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BioSig Installs its Signal Processing Technology for Arrhythmia Care at a Leading Hospital in Boston

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BioSig Technologies announces the installation of a PURE EP™ System at Beth Israel Deaconess Medical Center, increasing its installed centers to 16. The evaluation is expected to begin in December 2021. To date, over 71 physicians have conducted more than 1,600 cases with the system, indicating growing adoption. Clinical data shows a 75% improvement in intracardiac signal quality. With 33 million people affected by atrial fibrillation globally, BioSig aims to capitalize on this significant market through its innovative technology.

Positive
  • Installation of PURE EP™ System at Beth Israel Deaconess Medical Center, expanding the network to 16 centers.
  • Over 1,600 patient cases completed with the PURE EP™ System, indicating strong clinical interest.
  • Published study showing 75% improvement in signal quality, supporting the effectiveness of the product.
Negative
  • None.

Latest installation follows a steady rise in patient cases conducted with the PURE EP™ System

Westport, CT, Nov. 08, 2021 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (Nasdaq: BSGM) ("BioSig" or the "Company"), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it is installing a PURE EP™ System for an evaluation at the Beth Israel Deaconess Medical Center (BIDMC) in Boston, MA. This new evaluation agreement brings the Company up to 16 installed centers. Procedural cases are expected to commence in early December at this renowned medical center.

Beth Israel Deaconess Medical Center is a world-class teaching hospital of Harvard Medical School. It is part of Beth Israel Lahey Health, a new healthcare system that brings together academic medical centers and teaching hospitals, community and specialty hospitals, and more than 4,000 physicians, and 35,000 employees.

“Harvard’s scientific and clinical legacy in cardiology is appreciated worldwide.  Drs. Mark Josephson and Dr. Peter Zimetbaum provided the original inspiration for launching this technology and it is exciting to be able to bring our platform to this original site of conception. It is a true privilege to be able to work with some of the best clinician-educators at Beth Israel and Harvard Medical School, and we have no doubt that this clinical collaboration will lead to impactful results both for our clinical and commercial strategies and for the broader field,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

To date, over 71 physicians have completed over 1600 patient cases with the PURE EP™ System. The Company is in a focused commercial launch of the PURE EP™ System in the Northeast, Texas, and Florida. The technology is in regular use in some of the country’s leading centers of excellence, including Mayo Clinic, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, and New York Presbyterian / Weill Cornell Medical Center.

Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™ signals over conventional sources.

One in 18 Americans suffers from a cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 20501. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually2.

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

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) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and 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.




1 Top 10 Things You should Know About Heart Rhythm; Scripps Health.

2 Managing Atrial Fibrillation; Lisa Eramom MA, Medical Economics Journal, February 25, 2019, Volume 96, Issue 4



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