Santa Monica, CA, March 28, 2018 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (OTCQB: BSGM) announced that the Company has filed 510(k) application to the U.S. Food and Drug Administration (FDA) for its first product, PURE EP(TM) System.
PURE EP System is a surface electrocardiogram and intracardiac multichannel recording system that acquires, processes and displays high fidelity cardiac recordings required during electrophysiology studies and catheter ablation procedures. The non-invasive PURE EP System is categorized as a Class II medical device according to the FDA and is subject to 510(k) performance standards and regulatory controls. The PURE EP System aims to minimize noise and artifacts and acquire high fidelity cardiac signals, which will potentially increase these signals’ diagnostic value, and offer improved accuracy and efficiency of the EP studies and related procedures.
Atrial fibrillation is the most common arrhythmia currently affecting 33.5 million people worldwide, with 6.1 million people in the U.S. Atrial fibrillation increases the risk of stroke by 4 to 5 times and contributes to ca. 750,000 hospitalizations per year. The current market of EP is currently estimated at $4.6 billion and growing at 10.5% rate annually.
Between 2015-2018 BioSig has performed eleven pre-clinical studies at Mayo Clinic in Rochester, MN and one study at Mount Sinai Hospital in New York, NY. The results of these studies have been documented in seven peer reviews, including the Journal of Innovations in Cardiac Rhythm Management (JICRM) and the Journal of the American College of Cardiology (JACC).
In October 2017 BioSig announced the results of a nationwide survey of electrophysiologists. Survey respondents rated all six features of the PURE EP System as being ‘Very Helpful’ for their ablations, emphasizing overall ‘noise’ reduction and improved signal clarity/accuracy as key benefits.
In November 2017 BioSig engaged California based Sherpa Technology Group as its intellectual property advisors.
“Our Company’s mission is to improve the standards of patient care worldwide. Submission of 510(k) application is a major milestone, which, once completed, will allow us to bring the PURE EP System to the EP community. Patient-centred innovation is at the heart of what we do, and we will continue to work rigorously to address unmet clinical needs,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.
About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology 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, Los Angeles-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System. The technology has been developed to address an unmet need in a large and growing market.
The Company’s first product, 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 the prevalent and deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP System.
Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.