BioSig Increases Installation Footprint Adding St. Elizabeth’s Medical Center to Roster of Premium Medical Institutions Utilizing the PURE EP System
September 13 2021 - 8:00AM
BioSig Technologies, Inc. (Nasdaq: BSGM) ("BioSig" or the
"Company"), a medical technology company commercializing an
innovative signal processing platform designed to improve signal
fidelity and uncover the full range of ECG and intra-cardiac
signals, today announced the Company would be installing a PURE
EP(tm) System for evaluation at St. Elizabeth’s Medical Center
in Boston, MA. The Company initiated this new evaluation program
under the leadership of Michael Orlov, M.D., aiming to assess the
PURE EP(tm) System during a series of physiologic pacing
procedures. Physiologic pacing is an emerging pacing technique
designed to activate the normal cardiac conduction system and
synchronize contraction of the ventricles. This approach to pacing
the heart has demonstrated improved clinical and hemodynamic
benefits beyond standard pacing techniques.
“We are pleased to grow our clinical presence in Boston and
collaborate with Dr. Orlov on this expanded use of the PURE EP(tm)
System. The physiologic pacing procedure could benefit from
advanced signal information to optimize lead placement and improve
procedural outcomes. We look forward to combining our cardiac
signal acquisition technology with advanced pacing therapies to
treat more cardiac rhythm disorders,” commented Kenneth L.
Londoner, Chairman, and CEO of BioSig Technologies, Inc. “This
marks our 13th hospital partner, and we remain on track to achieve
our 2021 goals of targeted market expansion.”
The PURE EP(tm) is an FDA 510(k) cleared non-invasive class II
device that aims to drive procedural efficiency and efficacy in
cardiac electrophysiology. To date, over 60 physicians have
completed over 1300 patient cases with the PURE EP(tm) System
across twelve clinical sites.
The Company recently completed its first multi-centered,
prospective clinical trial and presented preliminary clinical data
during the annual Heart Rhythm 2021 convention in July in Boston,
MA.
The Company is in a focused commercial launch of the PURE EP(tm)
System in the Northeast, Texas, and Florida and is in regular use
in some of the country’s leading centers of excellence, including
the Mayo Clinic in Rochester, MN, and St. David’s Medical Center in
Austin, TX.
One in 18 Americans suffers from a cardiac arrhythmia. Atrial
fibrillation is the most common arrhythmia type, affecting over 33
million people worldwide, including over 6 million in the U.S. The
number of people suffering from atrial fibrillation is expected to
reach 8-12 million by 20501. According to the Centers for
Disease Control and Prevention (CDC), atrial fibrillation causes
more than 750,000 hospitalizations in the U.S. each year, resulting
in approximately $6 billion in healthcare spending annually2.
About St. Elizabeth's Medical Center St.
Elizabeth's Medical Center, a Boston University Teaching Hospital,
offers patients access to some of Boston's most respected
physicians and advanced treatments for a full range of medical
specialties, including family medicine, cardiovascular care, women
and infants' health, cancer care, neurology care, and orthopedics.
The 308-bed tertiary care facility is part of Steward Health
Care.
About BioSig Technologies BioSig Technologies
is a medical technology company commercializing a proprietary
biomedical signal processing platform designed to improve signal
fidelity and uncover the full range of ECG and intra-cardiac
signals (www.biosig.com).
The Company’s first product, PURE EP(tm) System is a
computerized system intended for acquiring, digitizing, amplifying,
filtering, measuring and calculating, displaying, recording, and
storing electrocardiographic and intracardiac signals for patients
undergoing electrophysiology (EP) procedures in an EP
laboratory.
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) the geographic, social and
economic impact of COVID-19 on our ability to conduct our business
and raise capital in the future when needed, (ii) our inability to
manufacture our products and product candidates on a commercial
scale on our own, or in collaboration with third parties; (iii)
difficulties in obtaining financing on commercially reasonable
terms; (iv) changes in the size and nature of our competition; (v)
loss of one or more key executives or scientists; and (vi)
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.
1 Top 10 Things You should Know About Heart Rhythm; Scripps
Health.
2 Managing Atrial Fibrillation; Lisa Eramom MA, Medical
Economics Journal, February 25, 2019, Volume 96, Issue 4
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
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