ENDRA Life Sciences Plans to Submit De Novo Request to U.S. FDA for its TAEUS® System in Coming Weeks

Rhea-AI Summary

ENDRA Life Sciences Inc. (NASDAQ: NDRA) has announced significant progress in preparing a De Novo request for its Thermo Acoustic Enhanced UltraSound (TAEUS) system to the U.S. FDA. Completion of documentation is expected by the end of Q3, with the submission anticipated shortly thereafter. The TAEUS system, designed to non-invasively assess Non-Alcoholic Fatty Liver Disease (NAFLD), is already CE-marked for sale in Europe. A successful De Novo request could enhance its market position in the U.S., targeting over one billion people affected by NAFLD globally.

Positive

• Progress made towards a De Novo submission to the FDA with completion expected soon.
• TAEUS system has CE mark approval for sale in Europe, indicating established credibility.
• Potential to capture a significant market for NAFLD, affecting over one billion people globally.

Negative

• None.

ANN ARBOR, Mich.--(BUSINESS WIRE)-- ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS^®), announces an update to its plan to submit a De Novo request for the TAEUS system to the U.S. Food and Drug Administration (FDA).

“I’m pleased to announce that preparation of the De Novo documentation by the end of the third quarter is substantially complete,” said ENDRA's Chairman and Chief Executive Officer Francois Michelon. “Our remaining efforts are focused on the TAEUS and MRI confirmatory data portion of the submission with ENDRA's clinical collaborators, and we expect to submit the De Novo request in the coming weeks. We appreciate the continued support of shareholders as we believe the De Novo process will assist ENDRA in achieving the strongest market position in the United States with TAEUS-optimized claims.”

The TAEUS system is intended to characterize fatty liver tissue as a means to non-invasively assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD). TAEUS is already approved for sale in countries that recognize the CE mark, including those in the European Union. The De Novo request provides a pathway in the United States for an entirely new product classification and, if granted, promises to strengthen TAEUS’ competitive position with its distinctive, patent-protected capabilities as a non-invasive point-of-care tool to characterize NAFLD, which impacts over one billion people globally.

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 1/50^th 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220929005907/en/

Irina Pestrikova

Senior Director, Finance

investors@endrainc.com

www.endrainc.com



Investor Relations:

Yvonne Briggs

LHA Investor Relations

(310) 691-7100

YBriggs@lhai.com

Source: ENDRA Life Sciences Inc.

FAQ

What is the current status of ENDRA Life Sciences' De Novo request for TAEUS?

ENDRA Life Sciences is preparing to submit a De Novo request for TAEUS to the FDA, with documentation completion expected by the end of Q3.

How does TAEUS assist in assessing Non-Alcoholic Fatty Liver Disease?

TAEUS non-invasively characterizes fatty liver tissue to monitor Non-Alcoholic Fatty Liver Disease (NAFLD).

What is the significance of the CE mark for TAEUS?

The CE mark approval allows TAEUS to be marketed and sold in European countries, indicating regulatory compliance and product credibility.

What market potential does TAEUS target?

TAEUS targets over one billion people worldwide affected by Non-Alcoholic Fatty Liver Disease.

When does ENDRA expect to submit the De Novo request to the FDA?

ENDRA expects to submit the De Novo request in the coming weeks.