ENDRA Life Sciences Builds on CE Mark Approval

The pioneer of Thermo Acoustic Enhanced UltraSound advances its commercialization plan and intellectual property portfolio and reaffirms guidance to file 510(k) application with the FDA

ANN ARBOR, MI / ACCESSWIRE / April 30, 2020 / ENDRA Life Sciences Inc. (“ENDRA”) (NASDAQ:NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today provided an update on its progress across a variety of initiatives intended to leverage the recent approval of the CE Mark (Conformité Européene) for its TAEUS FLIP (Fatty Liver Imaging Probe) System. ENDRA also provided an update on the status of its FDA 510(k) submission and intellectual property.

“ENDRA’s goal is to develop TAEUS applications in areas of high unmet clinical need. Our initial focus is on helping the more than 1 billion people globally affected by Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH), where there is a desperate need for a practical tool to assess and monitor liver fat,” said Francois Michelon, Chief Executive Officer of ENDRA. “The receipt of the CE Mark for our TAEUS liver system in the first quarter was a key milestone, enabling ENDRA to initiate its plan to commercialize the company’s disruptive technology in 2020,” continued Michelon. “We have been moving aggressively to capitalize on our CE Mark and first-mover advantage through a number of actions, including the launch of new clinical education tools and the development of a network of potential TAEUS evaluation sites in Europe, where we see the greatest opportunity to achieve near-term commercial success.”

The company’s recent commercialization activities include several mutually supportive elements, including:

  • Recruiting sales professionals in several high-value European markets, including France and Germany
  • Advancing discussions with existing and potential TAEUS evaluation sites, where clinical partners have indicated they are eager to move forward with TAEUS installations and clinical evaluations as soon as practical, in accordance with the industry’s current focus on the COVID-19 epidemic
  • Enhancing clinical education tools to support ENDRA’s sales and marketing teams, including:
    • A new liver-focused website (www.endrainc.com), launched on April 30, that reinforces our commitment to enabling better, earlier detection of NAFLD AND NASH. The site is being translated into multiple languages to educate the market and support rapid commercial pipeline expansion.
    • “How to use the TAEUS Liver Device,” a new educational video that will be shared with over 2000 interested clinicians we have developed relationships with through marketing outreach, participation in key global clinical conferences, and contributions from partners like GE Healthcare.

FDA 510(k) Submission and Intellectual Property Update

In the U.S., ENDRA remains on track with its stated objective to submit its 510(k) application with the FDA in the current quarter. This will potentially position the company to receive clearance in the second half of 2020.

The company also continues to strengthen its intellectual property portfolio as a key competitive advantage in the commercialization of TAEUS. On April 28, 2020 ENDRA was issued a utility patent (US10,631,734) from the United States Patent and Trademark Office for its “METHOD AND SYSTEM FOR MONITORING TISSUE TEMPERATURE.”

The recently-issued ‘734 patent expands our IP portfolio to 68 filed, issued, pending and/or licensed assets, and underscores our commitment to research and development as well as to expanding the commercial potential for our TAEUS System,” said Michelon. “It provides more robust IP protection for our TAEUS platform in a future key clinical market — monitoring tissue temperature during thermal ablation and cryotherapy procedures, for which there are currently no practical clinical tools.”

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 CT or MRI, but at 1/50thof the cost, at the point of patient care. TAEUS is designed to work in concert with the over one million 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. www.endrainc.com

Forward-Looking Statements

All statements in this 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 forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “goal,” “estimate,” “anticipate” or other comparable terms. Examples of forward-looking statements include, among others, statements we make regarding expectations regarding the registration of our TAEUS device in European jurisdictions and the timing of a U.S. 510(k) regulatory submission and approval for our TAEUS device; plans relating to our supply chain and commercialization of the TAEUS device, including its adoption by clinicians; and expectations concerning ENDRA’s product development and business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including, among others, the following: our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals; the impact of the COVID-19 pandemic on our business strategy; our ability to find and maintain development partners, market acceptance of our technology, the amount and nature of competition in our industry; our ability to protect our intellectual property; and the other risks and uncertainties described in ENDRA’s filings with the Securities and Exchange Commission. The forward-looking statements made in this release speak only as of the date of this release, 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:
David Wells
Chief Financial Officer
(734) 997-0464

Media Relations Contact:
Denise DiMeglio
(610) 228-2102

Investor Relations Contact:
Joe Hassett

SOURCE: ENDRA Life Sciences Inc.

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