BioSig’s PURE EP™ System Highlighted in the Journal of Atrial Fibrillation & Electrophysiology
December 06 2022 - 8:30AM
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the
“Company”) an advanced digital signal processing technology company
delivering unprecedented accuracy and precision to intracardiac
signal visualization with its proprietary PURE EP™ System, today
announced that a peer-reviewed case report titled, “Confirmation of
Acute Pulmonary Vein Reconnection with The Utilization of PURE EP’s
High-Frequency Algorithm (HFA)” has been published in the Journal
of Atrial Fibrillation & Electrophysiology. The publication is
available electronically via the JAFIB-EP open access digital
journal.
Co-authored by Roy Chung, MD, Clinical Cardiac
Electrophysiologist at Cleveland Clinic and Zachary Koch, CCDS,
CEPS, Clinical Director at BioSig Technologies, Inc., the case
report describes a 65-year-old patient with a medical history of
symptomatic and persistent atrial fibrillation undergoing pulmonary
vein isolation (PVI). PURE EP™’s HFA signal analysis was observed
alongside the simultaneous signal anno New Primary Logo New Primary
Logotation produced by a 3D mapping system. PURE EP™’s real-time
HFA identified early local activation, providing a clear and
precise location that served as the primary target for ablation
therapy during the procedure. Results from the case study support
the efficacy of PURE EP™’s HFA in identification of the pulmonary
vein gap compared to the inferior annotation produced by the 3D
mapping system.1
“This case study adds to the growing pipeline of clinical
evidence validating the PURE EP™ System as an essential and
valuable technology for today’s EP lab—particularly for challenging
cases,” commented Gray Fleming, Chief Commercial Officer, BioSig
Technologies, Inc. “We believe that these findings, along with
other clinical applications we continue to explore in collaboration
with the Cleveland Clinic, demonstrate PURE EP™’s ability to set
new standards in the field of electrophysiology.”
In October, the Company signed a master research agreement with
Cleveland Clinic to explore expanded applications for its digital
signal processing technology.
The proprietary High Frequency Algorithm (HFA)—a proprietary
feature found only in the PURE EP™ System—reclaims the specificity
lost within the blended data of the traditional bipolar wave. HFA
enables electrophysiologists to apply specific near-field frequency
data to the treatment of even the most complex arrhythmias. By
removing unnecessary distractions, the PURE EP™ System with HFA
preserves the value of cardiac signals and delivers clear,
actionable insights to today’s electrophysiologist.
About BioSig TechnologiesBioSig Technologies is
an advanced digital signal processing technology company bringing
never-before-seen insights to the treatment of cardiovascular
arrhythmias. Through collaboration with physicians, experts, and
healthcare leaders across the field of electrophysiology (EP),
BioSig is committed to addressing healthcare’s biggest priorities —
saving time, saving costs, and saving lives.
The Company’s first product, the PURE EP™ System, an FDA 510(k)
cleared non-invasive class II device, provides superior, real-time
signal visualization allowing physicians to perform insight-based,
highly targeted cardiac ablation procedures with increased
procedural efficiency and efficacy.
The PURE EP™ System is currently in a national commercial launch
and an integral part of well-respected healthcare systems, such as
Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic,
and Kansas City Heart Rhythm Institute. In a blinded clinical
study recently published in the Journal of Cardiovascular
Electrophysiology, electrophysiologists rated PURE EP™ as
equivalent or superior to conventional systems for 93.6% of signal
samples, with 75.2% earning a superior rating.
The global EP market is projected to reach $16B in 2028 with a
11.2% growth rate.2
Forward-looking StatementsThis 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 Koch W. Zachary; Chung, Roy (2022), Confirmation of Acute
Pulmonary Vein Reconnection with Case Report: The Utilization of
PURE EP’s High-Frequency Algorithm (HFA), Journal of Atrial
Fibrillation & Electrophysiology, Volume 15, Issue 6, Nov 2022.
https://jafib-ep.com/journal/volume-15-issue-6-nov-2022/confirmation-of-acute-pulmonary-vein-reconnection-with-the-utilization-of-pure-eps-high-frequency-algorithm-hfa/
2 Global Market Insights Inc. March 08, 2022.
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
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