BioSig Technologies, Inc. (OTCQB:BSGM), a medical device company developing a proprietary platform designed to address an unmet technology need within the emerging electrophysiology (EP) marketplace, announced today that they have made significant progress towards commercialization of their proprietary PURE EP System. The PURE EP System is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms.
The Company recently received the first production units of the PURE EP System from its manufacturing partner. In addition to ongoing testing and development with current partners, BioSig has been demonstrating this system to select industry leaders. Additionally, they announced that Mr. Joseph W. Rafferty has joined BioSig Technologies and will serve as Chief Commercialization Officer. Joe adds more than 30 years of experience to BioSig and has assisted with the successful launch of a number of new technologies into the medical marketplace working for Johnson & Johnson, Boston Scientific, and CR Bard.
BioSig management is currently preparing a 510(k) submission to the Food & Drug Administration (FDA) for commercialization in the U.S., and planning its European regulatory process with the National Standards Authority of Ireland (NSAI) which serves as the Notified Body to obtain the CE Mark. CE marking is a mandatory conformity marking for certain products sold within the European Union.
Allied Market Research, projects that the global Electrophysiology Market is expected to reach $8.2 billion by 2022, recording a CAGR of 13.4% during the period 2016-2022. The market is driven primarily by growth in incidence of atrial fibrillation, one of the most common heart rhythm disorder or cardiac arrhythmia, and an aging baby boomer generation with high-risk of targeted diseases.
Mr. Kenneth Londoner, CEO & Chairman of BioSig Technologies, Inc. commented, “Management is confident that we established a strong foundation for future growth while completing the tasks required to achieve commercialization. Our novel technology, coupled with our strategic management hires and long standing clinical relationships have positioned us to bring our PURE EP System to the global EP market in 2018. Going forward, we will continue to establish and leverage strategic relationships that will assist in the development and sale of our proprietary systems to this vastly underserved market.”
About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary technology platform designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Minneapolis-based BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.
The PURE EP System is a novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main goal is to deliver technology to improve upon catheter ablation treatments for prevalent and deadly arrhythmias. BioSig has partnered with Minnetronix on technology development.
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