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ENDRA Life Sciences Submits Technical File for CE Mark
Thursday, December 19, 2019 8:30 AM
Regulatory filing is a major step toward commercialization of TAEUS liver device
ANN ARBOR, MI / ACCESSWIRE / December 19, 2019 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ:NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS™), today announced that it has submitted its Technical File for CE Mark review to its Notified Body.
"Our CE Mark submission is a significant milestone for ENDRA," said Francois Michelon, ENDRA's chairman and chief executive officer. "It is the culmination of years of scientific research, quality system implementation and clinical data collection, and I'm very proud of the ENDRA team. "Our technical file is now in review and we anticipate receiving CE Mark for the TAEUS FLIP device in the first half of 2020, with the subsequent commercialization of the TAEUS liver system expected to commence in Europe in mid-2020. ENDRA also expects to submit a 510(k) application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance in 2020," continued Mr. Michelon.
The CE Mark represents a company's claim that a product meets the essential requirements of relevant European directives, and it is a legal prerequisite in order to place a device on the market in the European Union. ENDRA received ISO 13485:2016 certification, a prerequisite for a CE Mark, in May of 2019. The ISO 13485:2016 standard for medical devices establishes the requirements for a comprehensive system, covering the design, manufacture, and distribution of medical devices. Receipt of a CE Mark will allow the TAEUS liver device to be commercialized for use as a liver assessment tool for NAFLD and NASH, chronic liver conditions affecting 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 CT or MRI, but at 1/50th of 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
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 estimates of the timing of future events and achievements, including obtaining a CE Mark and U.S. Food and Drug Administration ("FDA") 510(k) approval and commercializing the TAEUS device; 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; 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.
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SOURCE: ENDRA Life Sciences Inc.