Trial designed to study safety and effectiveness for a non-invasive diagnostic device for cardiovascular health management
VANCOUVER, British Columbia, Feb. 20, 2018 — Lexington Biosciences, Inc. (CSE:LNB) (OTCQB:LXGTF) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to announce 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”). Dr. 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. Dr. Tison’s interests include applying machine learning and deep-learning techniques to large-scale electronic health data from heterogeneous sources to achieve the goal of personalized cardiovascular prognosis and disease prevention.
Dr. Tison, lead investigator of the HeartSentry study notes, “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. The team has put in many long hours designing and iterating the product, and I am excited to be able to use it with patients.”
Lexington’s President Eric Willis comments, “The enrollment of the first patient in this next phase clinical trial is a significant milestone for our growing company. In just over a year we have rapidly moved from concept to clinical trial and our business plans for 2018 continue to be dynamic. The inquiries we have received in recent months are extremely positive and support our belief that there is a great opportunity ahead as we continue to move towards our goal of launching HeartSentry into the commercial arena. 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 front line workers with simple, effective diagnostic tools. We believe todays 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.”
In related news, the Company plans to provide regular social media updates regarding the progress of the clinical study. To access these updates, the public is invited to follow us on Facebook, Twitter and LinkedIn.
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To find out more about Lexington Biosciences, interested readers are invited to visit our website and view our video featuring principal HeartSentry inventor Dr. Jonathan Maltz, Ph.D., which provides an excellent overview of our business proposition and opportunity ahead
About Diablo Clinical Research
Established in 1995, the team at Diablo works with pharmaceutical/biotech companies to conduct research to find potential new treatments for a variety of health conditions. Patient volunteers receive all appropriate and pertinent labs, physical and specialty exams, as well as specialty consults completely free of charge. No insurance is required, and volunteers are compensated for each clinical trial conducted at the Diablo research clinic. The company operates with over 90-years of combined expertise in endocrinology, internal medicine, cardiology and neurology. To-date, the clinic has conducted over 600 studies with a database of over 13,000 patients including individuals who have either completed a study, are currently enrolled in a study, or have expressed interest in participating in a study. Diablo Clinical research has a proven track record for providing safe, top quality care to patients, and comprehensive, reliable data to sponsoring companies such as Lexington Biosciences. Find out more: www.diabloclinical.com.
About Lexington Biosciences, Inc. (CSE:LNB) (OTCQB:LXGTF)
Lexington Biosciences is a medical device company developing the HeartSentry, a new non-invasive diagnostic device to measure and monitor cardiovascular health by assessing the function of a person’s vascular endothelium – the vital innermost lining of the cardiovascular system. Currently, the standard of care is measurement using expensive external ultrasound by a highly trained technician. The HeartSentry core technology was developed at the University of California Berkeley over a fifteen-year R&D period involving many research studies and product iterations resulting in a portfolio of multiple pending and issued patents licensed to the company. Our aim is to make HeartSentry accurate, quick, and cost effective so it can become the standard of care for cardiologists, general practitioners, and ultimately patients for first line evaluation of a person’s cardiovascular health. Lexington is engaged with the US FDA and other regulatory agencies on the required product approvals for the HeartSentry. For more information about the company please visit: https://lexingtonbiosciences.com/.
On Behalf of the Board,
CEO & Director
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The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.
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