Company prepares for multicenter pivotal clinical study
VANCOUVER, British Columbia, June 27, 2018 — Lexington Biosciences, Inc. (CSE:LNB) (OTCQB:LXGTF) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to announce the completion of the initial HeartSentry study conducted at San Francisco Bay-area Diablo Clinical Research.
“We are pleased with the performance of the HeartSentry device to-date,” notes Company CEO, Eric Willis. “We are looking forward to the next phase of our clinical study which will provide the larger demographic and diagnosis-specific data points required for FDA submission. Once again, we find ourselves moving ahead at an excellent pace as we move towards our clinical goals.”
As part of the clinical study protocol, the data acquired from this initial study effectively provides critical guidance for key aspects of the pivotal study itself. With the conclusion of the initial term of work at Diablo Clinical Research, the Company moves ahead under the continued expert leadership of Dr. Geoff Tison, M.D. M.P.H, into an advanced stage multicenter trial.
Lexington Biosciences will immediately embark on the implementation of agreements with several trial locations which have been previously contacted as potential study sites. Dr. Tison will utilize the initial data to update patient examination protocols as required, and both he and the Company will work with each facility to begin enrollment of a significantly larger patient sample from their respective clinical databases.
Jonathan S. Maltz, Ph.D., Lexington’s lead researcher, Chief Scientific Advisor, and one of the driving forces behind the development of the HeartSentry technology remains closely involved at every step of the process and remains very pleased with the device performance throughout this initial phase.
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 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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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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