(FinancialPress) — Today, arrhythmia patients have more effective options than ever for treating conditions such as atrial fibrillation (AF), atrial flutter (AFL), supra ventricular tachycardia (SVT) and ventricular tachycardia (VT). Pills can often be effective for early stages AFL and even help with chronic AF to a degree, while cardiac ablation procedures have become a staple in treatment protocols. Science and technology have come a long way for the benefit of patients, but arrhythmia solutions are by no means perfect, which is where companies like BioSig Technologies (BSGM) are looking to make the next big step forward in effective therapies.
Challenges still abound the conditions, evidenced by many patients requiring more than one ablation procedure and many still failing to realize the complete disappearance of the arrhythmia. This could be underpinned by current electrophysiological (EP) recording systems used in the ablations best serving AFL and SVT, arrhythmias that are characterized by large amplitude, low-frequency signals, which are more easily seen with today’s technology.
The more complex arrhythmias, like AF and VT, are characterized by low amplitude, high-frequency signals, which highlight shortcomings of current EP recording and video systems by failing to give the physician the best view possible of electrical signals. This explains why 3D anatomical mapping is often the approach of choice to guide the ablations, even though it does a poor job at providing clarity on the durability of a lesion in tissue causing the problem.
That’s where BioSig hopes to bridge a substantial gap in ablation procedures with its PURE EP, a proprietary system that blocks out noise, provides high frequency and low amplitude information. Ultimately, this provides electrophysiologists fully defined signals from the pulmonary vein, a critical factor in successful ablation procedures.
As BioSig works towards an FDA marketing authorization via the 510(k) pathway to enter the $4.6 billion EP market this year, the Santa Monica, CA-based company is taking the necessary steps to shore-up its fundamentals in preparation for the commercial launch of the PURE EP System.
On Tuesday, BioSig said it partnered with Charles Austin and JK Advisors to scale up operational activities by leveraging Austin’s more than 25 years of experience in medical devices, pharmaceuticals and consumer products. Austin held several senior leadership positions at healthcare juggernaut Johnson & Johnson, including Company Group Chairman for Ethicon Surgical Care and Worldwide President for Ethicon Endo-Surgery. Most recently, he was Corporate VP, Global Supply Chain at J&J and a member of the J&J Management Committee, where he was responsible for over 60,000 associates at 130 sites around the world while overseeing over 500 external manufacturers, over $22 billion in direct spend and supported more than $70 billion in sales.
“BioSig has impressed us with a strong value proposition and support of leading centers of excellence in the industry. I’m delighted to join the BioSig team at this important time and contribute my knowledge to take the company to the next level,” Austin said in a statement announcing his appointment.
Austin coming on board came just six days after Steven Chaussy assumed the role of Chief Financial Officer at BioSig. Chaussy, whom BioSig CEO Ken Londoner described as “supporting BioSig from the very beginning of our journey,” has a successful track record in driving profitability and expansion across three decades of providing services as a consultant and serving as CFO of public and private companies.
Those appointments bookended news that BioSig completed a private placement that raised $4.51 million through the issuance of approximately 3 million shares at $1.50 per share and a half warrant with a 3-year expiration at a cash exercise price of $1.50. The raise, completed at price points above the current share price speaks volumes to the confidence and long-term vision of investors that Londoner categorized as building “the foundation of our shareholder base,” investments that will be integral to BioSig meeting its goal of a commercial launch later this year.
Less than two weeks into the new year, BioSig is making all the right moves to set 2018 as an inflection point for its company and potentially as a paradigm shifter benefiting the EP space and the quality of life for AF and VT sufferers everywhere.
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