Another milestone achieved as the Company moves towards HeartSentry human trials
Lexington Biosciences, Inc. (CSE:LNB) (OTCQB:LXGTF) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to announce it has completed its requisite documentation and submitted an application for Institutional Review Board (“IRB”) approval of its pilot clinical study.
In preparation for commercialization of the HeartSentry device, the pathway for regulatory approval includes a clinical study utilizing human subjects. In preparation for the study, approval by an IRB, or ethics board, is necessary before all but the most informal human research can begin. The IRB scrutinizes the study for both medical safety and protection of the patients involved in the study before it allows the study to commence. In some instances, it may require changes in study procedures or in the explanations given to the patient. Lexington engaged professional regulatory and clinical advisory assistance to ensure accuracy and diligence of its clinical protocol and procedures prior to submission.
Lexington’s President Eric Willis comments, “Our IRB submission signals the start of a whole series of steps required to achieve eventual FDA clearance for our HeartSentry device. We worked diligently to submit a comprehensive application and look forward to a timely response. Once an approval is in-hand we can immediately move ahead into the investigative phase of the study. It is an exciting time at Lexington and we are really pleased to be on schedule with the execution of our strategic plan. 2018 is expected to be a pivotal year for us, with all our hard work coming to fruition as we continue to build a viable and sustainable venture providing real help for millions of potential consumers.”
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. Please also follow us on Facebook, Twitter and LinkedIn.
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 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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