Welcome to our dedicated page for Endra Life Sciences news (Ticker: NDRA), a resource for investors and traders seeking the latest updates and insights on Endra Life Sciences stock.
ENDRA Life Sciences Inc. reports developments in thermoacoustic biomarker imaging, including its TAEUS® Liver device for measuring liver fat in steatotic liver disease, MASLD and MASH. Company news commonly covers clinical feasibility work comparing TAEUS measurements with MRI-PDFF, device repeatability and reproducibility, and business updates tied to operating results.
NDRA updates also include capital and treasury actions, such as private placement financing and a digital asset treasury strategy involving HYPE token holdings and staking. Corporate news has included strategic-review announcements and Nasdaq listing-compliance matters.
ENDRA Life Sciences (NASDAQ: NDRA), a pioneer in Thermo Acoustic Enhanced UltraSound (TAEUS®), announced a significant update following an in-person meeting with the FDA. The meeting focused on the clinical trial design of the TAEUS liver device, which is important for ENDRA's U.S. De Novo filing. ENDRA presented a detailed description of TAEUS technology and a synopsis of their clinical study, which spans a fat fraction range representative of steatotic liver disease in the U.S.
The company provided background clinical data and statistical analyses from 45 historical study participants. The meeting highlighted ENDRA's proposed pivotal clinical study and included a demonstration of the TAEUS procedure. Key ENDRA team members, including technical staff and biostatisticians, attended the meeting. The FDA's feedback was deemed constructive, and ENDRA plans to update its clinical study protocol and statistical plan for FDA submission. This close engagement aims to ensure alignment on the pivotal study design for a future De Novo submission.
ENDRA Life Sciences (NASDAQ: NDRA) announced its Q1 2024 financial results, reporting a net loss of $2.8 million, or $0.26 per share, a slight improvement from a $2.9 million net loss in Q1 2023. Operating expenses decreased to $2.8 million from $2.9 million due to lower R&D costs. Cash and cash equivalents stood at $1.1 million as of March 31, 2024.
Key developments include the installation of the first TAEUS system in the UK at King’s College Hospital for clinical evaluation, aimed at assessing its liver fat measurement accuracy against MRI. The study will involve approximately 75 subjects. ENDRA is also advancing its FDA De Novo application for TAEUS, with a pre-submission meeting scheduled for Q2 2024. The company expanded its intellectual property portfolio, obtaining eight new patents in Europe and China, bringing the total to 80 issued patents globally. ENDRA is exploring licensing opportunities in non-core indications to enhance its IP portfolio value.
ENDRA Life Sciences Inc. (NASDAQ: NDRA) will report financial results for the first quarter of 2024 on May 14, 2024. The company will hold a conference call and webcast to discuss the results and recent corporate developments. Participants can pre-register for the call for immediate access.
ENDRA Life Sciences Inc. (NASDAQ: NDRA) has strengthened its intellectual property with the issuance of five new international patents, including three in Europe and two in China. This brings ENDRA's IP portfolio to a milestone of 80 issued patents worldwide, protecting its Thermo Acoustic Enhanced UltraSound (TAEUS®) technology. The patents cover innovative solutions for providing RF energy to tissue, determining material types, and monitoring tissue temperature during surgical procedures, expanding the application of TAEUS technology.
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