.

 

Company Contact:

Irina Pestrikova

Senior Director, Finance

investors@endrainc.com

www.endrainc.com

 

Investor Relations Contact:

Yvonne Briggs

LHA Investor Relations

(310) 691-7100

ybriggs@lhai.com

 

[Financial Tables Follow]

 

 

 

 

ENDRA Life Sciences Inc.

Consolidated Balance Sheets

 

 

 

June 30,

 

 

December 31,

 

Assets

 

2023

 

 

2022

 

Current Assets

 

(Unaudited)

 

 

 

Cash

 

$ 4,819,459

 

 

$ 4,889,098

 

Prepaid expenses

 

 

506,914

 

 

 

490,299

 

Inventory

 

 

2,757,633

 

 

 

2,644,717

 

Total Current Assets

 

 

8,084,006

 

 

 

8,024,114

 

Non-Current Assets

 

 

 

 

 

 

 

 

Fixed assets, net

 

 

192,874

 

 

 

235,655

 

Right of use assets

 

 

431,842

 

 

 

505,816

 

Prepaid expenses, long term

 

 

530,068

 

 

 

502,576

 

Other assets

 

 

5,986

 

 

 

5,986

 

Total Assets

 

$ 9,244,776

 

 

$ 9,274,147

 

 

 

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current Liabilities

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$ 1,841,562

 

 

$ 1,523,012

 

Lease liabilities, current portion

 

 

163,013

 

 

 

152,228

 

Loans

 

 

28,484

 

 

 

28,484

 

Total Current Liabilities

 

 

2,033,059

 

 

 

1,703,724

 

 

 

 

 

 

 

 

 

 

Long Term Debt

 

 

 

 

 

 

 

 

Lease liabilities

 

 

281,154

 

 

 

365,919

 

Total Long Term Debt

 

 

281,154

 

 

 

365,919

 

 

 

 

 

 

 

 

 

 

Total Liabilities

 

 

2,314,213

 

 

 

2,069,643

 

 

 

 

 

 

 

 

 

 

Stockholders’ Equity

 

 

 

 

 

 

 

 

Series A Convertible Preferred Stock, $0.0001 par value; 10,000 shares authorized; 141.397 shares issued and outstanding

 

 

1

 

 

 

1

 

Series B Convertible Preferred Stock, $0.0001 par value; 1,000 shares authorized; no shares issued and outstanding

 

 

-

 

 

 

-

 

Series C Convertible Preferred Stock, $0.0001 par value; 100,000 shares authorized; no shares issued and outstanding

 

 

-

 

 

 

-

 

Common stock, $0.0001 par value; 80,000,000 shares authorized; 7,481,603 and 3,169,103 shares issued and outstanding, respectively

 

 

748

 

 

 

317

 

Additional paid in capital

 

 

94,297,167

 

 

 

89,068,015

 

Stock payable

 

 

2,427

 

 

 

6,073

 

Accumulated deficit

 

 

(87,369,780 )

 

 

(81,869,902 )

Total Stockholders’ Equity

 

 

6,930,563

 

 

 

7,204,504

 

Total Liabilities and Stockholders’ Equity

 

$ 9,244,776

 

 

$ 9,274,147

 

 

 

 

 

ENDRA Life Sciences Inc.

Consolidated Statements of Operations

(Unaudited)

 

 

 

Three Months Ended

 

 

Three Months Ended

 

 

Six Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

June 30,

 

 

June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating Expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$ 1,400,182

 

 

$ 1,847,560

 

 

$ 2,791,496

 

 

$ 3,060,582

 

Sales and marketing

 

 

247,773

 

 

 

342,039

 

 

 

429,389

 

 

 

681,942

 

General and administrative

 

 

1,346,610

 

 

 

1,382,094

 

 

 

2,713,008

 

 

 

2,684,438

 

Total operating expenses

 

 

2,994,565

 

 

 

3,571,693

 

 

 

5,933,893

 

 

 

6,426,962

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

(2,994,565 )

 

 

(3,571,693 )

 

 

(5,933,893 )

 

 

(6,426,962 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other Expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense)

 

 

437,433

 

 

 

(19,374 )

 

 

434,015

 

 

 

(22,307 )

Total other expenses

 

 

437,433

 

 

 

(19,374 )

 

 

434,015

 

 

 

(22,307 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations before income taxes

 

 

(2,557,132 )

 

 

(3,591,067 )

 

 

(5,499,878 )

 

 

(6,449,269 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Loss

 

$ (2,557,132 )

 

$ (3,591,067 )

 

$ (5,499,878 )

 

$ (6,449,269 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share – basic and diluted

 

$ (0.43 )

 

$ (1.17 )

 

$ (1.20 )

 

$ (2.46 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares – basic and diluted

 

 

5,996,186

 

 

 

3,082,209

 

 

 

4,582,645

 

 

 

2,617,878

 

 

 

 

 

ENDRA Life Sciences Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

Six Months Ended

 

 

Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2023

 

 

2022

 

Cash Flows from Operating Activities

 

 

 

 

 

 

Net loss

 

$ (5,499,878 )

 

$ (6,449,269 )

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

69,781

 

 

 

40,739

 

Fixed assets write off

 

 

-

 

 

 

599,886

 

Stock compensation expense including common stock issued for RSUs

 

 

493,134

 

 

 

-

 

Amortization of right of use assets

 

 

73,974

 

 

 

67,158

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Increase in prepaid expenses

 

 

(44,107 )

 

 

513,140

 

Increase in inventory

 

 

(112,916 )

 

 

(1,090,150 )

Increase in accounts payable and accrued liabilities

 

 

318,550

 

 

 

(51,072 )

Decrease in lease liability

 

 

(73,980 )

 

 

(64,284 )

Net cash used in operating activities

 

 

(4,775,442 )

 

 

(6,433,852 )

 

 

 

 

 

 

 

 

 

Cash Flows from Investing Activities

 

 

 

 

 

 

 

 

Purchases of fixed assets

 

 

(27,000 )

 

 

(149,153 )

Net cash used in investing activities

 

 

(27,000 )

 

 

(149,153 )

 

 

 

 

 

 

 

 

 

Cash Flows from Financing Activities

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock

 

 

4,712,750

 

 

 

8,399,512

 

Proceeds from issuance of warrants

 

 

20,053

 

 

 

-

 

Net cash provided by financing activities

 

 

4,732,803

 

 

 

8,399,512

 

 

 

 

 

 

 

 

 

 

Net increase (decrease) in cash

 

 

(69,639 )

 

 

1,816,507

 

 

 

 

 

 

 

 

 

 

Cash, beginning of period

 

 

4,889,098

 

 

 

9,461,534

 

 

 

 

 

 

 

 

 

 

Cash, end of period

 

$ 4,819,459

 

 

$ 11,278,041

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of cash items

 

 

 

 

 

 

 

 

Interest paid

 

$ -

 

 

$ -

 

Income tax paid

 

$ -

 

 

$ -

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of non-cash items

 

 

 

 

 

 

 

 

Stock dividend payable

 

$ (3,646 )

 

$ (8,049 )

Right of use asset

 

$ 431,842

 

 

$ 576,255

 

Lease liability

 

$ 444,167

 

 

$ 586,193

 

 

 #   #   #

 

 

 

EX-99.2 3 ndra_ex992.htm PRESS RELEASE ndra_ex991.htm

EXHIBIT 99.1

  

ENDRA Life Sciences Submits De Novo Request for its TAEUS® System Liver Fat Application to the U.S. FDA

 

Announces Positive Topline Data from Clinical Studies Comparing TAEUS with MRI-PDFF

,

ANN ARBOR, Mich. (August 14, 2023) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces the submission of a De Novo request to the U.S. Food and Drug Administration (FDA) for the TAEUS system.  The TAEUS system is ENDRA’s proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease (NAFLD).

 

The submission included patient scans from established clinical study sites comparing TAEUS liver fat fraction estimates to MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction), which is the gold standard for clinical measurement of liver fat fraction. The study data yielded a sensitivity of 90%. TAEUS estimates of liver fat fraction were strongly correlated to MRI-PDFF scores with a Pearson correlation coefficient of r=0.78.

 

“The submission of the De Novo request for our TAEUS system is a significant milestone for ENDRA as it includes additional confirmatory data from our current clinical study sites that are consistent with the results from our initial human feasibility study. We are thrilled to file this request and believe the De Novo process holds potential to set the bar for an entirely new product classification by showcasing TAEUS’ capabilities as being novel and powerful,” stated ENDRA's Chairman and Chief Executive Officer Francois Michelon. "We believe our submission is robust and we look forward to working with the FDA as they proceed with their review. TAEUS has the potential to fulfill an unmet need as a non-invasive, point-of-care tool for the assessment of fatty liver disease, which affects more than one billion people globally, and to do so at one-50th the cost of an MRI.”

 

ENDRA management will discuss this De Novo submission and provide a general business update during the company’s previously scheduled second quarter financial results conference call, being held today at 4:30 p.m. Eastern time.

 

 

1

 

 

About ENDRA Life Sciences Inc.

 

ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), a ground-breaking technology being developed to visualize tissue like MRI, but at 1/50th the cost and at the point of patient care. TAEUS® is designed to work in concert with over 500,000 ultrasound systems in use globally today. TAEUS® is initially focused on the measurement of fat in the liver as a means to assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD) and inflammation (NASH), chronic liver conditions that affect over one billion people globally, and for which there are no practical diagnostic tools. Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS®, including visualization of tissue temperature during energy-based surgical procedures. For more information, please visit www.endrainc.com.

 

Forward-Looking Statements

 

All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of terms such as “approximate,” "anticipate," “attempt,” "believe," "could," "estimate," "expect," “forecast,” “future,” "goal," “hope,” "intend," "may," "plan," “possible,” “potential,” “project,” "seek," "should," "will," “would,” or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Examples of forward-looking statements for ENDRA include, among others: estimates of the timing of future events and anticipated results of our development efforts, including the timing for receipt of required regulatory approvals and product launches; future financial position and projected costs and revenue; expectations concerning ENDRA's business strategy; ENDRA’s ability to find and maintain development partners; market acceptance of ENDRA’s technology and the amount and nature of competition in its industry; and ENDRA’s ability to protect its intellectual property. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements as a result of various factors including, among others: the ability to raise additional capital in order to continue as a going concern; the ability to obtain regulatory approvals necessary to sell ENDRA medical devices in certain markets in a timely manner, or at all; the ability to develop a commercially feasible technology and its dependence on third parties to design and manufacture its products; the impact of COVID-19 on ENDRA’s business plans; the ability to find and maintain development partners; market acceptance of ENDRA’s technology and the amount and nature of competition in its industry; ENDRA’s ability to protect its intellectual property; and the other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the Company’s most recent Annual Report on Form 10-K and in subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this press release speak only as of the date of issuance, and ENDRA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.

 

 

2

 

 

Company Contact:

Irina Pestrikova

Senior Director, Finance

investors@endrainc.com

www.endrainc.com

 

Investor Relations Contact:

Yvonne Briggs

LHA Investor Relations

(310) 691-7100

YBriggs@lhai.com

 

# # #

 

3

 

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