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BioSig’s Signal Processing System for Arrhythmia Care To Be Featured At The Kansas City Heart Rhythm Symposium

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BioSig Technologies announced its participation in the Kansas City Heart Rhythm Symposium on August 21-22, 2021, showcasing its PURE EP(tm) System. At the event, Dr. Amin Al-Ahmad will present findings from the PURE EP 2.0 trial to address challenges in electrophysiology labs. The PURE EP(tm) System has achieved FDA 510(k) clearance and has been utilized in over 1,260 patient cases across eleven clinical sites. The company aims to leverage its recent success to enhance procedural efficiency in heart rhythm management.

Positive
  • FDA 510(k) clearance for PURE EP(tm) System.
  • Participation in Kansas City Heart Rhythm Symposium to enhance visibility.
  • Clinical data from PURE EP 2.0 trial showcases product effectiveness.
  • Demonstrated interest with over 1,260 patient cases across eleven sites.
Negative
  • Reliance on ongoing clinical support from key physicians.
  • Uncertainty regarding future financing and regulatory hurdles.

A physician user from a leading medical center of excellence will present the technology and discuss recent clinical data

Westport, CT, Aug. 19, 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 it would participate in the Kansas City Heart Rhythm Symposium, due to take place on August 21-22, 2021 at the Overland Park Convention Center.

The Company’s clinical and commercial teams will host product demonstrations that will showcase the latest clinical data and the newest software features of its PURE EP(tm) System, the non-invasive class II device that aims to drive procedural efficiency and efficacy in electrophysiology.  The Company’s technology will also be featured in a presentation at the Technology Theater during the Symposium. 

The presentation titled “PURE EP(tm) - A New Standard in Signal Processing” will be conducted during the sessions beginning at noon on Saturday, August 21, 2021, at the Technology Theatre. Amin Al-Ahmad, M.D., a cardiac electrophysiologist at the Texas Cardiac Arrhythmia Institute and one of the most experienced users of BioSig’s PURE EP(tm) System, will speak about the ongoing challenges electrophysiology labs face today and how the PURE EP(tm) System addresses those long-standing limitations. The presentations will also feature the key findings and conclusions of the PURE EP 2.0 trial. The presentation will be made available on the Company’s website on Monday, August 23, 2021.

“We are pleased to participate in the Kansas City Heart Rhythm Symposium. Over the past several months, we have made significant progress, including a very strong response at the recent Heart Rhythm Society Convention in Boston. We’re looking forward to building on that momentum and showcasing the strength and differentiation of our technology. We would like to thank Dr. Amin Al-Ahmad for his continued clinical support and to Dr. Dhanunjaya Lakkireddy, the Symposium’s course director and current PURE EP(tm) user, for his leadership during this important industry event,” commented Olivier Chaudoir, Senior Director of Marketing at BioSig Technologies, Inc.

To date, 59 physicians have completed more than 1,260 patient cases with the PURE EP(tm) System across eleven clinical sites. The PURE EP(tm) System has been awarded FDA 510(k) clearance. The Company commenced a targeted commercial launch in 2020 and completed commercial sales to St. David’s HealthCare of Austin, Texas, an HCA Healthcare-owned hospital, and Mayo Foundation for Medical Education and Research.

Kansas City Heart Rhythm Symposium 2021
The Kansas City Heart Rhythm Symposium is an EP-focused medical education event for the neighboring four state regions. A variety of topics will provide specialists and generalists an update on the evolution of disease processes, diagnostic tools, therapeutic strategies, and ethical issues in the advancement of patient care.

The purpose of this symposium is to update medical practitioners in the greater Midwest region as well as nationally on the future of cardiac electrophysiology (EP) and new diagnosis and treatment guidelines in the care and management of patients with arrhythmias, heart failure, and other issues impacting the electrical system of the body. Participants will learn about advances in ablation techniques, device management, appropriate use criteria, and survey new developments in guidelines and recommendations. A review of clinical trials that have helped change the clinical practice of EP will also be held. Participants in this symposium will examine the latest trends in Left Atrial Appendage (LAA) treatment options and gain a greater understanding of anticoagulation and stroke prophylaxis. The unprecedented era that healthcare providers have faced during the COVID-19 pandemic has led to countless unanswered questions and forced clinicians and patients to adapt to the current environment. Evidence indicates that COVID-19 infection and its recovery period are associated with cardiac compromise. For example, between 9%-17% of hospitalized patients with COVID-19 have evidence of arrhythmias. (Chung 2021) As such, the diagnosis, management, and risk stratification of these complications will be discussed.

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, the 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. 


FAQ

What is the purpose of BioSig Technologies' participation in the Kansas City Heart Rhythm Symposium 2021?

BioSig Technologies aims to showcase its PURE EP(tm) System and discuss recent clinical data at the Kansas City Heart Rhythm Symposium.

Who will present at the Kansas City Heart Rhythm Symposium for BioSig Technologies?

Dr. Amin Al-Ahmad, a cardiac electrophysiologist, will present findings from the PURE EP 2.0 trial.

What is the PURE EP(tm) System?

The PURE EP(tm) System is a non-invasive class II medical device designed to improve procedural efficiency and efficacy in electrophysiology.

How many patient cases have been completed using the PURE EP(tm) System?

To date, 59 physicians have completed over 1,260 patient cases using the PURE EP(tm) System.

What recent clearance did the PURE EP(tm) System receive?

The PURE EP(tm) System has received FDA 510(k) clearance.

BioSig Technologies, Inc.

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