VANCOUVER, British Columbia, March 05, 2018 (GLOBE NEWSWIRE) — Lexington Biosciences, Inc. (CSE:LNB) (LXGTF) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to provide an early update of its clinical trial and patient enrollment. As previously announced, the Company’s HeartSentry device is undergoing clinical studies designed to measure the safety and effectiveness of the patented technology designed for cardiovascular health diagnosis.
The team at San Francisco Bay-area Diablo Clinical Research, site of the investigative study has advised the Company that five patients have now been successfully enrolled and admitted to the program, and have undergone the first series of tests with HeartSentry. Under the expert leadership of Dr. Geoff Tison, M.D. M.P.H., initial results indicate the device is functioning as designed with quantifiable results.
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 notes, “I am really excited to report that the Gen-1 HeartSentry devices are working well. All the machines are functioning within their operational parameters and delivering excellent results, and the data is being collected as designed. After fifteen years of effort, it’s truly remarkable to watch our hard work undergoing rigorous examination in a clinical environment. I am watching events closely and at this point couldn’t be happier.”
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 patients for first-line evaluation of cardiovascular health.
Lexington’s President Eric Willis advises, “It has been gratifying to watch our first patients providing the researchers with the beginning of what we believe will become a wave of consistently replicable data in the days and weeks ahead. We have been advised that the investigative team intends to increase the first cohort of patients to an enrollment that will generate ample data requiring a break in mid-March to collate and assess the initial results. Based on their assessment, activities for a second round of enrollment and additional studies could commence as early as the end of the month. We anticipate this process to be repeated several times as we move ahead to build the requisite data sets for our formal submission to the FDA. Needless to say, the early results have produced lots of smiling faces, and we are beginning to accelerate a number of strategic initiatives to ensure we are fully prepared to move quickly upon completion of the study. It’s an exciting time at Lexington, and we are all very proud of what we have been able to accomplish in such a short time. I want to personally thank all our investors, as we wouldn’t be here today without your commitment and help.”
As previously announced, the Company aims to continue efforts to provide regular news and 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. To receive our newsletter and news alerts direct to your inbox, you can signup at any time on any of the signup opportunities or “contact” page of our website.
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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) (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
CAUTIONARY DISCLAIMER STATEMENT: The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
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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