ENDRA meets with FDA on liver device clinical trial design By Investing.com


ANN ARBOR, Mich. – ENDRA Life Sciences Inc. (NASDAQ: NASDAQ:), a developer of Thermo Acoustic Enhanced UltraSound (TAEUS®) technology, has concluded a pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding its TAEUS liver device. The meeting, which took place at the FDA’s Maryland headquarters, aimed to discuss the clinical trial design for the device, a key step toward a U.S. De Novo regulatory filing.

During the meeting, ENDRA provided the FDA with comprehensive information on the TAEUS technology and its intended use in clinical testing. The company also presented a clinical study synopsis that included background clinical data and statistical analyses from historical study participants. The TAEUS liver device is designed to non-invasively assess fatty tissue in the liver, a condition that affects over two billion people worldwide.

The FDA provided feedback that ENDRA management believes was constructive and will inform the finalization of the clinical study protocol and statistical plan. The company expects to receive the official Meeting Minutes in June, which will guide the submission process to the FDA before the study begins.

Michael Thornton, ENDRA’s Chief Technology Officer, expressed optimism about the company’s engagement with the FDA, stating, “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.”

The TAEUS technology is designed to characterize tissue similarly to an MRI but at a fraction of the cost and at the point of patient care. It is intended to complement the over 700,000 ultrasound systems currently in use globally. While the initial focus is on liver applications, ENDRA is exploring other potential uses for TAEUS, including non-invasive visualization of tissue temperature during surgical procedures.

This meeting marks a significant milestone for ENDRA as it moves closer to potentially bringing its TAEUS liver device to the U.S. market, subject to FDA approval. The information in this article is based on a press release statement.

InvestingPro Insights

As ENDRA Life Sciences Inc. (NASDAQ: NDRA) engages with the FDA to advance their TAEUS liver device, investors are closely monitoring the company’s financial health and stock performance. Despite holding more cash than debt on its balance sheet, an important sign of financial stability, ENDRA is quickly burning through cash, which could impact its ability to fund ongoing operations and research. Analysts are also not optimistic about the company’s profitability in the near term, as they do not anticipate ENDRA will be profitable this year.

InvestingPro data sheds light on the financial metrics that may concern investors. With a market cap of approximately 3.39M USD, ENDRA’s Price / Book ratio for the last twelve months as of Q1 2024 stands at 0.92, suggesting the stock is trading near its book value.

Yet, the company’s operating income shows a significant loss of -10.36M USD for the same period, with a corresponding negative EBITDA of -10.26M USD. This financial performance is reflected in the stock’s return metrics, with a 1-year price total return of -80.69% as of the 141st day of 2024.

Investors looking to dive deeper into ENDRA’s financials and stock performance can find additional analysis and metrics on InvestingPro. There are 11 more InvestingPro Tips available for NDRA at Investing.com/pro/NDRA, offering a comprehensive look at the company’s financial health and stock valuation. To gain access to these insights, readers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.

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