BioSig Allowed a U.S. Patent for PURE EP™ Simulator
Santa Monica, CA, June 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 U.S. Patent & Trademark Office allowed a U.S. patent application covering its electrophysiology simulator. The patent application number 15/103,278 entitled, "Systems and Methods For Evaluation of Electrophysiology Systems" was filed on June 9, 2016. The patent has not yet been published.
The allowed claims address a system for determining the accuracy of an EP recorder or a mapping system in the acquisition of cardiac signals. The simulator is designed to generate digital or analog simulated waveforms for electrocardiograms, unipolar or bipolar electrograms or cardiac activation maps. The PURE EP™ Simulator has been previously evaluated for a commercialization pathway by Health Research International, Cleveland, Ohio. This patent should help the Company move this system forward as a valuable additional technology in BioSig’s product pipeline to be marketed to U.S. hospital systems.
“We are delighted that our application for an electrophysiology simulator has been allowed by the U.S. Patent & Trademark Office. We believe that our system may become a valuable assistant in many research and clinical EP labs and may open doors to simulation-guided approaches to advance understanding of current arrhythmia therapies,” stated Kenneth L. Londoner, Founder, Chairman and CEO of BioSig Technologies, Inc.
The PURE EP™ 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.
Previously, BioSig announced that it was allowed 33 patent claims covering its PURE EP™ System. In the first half of 2019, BioSig successfully conducted first patient cases using its PURE EP™ System at the Texas Cardiac Arrhythmia Institute in Austin, TX, Greenville Memorial Hospital in Greenville, SC and Indiana University School of Medicine. These initial experiences suggested improved cardiac signal detection and fidelity compared to the data acquired using the existing recording devices in the EP lab.
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
Released June 6, 2019
