Santa Monica, CA, Nov. 14, 2017 (GLOBE NEWSWIRE) -- 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.
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.
Contact: Natasha Russkina BioSig Technologies, Inc. VP Business Development & Corporate Finance nrusskina@biosigtech.com +41 (0) 76 823 7527
