Lexington Biosciences Inc. (CSE:LNB) (OTC:LXGTF) plans to commercialize an at-home product to better predict whether a person is at risk for cardiovascular disease
Angela Harmantas | May 31, 2018 | SmallCapPower: Cardiovascular disease is leading cause of death in North America, and yet, nearly one-third of those deaths are preventable. Annually, over 1.5 million people die of a heart attack or stroke in the United States. For most people, the first symptom of cardiovascular disease is a heart attack or stroke.
One way that has been shown to predict whether a person is at risk for heart disease is by measuring his or her endothelial function, a single layer of cells that line the heart, blood and lymphatic vessels, which act as a shield to prevent plaque from forming inside the artery wall. Currently, this measurement can only be done with ultrasound or by using a product called EndoPAT. However, these methods of testing are cumbersome, time consuming, and costly.
Lexington Biosciences Inc. (CSE:LNB) (OTC:LXGTF) hopes to revolutionize the self-monitoring medical device sector with its new product called HeartSentry. The product is designed to tell the users whether they are at risk for a heart attack or stroke. A simple cuff, similar to a blood pressure device, measures a person’s endothelial function. Think Fitbit for your heart.
HeartSentry stimulates the endothelium and accurately measures the arterial response, or Flow Mediated Dilation (FMD), by reading how quickly full flow is restored to the artery after dilation. “A 1% decrease in the functioning of that leads to an 8% increase in the likelihood of a cardiovascular event,” explained Donald McInnes, advisor at Lexington Biosciences. “Just a 5% decrease in your FMD corresponds to a 40% increased chance of a cardiac event.”
The technology was invented and developed over 15 years by Jonathan Maltz, PhD, and Thomas Budinger, MD, PhD, at the Lawrence Berkeley National Laboratory in California. The Berkeley lab patented their work and licenced it to Lexington Biosciences. Since then, Lexington BioSciences has raised $3.6 million, the bulk of that spent on research and development. Dr. Maltz now serves as the Company’s Chief Scientific Advisor.
Clinical trials are already underway, and the Company hopes to receive full FDA approval by the end of 2018. An initial study to establish HeartSentry’s measurement range for endothelial dysfunction diagnosis showed promising results based on a sample of 50 people. The pivotal next trial will include 150 people, which Lexington co-founder Donald McInnes says is “not a high hurdle.” Once HeartSentry receives FDA approval, Lexington BioSciences is looking at various ways to commercialize the product. “We need the cardiovascular world to believe in what we’re doing,” said Mr. McInnes. “The way to really sell this is if we can create that consumer market product. There’s only so many doctors and nurses who need this blood pressure cuff-type device.”
If Lexington BioSciences can position HeartSentry as a part of the home health monitoring technology sector, Fitbit or Apple Inc. could be potential partners. “Fitbit has been buying some companies so that they can do more than just count your steps,” said Donald McInnes. “If you’re the consumer, you don’t want multiple devices that do the same thing, you want one device that can do multiple things. Over time, there will be a convergence.”
According to Global Industry Analysts Inc., the blood pressure monitor market is forecast to exceed $2.6 billion by 2020. Donald McInnes lays out the investment proposition: “If we partnered with an existing cuff manufacturer and they got 10% of that $2.6 billion per year market, that’s $260 million in sales. If we have a 10% licence on that, that’s $26 million a year of free cash for our shareholders that you would probably value at eight times cash or more. Eight times $26 million gets you to over a $200 million U.S. valuation. Today, our market cap is under $15 million Canadian. For an investor, this is a huge opportunity.”
At its core, Lexington BioSciences is hoping to change cardiovascular disease management from reactive to predictive. “The upside for investors is pretty high from where we are today with how big we see the wearable consumer healthcare market is,” said McInnes. “If we just capture a tiny fraction of what that might be, I think that translates into a lot of value for our shareholders.”
Disclosure: Neither the author nor her family own shares in the company mentioned above.
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