“With today’s (11/30/17) announcement (lxgtf)’S plans are now advancing to initiate commencement of a pilot clinical research study designed to begin gathering the foundational dataset aimed at supporting FDA clearance.”
VANCOUVER, BC–(Marketwired – Nov 30, 2017) – Lexington Biosciences, Inc. ( CSE : LNB ) ( OTCQB : LXGTF ) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to announce the engagement of San Francisco Bay Area-based Diablo Clinical Research to conduct its upcoming HeartSentry pilot clinical studies.
Lexington recently announced delivery of its initial order of HeartSentry devices slated for clinical trials. With today’s announcement, plans are now advancing to initiate commencement of a pilot clinical research study designed to begin gathering the foundational dataset aimed at supporting FDA clearance.
Diablo Clinical Research has specialized in clinical research for over 22 years. Founded in 1995, Diablo’s team has conducted over 600 studies with thousands of patients and in the process, has assembled a database comprising over 15,000 patients who have either completed a study, are currently enrolled in a study, or have expressed interest in future clinical study participation. The firm has 4 MDs on staff with specialties in endocrinology, internal medicine, and cardiology. Find out more at: www.diabloclinical.com.
Dr. Geoff Tison, Cardiologist and Assistant Professor in the Division of Cardiology at the University of California San Francisco and Medical Advisor to the company comments, “After a fifteen-year research process, I am excited to see Lexington beginning their clinical research efforts in order to gather clinical study data for the HeartSentry device. With the recent publication of the more stringent American Heart Association hypertension management guidelines, there is increased awareness of the need to more closely monitor patients for cardiovascular risk factors, which HeartSentry is well positioned to do.”
Lexington’s President Eric Willis comments, “After nine months of concerted effort by our design and production team, the arrival of our first human-use HeartSentry devices allows us to accelerate our plans to move ahead with our pilot study. Diablo Clinical Research is a proven and respected establishment with the capability to launch our research program efficiently and cost-effectively. They have been extremely helpful in the determination process which has led to today’s announcement. We are excited to begin this next step of our development phase, and look forward to sharing quantifiable results in the near future.
To find out more about Lexington Biosciences, interested readers are invited to visit our website and view our videofeaturing 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 a person’s 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 portfolio of multiple pending and issued patents licensed to the company. By taking delivery of the clinical trial ready HeartSentry units the company will commence studies as soon as possible. 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/.
CEO & Director
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This news release contains forward-looking statements relating to the completion of the listing of the Company’s shares on the Canadian Securities Exchange and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the Canadian Securities Exchange and other risks detailed from time to time in the filings made by the Company with securities regulations.
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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