LOS ANGELES, CA March 23, 2015 / BioSig Technologies (OTCQB: BSGM), a medical device company developing PURE EP(TM) a proprietary technology platform designed to improve the clinical outcomes of electrophysiology (EP) procedures, today announced Jay Millerhagen has been appointed Vice President, Clinical Affairs. Mr. Millerhagen has over 25 years of experience developing, evaluating and launching new medical technologies and therapies.
Most recently, Mr. Millerhagen served as Vice President, Clinical Affairs and Market Development for RESPICARDIA, Inc., in Minnetonka, MN. At RESPICARIDIA, he led all clinical operations, staffing and site management leading to the pivotal IDE trial of the fully implantable remedē System for the treatment of Central Sleep Apnea.
Prior to joining RESPICARDIA, Mr. Millerhagen served in positions of increasing responsibility at St Jude Medical in St. Paul, MN. From 2011 to 2012, as Vice President, Clinical Affairs, he lead a team of 20 in-house clinical personnel and a team of 22 field clinical engineers to execute a series of clinical studies targeted at addressing cardiac arrhythmias. He oversaw the team that completed enrollment in five major IDE (investigational device exemption) trials most of which were completed several months ahead of schedule. From 2007 to 2010, Mr. Millerhagen served as Senior Director, Clinical Affairs. He was the first to design, submit and secure approval of an IDE from the FDA for a novel open irrigated ablation catheter based indication for Atrial Fibrillation.
For eighteen years (1989-2007) Mr. Millerhagen held senior positions at Boston Scientific Corporation. Joining the company as a Manager of New Product Planning, he co-authored a patent on a pacemaker based on hemodynamic performance. Promoted to Director, he oversaw Brady Marketing, Heart Failure Research and Development, Heart Failure Marketing and from 2004 to 2007, he served as Director, Business Alliance Marketing with industry giants Johnson & Johnson and GE Healthcare. During his tenure at Boston Scientific he directed numerous areas of cardiovascular health.
Mr. Millerhagen received his MBA from the University of St. Thomas, St. Paul, MN, earned an MS in Exercise Physiology from St. Cloud State University, St. Cloud, MN, and a BA in Physiology and Psychology from Concordia College, Moorhead, MN. He has been member of the Heart Rhythm Society (NASPE), the Heart Failure Society of America, and the American College of Sports Medicine.
Greg Cash, BioSig CEO, said, "We are delighted Jay will lead our clinical affairs program at BioSig Technologies. He has a long and very successful career in cardiovascular devices, their application, clinical development, and designing strategic plans as products move toward for FDA approval. The entire company will certainly benefit from his extensive experience."
Jay Millerhagen stated, "I am very pleased to join BioSig Technologies. Having spent my career at leading cardiovascular companies, I see many opportunities to create and build the Company's clinical affairs strategy and team. The entrepreneurial atmosphere was evident from the first time I met with BioSig. I look forward to the challenges and successes we will all encounter."
Kenneth L. Londoner, Co-founder and Executive Chairman added: "BioSig has always been focused on bringing leading talent to the Company. We have a world class, independent Board of Directors and now we are building out a world class management team. I am excited to welcome Jay to the team and look forward to his many contributions in making the PURE EP system the future gold standard in the EP Lab."
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 guidance 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) approval 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.
Forward-Looking Statements
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.