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BioSig Announces New Evaluation Agreement for its PURE EP System with Cleveland Clinic

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BioSig Technologies, Inc. (NASDAQ: BSGM) announced a 60-day evaluation agreement with Cleveland Clinic for its PURE EP(TM) System, enhancing electrophysiology by improving intracardiac signal fidelity. The evaluation follows the induction of a new commercialization team and aligns with the company's national rollout strategy. Over 75 physicians have utilized this technology in over 2500 patient cases, indicating significant clinical interest. The PURE EP(TM) System demonstrated a 75% improvement in signal quality according to a recently published multi-center study.

Positive
  • 60-day evaluation agreement with Cleveland Clinic for the PURE EP(TM) System.
  • The evaluation supports the national rollout strategy, showcasing the technology's potential.
  • Over 75 physicians and 2500 patient cases demonstrate growing clinical acceptance.
  • Published study shows a 75% overall improvement in signal quality from the PURE EP(TM) System.
Negative
  • None.

Leading Center of Excellence will participate in a 60-day evaluation of The Company’s signal processing technology

Westport, CT, June 22, 2022 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”) a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, today announced it has entered an evaluation agreement for its PURE EP(TM) System with the Cleveland Clinic.

The evaluation agreement marks the first since BioSig inducted a new commercialization team. Consistent with The Company’s stated national rollout strategy, Cleveland Clinic will participate in a 60-day evaluation of BioSig’s PURE EP(TM) System. The Company recently announced that is has restructured its clinical support and installation teams to streamline and accelerate the pathway from product evaluation to adoption.

“We are excited to include Cleveland Clinic as an evaluation center for the Pure EP System. We look forward to working alongside their physicians to demonstrate the superior signal quality that can be achieved on even the most difficult arrhythmias,” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc. 

Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. As a leader in arrhythmia treatment and diagnosis, Cleveland Clinic medical centers include state-of-the-art electrophysiology laboratories, world-class physicians and researchers, and the latest cutting-edge technologies and protocols deployed for the treatment of heart abnornmalities. To learn more, visit clevelandclinic.org

 

To date, over 75 physicians have completed over 2500 patient cases with the PURE EP(TM) System. The Company is in a national commercial launch of the PURE EP(TM) System. The technology is in regular use in some of the country’s leading centers of excellence, including Mayo Clinic, and Texas Cardiac Arrhythmia Institute at St. David’s Medical Center.

Clinical data acquired by the PURE EP(TM) System in a multi-center study at centers of excellence including Texas Cardiac Arrhythmia Institute at St. David’s Medical Center  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(TM) signals over conventional sources.

 

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(TM) System, is a novel signal processing and acquisition platform designed to extract advanced diagnostic and therapeutic data that enhances physician workflow and increases throughput. PURE EP(TM) was engineered to address the limitations of existing EP technologies by empowering physicians with superior signals and actionable insights.

 

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.


FAQ

What is the recent collaboration between BioSig Technologies and Cleveland Clinic?

BioSig Technologies announced a 60-day evaluation agreement with Cleveland Clinic for its PURE EP(TM) System.

What are the benefits of the PURE EP(TM) System according to the latest study?

The PURE EP(TM) System showed a 75% improvement in intracardiac signal quality and achieved a 93% consensus among blinded reviewers.

How many patient cases have utilized the PURE EP(TM) System?

Over 2500 patient cases have been completed with the PURE EP(TM) System.

What is BioSig Technologies' strategy following the recent evaluation agreement?

The agreement aligns with BioSig's national rollout strategy and follows the induction of a new commercialization team.

What does the publication of the multi-center study signify for BioSig Technologies?

The publication validates the efficacy of the PURE EP(TM) System in improving signal fidelity in electrophysiology.

BioSig Technologies, Inc.

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