Company prepares for volunteer enrollment
VANCOUVER, British Columbia, Jan. 24, 2018 — Lexington Biosciences, Inc. (CSE:LNB) (OTCQB:LXGTF) (the “Company” or “Lexington”), a development-stage medical device company, is pleased to announce its recent application for Institutional Review Board (“IRB”) approval of its pilot clinical study at Diablo Clinical Research has been approved.
As previously noted, approval by an IRB, or ethics board, is necessary before human research can begin. The IRB has reviewed Lexington’s submission for both medical safety and protection of the patients involved in the study and has subsequently advised of its approval as submitted. With approval in-hand, the Company has engaged a clinical investigative team and research site in preparation for the process of volunteer enrollment.
Lexington’s President Eric Willis comments, “The rapid approval of our clinical study submission speaks volumes to our team’s diligent attention to the design of the product and required documentation, as well as the format of the proposed study itself. We are planning to immediately move ahead into the investigative phase of our studies aimed at achieving eventual FDA clearance for our HeartSentry device. This means we are proceeding rapidly toward our strategic goals. Our thorough planning means we are also in great shape to act on the approval right away. We are very happy to begin this most critical phase of our development to-date and look forward to the work ahead.”
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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