Minneapolis, MN, Oct. 24, 2017 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has engaged Quintain Project Solutions LLC as the manufacturing project management leader for the PURE EP(TM) System.
Philadelphia-based Quintain Project Solutions LLC is a boutique consulting firm focused on providing strategic project management, risk management, process improvement, cost management, contract compliance and forensic project analysis to companies across several industries. The company’s Principal, Mark D. Steele, PE, CCP, an author of “Projects On Purpose”, is an experienced engineer and project management consultant with over 25 years of experience. Throughout his career, Mr. Steele has assisted clients with complex, critical projects ranging in size from a few million to a few billion dollars.
With proven project management expertise, Mr. Steele will lead the BioSig PURE EP manufacturing project team through the final testing, production, regulatory clearance and, finally, into production of initial commercial units.
“We are excited to be working with BioSig and its manufacturing partner, Minnetronix, during this critical time in preparation for FDA submission and commercialization. We will be assisting the Company every step of the way to ensure project success,” commented Mr. Steele.
“Mark has impressed everyone on our team with his ability to tackle a project, quickly identifying critical points that will allow him to effectively drive PURE EP product delivery to a successful completion. Quintain will be the point of interface for the Company and our contract manufacturer, Minnetronix, taking on the PURE EP verification and validation testing process. These test results provide critical data sets for the Company’s FDA submission,” said Kenneth Londoner, Chairman & Chief Executive Officer of BioSig Technologies, Inc.
About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary technology platform designed to improve the $4.6 billion electrophysiology (EP) marketplace (www.biosigtech.com). Led by a proven management team and a veteran, independent Board of Directors, Minneapolis-based BioSig Technologies is preparing to commercialize its PURE EP(TM) System. The technology has been developed to address an unmet need in a large and growing market.
The 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 deadly arrhythmias, Atrial Fibrillation and Ventricular Tachycardia. BioSig has partnered with Minnetronix on technology development and is working toward FDA 510(k) clearance for the PURE EP System.
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 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 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.