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BioSig Conducts First Patient Cases with PURE EP(tm) System at Memorial Hospital of South Bend, Indiana

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BioSig Technologies, Inc. (NASDAQ: BSGM) announced the installation and first patient cases of its PURE EP(tm) System at Memorial Hospital in South Bend, Indiana. The evaluation is led by cardiologists Vinod Chauhan, M.D., and Deepak Gaba, M.D. To date, over 450 cases have been conducted across seven clinical sites. The company has initiated commercial sales of the system, emphasizing the importance of addressing heart rhythm disorders, especially amid the COVID-19 pandemic. BioSig continues to expand its clinical operations in 2021.

Positive
  • Initiated commercial sales of the PURE EP(tm) System.
  • Over 450 patient cases performed by more than 30 physicians.
  • Expansion of clinical operations expected throughout 2021.
Negative
  • Risks associated with COVID-19 affecting business operations.
  • Potential difficulties in obtaining regulatory approval.
  • Uncertainties in manufacturing products on a commercial scale.

PURE EP(tm) system evaluation conducted under the leadership of Cardiologists Vinod Chauhan, M.D. and Deepak Gaba, M.D. Memorial Hospital is nationally recognized for its emphasis on innovation.

Westport, CT, Jan. 12, 2021 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that the Company installed its PURE EP(tm) System and conducted first patient cases at Memorial Hospital of South Bend, part of Beacon Health System, in South Bend, Indiana. 

PURE EP(tm) System evaluation is being conducted under the leadership of Vinod Chauhan, M.D. and Deepak Gaba, M.D.

“We are very pleased to commence our clinical operations at Memorial Hospital, an outstanding clinical site that is recognized nationally for its commitment to high-quality care and innovation. As we continue to learn more about the coronavirus and its detrimental effects on cardiovascular health, we realize that treating heart rhythm disorders has never been more important. We recently initiated commercial sales of the PURE EP(tm) System. Our team looks forward to helping as many physicians and patients as possible as we expand our clinical footprint and provide the infrastructure to achieve much more throughout 2021,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.

To date, more than 450 patient cases have been conducted with the PURE EP(tm) System by over 30 physicians across seven clinical sites. BioSig is currently conducting patient cases under the clinical trial titled “Novel Cardiac Signal Processing System for Electrophysiology Procedures (PURE EP 2.0 Study)” at Texas Cardiac Arrhythmia Research Foundation (TCARF) in Austin, Texas, Mayo Clinic Florida Campus in Jacksonville, Florida, and Massachusets General Hospital in Boston, MA. 


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 computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of 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. 

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FAQ

What is the PURE EP(tm) System by BioSig Technologies?

The PURE EP(tm) System is a biomedical signal processing platform designed to enhance signal fidelity for ECG and intra-cardiac signals.

Where was the PURE EP(tm) System first installed?

The first installation of the PURE EP(tm) System was at Memorial Hospital in South Bend, Indiana.

How many patient cases have been conducted with the PURE EP(tm) System?

Over 450 patient cases have been conducted with the PURE EP(tm) System to date.

Who leads the evaluation of the PURE EP(tm) System?

The evaluation is led by cardiologists Vinod Chauhan, M.D. and Deepak Gaba, M.D.

What are the risks associated with BioSig Technologies' operations?

Risks include impacts from COVID-19, manufacturing issues, regulatory approval uncertainties, and competition.

BioSig Technologies, Inc.

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