Westport, CT, July 15, 2019 (GLOBE NEWSWIRE) —
1) New units to be prepped for next phase of targeted commercial launch strategy
2) Company includes 3 additional hospitals to its list of medical institutions for delivery in 2019 to demonstrate the technology
3) Proprietary device is designed to record and display high-fidelity cardiac signals with enhanced visualizations tools
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 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.
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.
CONTACT: Natasha Drapeau BioSig Technologies, Inc. Executive Vice President 54 Wilton Road, 2nd floor Westport, CT 06880 [email protected] 310-620-9320
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