ENDRA Life Sciences Launches Clinical Study at LMU University Hospital
ENDRA Life Sciences Inc. (NASDAQ: NDRA) is excited to announce the activation of a significant post-market clinical study involving its innovative TAEUS liver system. This important initiative is taking place at LMU University Hospital, located in Munich, one of Europe’s leading medical research institutions. The first patient has already been scanned, marking a crucial milestone in the study's execution.
A Golden Opportunity for TAEUS Technology
The study aims to gather valuable data to compare the capabilities of TAEUS in measuring liver fat with those of the established MRI-PDFF test. By collecting real-world clinical evidence, the research will help establish the TAEUS system as a vital tool in managing metabolic diseases. Researchers at LMU University Hospital are keen to present the outcomes of this study at upcoming medical conferences, ultimately leading to a peer-reviewed publication.
Strengthening Partnerships in Healthcare
Throughout this development, Alexander Tokman, the Acting Chief Executive Officer of ENDRA, shared his optimism about the partnership with LMU University Hospital. He stressed the importance of this collaboration in enhancing ENDRA's clinical data portfolio, which supports the company's upcoming FDA De Novo submission anticipated in mid-2025. "We believe the data collected through this study will underscore TAEUS technology’s reliability and accuracy as a biomarker for liver fat, marking our initial strategic entry into Germany’s expansive healthcare market, the largest in Europe," said Tokman.
LMU University Hospital: A Medical Powerhouse
The LMU University Hospital is instrumental in shaping healthcare in Germany and beyond. As one of the largest university hospitals in Europe, it serves roughly 500,000 patients each year, supported by a dedicated team of over 11,000 professionals across more than 50 specialized clinics and departments. Its advanced facilities include a leading oncological center and Bavaria's most extensive transplant center.
About ENDRA Life Sciences Inc.
ENDRA Life Sciences stands at the forefront of medical innovation with its pioneering Thermo Acoustic Enhanced UltraSound (TAEUS) technology. Capable of characterizing tissue similar to an MRI but at a fraction of the cost, TAEUS focuses on the non-invasive assessment of fatty tissue in the liver. Conditions such as Steatotic Liver Disease (SLD), affecting over two billion people worldwide, lack practical diagnostic tools. ENDRA is also investigating various additional applications for TAEUS, including real-time visualization of tissue temperature during energy-based surgical procedures. For more details, please visit www.endrainc.com.
Frequently Asked Questions
What is the TAEUS system?
The TAEUS system developed by ENDRA Life Sciences provides a non-invasive method to assess liver fat, offering an alternative to traditional MRI techniques.
Where is the clinical study taking place?
The clinical study is being conducted at LMU University Hospital in Munich, Germany, renowned for its medical research capabilities.
What is the significance of the study?
The study will generate real-world clinical evidence to validate the effectiveness of the TAEUS system in comparison to the MRI-PDFF standard in liver fat measurement.
What are the future plans for ENDRA Life Sciences?
ENDRA plans to use the findings from this study to support an FDA De Novo submission, aiming for regulatory approval to enhance their market presence.
How does TAEUS benefit patients?
The TAEUS system offers a cost-effective, non-invasive diagnostic tool that can significantly improve the assessment and management of liver conditions, ultimately benefiting patients globally.