Things keep getting better for some of our currently featured stocks, and if this morning's news from Vitality Biopharma, Inc. (OTCBB: VBIO) and Biotricity, Inc. (OTCBB: BTCY) is any indication of what's to come, one better start paying close attention to what the PR pipeline is starting to tell us with these two potentially promising small caps.
Biotricity, Inc. (OTCBB: BTCY), a medical diagnostic and consumer healthcare technology company dedicated to delivering innovative, biometric remote monitoring solutions, has filed for a second and final 510(k) for the hardware portion of its Bioflux solution with the U.S. Food and Drug Administration (FDA). Biotricity expects to receive a response from the FDA on its 510(k) submission by summer 2017. Biotricity has already received FDA approval for the software portion of its remote cardiac monitoring wearable.
This 510(k) is the final regulatory requirement needed for Biotricity to bring its Bioflux solution to the multi-billion dollar cardiac monitoring market. Biotricity's flagship product, the Bioflux solution, combines a proprietary mobile ECG monitoring device and an ECG viewer software package. Together with an accredited 24 hour, 7 day per week, ECG monitoring facility, Bioflux enables physicians to remotely monitor and diagnose patients with cardiovascular disease and coronary heart disease by detecting arrhythmias.
Biotricity founder and CEO Waqaas Al-Siddiq commented, "The company is incredibly excited about reaching this key milestone. Submitting a 510(k) for our hardware is a very important step for the company as we prepare to commercialize our first medical solution. We believe significant opportunity exists for our remote patient monitoring solutions to gain traction in the rapidly expanding diagnostic and preventative healthcare markets."
It's that second to last sentence above that's going to likely end up being the big game changer for BTCY on a go-forward basis. Although the stock has been quiet for quite some time, this type of sideways activity never lasts forever. And, when investors consider Biotricity is literally in that last long mile toward commercialization now, it's entirely possible shares of BTCY may be fast approaching a very key inflection point, one that could be a prelude to much higher levels ahead.
The cardiac monitoring industry is huge, and it's only growing based on the research we've done in recent weeks. Take a look at Edwards Lifesciences Corp. (NYSE: EW), BioTelemetry, Inc. (NASDAQ:BEAT), AngioDynamics Inc. (NASDAQ:ANGO), and Spectranetics Corp. (NASDAQ:SPNC). Those are just a few key players in a growing space.
So, should Biotricity's biometric remote monitoring solutions start to take hold and really start to grab even a little of the market share, this current $66M small cap could end up being a gift for early stage investors. There's even a legit possibility if the company can start to turn some heads on the commercial front that a larger player could come in and snap them up.
VBIO Adds FDA Pro to the Roster
In other news, Vitality Biopharma, Inc. (OTCQB: VBIO), which is dedicated to the development of cannabinoid prodrug pharmaceuticals, and unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders, today announced the appointment of Tracy Rockney, J.D., Co-Founder & Chief Operating Officer, OneSource Regulatory, to the position of Senior Regulatory Advisor.
Tracy Rockney, J.D. was formerly VP, Regulatory Affairs at AbbVie Inc. from May 2010 to May 2015, leading executive functions related to regulatory policy and intelligence, and from August 1993 to January 2005 she held positions of increasing responsibility with Pfizer (formerly Wyeth). From January 2005 to April 2010, she held positions with Shire Pharmaceuticals ("Shire"), including serving as Senior Director, Regulatory Affairs. This included responsibilities as Therapeutic Area Head for Shire's Gastrointestinal Business Unit, Regulatory Advertising & Promotion and CMC.
In January 2007, during her tenure with Shire, Ms. Rockney led the regulatory team and negotiations with FDA for LIALDATM. The FDA approved Shire's LIALDATM with MMX(R) technology, which was the first once-daily oral formulation of mesalamines. Mesalamines are part of the drug class of aminosalicylates, now part of the clinical standard-of-care for treating inflammatory bowel disease. LIALDATM was found to be effective in Phase 3 trials for inducing remission of active mild-to-moderate ulcerative colitis after eight weeks of treatment. LIALDATM (also now marketed as Mezavant(R)) had U.S. sales in 2016 of $714 million, which increased by 16% relative to 2015 sales.
Vitality Biopharma has developed a new class of cannabinoid pharmaceuticals, known as cannabosides, which upon ingestion can enable the targeted delivery of THC and cannabidiol (CBD) to the gastrointestinal tract. Cannabosides could provide therapeutic benefits for inflammatory bowel disease while eliminating or reducing drug psychoactivity. Approximately 1.4 million Americans are affected by inflammatory bowel disease, including Crohn's disease and ulcerative colitis. Most patients are diagnosed before age 30 and require life-long treatment.
"We're very excited to have Tracy join our team, as a regulatory leader with a clear track record of innovation and success with development of new drugs for gastrointestinal disorders," said Robert Brooke, Chief Executive Officer of Vitality Biopharma.
All I'm going to say here is "read between the lines". Not only is this a very big announcement in terms of what it's suggesting about VBIO's future, it's also telling us the company is very serious about becoming a leader in the cannabinoid pharma, an industry sure to grown in leaps and bounds over the next several years.
While many still scrutinize and criticize the idea of legalizing marijuana for recreational use, we think it's pretty safe to assume at this point cannabis is and probably will continue to be a winning sector in the biotech and pharma space.