Benzinga | Jul 13, 2021 02:31PM EDT

BigSig Technologies Reports Signed New Deal With Medical City North Hills In Texas For Clinical Evaluation Of Co.'s PURE EP Technology For Arrhythmia Care

BioSig Technologies, Inc. (NASDAQ:BSGM) ("BioSig" or the "Company"), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it has signed a new agreement with Medical City North Hills in North Richland Hills, Texas, for the clinical evaluation of its PURE EP(tm) technology for arrhythmia care.

Medical City North Hill is one of the area's leading providers of cardiac care that includes ablations for atrial fibrillation, atrial flutter and supraventricular tachycardia, and other types of electrophysiology studies. As part of the evaluation agreement, Medical City North Hills clinical representatives will provide on-site training and assist with data collection and interpretation and workflow customization for every physician and all electrophysiology lab staff members to ensure optimal user experience.

Texas is one of the three strategic areas that BioSig is focused on in the targeted commercial launch phase, alongside the Northeast and Florida. BioSig's PURE EP(tm) technology is currently installed at several clinical sites in Texas, including Houston Methodist Hospital, the highest-ranked facility for adult cardiology and heart surgery in Texas, according to the U.S. News & World Report1. Medical City Healthcare is one of the region's largest, most comprehensive health care providers and includes 16 hospitals in the Dallas-Fort-Worth area.

"We are pleased to start conducting patient cases at another outstanding hospital in Texas," commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc. "With over 400 electrophysiology labs, the state of Texas is home to some of the greatest cardiac care facilities in our country. We look forward to collaborating with the physician team at Medical City North Hills as we continue to advance and expand upon our clinical and commercial strategy."

The PURE EP(tm) is an FDA 510(k) cleared, non-invasive class II device that aims to drive procedural efficiency and efficacy in electrophysiology. More than 50 physicians have completed over 1000 patient cases with the PURE EP(tm) System across twelve clinical sites.

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 that acquired multiple PURE EP(tm) units for clinical use across their Minnesota, Florida and Arizona campuses.

One in 18 Americans suffers from cardiac arrhythmia. Atrial fibrillation is the most common arrhythmia type, affecting over 33 million people worldwide, including over 6 million in the U.S. The number of people suffering from atrial fibrillation is expected to reach 8-12 million by 20502. According to the Centers for Disease Control and Prevention (CDC), atrial fibrillation causes more than 750,000 hospitalizations in the U.S. each year, resulting in approximately $6 billion in healthcare spending annually3.