With Latest Update, FDA Approval Soon Could Send BTCY Ripping

Response to US FDA Request Met, BTCY Could be Right Around the Corner From an FDA Clearance by Year-End, Likelihood of Approval is High

Unexpected News Can Send Stocks--Especially Biomedical Stocks--Flying Quickly, Like NKTR and EKSO Recently

Off-the-radar medical device company Biotricity (OTCQB: BTCY) is around the corner from the biggest update in the company's history, which could send the stock flying to new highs.

Last week, Biotricity announced that as part of U.S. Food And Drug Administration approval process through their 510(K) submission, they have filed a response to the agency's most recent information request, and a decision could be made within the next 30 days on the company's Bioflux device.

Bioflux MCT is a mobile cardiac telemetry device that enables healthcare providers to monitor a patient's heartbeat and ECG remotely over the course of days or weeks. Cardiac monitoring is a $22 billion industry today, and as technology has improved, more and more of this industry is moving towards remote devices, like Bioflux. Other public companies shortly on the market, where BTCY could be by 2018, are valued at 10x or more of little BTCY.

Biotricity filed their 510(K)--which is similar to a New Drug Application, but for devices--in April of this year, and the FDA had requested more information on the carrying pouch earlier this fall. With this latest piece of news, Biotricity is acknowledging that all of this information has been collected and submitted back to the FDA. This could be the final piece before the device is cleared for sale in the U.S., and a response is typical within 30 days setting up a huge catalyst by year-end.

According to the company, "Biotricity is pleased that it was able to collect all the information requested and submit its response in a timely manner. The company is confident in its FDA process and believes it is well positioned to achieve its target timetable." Reading between the lines, investors can likely conclude that the FDA's previously requested testing of the biocompatibility of the external pouch used by patients to carry the Bioflux device, was a success, and the company should hear back by the end of the year on Bioflux's status with the FDA.

Biotricity About to Enter Multi-Billion-Dollar Medical Market With Quality Product Offering

With a FDA decision imminent, Biotricity could be about to join the big leagues of medical device manufacturers in the exciting and growing mobile monitoring space.

Biotricity will be joining the likes of IRhythm (NASDAQ: IRTC), which has a market value of $1.18 billion based on sales of their similar mobile monitoring device of just $64 million in 2016. Why the high market capitalization? Investors recognize that this market is huge and growing, and physicians are increasingly moving towards these high-tech solutions to an old problem.

For years, patients suspected of having heart trouble in the form of atrial fibrillation wore bulky, imperfect ECG devices to acquire a few days of electrical data from the heart. Today, devices like Bioflux provide real-time monitoring and transmission via cellular connection of ambulatory patients' ECG information. The data is used in the evaluation and diagnosis of suspected heart conditions. The process has been streamlined tremendously in the last three years as the cost, size, and efficiency to develop and manufacture these devices has come down.

One of the other very few pure-play companies in this industry, BioTelemetry (NASDAQ: BEAT), is on track to generate over $220 million in sales from their cardiac monitoring business this year. The company is valued by the public markets at nearly $1 billion! Investors recognize that mobile monitoring and algorithmic services that streamline the diagnosis process is a rapidly growing market.

What truly sets Biotricity apart is threefold:

First, the size and efficiency of the Bioflux device should make it attractive to patients.

Second, the model with which the company plans to bring Bioflux to the market is unique, incentivizing physicians who typically make little to no money for their practice when using other, competing mobile cardiac devices.

Third, Biotricity is developing a platform approach to mobile care that could quickly lead to product launches in diabetes and other chronic, multi-billion-dollar settings. The applications are boundless as technology gets better, smaller, and cheaper.

Unexpected News Can Send Healthcare Stocks Ripping, Biotricity Under The Radar

Remarkably Biotricity's possible entrance into this booming medical device space has gone mostly unnoticed by the public markets, with the company remaining well under a $100 million market valuation. But that could change quickly with a potential FDA clearance announcement before the end of the year.

Examining the performance of similar small-cap health care companies shows just how big this kind of unexpected news could be.

Shares of Ekso Bionics Holdings, Inc (NASDAQ: EKSO), for instance, recently soared on news that Ford Motor Company (NYSE: F) has been testing EKSO's upper-body, robotic exoskeleton at two U.S. factories. With this unexpected news, EKSO has rallied by an astonishing 240% in just a week's time.

Similarly, Nektar Therapeutics (NASDAQ: NKTR) has gained about $3 BILLION in market capitalization on news that the company's early immuno-oncology drug NKTR-214 performed well in combination with Bristol Myers Squibb's (NYSE: BMY) multibillion-dollar drug Opdivo, in cancer. The news was unexpected, which is why NKTR shares have almost doubled in the month of November.

In biomedical investing, it often pays to understand what's going on in FRONT of news, when other market participants simply aren't paying attentiong. Expected events simply don't have the same impact as those that the market wasn't paying attention to. With such low trading volume and an under-the-radar catalyst approaching, BTCY has the right setup for a big move.

About One Equity Stocks

One Equity Stocks is a leading provider of research on publicly traded emerging growth companies. Our team is comprised of sophisticated financial professionals that strive to find the companies and management teams that will outperform the market and deliver investment returns to our subscribers. We are not a licensed broker-dealer and do not publish investment advice and remind readers that investing involves considerable risk. One Equity Stocks encourages all readers to carefully review the SEC filings of any issuers we cover and consult with an investment professional before making any investment decisions. One Equity Stocks is a for-profit business and is usually compensated for coverage of issuers. In the case of BTCY, we are reimbursed for actual costs of this distribution and have received 40,000 shares of restricted stock for Business Development, Capital Markets and Research Services. We will likely receive additional compensation in the future. Please contact us at info@investorclick.net for additional information or to subscribe to our intelligence service.