ENDRA Life Sciences Inc. - NDRA STOCK NEWS

ENDRA Life Sciences Inc. (NASDAQ: NDRA) raised $8.7 million from the sale of approximately 20.6 million shares at an average price of $0.42 per share. This funding aims to extend the company’s cash runway into 2023, allowing it to strengthen its balance sheet amid challenging market conditions. CEO Francois Michelon highlighted that these funds will support operations and commercial activities in Europe, alongside advancing the TAEUS system through regulatory processes in the U.S.

ENDRA Life Sciences (NASDAQ: NDRA) has received ISO 13485:2016 recertification from the British Standards Institution. This certification indicates the company's adherence to quality management standards essential for the medical device sector. It confirms the robust foundation of ENDRA's Quality Management System, which is critical for its TAEUS® technology. The recertification further supports ENDRA's strategy in developing thermoacoustic imaging systems to address unmet clinical needs, particularly in liver health diagnostics and energy-based surgical procedures.

ENDRA Life Sciences (NASDAQ: NDRA) reported its fourth quarter and full year 2021 results, highlighting a net loss of $3.1 million, or $0.07 per share, for Q4, compared to a net loss of $2.3 million in Q4 2020. Full-year net loss stood at $11.2 million, or $0.28 per share, an improvement from $11.7 million in 2020. The company achieved clarity on its U.S. regulatory strategy for its TAEUS system, pursuing a De Novo pathway, and expanded its clinical partnerships in China and Europe. Cash and equivalents as of December 31, 2021, were $9.5 million, supporting ongoing commercial activities.

ENDRA Life Sciences Inc. (NASDAQ: NDRA) has received two new patents from the Chinese National Intellectual Property Administration, enhancing its intellectual property in the Chinese market. The patents, titled ‘927 and ‘250, focus on methods for determining tissue fat content and a radio frequency applicator for the TAEUS technology. With 11 patents now in China and a total of 89 globally, ENDRA aims to improve diagnostic tools for liver conditions affecting over one billion people. This development comes shortly after the announcement of a research partnership with Shanghai General Hospital.

ENDRA Life Sciences Inc. (NASDAQ: NDRA) will release its fourth quarter 2021 financial results on March 30, 2022, after U.S. markets close. A conference call and webcast will follow at 4:30 p.m. Eastern time, covering the results and recent corporate developments. Interested participants are encouraged to pre-register for the call or can join via specific dial-in numbers. The company is known for its innovative Thermo Acoustic Enhanced UltraSound (TAEUS®) technology aimed at liver health assessments, which could revolutionize diagnostic practices for chronic liver diseases.

ENDRA Life Sciences Inc. (NASDAQ: NDRA) announced participation in two investor conferences in March. The company will attend the 34th Annual ROTH Conference from March 13-15, 2022, where management will be available for one-on-one meetings on March 14 and a pre-recorded presentation will be posted online. Additionally, ENDRA will present at Oppenheimer’s 32nd Annual Healthcare Conference on March 15 at 2:40 p.m. ET and offer virtual one-on-one meetings. ENDRA is known for its TAEUS® technology for liver health assessment.

ENDRA Life Sciences Inc. (NASDAQ: NDRA) has been granted U.S. Patent No. 11266314, which protects its TAEUS technology's method for determining material types. This patent enhances ENDRA's intellectual property strategy, potentially expanding applications beyond liver measurements and into broader clinical and non-clinical spheres. Currently, the company holds 89 intellectual property assets globally. ENDRA aims to revolutionize diagnostic imaging at lower costs, particularly addressing chronic liver conditions affecting over one billion people.

ENDRA Life Sciences Inc. (NASDAQ: NDRA) has received two new patents from the European Patent Office, enhancing its intellectual property portfolio. The patents include: European Patent No. 3668382, which safeguards a method for estimating fat content using a single thermoacoustic measurement, and European Patent No. 3661416, which protects a method using multiple measurements. These developments aim to advance ENDRA's TAEUS® technology, targeting clinical needs in liver disease assessment, and expand its existing portfolio of 89 patents.

ENDRA Life Sciences Inc. (NASDAQ: NDRA) has announced a strategic shift in its regulatory approach for the TAEUS System, designed to assess fatty liver tissue, now pursuing the De Novo pathway instead of a 510(k) application. This decision follows constructive discussions with the FDA, aiming for enhanced market claims. The De Novo process allows for a unique product classification, setting a higher standard for the TAEUS System. The company plans to withdraw its current 510(k) application and focus on limited confirmatory clinical data needed for the De Novo submission, expected to foster competitive advantages.