ENDRA Provides Update Following In-person Meeting with FDA
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Increases clarity for ENDRA on regulatory path forward for TAEUS
ANN ARBOR, Mich., May 20, 2024--(BUSINESS WIRE)--ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS?), announced that it has completed what it considers to be a highly informative pre-submission meeting with the U.S. Food and Drug Administration (FDA) related to the clinical trial design of the TAEUS liver device in support of its U.S. De Novo filing.
Prior to the meeting, ENDRA provided the FDA with a detailed description of the TAEUS technology to be used in clinical testing, along with a clinical study synopsis outlining a prospective hypothesis-driven, statistically powered multicenter clinical study spanning a fat fraction range representative of steatotic liver disease in the U.S., ranging from healthy to severe. In support of the proposed statistical analysis plan, ENDRA provided background clinical data and statistical analyses from 45 historical study participants.
The meeting was held at FDA's Maryland headquarters and focused on ENDRA’s proposed pivotal clinical study. During the meeting ENDRA also demonstrated the TAEUS procedure using anatomical phantoms of the liver.
The ENDRA team in attendance included key technical staff, a regulatory/clinical lead with over 20 years of first-of-a-kind medical device experience, a senior biostatistician familiar to the FDA, and liver ultrasound and MRI radiology experts.
Management believes that the meeting was highly informative and views the FDA’s feedback as very constructive. Based on the feedback received as well as the Meeting Minutes expected in June, ENDRA will update its pivotal clinical study protocol and statistical plan for submission to the FDA as a next step prior to initiating the study.
"ENDRA's new regulatory approach is focused on close engagement with the FDA to ensure alignment on our pivotal study design and statistical plan, in support of a future De Novo submission," said Michael Thornton, ENDRA's Chief Technology Officer. "We believe this in-person meeting with the FDA helped clarify the path forward for ENDRA. We look forward to maintaining close collaboration with the FDA throughout the process."
About ENDRA Life Sciences Inc.
ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS?), a ground-breaking technology that characterizes tissue similar to an MRI, but at 1/40th the cost and at the point of patient care. TAEUS? is designed to work in concert with the more than 700,000 ultrasound systems in use globally today. TAEUS? is initially focused on the non-invasive assessment of fatty tissue in the liver. Steatotic liver disease (SLD, formerly known as NAFLD-NASH) is a chronic liver disease spectrum that affects over two 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 non-invasive visualization of tissue temperature during energy-based surgical procedures. For more information, please visit www.endrainc.com.