BioSig Announces Physician-Initiated Research Protocol at The Kansas City Heart Rhythm Institute
Led by Dhanunjaya DJ Lakkireddy, MD., the study will investigate expanded applications for the signals acquired by BioSig’s PURE EP(T.M.) System
Westport, CT, July 21, 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 that Dhanunjaya DJ Lakkireddy, MD, Medical Director for the Kansas City Heart Rhythm Institute, will initiate a research protocol analyzing the signals acquired by the PURE EP(T.M.) System during Radiofrequency (RF) ablation.
The single center study at Overland Park Regional Medical Center and officially registered with clinicaltrials.gov [NCT05464537], will include 30 participants with paroxysmal atrial fibrillation (AF) undergoing pulmonary vein isolation (PVI). The study aims to build on previous research that claims the loss of the negative component of the unipole during PVI can serve as a tool for achieving durability with overall lesser procedure time and no significant increase in adverse events. AF recurrence will be examined at 6 and 12-months post-procedure.
“Positive results from this study could substantially emphasize the value of the PURE EP System in the EP lab by decreasing procedural cost specific to both time and product spend,” commented Gray Fleming, Chief Commercialization Officer, BioSig Technologies, Inc.
Dr. Lakkireddy is a board-certified, fellowship-trained cardiologist specializing in electrophysiology. With more than 15 years of experience, he has specialized interest in complex arrhythmia management for all types of arrhythmias conditions. The Company recently announced that Overland Park Regional Medical Center (OPRMC) has signed an agreement to purchase the Pure EP(T.M.) System under the terms of the Company's new leasing program. This represents BioSig's first national purchasing agreement since announcing The Company's new commercial structure and clinical support teams.
About The Kansas City Heart Rhythm Institute
The Kansas City Heart Rhythm Institute brings the highest quality clinical care, research and arrhythmia education to Kansas City and the surrounding area. With eight practicing Electrophysiologists, the Kansas City Heart Rhythm Institute has three Electrophysiology clinics in the greater Kansas City area as well as outreach locations in four major hospitals.
About Overland Park Regional Medical Center
Overland Park Regional Medical Center is a licensed 343-bed facility offering acute medical care services to patients. Cardiovascular programs at OPRMC have received certification from The American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). OPRMC's clinician and physician experts excel in a wide range of interventional cardiology practices and complex electrophysiology procedures, including Complex Arrhythmia Management (AF, VTACH, PVC, SVT), Convergent AF Ablation (with C.T. surgeon and E.P.), Leadless Pacemakers & Internal Cardiac Defibrillators, and Left Atrial Appendage Closure.
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(T.M.) 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(T.M.) was engineered to address the limitations of existing EP technologies by empowering physicians with superior signals and actionable insights.
The Company is in a national commercial launch of the PURE EP(T.M.) 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(T.M.) 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(T.M.) signals over conventional sources.
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) market conditions and the Company’s intended use of proceeds, (ii) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (iii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iv) difficulties in obtaining financing on commercially reasonable terms; (v) changes in the size and nature of our competition; (vi) loss of one or more key executives or scientists; and (vii) 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.
Andrew Ballou BioSig Technologies, Inc. Vice President, Investor Relations 55 Greens Farms Road, 1st Floor Westport, CT 06880 aballou@biosigtech.com 203-409-5444, x13
Released July 21, 2022
