Lexington Biosciences Inc.
Revolutionary Cardiovascular Health Monitoring

Every year one in three deaths are caused by heart disease, stroke and for nearly half these people very first symptom is a major cardiac event. Cardiovascular diseases claim more lives each year than all forms of cancer and Chronic Lower Respiratory Disease combined accounting for 17.3 million deaths per year, a number that is expected to grow to more than 23.6 million by 2030. Many of these deaths could be prevented if there was a simple way to detect heart disease before it becomes critical. This was the thought that led Vancouver-based Lexington Biosciences Inc.—a development-stage medical device company to develop the HeartSentry—a diagnostic product measurement of endothelial function which detects the early stages of heart disease.

Today, diagnostic candidates must consult with their physician, book an appointment, and visit a specialized facility in order to undergo an assessment with a trained technician. The current standard for arterial endothelial assessment requires a visit to a diagnostic center where a technician employing a high-resolution ultrasound imager will take approximately an hour to perform the diagnostic measurements. The physicians have long wanted to be able to easily measure the viability of the endothelium. So physicians should be encouraged that they finally have a simple tool that really anybody can use. Lexington has developed a combination device that measures both blood pressure and endothelial function. This increases the value and interest in purchasing a blood pressure and endothelial function monitoring device, and will deliver a more accurate picture of cardiovascular health.

A Completely Automated Solution

In collaboration with California’s San Francisco Bay Area-based Diablo Clinical Research Lexington Biosciences conducted clinical trial work. The firm’s flagship product, 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.

HeartSentry is a revolutionary, simple, and effective technology for personalized measurement and monitoring of vascular health. The device is designed to measure the function of the endothelium, the cells that line all arteries and are critical to the prevention of atherosclerosis, heart attacks and stroke. HeartSentry Is a modern design, easy to use, cloud connected smart phone app.

Our goal is to begin marketing the HeartSentry in 2019 to clinicians once FDA 510(K) clearance is obtained

The unit is designed to communicate via Bluetooth technology to provide up-to-date and accurate readings of an individual’s complete cardiovascular health through electronic monitoring for cardiovascular risk-assessment and to aid treatment effectiveness for the prevention of heart attack and stroke. The HeartSentry measures arterial volume that increases when the endothelial cells of the artery are stimulated and the muscles in the wall of the artery relax. While using an ultrasound transducer to image the arteries in patients arm takes time and is very susceptible to error if not done correctly by qualified technician but using HeartSentry is completely automated and not user-dependent.

Outwardly identical to a standard blood pressure cuff, the HeartSentry demonstrated a strong correlation to ultrasound results in initial studies with 50 patients. More significantly it demonstrated 500 percent sensitivity over ultrasound, consistently higher accuracy and much lower variability.

HeartSentry targets the rapidly growing self-measurement medical device sector and is designed for both personal and clinical use. Simplicity and functionality are key elements of the design and also because this device is so simple and affordable this makes it attractive for users over the world in assessing cardiovascular disease proving patient outcomes.

Getting to the Bottom of Heart Disease

The system starts with base line measurement by briefly inflating the cuff to the moderate pressure, after a pause the cuff then re-inflates to a higher pressure in order to reduce blood flow for up to three minutes. When the blood is released the fast flowing blood simulates receptors on the endothelium and this causes the artery to relax. This relaxation is the test for the nitric oxide pathway—a key factor in determining arterial health. Heart sentry then takes a final measurement at moderate pressure and app compares the waveforms using a metric that identifies how active the endothelial shield is. It also displays heart beat and traditional blood pressure measurements, the systems connectivity to the apps and remote monitoring systems provides unravel personal diagnostics for monitoring and preventing cardiovascular events.

Currently, five patients have 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.

Becoming the Standard of Care

Lexington is currently taking steps to commercialize a universal, simple, effective and revolutionary technology for personalized measurement and monitoring of vascular health to prevent cardiovascular disease at its earliest stages. The company has assembled a top notch scientific business and financial team to guide and propel sentry device to market. “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” says Eric Willis, President, Lexington Biosciences. The principals, directors and advisors of Lexington BioSciences have been individually and collectively involved in raising extensive capital funding for their private and public companies. Team members have held numerous executive leadership positions encompassing biotechnology, and medical device companies, as well as multi-national corporations. The team includes inventors, scientists, and business people who have successfully started, built and grown multiple life science companies.

"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"

2017 has been an incredibly exciting time for the company building the product at a rapid pace. Further, Lexington is engaged with the US FDA and other regulatory agencies on the required product approvals for the HeartSentry. The firm’s scientific research support and prudent business leadership aims to realize the successful introduction of this potentially disruptive technology to directly target the unmet medical need for early detection in this rapidly growing global marketplace. The HeartSentry’s pilot trial will be completed before the end of the second quarter of this year. “Our goal is to begin marketing the HeartSentry in 2019 to clinicians once FDA 510(K) clearance is obtained” concludes Willis.