BioSig Technologies, Inc. to Receive 15 Units of PURE EP™ System from Manufacturer for Commercial Installation

BioSig Technologies, Inc., a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the electrophysiology (EP) marketplace, announced that it will be receiving 15 units of its PURE EP™ System from its manufacturer in preparation for the Company’s limited market release later this month.

BioSig recently added 3 hospitals, including two distinguished academic centers, to its list of medical institutions that have agreed to receive the device in 2019 to evaluate the PURE EP™ System. These new units, which are being provided at BioSig’s expense on a short-term basis, will be used for a series of short- and long-term (up to 180 days) external evaluation studies, which form an essential part of a targeted commercial launch. Currently, management is engaged with other facilities throughout the country. These initial shipments are part of the Company’s stated plans following the recent successful completion of initial clinical cases at the Texas Cardiac Arrhythmia Institute in Austin, TX, Greenville Memorial Hospital in Greenville, SC, and Indiana University School of Medicine.

“We are extremely pleased to be on track and schedule with the initial installments of our technology, as we move into the commercialization phase of our strategic business model,” stated Mr. Kenneth L. Londoner, Founder, Chairman and CEO of BioSig Technologies, Inc. “The feedback from hospitals, clinics and physicians has been very encouraging. We have been actively adding to our clinical, commercial, engineering and operational teams in anticipation of the expansion of working with leading medical centers in the U.S. We look forward to initiating commercialization as we establish ourselves as a market innovator in the medical technology sector.”

PURE EP™ System is an FDA-approved proprietary signal acquisition and processing technology. The device 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. The device aims to minimize noise and artifacts and acquire high-fidelity cardiac signals. Improving fidelity of acquired cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and related procedures.

BioSig recently announced that it has been added to the Russell 3000 Index and was allowed 33 patent claims covering its PURE EP™ System.

About BioSig Technologies
BioSig Technologies is a medical technology company developing a proprietary biomedical signal processing platform designed to improve the electrophysiology (EP) marketplace (www.biosig.com). Led by a proven management team and a veteran Board of Directors, BioSig Technologies is preparing to commercialize its PURE EP™ System. The technology has been developed to address an unmet need in a large and growing market.
The Company’s first product, PURE EP™ 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. The system is indicated for use under the supervision of licensed healthcare practitioners who are responsible for interpreting the data. This novel cardiac signal acquisition and display system is engineered to assist electrophysiologists in clinical decision-making during electrophysiology procedures in patients with abnormal heart rates and rhythms. BioSig’s ultimate goal is to deliver technology to improve upon catheter ablation treatments for the prevalent and potentially deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and received FDA 510(k) clearance for the PURE EP™ System in August 2018.