Researchers from Cleveland Clinic will be presenting data from
three abstracts at Heart Rhythm 2023 that evaluated an optimized
radiofrequency ablation technique for pulmonary vein isolation
(PVI)—a type of ablation procedure used to treat atrial
fibrillation (AF)—compared to the existing standard, the Ablation
Index™. Researchers used BioSig Technologies, Inc. (NASDAQ: BSGM)
proprietary PURE EP™ Platform for real-time tissue-specific
feedback to achieve equal lesion quality and dimension in a third
of the time as conventional methods that rely on surrogate metrics.
Across all three studies, researchers compared the efficacy of
using unipolar signals to guide procedures to the current standard
of using an Ablation Index™. While there is a well-established body
of pre-clinical evidence validating the use of unipolar signals to
assess the efficacy of ablationi, capturing the unipolar signal has
been a challenge with existing processing platforms due to room and
radiofrequency noise saturation, wandering baseline, and improper
filtering.
“Despite past evidence suggesting validation and efficacy,
unipolar signals have not been used to help guide lesion and
ablation because of their susceptibility to interference from an
inherently noisy lab environment,” said Oussama Wazni, MD, MBA,
section head, cardiac electrophysiology and pacing at Cleveland
Clinic and lead researcher. "These studies suggest that the
preservation of raw cardiac signal enables the use of unipolar
signals to help guide ablations, while improving lesion precision
and reducing procedure time."
Zachary Koch, Principal Advisor of Product Development at BioSig
Technologies added, "We are thrilled to collaborate with the
Cleveland Clinic on these important studies that showcase the
potential of our PURE EP™ Platform to deliver unprecedented clarity
of the raw electrical signal. The PURE EP™ engineering enables
physicians to access the value of unipolar radiofrequency guidance,
established by previous studies. These new studies not only
validate previous findings, but also identify optimal duration and
placement of radiofrequency therapy at the tissue level, unlocking
potential time savings and improved efficacy.”
Topline findings from the three abstracts are below,
highlighting how this new approach improves radiofrequency ablation
techniques for atrial fibrillation treatment by reducing procedure
time, maintaining accuracy, and enhancing precision.
Reducing procedure timeThe first abstract,
entitled "Unipolar Signal Modification-Guided Radiofrequency
Ablation," conducted in swine and human models, found
radiofrequency ablation guided by unipolar signal modification
achieved identical transmural lesion dimensions for atrial tissue
thickness less than three millimeters, with ablation time being
significantly shorter (8 seconds) than ablation index-guided
procedures (24 seconds).
Maintaining accuracyThe second abstract,
entitled "Feasibility of Unipolar Signal Guided Ablation in
Creating Contiguous Lines of Conduction Block: A Proof-of-Concept
Study," demonstrated that unipolar electrograms accurately placed
and spaced transmural lesions to prevent gaps, creating a
successful bidirectional block in four of the five swine models. A
single gap was left in the linear application of the fifth model
due to a misinterpretation of the unipolar EGM during pacing. In
this study, physicians were blinded to the 3D mapping system
traditionally used to measure lesion location and spacing and
relied entirely on unipolar morphology as seen on the PURE EPTM
Platform.
Enhancing precisionThe third abstract, entitled
“Comparison of Unipolar Electrogram Monitoring during
Radiofrequency Ablation in Viable and Ablated Myocardium: Loss of
the S-component” showed that unipolar electrogram monitoring can
differentiate between healthy and scarred tissue in both singular
isolated lesions and contiguous lesions that constitute an ablation
line. This information is critical to inform lesion placement in a
clinical setting where the lesion diameter can vary based on the
catheter orientation. Currently, 14.4 million Americans
suffer from cardiac arrhythmias. Atrial fibrillation, of which
paroxysmal atrial fibrillation is a subtype, is the most common
arrhythmia affecting as many as 6.1 million people in the US now
and expected 8-12 million by 2050. Atrial fibrillation increases
the risk of stroke 4 to 5-fold and contributes to ~750,000
hospitalizations per year. The direct cost of atrial fibrillation
is approximately $6 billion annually; adding other indirect costs
brings the total cost of atrial fibrillation to $26 billion.ii
The PURE EPTM Platform is a non-invasive platform designed to
aid electrophysiologists in acquiring high-quality cardiac signals
during electrophysiology (EP) procedures. It has received 510(k)
clearance from the U.S. Food and Drug Administration (FDA) and is
currently in use at several hospitals in the United States.
About The PURE EP™ PlatformThe PURE EP™
Platform is a unique combination of proprietary hardware and
software that enables the real-time acquisition of raw signal
data—absent of unnecessary noise or interference—allowing
physicians to make informed clinical decisions based on clear and
precise data. With the heightened visualization of active signals,
the PURE EP™ Platform is facilitating personalized patient care and
innovations in the field of electrophysiology. 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 PURE EP™
Platform is currently in a national commercial launch and an
integral part of well-respected healthcare systems, such as
Cleveland Clinic, Mayo Clinic, Texas Cardiac Arrhythmia Institute,
and Kansas City Heart Rhythm Institute.
About BioSig Technologies, Inc.BioSig
Technologies is an advanced medical 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 global EP market is
projected to reach $16B in 2028 with an 11.2% growth rate.i
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.
i Global Market Insights Inc. March 08, 2022.
i Bortone, A., Appetiti, A., et al., “Unipolar Signal
Modification as a Guide for Lesion Creation During Radiofrequency
Application in the Left Atrium”, September 18, 2013 at DOI:
10.1161/CIRCEP.113.000749.
ii MarketWatch Global Electrophysiology Device Market Could
Exceed $12.2 Billion By 2026. Definitive Healthcare, U.S. News
& World Report, Newsweek, and BioSig estimates.
For media inquiries:
Katie Freshwater
BioSig Technologies, Inc.
Vice President, Marketing
55 Greens Farms
Westport, CT 06880
kfreshwater@biosigtech.com
203-409-5444, x162
For investor relations:
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
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