BioSig Commences Clinical Trial Enrollment for PURE EP System
November 21 2019 - 7:52AM
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the
“Company”), a medical technology company developing a proprietary
biomedical signal processing platform designed to improve signal
fidelity and uncover the full range of ECG and intra-cardiac
signals, today announced that the Company commenced its first
clinical trial for its PURE EP™ System.
Texas Cardiac Arrhythmia Research Foundation (TCARF) in Austin,
Texas, is the first institution to conduct patient cases under the
clinical trial titled, “Novel Cardiac Signal Processing System for
Electrophysiology Procedures (PURE EP 2.0 Study)”. Eight patient
enrollments were achieved during the first week of the trial. The
data collected during the trial is planned to be submitted for
abstract consideration at leading industry events throughout 2020,
including The Heart Rhythm Scientific Sessions in May 2020.
“Our first clinical trial is an inflection point for our
Company, and we are pleased to initiate it with Texas Cardiac
Arrhythmia Institute at St. David’s Hospital in Austin, Texas,”
commented Kenneth L. Londoner, Chairman and CEO of BioSig
Technologies, Inc.
The Shareholder Letter issued by the Company on November 14,
2019 announced several upcoming installations of the Company’s PURE
EP(tm) System, including Mayo Clinic Jacksonville, FL, which is
also expected to take part in the clinical trial. This allows the
Company to commercialize its product in the rapidly growing $4.6
billion electrophysiology market, and the Company believes trial
data may play an important role in advancing broader commercial
adoption across the universe of medical centers providing catheter
ablation treatments.
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 EPTM
System. The technology has been developed to address an unmet need
in a large and growing market.
The Company’s first product, PURE EPTM 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 EPTM System in August 2018.
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 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.
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x119
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