ENDRA’s Ongoing Multisite Pilot Study Reveals Important Enhancements to Boost TAEUS Liver Accuracy and Repeatability Against MRI Gold Standard

By: ENDRA Life Sciences Inc. via Business Wire

June 16, 2025 at 08:00 AM EDT

Refinements to probe configuration and proprietary algorithms are expected to drive substantial improvements in MRI-PDFF correlation

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer in imaging technologies for the early detection and monitoring of metabolic liver disease, today announced that its ongoing multisite pilot study has helped to identify several product enhancements to further improve the performance of its TAEUS^® Liver system against the gold standard, MRI. These findings are expected to drive substantial improvements to the device’s probe design and proprietary algorithms, measurably improving diagnostic accuracy and repeatability. These enhancements are currently being implemented and are expected to strengthen the outcomes of the Company’s planned U.S. Food and Drug Administration (“FDA”) De Novo pivotal study.

Consistent with its revamped go-to-market strategy, ENDRA is conducting a multisite clinical initiative designed to bolster the diagnostic performance of TAEUS Liver prior to initiation of the FDA pivotal study. In collaboration with several leading imaging centers, the Company has collected liver fat measurement data from more than 100 subjects that compare TAEUS scans against MRI-PDFF.

“We’re seeing compelling results from our data-rich, multisite clinical approach that support the strength of our TAEUS Liver technology and help us to identify rapid product enhancement opportunities that should significantly de-risk the upcoming FDA De Novo pivotal study and ultimately position the technology with a meaningful competitive differentiation in the marketplace,” said Alexander Tokman, CEO of ENDRA.

Building on this momentum, ENDRA plans to add several clinical sites to the ongoing clinical pilot study in the U.S. and Canada to confirm the anticipated gains of the TAEUS probe and algorithm enhancements. Armed with this additional data, ENDRA expects to be well-positioned to align with the FDA on the TAEUS Liver device’s pivotal study endpoints and final protocol, which will serve as the basis for a De Novo submission.

In a decisive shift, late last year the Company overhauled its clinical and regulatory strategy. Instead of relying on retrospective data from a limited number of subjects, ENDRA implemented a 100+ patient pilot study to validate and finetune TAEUS algorithms and design. Subsequent to the completion of the pilot study and pending alignment with the FDA, ENDRA plans to conduct a prospective, hypothesis-driven, statistically powered, multisite pivotal clinical study that is expected to enroll approximately 250 patients. This plan is intended to deliver robust evidence for a De Novo submission to the FDA, ensuring scientific rigor to support a successful regulatory outcome.

About ENDRA Life Sciences Inc.

ENDRA Life Sciences is the pioneer of Thermo-Acoustic Enhanced UltraSound (TAEUS^®), a ground-breaking technology being developed to assess tissue fat content and monitor tissue ablation during minimally invasive procedures, at the point of patient care. TAEUS^® is focused on the measurement of fat in the liver as a means to assess and monitor steatotic liver disease and metabolic dysfunction-associated steatohepatitis, chronic liver conditions that affect over two billion people globally, and for which there are no practical diagnostic tools. For more information, please visit www.endrainc.com.

Forward-Looking Statements

All statements in this press 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 terms such as “approximate,” "anticipate," “attempt,” "believe," "could," "estimate," "expect," “forecast,” “future,” "goal," “hope,” "intend," "may," "plan," “possible,” “potential,” “project,” "seek," "should," "will," “would,” or other comparable terms (including the negative of any of the foregoing), although some forward-looking statements are expressed differently. Examples of forward-looking statements for ENDRA include, among others: the design and results of planned clinical trials; expectations with respect to FDA requirements regarding its clinical trials and De Novo submission for its TAEUS liver device; anticipated designs and capabilities of its TAEUS liver device; estimates of the timing of future events and anticipated results of its development efforts, including the timing of submission for and receipt of required regulatory approvals and product launches and sales; statements relating to future financial position and projected costs and revenue; expectations concerning ENDRA's business strategy; and statements regarding ENDRA’s ability to find and maintain development partners. Forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements as a result of various factors including, among others: the ability to raise additional capital in order to continue as a going concern; the ability to obtain FDA and other regulatory approvals necessary to sell ENDRA medical devices in certain markets in a timely manner, or at all; the ability to develop a commercially feasible technology and its dependence on third parties to design and manufacture its products; ENDRA’s ability to maintain compliance with Nasdaq listing standards and remain listed on a securities exchange; ENDRA’s dependence on its senior management team; market acceptance of ENDRA’s technology and the amount and nature of competition in its industry; ENDRA’s ability to protect its intellectual property; and the other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recent Annual Report on Form 10-K and in subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. The forward-looking statements made in this press 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250616575045/en/

Contacts

Company Contact:

Investor relations

investors@endrainc.com

www.endrainc.com

Investor Relations Contact:

Yvonne Briggs

Alliance Advisors IR

(310) 691-7100

ybriggs@allianceadvisors.com

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ENDRA’s Ongoing Multisite Pilot Study Reveals Important Enhancements to Boost TAEUS Liver Accuracy and Repeatability Against MRI Gold Standard

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