Company embarks on pivotal clinical study
VANCOUVER, British Columbia, Aug. 21, 2018 — Lexington Biosciences, Inc. (CSE: LNB) (OTCQB: LXGTF) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to announce the Medical College of Wisconsin as the first site in its multicenter clinical study for the HeartSentry portable cardiovascular health monitor.
“Our initial trials provided us an extensive data set regarding functional efficacy and safety.” states Company CEO, Eric Willis. “Now we move into the next phase of our clinical study with a much larger demographic alongside diagnosis-specific data points to meet the requirements for FDA submission. The team in Wisconsin have been very helpful and we selected them due to their expertise in the field of endothelial function and cardiovascular medicine along with their proven ability to run clinical trials quickly, efficiently, and with a commitment to data integrity. We plan on announcing our other clinical trial centers shortly and are very pleased with the quality of the broader clinical research team.”
As a research center, the Medical College of Wisconsin is the second largest research institution in the state with $234M invested in research, teaching, training and related purposes in FY 2017, which ultimately leads to improved patient care and health outcomes. Its faculty conducted more than 2,800 research studies, including clinical trials last fiscal year, and overall it is the largest research center in the Milwaukee metropolitan area.
Lexington Biosciences is conducting the clinical trial process under the leadership of Dr. Geoff Tison, M.D. M.P.H, and is working closely with several potential partners for the implementation of clinical trial contracts. Dr. Tison and Lexington’s Chief Technical Advisor, Dr. Jonathan Maltz, have reviewed the initial data in order to update patient examination protocols and will collaborate with each new facility to begin enrollment of a suitably large patient sample from their respective clinical databases.
HeartSentry was designed as a diagnostic device offering a new approach to non-invasive measurement and monitoring of cardiovascular health by assessing the function of a patient’s vascular endothelium, the vital innermost lining of the cardiovascular system. The Company designed HeartSentry to be accurate, quick, and cost-effective, with the intent to position it to become the standard of care for cardiologists, general practitioners, and ultimately for patients as a first-line evaluation of cardiovascular health.
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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 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 Lawrence Berkeley National Laboratory 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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