2018 may have been a tough year for the markets, but it certainly wasn’t for BioSig Technologies (NASDAQ: BSGM), as the little company grew up in a big way. The fundamental advancements were rewarded by stockholders, evidenced by the shares of BSGM appreciating by 21.3% in 2018.
Shareholders had plenty of cause to applaud BioSig for a litany of accomplishments. For starters, the medical device maker graduated from the over the counter markets to a senior exchange, listing on the Nasdaq Capital Market in September. Further, BioSig raised $13.5 million in quality capital to fund the next steps in expanding the pipeline and commercializing its PURE EP™ System. The company now has almost 3,400 shareholders.
PURE EP System is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision-making during procedures to diagnose and treat patients with abnormal heart rates and rhythms, including Atrial Fibrillation and Ventricular Tachycardia. In September, the FDA granted 510(k) clearance to BioSig for PURE EP, effectively giving the green light for commercialization of the cutting-edge system.
Some of the finest cardiac medical centers in the world are involved with PURE EP System, namely Mayo Clinic and Texas Cardiac Arrhythmia Institute. These venerable institutions have signed agreements with BioSig for the first commercial installations of the systems. 17 pre-clinical studies of PURE EP System included other upper echelon institutions, such as Mount Sinai and UCLA medical centers.
All of this research and preparation laid the groundwork for BioSig to conduct the First-in-Human study of PURE EP System, which is expected this quarter and will be hosted by Mayo Clinic and Texas Cardiac Arrhythmia Institute. This is a critical component of commercialization, with other leading centers expected to install the system and provide feedback subsequent to the human study. This information is part of a methodical approach that will allow BioSig to be properly positioned to ramp-up commercialization efforts in 2020.
To that point, results from the human trial is planned to be presented in May at Heart Rhythm Scientific Sessions, the largest event in BioSig’s industry, where the company can show-off its technology to a large community of potential customers.
Looking further down the road, Mayo Clinic has come on as a strategic collaborator to explore other indications and applications where PURE EP System could prove valuable in treating patients with different diseases and conditions.
BioSig also expanded its global footprint as it looks ahead to commercialization of PURE EP System and future innovation. New hubs were opened in Austin, Texas and Norwalk, Connecticut, joining the corporate headquarters in Santa Monica, California and rep office in Geneva, Switzerland.
Internally, the company is stronger than ever with the formation of an Advisory Board made up of seasoned veterans lending their expertise in finance, commercialization, government affairs, capital markets, clinical fields and strategic partners.
Backstopped by these developments and upcoming milestones, ROTH Capital Partners has given BSGM a “Buy” rating with a price target of $14.00 per share. After closing December 31, 2018 at $4.27, shares are up 19.9% so far in 2019 as of the close of trading on Friday, February 15, 2019, meaning ROTH sees a lot more upside to BioSig as commercialization of PURE EP System draws closer.
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