ENDRA Life Sciences Installs First TAEUS(R) System and Begins Scanning at Rocky Vista University

Rhea-AI Summary

ENDRA Life Sciences (NASDAQ:NDRA) announced that Rocky Vista University College of Osteopathic Medicine has initiated patient scans using its TAEUS system to evaluate Non-Alcoholic Fatty Liver Disease (NAFLD) in Utah. This marks the first real-world use of TAEUS in the U.S. The study aims to analyze 200 volunteers while collecting clinical data to bolster commercialization efforts. ENDRA has received the CE mark for European sales and is seeking FDA clearance in the U.S. The initiative highlights TAEUS's potential in addressing a significant clinical need for non-invasive liver assessments.

Positive

• Initiation of patient scans at Rocky Vista University marks a significant step toward real-world application of TAEUS technology.
• Study aims to enroll 200 volunteers, providing a diverse patient data set for enhancing clinical utility of TAEUS.
• INDRA has received CE mark approval for TAEUS in Europe, facilitating international sales.

Negative

• Pending FDA clearance for the TAEUS system may delay U.S. commercialization efforts.
• The ongoing need for clinical evidence to support future sales could prolong time to market.

ANN ARBOR, MI / ACCESSWIRE / November 12, 2020 / ENDRA Life Sciences Inc. ("ENDRA") (NASDAQ:NDRA), a developer of enhanced ultrasound technologies, today announced that Rocky Vista University College of Osteopathic Medicine ("RVUCOM") has begun scanning patients in its clinical study of ENDRA's Thermo-Acoustic Enhanced Ultrasound (TAEUS^Ⓡ) clinical system to assess Non-Alcoholic Fatty Liver Disease ("NAFLD"). The studies are being conducted at RVUCOM's Ivins, Utah location will be the first real-world cases to be performed with TAEUS in the U.S.

ENDRA has received the CE mark to sell the TAEUS system in Europe, and is awaiting clearance by the U.S. Food and Drug Administration for its 510(k) application to begin sales in the U.S. The data from the RVUCOM study, along with other announced and future studies, will be used to further build the clinical evidence base and establish the clinical utility of the TAEUS system in patients with NAFLD to support current and future commercialization efforts.

The goals of the RVUCOM study, include:

• Comparing results obtained with ENDRA's commercial design TAEUS liver device against a baseline measure of liver fat as determined by MRI-PDFF (magnetic resonance imaging proton density fat fraction);
• Scanning a target of 200 volunteers including fatty liver patients and healthy controls to contribute additional diversity and volume of patient data; and,
• Providing ENDRA with ongoing clinical feedback regarding TAEUS product design, clinical workflow and clinical performance.

The principal investigator in the RVUCOM study, Jing Gao, M.D., who is a member of ENDRA's scientific advisory board ("SAB"), commented, "This is an exciting step for ENDRA and for Rocky Vista University as we advance use of the TAEUS platform in a real-world clinical setting. We believe TAEUS has the potential to address a significant unmet clinical need for the robust, practical, non-invasive assessment of liver fat."

"Working with RVUCOM and other leading clinical reference sites is an essential part of building our base of clinical evidence to support commercialization efforts for TAEUS," said ENDRA Chief Commercial Officer Renaud Maloberti. "We look forward to supporting and learning from RVUCOM, as well as other medical facilities that will be evaluating TAEUS."

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 MRI, but at 1/50th the cost and 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. For more information, please visit www.endrainc.com. See more. Do more. Live better.^Ⓡ

About Rocky Vista University

Rocky Vista University is an independent, privately-funded health sciences university. The University has campus locations in Parker, CO and Ivins, UT and is fully accredited by the Higher Learning Commission. The College of Osteopathic Medicine is fully accredited by the Commission on Osteopathic College Accreditation Additionally, Rocky Vista University owns and operates the Rocky Vista Health Center in Parker, Colorado, a primary care medical facility which provides continued health care and health maintenance for its patients. For more information, please visit www.RVUCOM.edu/.

Forward-Looking Statements

All statements in this news 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, estimates of the timing of future events and achievements, such as the expectations regarding commercializing the TAEUS device, establishing evaluation reference sites and initial sales in Europe, receipt of U.S. Food and Drug Administration regulatory approval, 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, our ability to develop a commercially feasible technology; receipt of necessary regulatory approvals; the impact of COVID-19 on our business plans; our ability to find and maintain development partners, market acceptance of our technology and 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 news release speak only as of the date of issuance, 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
investors@endrainc.com
www.endrainc.com

Investor Relations Contact:

Kim Sutton Golodetz
LHA Investor Relations
(212) 838-3777
kgolodetz@lhai.com

SOURCE: ENDRA Life Sciences Inc.

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FAQ

What is the latest development for ENDRA Life Sciences (NDRA) concerning TAEUS?

ENDRA Life Sciences has commenced patient scanning at Rocky Vista University using its TAEUS technology to assess Non-Alcoholic Fatty Liver Disease.

When did ENDRA start patient scans for TAEUS?

Patient scans began recently, marking the first real-world application of TAEUS in the U.S.

What are the goals of ENDRA's study at Rocky Vista University?

The study aims to compare TAEUS results against MRI-PDFF measurements, enroll 200 volunteers, and provide clinical feedback on the device.

Has ENDRA received any regulatory approvals for TAEUS?

Yes, ENDRA has received the CE mark for selling TAEUS in Europe and is awaiting FDA clearance in the U.S.

What significance does the RVUCOM study hold for ENDRA Life Sciences?

The RVUCOM study is crucial for building clinical evidence and supporting future commercialization of the TAEUS system.