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Thursday, 12/28/2017 12:33:25 PM

Thursday, December 28, 2017 12:33:25 PM

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Another nice mention for LXGTF:

FDA’s Focus On Medical Devices Is Grabbing Investor Attention
Nov. 30, 2017 3:25 PM ET|Includes: Apple Inc. (AAPL), ABT, AMZN, DXCM, LXGTF
Summary
Growing demand for early detection & prevention is bringing rise to new technology for personal diagnosis and analysis.

The FDA has been clearing new medical technology devices for in home use.

The increasing population of 55+ who are tech savvy and self aware of medical conditions could help boost further growth to this industry.

If the bitcoin boom hasn’t convinced you that industry is going by way of more technology based solutions, then this could. In recent weeks, the FDA has been targeting technology and more specifically, that of medical devices that can be worn & self analyzed by their wearers. Right now, it would appear that the first to market have been targeting one of the biggest threats to human health, which is heart disease.

Global Industry Analysts, Inc. projects the market for blood pressure monitoring and measurement instruments to be in the realm of $3 billion by 2022. The main driver to this has been boosted by the growing prevalence of higher blood pressure and a greater need to reduce the risks that are related to untreated hypertension.

We’re talking things like strokes, aortic dissection, cardiomyopathy, and the like; something that affects 1 of 3 U.S. adults (~75 million people). It has been called the “silent killer” because it often has no warning signs or symptoms.

This all boils down to an annual cost of about $46 billion each year. Also, the chances of getting hypertension as an older adult over the age of 55 increase dramatically. For these reasons, many tech companies have focused on creating devices or solutions for early detection, which can lead to early prevention, in turn.

Heart Monitoring Devices Are Growing In Popularity And Tech Advancement
In fact, just recently, Apple (AAPL)’s new smart watch, for example, has come one step closer to fulfilling the goal of playing a part in this technology boom for medical devices.

The Food and Drug Administration has just cleared AliveCor’s Kardiaband EKG reader as the first medical device accessory for the Apple Watch. The new Apple Watch accessory, Kardiaband, clicks into a slot on the Watchband to detect abnormal heart rhythm and atrial fibrillation (AFib).

Similarly, Lexington Biosciences (OTCQB:LXGTF), a Canadian corporation, has a technology of its own. Instead of simply recording cardiac function, their device called HeartSentry focused on measurement of endothelium functions. If you aren’t savvy in biotech jargon, the endothelium is made up of the cells that line all arteries and are critical to the prevention of atherosclerosis, heart attacks and stroke.

According to the company, “The unit is designed to utilize Bluetooth and Cloud technology to provide up-to-date and accurate readings of an individual’s complete cardiovascular health via electronic monitoring for risk-assessment and treatment effectiveness targeting the prevention of heart attack and stroke.”

On Thursday, the company formally announced that it had engaged a clinical research organization to help Lexington handle upcoming pilot clinical studies of its HeartSentry. This announcement came several weeks after the company initially received its first human use trial units.

In a previous announcement, company President, Eric Willis explained, “We look forward to being able to commence study enrollment in our upcoming HeartSentry clinical study in order to gather the foundational dataset aimed at supporting FDA clearance.”

Amazon To Make A Play At Medical Devices?
If the news of Amazon (AMZN) looking to buy a pharmacy wasn’t obscure enough, the mega corp could actually be taking a different approach to the medical industry. In fact, after being approved for several wholesale pharmacy licenses in a number of US states, the company could actually be looking to sell medical devices. According to Business Insider, “Correspondence between the company and regulators in Tennessee and Indiana revealed that Amazon will not be using the licenses to sell and store prescription drugs, according to investment firm Jeffries. Instead, the company will likely begin shipping medical devices and supplies in its Indiana fulfillment center.”

This could open up opportunities for many companies targeting medical device sales in the marketplace. Abbott Labs (ABT) is another company that has its own key technology, which has actually been overlooked in the past. However, in September, more light was shed on it after the U.S. Food and Drug Administration approved the company's FreeStyle Libre Flash Glucose Monitoring System.

In fact, this was so big for Abbott that it actually caused competitor, DexCom (DXCM), to see its stock price crumble because of the potential threat that Abbott’s product posed. Even with DexCom developing a “no-finger-stick” device, timing shows that the company is still about a year away from being able to market the product. However, shares of DexCom have been on the rise since the beginning of November.

Cause For Attention
With the FDA paying close attention to medical devices right now, it should come as no surprise to investors that this arena could be ripe with opportunity. As we’ve seen from just a few examples here, just because there’s already competition, that only stokes the fire even more for further development and enhancement to address unmet needs.

Bolstered by the “early detection/prevention” theme, an aging population will also be in focus as these devices could benefit from the unique increase in the 55+ demographic. Of course there are always risks that key trials stumble but with the case for medical devices, unique technology has obviously been a true driver for companies in this space.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

Additional disclosure: Contributor's Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.