Santa Monica, CA, May 06, 2019 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the electrophysiology (EP) marketplace, today announced that the Company conducted patient cases using the PURE EP(tm) System at Indiana University School of Medicine. The cases were conducted under the leadership of Prof. John M. Miller, M.D. and Dr. Mithilesh K. Das, MBBS.
“We found that the clarity of the signals made a great difference in the confidence with which we could continue applying ablation energy to an abnormal pathway that was in the region of the normal conduction system; BioSig technology allowed us to see a clear signal from the normal conduction pathway during ablation that was obscured by noise on our standard recordings. It was a jaw-dropper!” commented Prof. M. Miller, M.D.
A recognized expert in catheter and intraoperative mapping and ablation of ventricular tachyarrhythmias, Dr. Miller initially received his training in cardiovascular and cardiac electrophysiology under the tutelage of Dr. Mark Josephson at the Hospital of the University of Pennsylvania. He joined the Indiana University School of Medicine as a full professor of medicine to lead its clinical cardiac electrophysiology group in 1998. Since then, he has continued to be an active clinician, educator, author and clinical investigator. Prof. Miller has authored more than 200 scientific publications and has served on many national committees. He oversees a nationally regarded, rigorous fellowship training program in cardiac electrophysiology at the IU School of Medicine.
The PURE EP(tm) System was used during procedures on patients with atypical flutter, atrioventricular nodal reentry tachycardia (AVNRT), atrial fibrillation, SVT, PVC and a rare case of dual septal pathway.
“We are honored to be able to work with Dr. Miller and Indiana University as one of the first centers of excellence to conduct patient cases with our PURE EP(tm) System. We have tremendous respect for Dr. Miller and his team at IU School of Medicine for their collective achievements in clinical electrophysiology and look forward to building upon their findings during this pivotal phase,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies.
Indiana University School of Medicine was the third center to receive the PURE EP(tm) System. Previously, BioSig announced that it successfully conducted first patient cases using the PURE EP(tm) System at the Texas Cardiac Arrhythmia Institute in Austin, TX in February 2019 and Greenville Memorial Hospital in Greenville, SC in April 2019. These initial experiences suggested improved cardiac signal detection and fidelity.
BioSig is exhibiting at the Heart Rhythm Society’s 40th Annual Scientific Sessions on May 8-11, 2019 at Moscone Center in San Francisco, CA. BioSig conducted seventeen pre-clinical studies using the PURE EP(tm) System to date, the results of which have been published in a number of journals. BioSig’s latest manuscript on pre-clinical research entitled “Evaluation of Real Time Catheter Tissue Contact using Unipolar Intracardiac Signal Morphology” has been recently accepted to the 41st International Engineering in Medicine and Biology Conference.
The PURE EP(tm) System is indicated as 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 under the supervision of licensed healthcare practitioners who are responsible for interpreting the data.
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.
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) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) 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.
Natasha Drapeau BioSig Technologies, Inc. Executive Vice President 12424 Wilshire Blvd, Ste 745 Los Angeles, CA 90025 ndrapeau@biosigtech.com 310-620-9320
