BioSig Technologies, Inc. (OTCQB: BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has engaged Tiffini Wittwer as Chief Regulatory and Compliance Officer for the upcoming regulatory clearance of PURE EP(TM) System.
BioSig Technologies, Inc. (OTCQB:BSGM), a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has engaged Tiffini Wittwer as Chief Regulatory and Compliance Officer for the upcoming regulatory clearance of PURE EP(TM) System.
Mrs. Wittwer brings to BioSig over 15 years of experience in FDA regulatory affairs on behalf of public and private companies, most notably Trice Medical, Inc., Embrella Cardiovascular, Inc. (acquired by Edwards Lifesciences in 2011) and Cardica, Inc. During her career, Mrs. Wittwer has successfully delivered FDA 510(k) clearance of mi-eye(TM) and mi-eye 2(TM) visualization systems for Trice Medical and CE mark for Embrella Cardiovascular’s Embolic Deflector system for the use during transcatheter heart valve procedures. In 2016, the sales of transcatheter heart valves represented 55% of all net sales of Edwards Lifesciences.
“I am pleased to join BioSig during this important time in preparation for FDA 510(k) submission for the PURE EP System. Commercialization is fully dependent on the success of the steps leading to the regulatory clearance. I look forward to contributing my knowledge and expertise to ensure a timely submission of the Company’s 510(k) application with FDA,” commented Mrs. Wittwer.
“Tiffini has been recommended to us for her outstanding work with getting FDA approvals for cardiac medical devices. Her track record in successfully delivering regulatory clearances on both sides of the Atlantic is of significant value to the future commercialization of our technology both in the US and in Europe. We remain fully on track for the targeted launch of our commercial efforts in the second half of 2018,” said Kenneth Londoner, Chairman & Chief Executive Officer of BioSig Technologies, Inc.
About BioSig Technologies
BioSig Technologies is a medical device company developing a proprietary biomedical signal processing technology 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, Los Angeles-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 Company’s first product, PURE EP(TM) 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.
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.
Click here to connect with BioSig Technologies, Inc. (OTCQB:BSGM) for an Investor Presentation