ANN ARBOR, Michigan – November 2, 2017 – ENDRA Life Sciences Inc. (“ENDRA” or the “Company”) (NASDAQ: NDRA), a developer of enhanced ultrasound technologies, has partnered with StarFish Medical (“StarFish”), Canada’s largest medical device development and contract manufacturing company and CriTech Research Inc. (“CriTech”), a U.S. firm specializing in medical device software development, to commence productization of ENDRA’s Thermo Acoustic Enhanced Ultrasound (TAEUS™) device targeting Non-Alcoholic Fatty Liver Disease (NAFLD).
The agreements call for StarFish and CriTech to provide ENDRA with the specialized engineering resources necessary to translate the company’s current prototype TAEUS™ device into a clinical product meeting CE regulatory requirements required for commercial launch in the European Union, targeted for 2018, followed by FDA submission for the U.S. market.
ENDRA’s TAEUS technology, which uses RF energy to enhance ultrasound, is designed to enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only on CT & MRI — at a fraction of the cost, and at the point-of-care. ENDRA’s first TAEUS application will focus on the quantification of fat in the liver for early detection and monitoring of NAFLD, which affects over 1 billion people globally.
Francois Michelon, ENDRA’s Chairman and CEO, commented: “After an extensive vetting process, we are very pleased to be working with StarFish and CriTech, both world-class firms specialized in medical device and software development. We deployed a parallel productization approach to follow the quickest path to commercialization, diversify our exposure to contract manufacturers and to leverage each partner’s expertise in hardware and software.
“ENDRA’s asset-light business model dovetails perfectly into our new partners’ successful track records of bringing CE and FDA approved medical technology to market. StarFish and CriTech offer strong and complementary core competencies with which ENDRA can execute its plan and manage development risk.
“The kickoff of this final development phase of the TAEUS liver device with well established partners is a major milestone supporting ENDRA’s timeline to introduce a game-changing fatty liver diagnostic tool in Europe in 2018,” concluded Michelon.
“We are thrilled to be working with one of the true innovators in ultrasound,” said Scott Phillips, Founder and CEO of StarFish. “ENDRA’s TAEUS technology is unique and we believe the first clinical TAEUS application will represent a big step forward in liver disease diagnostics.”
About ENDRA Life Sciences Inc.
ENDRA Life Sciences Inc. (“ENDRA”) (NASDAQ: NDRA) is a developer of enhanced ultrasound technologies. ENDRA’s Photo-Acoustic Nexus-128 system is currently used by leading global medical researchers to screen and modify disease models with high image quality and volume scanning speed. ENDRA is developing a next generation Thermo-Acoustic Enhanced UltraSound (“TAEUS”) system to enable clinicians to visualize human tissue composition, function and temperature in ways previously possible only on CT & MRI — at a fraction of the cost, and at the point-of-care. ENDRA’s first TAEUS application will focus on the quantification of fat in the liver, for early detection and monitoring of Non-Alcoholic Fatty Liver Disease, which affects over 1 billion people globally. ENDRA’s goal is to bring new capabilities to ultrasound — thereby broadening access to better healthcare. For more information, please visit www.endrainc.com.
About StarFish Medical
StarFish Medical is an ISO 13485 certified product engineering firm with offices in Victoria, British Columbia, and Toronto, Ontario, 100% dedicated to the medical device and life science marketplace. StarFish partners with innovative companies to create and manufacture
breakthrough products for a full range of medical specialty areas including: Cardiovascular, Digital Health, IVD, Ophthalmology, Optics, and Ultrasound. StarFish’s expertise includes electronics, mechanical, human factors, usability, and software systems engineering. For more information, please visit www.starfishmedical.com.
About CriTech Research
CriTech Research Inc., headquartered in Saline, Michigan (near ENDRA’s headquarters in Ann Arbor), has more than 20 years of experience in the development and testing of safety-critical software for medical devices. CriTech is certified to ISO13485 and ISO 9001 for software development. CriTech’s customers range from large, established companies to startups, with products from all FDA device classes (I, II, III) and IEC 62304 software safety classifications (A, B, C). CriTech’s proven history of success with medical device software validation & verification extends to over 400 projects completed and having received FDA and/or EU approval. For more
information, please visit: www.critech.com.
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 concerning ENDRA’s ability to secure regulatory approvals; anticipated product pricing; expectations with respect to current and future partnerships, including those with StarFish and Critech; estimates of the timing of future events and achievements; and expectations concerning ENDRA’s 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; 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 forwardlooking statements to reflect actual results or changes in expectations, except as otherwise required by law.