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™ System

Westport, CT, July 21, 2022 – BioSig Technologies, Inc., a medical technology company advancing electrophysiology workflow by delivering greater intracardiac signal fidelity through its proprietary signal processing platform, 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™ 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™ 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.

The Company's first product, PURE EP™ 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™ 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™ 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™ 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™ signals over conventional sources.