News | Cardiovascular Clinical Studies | February 20, 2018

Lexington Begins HeartSentry Clinical Trial

Trial designed to study safety and effectiveness for a non-invasive diagnostic device for cardiovascular health management

Lexington Begins HeartSentry Clinical Trial

February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commencement of its clinical trial and first patient enrollment.  These clinical studies are designed to measure the safety and effectiveness of the HeartSentry technology for cardiovascular health diagnosis.

HeartSentry is a new non-invasive diagnostic device that is designed to measure and monitor cardiovascular health by assessing the function of a patient’s vascular endothelium, the vital innermost lining of the cardiovascular system. The core technology of HeartSentry was developed at the University of California Berkeley over a fifteen-year research and development period involving an award-winning scientific team dedicated to solving the holy grail of cardiovascular medicine, being able to cost-effectively predict the development and progression of cardiovascular disease.  The early research studies and product iterations resulted in a portfolio of multiple pending and issued patents being licensed to the company.

As previously announced, the company has engaged the services of Diablo Clinical Research in California’s San Francisco Bay area as its investigative site based on their proven track record for providing safe, top-quality care to patients and comprehensive, reliable data to sponsoring companies such as Lexington. The lead independent investigator is Geoff Tison, M.D. M.P.H., a cardiologist and an assistant professor in the Division of Cardiology at the University of California, San Francisco (“UCSF"). Tison brings expertise in clinical research, where he is an investigator in the UCSF Health eHeart study and leads several clinical research studies at UCSF.

Tison noted, “I am thrilled to be a part of the next phase of human clinical evaluation of the HeartSentry product.  We are studying its ability to measure the presence of cardiovascular disease before the onset of symptoms, which would have broad implications for cardiovascular medicine.”

Lexington’s President Eric Willis said, “The enrollment of the first patient in this next phase clinical trial is a significant milestone for our growing company. Heart disease is a major health concern around the world, and with accessible early diagnosis, many corrective treatment options are available. But the first step is providing the healthcare frontline workers with simple, effective diagnostic tools. We believe today’s first patient is the launching pad for what could be an important shift in the field of cardiovascular health diagnostics and could eventually lead to saving thousands of lives every year.”

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