“We are pleased with the performance of the HeartSentry device to-date,” noted 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. 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.
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 15-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. The company’s 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 U.S. Food and Drug Administration and other regulatory agencies on the required product approvals for the HeartSentry.