Second Center to Report Positive Clinical Experience with PURE EP(tm) System
Santa Monica, CA, April 16, 2019 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (NASDAQ: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address unmet needs for the electrophysiology (EP) marketplace, today announced that the Company successfully conducted patient cases using PURE EP(tm) System at Greenville Memorial Hospital, part of Prisma Health System. PURE EP(tm) System is the Company’s FDA cleared proprietary electrocardiogram and intracardiac signal acquisition and amplification system. The patient procedures were conducted by Andrew Brenyo, MD, FHRS.
“Over the last two days I have been amazingly surprised at the fidelity and utility of the BioSig’s PURE EP(tm) System. I made sure to use it in cases of the highest complexity and found in more than one circumstance the behavior of the system such that I could visualize waveform signals that I could not on my usual recording system. This led me towards a better understanding of a tachycardia event. I would count myself lucky to have had this eye-opening experience highlighting the signals that I have been missing,” commented Dr. Brenyo.
The PURE EP(tm) System was used during the procedures on patients with ischemic ventricular tachycardias, atrial fibrillation, PVC and atypical flutters, and conducted in parallel with Abbott’s EnSite Precision(tm) and Biosense Webster’s (Johnson & Johnson) CARTO(tm) 3 cardiac mapping systems.
“Dr. Brenyo’s use of the PURE EP(tm) System allowed us to see high frequency, low amplitude signals during more advanced arrhythmia cases and repeat procedures,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies. “Positive clinical experience with our technology in the medical centers with diverse patient profiles is key to a strong market positioning. We believe that more clinical experience, delivered by the next set of centers scheduled to use PURE EP(tm) System in the coming months, will allow us to gain additional insight into our key value proposition and deliver on our strategic goals in the second half of the year.”
Greenville Memorial Hospital is the second installation site for PURE EP(tm) System. On February 20, 2019, BioSig announced that it successfully conducted first patient cases using PURE EP(tm) System at the Texas Cardiac Arrhythmia Institute in Austin, TX under the leadership of Andrea Natale, MD, FACC, FHRS, FESC, Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center. This initial experience suggested improved cardiac signal detection and fidelity.
The Company released its Shareholder Letter earlier in February 2019, where it stated its intentions to present the results from the initial clinical cases and the early feedback from the use of the PURE EP(tm) System to a larger community of physicians during the Heart Rhythm Society event in May 2019.
The PURE EP(tm) 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 PURE EP(tm) System 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. The results of pre-clinical studies have been published in a number of journals, including The Journal of Innovations in Cardiac Rhythm Management.
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, independent Board of Directors, Los Angeles-based 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 novel cardiac signal acquisition and display system which is engineered to assist electrophysiologists in clinical decision-making during procedures to diagnose and treat patients with abnormal heart rates and rhythms. BioSig’s main 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.
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.
BioSig Technologies, Inc.
Executive Vice President
12424 Wilshire Blvd, Ste 745
Los Angeles, CA 90025
310-620-9320, extension 119
Source: BioSig Technologies, Inc.
Released April 16, 2019