Lexington Biosciences has announced the completion of the initial HeartSentry study, conducted at San Francisco Bay-area Diablo Clinical Research (USA). As part of the clinical study protocol, according to a press release, the data acquired from this initial study effectively provides critical guidance for key aspects of the pivotal study itself.
The press release reports that 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. Lexington Biosciences 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.
With the conclusion of the initial term of work at Diablo Clinical Research, the Lexington Biosciences moves ahead under the continued expert leadership of Geoff Tison into an advanced stage multicentre trial. The company will immediately embark on the implementation of agreements with several trial locations that have been previously contacted as potential study sites. Tison will use the initial data to update patient examination protocols as required, and both he and the Company will work with each facility to begin enrolment of a significantly larger patient sample from their respective clinical databases.
CEO Eric Willis says: “We are pleased with the performance of the HeartSentry device to-date. 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.”