BioSig Announces Completion of PURE EP™ System Installation at New Medical Center
BioSig Technologies has commenced operations with its PURE EP™ System at Deborah Heart and Lung Center in New Jersey, marking a significant advancement in its clinical trials. This initiative aims to evaluate the effectiveness of the system in capturing intracardiac signals, crucial for electrophysiology procedures. Led by Dr. Raffaele Corbisiero, the trials are particularly timely due to the COVID-19 pandemic's impact on cardiovascular health. BioSig also expands its clinical study sites, now including prestigious institutions like Massachusetts General Hospital and UPenn.
- Initiation of clinical operations with the PURE EP™ System at Deborah Heart and Lung Center.
- Expansion of clinical trial sites to include Massachusetts General Hospital and Hospital of the University of Pennsylvania.
- Risks associated with the impact of COVID-19 on business operations and capital raising.
- Challenges in manufacturing and obtaining financing on commercially reasonable terms.
First Patient Cases with PURE EP System Conducted at Deborah Heart and Lung Center
Westport, CT, Oct. 29, 2020 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the “Company”), a medical technology company developing a proprietary 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™ System and started conducting patient cases at Deborah Heart and Lung Center in Browns Mills, New Jersey.
PURE EP™ System evaluation and clinical data collection is being conducted under the leadership of Raffaele Corbisiero, M.D.
“We are pleased to commence our clinical operations at Deborah Heart and Lung Center. As an innovative and rapidly growing company, we are excited to have physicians at Deborah not only utilize our technology, but also contribute to its advancement. Given COVID-19’s detrimental effects on cardiovascular health, this relationship cannot come at a more important time,” commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.
“Intracardiac signals are the foundation of everything we do in EP, but we can't treat what we don't see. I am impressed by our early experience with PURE EP™ showing more of the cardiac signals we want to see,” commented Raffaele Corbisiero, M.D., Deborah Heart and Lung Center.
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 and Mayo Clinic Florida Campus in Jacksonville, Florida. The Company recently added Massachusets General Hospital and the Hospital of the University of Pennsylvania to its clinical sites.
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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