Biotricity Draws Closer to a Critical Binary Moment for the Company
An Emerging Markets News Commentary
ORLANDO, Fla., May 22, 2020 (GLOBE NEWSWIRE) -- Breaking news last night commemorates a very important step for medical technology company Biotricity (BTCY). For our many readers following the Company and its investors, today is significant. What is coming for Biotricity is a binary event that could change its future dramatically.
Here’s what you need to know.
Today, Biotricity reported that it recently received correspondence from the FDA stating that its 510(k) submission for its next generation Bioflux Software Device is now in the Substantiative Phase of the review process with an expected response by the end of June. The Company goes on to say that it is confident in its FDA submission process, having received two previous 510(k)s for its Bioflux Device and Bioflux Software.
For them to say that in their release is bold.
What is the market opportunity?
The Bioflux Software Device is a high-precision, single-unit mobile cardiac telemetry (MCT) device that provides real-time monitoring and transmission of your ambulatory patients’ ECG information. The Bioflux® system is a complete solution for remote cardiac monitoring that merges seamlessly with physicians’ existing platforms and workflows.
Clearly, recent world events have obviated how important remote monitoring and assessment is and will be in the future. In our opinion, remote monitoring is the “Zoom” of healthcare, something that already existed but will now be a popular, ever growing way of doing things.
Why this matters:
A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed as safe and effective, at the very least, as a legally marketed device. It is an interactive process with reviewers who use manufacturer evidence to assess the substantial equivalence of the new device.
If approved, and again Biotricity has significant confidence in an approval, this greatly expedites their path to commercialization of the device in a very large market.
This FDA submission also highlights Biotricity’s focus on innovation and expansion of its technology. Alongside technology, the company has focused on applying technology in a recurring revenue business model. This model has led to triple digit growth, albeit despite recent events, which have instead made its technology even more applicable. This is evidenced by continued sales through recent events and an expected 20% growth for the quarter.
And while nothing is certain until it’s certain, if Biotricity is on the favorable side of an approval expected within 40 days or so, the Company will be one step closer to commercializing its proprietary cardiac monitoring device in a market that has certainly improved significantly while the product was being developed.
About Biotricity Inc.
Biotricity is a modern medical technology company focused on delivering innovative, remote biometric monitoring solutions to the medical and consumer markets, including diagnostic and post-diagnostic solutions for chronic conditions and lifestyle improvement. Biotricity’s R&D continues to focus on the preventative healthcare market, with a vision of putting health management into the hands of the individual. The company aims to support the self-management of critical and chronic conditions with the use of innovative solutions to ease the growing burden on the healthcare system. To learn more, visit www.biotricity.com.
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