Company guides to Q2:20 submission of 510(k) with robust filing package
ANN ARBOR, MI / ACCESSWIRE / March 19, 2020 / ENDRA Life Sciences Inc. (“ENDRA”) (NASDAQ:NDRA), the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announced further details on the expected timing of its planned TAEUS Fatty Liver Imaging Probe (FLIP) device 510(k) regulatory submission to the U.S. Food and Drug Administration (the “FDA”). The company previously communicated that it had anticipated filing a 510(k) submission during H1, and is now more specifically guiding to an expected Q2:20 submission.
“ENDRA’s rigor with the European regulatory process yielded a successful outcome with the receipt of the CE Mark earlier than planned, in March. The CE Mark enables commercialization of ENDRA’s TAEUS liver device in Europe,” said Francois Michelon, CEO of ENDRA.
“We are in the process of finalizing a robust 510(k) regulatory package, which includes some additional verification testing that was conducted during Q1,” continued Michelon. “The purpose of this testing was to further bolster our submission package, and ensure that we meet the FDA requirements for a 510(k) premarket notification filing. A Q2 submission positions us to receive approval of TAEUS FLIP in the U.S. in H2, and to initiate U.S. commercial activities in 2020.”
ENDRA expects the TAEUS FLIP device will be classified as a Class II device, which is typically “cleared to market” by the FDA through the 510(k) submission process and an FDA substantial equivalence decision of safety and performance as a legally marketed device or devices (“predicate”).
ENDRA, with support of regulatory consultants experienced with the FDA submission process, has continued to assess potential 510(k) predicate devices for ENDRA’s proprietary combination of existing imaging technologies, to demonstrate substantial equivalence. In early 2020, ENDRA became aware of a recently cleared 510(k) submission for a device that ENDRA believes offers some regulatory advantages as a predicate, helping to mitigate regulatory clearance risk. As a result, the company has decided to invest additional time in verification testing to support demonstration of substantial equivalence.
Ultimately, ENDRA believes this additional verification testing will yield the strongest possible FDA submission for ENDRA’s TAEUS liver device.
“We continue to move forward with our pre-commercial activities in the U.S., which are focused on educating clinicians on TAEUS FLIP and its potential utility in NAFLD and NASH, expanding our network of clinical partners, and supporting our current clinical partners who are ramping up their research evaluations of the TAEUS FLIP in a clinical setting,” explained Renaud Maloberti, ENDRA’s Chief Commercial Officer. “Our U.S. TAEUS clinical partners, including Rocky Vista University and the University of Pittsburgh Medical Center, will generate clinical data that will support our commercial activities long-term as they help build the clinical use case for TAEUS, drive interest in the technology and serve as important regional reference sites following FDA clearance.”
ENDRA expects to communicate an update on the 510(k) submission when it is filed with the FDA.
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
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 timing of submission of a U.S. 510(k) regulatory submission for our TAEUS device; our expectation of our TAEUS device obtaining FDA clearance; our expectations of announcing additional clinical evaluation sites; plans relating to our supply chain and commercialization of 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 TAEUS liver device not qualifying for 510(k) review as a Class II device; our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals/clearances; 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.
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