BioSig Secures Cash, Prepares For PURE EP 510(k) Application

Over the past month, BioSig Technologies, Inc. (BSGM) raised roughly $1.5 million in cash through the sale of nearly one million shares of common stock to accredited investors, which included participation from management, at $1.50 per share. Participants in the offering also recieved warrants to purchase one half a share at $1.50 that if exercised, would raise an additional $750,000. Additional details on the financing can be found in the SEC 8K filing.

The new cash will help BioSig complete the necessary 510(k)-enabling work currently underway on PURE EP prior to the filing expected in the second quarter 2017. This work position PURE EP for market approval in the third quarter 2017. Below is a quick update outlining the company's progress.

Significant Recent Progress

BioSig has been aggressively pursuing development of PURE EP over the past several years with proof-of-concept, validation, and preclinical studies largely funded by management. Advisory relationships for both the technology development and validation studies exist with leading medical centers in the U.S, including the Texas Cardiac Arrhythmia Institute in Austin, the Cardiac Arrhythmia Center at UCLA, Mount Sinai Medical Center in New York, Beaumont Medical Center in Detroit, Case Medical Center in Cleveland, the Heart Rhythm Institute in Oklahoma City, and Mayo Clinic in Rochester, Minnesota. 

Initial system concept validation took place at the Cardiac Arrhythmia Center at UCLA with the assistance of Dr. Kalyanam Shivkumar in June 2013. Subsequent preclinical studies have been performed at the Mayo Clinic in Rochester, Minnesota under the direction of Dr. Samuel J. Asirvatham and the Mount Sinai Hospital in New York City under the direction of Dr. Vivek Reddy. The main objective of these studies was to demonstrate the clinical potential of the PURE EP System.  

Much of this data has been presented and published at major medical conferences throughout 2016. For example, in March 2016, at the 13th Annual IDSS meeting, researchers from the Mayo Clinic presented pre-clinical data from three canine studies comparing BioSig's PURE EP System to a traditional FDA cleared recording system, System-A, which was later revealed to be CardioLab by GE Healthcare. Analysis of the two systems was done head-to-head, simultaneously, in real-time, and demonstrate that PURE EP offers enhanced recording and improved signal acquisition and differentiation compared to GE's market leading system. 

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