A New Age for Atrial Fibrillation Ablation: BioSig's PURE EP Enhanced Electrophysiology Recording System

BioSig Technologies (OTCQB:BSGM) is creating a new market segment with its PURE EP System, a surface electrocardiogram and intracardiac multichannel signal acquisition and analysis system, to overcome these obstacles.  The PURE EP System has been developed to provide a high resolution, high fidelity technology that minimizes noise without compromising signal quality.  The device is designed to acquire cardiac signals at levels the company believes are undetectable by any EP recording system marketed today, and provide visualization tools so clinicians can make more informed decisions in real-time during the procedure.  The aggregate benefits of the proprietary hardware and signal processing are designed to maximize ablation efficiency and minimize need for repeated procedures.
The concept for PURE EP was developed five years ago in collaboration with Texas Cardiac Arrhythmia Institute.  Since, BioSig has worked with some of the foremost cardiac arrhythmia centers in the country, including UCLA Health, Mount Sinai Medical Center in New York, UH Case Medical Center in Cleveland and Mayo Clinic in Rochester, Minnesota to develop PURE EP and conduct a series of pre-clinical trials.
Because PURE EP qualifies with the FDA as a Class II medical device, extensive clinical trials are not required.  A 510(k) marketing clearance creates a relatively short path to commercialization and only requires BioSig to show the device to be safe and substantially equivalent to another product on the market (predicate device).  BioSig intends to file its 510(k) application in the first half of 2017.
If approved for marketing, BioSig is entering into a large (estimated at approximately $4 billion currently) and growing EP market, with what could arguably be considered a better product.  In addition to other disruptive qualities, Dr. Samuel Asirvatham, a professor of medicine in the Mayo Clinic’s Division of Cardiovascular Diseases within the Department of Internal Medicine, noted in a BioSig presentation that, “[PURE EP’s] improved resolution may translate to better ability to pick up specific signals and relate them to specific structure and substrate.” He also added, “the display options are also more intuitive and flexible. For example, different filtering can be applied to the same signal and displayed as separate, simultaneous signals. Presently this is not possible with the existing systems to my knowledge.”
Analysts at Transparency Market Research forecast the global market for EP devices will grow at a 12.1 percent compound annual growth rate, from $2.5 billion in 2012 to $5.5 billion by 2019, making it one of the fastest growing medical device segments.  In the United States alone, the number of AF and VT arrhythmia ablations is forecast to grow at 10.5 percent from 2012 to 2017.
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