Experienced Medical Device Executive to Lead Company Through FDA Clearance Process
MINNEAPOLIS, May 11, 2015 (GLOBE NEWSWIRE) -- BioSig Technologies (OTCQB:BSGM), a medical device company developing PURE EP(TM) a proprietary technology platform designed to improve the clarity of clinical signals available for electrophysiology (EP) procedures, today announced Michele Chin-Purcell, Ph.D., will be joining the company as Vice President, Quality and Regulatory Affairs. Dr. Chin-Purcell has over twenty years of experience in Research, Quality and Regulatory Affairs in the life sciences.
Most recently, Dr. Chin-Purcell served as Senior Director, Regulatory Affairs at Spinal Modulation in Menlo Park, CA. At Spinal Modulation she led the PMA submission process for the Axium® Neurostimulator System for treatment of chronic neuropathic pain.
Prior to joining Spinal Modulation, Dr. Chin-Purcell served as Senior Director, Regulatory Affairs for the Atrial Fibrillation division of St Jude Medical in St. Paul, MN. From 2008 to 2010, she was Executive Director of the Department of Research Integrity and Oversight at the University of Minnesota.
For fourteen years (1995 to 2008), Dr. Chin-Purcell held management positions in Quality, Regulatory Affairs and Compliance at Guidant, which was acquired in this timeframe by Boston Scientific Corporation. Starting in 1995, she served as a Manager of Regulatory Affairs, responsible for PMA and IDE submissions to and approvals from the Food and Drug Administration. From 1999 to 2001, she was quality manager at the company's manufacturing facility in Clonmel, Ireland. From 2001 to 2008, Dr. Chin-Purcell served as Director of Global Compliance for the company.
Dr. Chin-Purcell received her Ph.D. and MS in Mechanical Engineering from the University of Minnesota and her BS in the same discipline from the University of California, Berkley.
Greg Cash, BioSig CEO, said, "We are thrilled Michele will lead our quality and regulatory affairs activities at BioSig Technologies. She has a long and successful career in medical device quality systems, regulatory affairs and corporate compliance. Michele has extensive experience in successfully obtaining FDA clearance for complex medical devices. We look forward to her expertise in the formulation and submission of our 510(k) for the PURE EP System."
Michele Chin-Purcell stated, "I am delighted to join BioSig Technologies. Having spent my career at leading cardiovascular companies and research institutions, I look forward to drawing on that experience to build the company's quality system and to obtain FDA clearance to market for the PURE EP System. The cardiac electrophysiology market is a vibrant and growing market, very open to new technologies and I am excited to join the talented team at BioSig."
About BioSig Technologies
BioSig is a medical device company that has developed a proprietary technology platform designed to greatly improve the $3 billion electrophysiology (EP) marketplace(1) (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Los Angeles-based BioSig is preparing to commercialize its PURE EP System.
PURE EP is a next-generation surface electrocardiogram and intracardiac multichannel recording and analysis system designed to assist electrophysiologists in making clinical decisions in real-time by acquiring and displaying high-fidelity cardiac signal recordings and providing clarity of data which may be used to guide the EP's in identifying ablation targets - areas of tissue to destroy that otherwise create a heart rhythm disturbance (arrhythmia).
Analysts 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(1) - making it one of the fastest growing medical device segments. Just in the US, the number of Atrial Fibrillation (AF) and Ventricular Tachycardia (VT) arrhythmia ablations is forecast to grow at 10.5 percent from 2012 to 2017(2).
BioSig intends to seek FDA 510(k) clearance for the PURE EP System. The Company has already achieved proof of concept validation through UCLA EP & Animal Labs, and is collaborating with several of the nation's most prestigious cardiac arrhythmia centers including Texas Cardiac Arrhythmia Institute, UCLA Cardiac Arrhythmia Center, and Mayo Clinic.
This release includes forward-looking statements. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, ability to obtain financing, regulatory approvals, competition and marketplace demand. More information, and BioSig risk factors, are set forth in its filings with the SEC. BioSig assumes no obligation to publicly update or revise its forward-looking statements.
(1) Electrophysiology Devices Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 – 2019
(2) HRI 2013 "Global Opportunities in Medical Devices & Diagnostics" report; triangulation of multiple sources; *AF includes left atrial tachycardia, left WPW, left atrial flutter.