BioSig Technologies' PURE EP System: Innovation for the $4 Billion Electrophysiology Market

MINNEAPOLIS, MN, July 28, 2016 /PRNewswire/ – Throughout the past two decades, catheter ablation for atrial fibrillation (AF) and ventricular tachycardia (VT), two conditions characterized by irregular heartbeat, has transitioned from a relatively unproven procedure to a common and important strategy for treating these complex arrhythmias.  The Centers for Disease Control estimates that AF alone, affects as many as 6.1 million Americans, generating about $6 billion in direct and $26 billion in indirect costs.
Because catheter ablation is now a class I recommendation for AF in drug refractory patients and class II recommendation as a front-line treatment for AF, procedural volumes are increasing rapidly.  This has created a great market opportunity for medical device maker BioSig Technologies, Inc. (OTCQB: BSGM), underscored by the cardiac electrophysiology (EP) marketplace growing at a 12.1% compound annual growth rate, representing the fastest growing segment of cardiology.
Even with the advances in ablation procedures, the next evolution in technology is necessary to improve patient outcomes and contain costs.  Due to a dearth of companies with innovative technologies to address the opportunity in a $4 billion market, premium valuations are being placed upon elite companies in the industry.  This is exemplified by major acquisitions in the past 18 months, including Stryker Corp. agreeing to pay defibrillator maker Physio-Control International for $1.28 billion; Abbott buying Topera for $350 million and agreeing to pay $25 billion for St. Jude Medical; Medtronic spending $272 million for Cardio Insight; and AtriCure buying nContact for $149 million.
BioSig Technologies (OTCQB:BSGM) is an emerging player in the EP space with its PURE EP™ System, a surface electrocardiogram (ECG) and intracardiac multichannel recording and analysis system developed to assist electrophysiologists in making clinical decisions in real-time, albeit diagnostic or during an ablation procedure.  BioSig has methodically developed PURE EP™ System by building a impressive management and advisory staff comprised of industry and finance experts and through collaborations and partnerships with some of the world’s leading EP institutions.
BioSig’s PURE EP™ System is designed to improve upon today’s devices used in AF and VT ablation procedures by using proprietary technology that, amongst other things, detects and displays high-fidelity cardiac signals that the company believes are currently undetectable with other recording devices, and reduces electrical noise to provide physicians with more precise cardiac signal data in real-time.  The technology, which has been refined in studies at Texas Cardiac Arrhythmia Institute, Mayo Clinic, Mount Sinai and UCLA with data presented at world-renowned conferences, has the potential to shorten procedure time and reduce the necessity for repeated procedures that are frequent with today’s devices.
PURE EP™ System is a case of a truly disruptive technology that BioSig intends to apply to bring to market via a 510(k) pathway with the Food and Drug Administration in the first half of 2017.  On Tuesday morning, the company provided shareholders with a comprehensive update on the status of development and strategic plan for PURE EP™ System, including ongoing research at Mayo Clinic, statistics on the market opportunity and an overview of the highly relevant experience of the leadership team.  BioSig also detailed a recent $4.5 million private placement, in which insiders including members of the management and board of directors purchased $630,000 of BSGM stock as a demonstration of their conviction in the future of the company.
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