BioSig’s PURE EP™ System Demonstrates Potential Time and Cost Savings at the 15th APHRS Scientific Session in Singapore
December 14 2022 - 8:00AM
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 its PURE EP™ System was featured in an
abstract presentation during the 15th Asia Pacific Heart Rhythm
Society (APHRS) Scientific Session in Singapore.
Results from the randomized study reveal the PURE EP™ System’s
potential to promote shorter procedural times and higher cost
savings during catheter ablations. The study enrolled 29 patients
with non-paroxysmal AF with post-ablation arrhythmia recurrence
(“redo AF”). The primary objective was to determine the difference
in procedural times when comparing ablations guided by PURE EP™’s
electrocardiogram (EGM) visualization to the conventional ECG
recording system. Study results demonstrated that the PURE EP™
System led to a mean procedure time reduction of 11.3 minutes.
Given that the mean cost of operating room time is approximately
$37 per minute1, the procedural time savings demonstrated by the
PURE EP™ System suggest potential cost savings of approximately
$418.10 per procedure. While this suggests that PURE EP™ might
promote shorter procedural times, further studies are
underway.
The abstract titled, “Reduced Time of Redo Atrial Fibrillation
Ablation Procedures with PURE EP™ Recording System for ECG/EGM
Visualization: A Randomized Study,” was presented as a poster
presentation by Dr. G. Joseph Gallinghouse, Cardiac
Electrophysiologist at St. David’s Medical Center in Austin,
TX.
“With over 75,000 AF ablations performed in the US each year2
the ability to demonstrate that PURE EP™ may reduce procedure times
resulting in potential healthcare cost savings is a landmark
milestone for the overarching value proposition of our technology,”
said Gray Fleming, Chief Commercialization Officer, BioSig
Technologies, Inc. “We believe a hospital can generate a meaningful
return on investment in the first year of ownership of a PURE EP™
System. Additional studies demonstrating compelling clinical
and economic value of the PURE EP™ System are in motion and we are
looking forward to sharing these insights with the EP and
healthcare community in the near future.”
APHRS 2022 represents the Company’s first abstract presentation
at an international conference. It also marks the first
physician-sponsored presentation unveiling clinical data from the
Company’s REDO AF Sub Study, initiated in July
2021. [ClinicalTrials.gov Identifier: NCT04964440].
About APHRS The APHRS is a leading
non-profit organization that represents medical, allied health, and
science professionals specializing in cardiac rhythm disorders in
the Asia-Pacific region. The annual Asia Pacific Heart Rhythm
Society (APHRS) is a premier event featuring industry workshops and
a core scientific program delivered by international and regional
speakers.
About BioSig Technologies BioSig
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.3
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) market conditions and the
Company’s intended use of proceeds; (ii) the geographic, social and
economic impact of COVID-19 on our ability to conduct our business
and raise capital in the future when needed; (iii) our inability to
manufacture our products and product candidates on a commercial
scale on our own, or in collaboration with third parties; (iv)
difficulties in obtaining financing on commercially reasonable
terms; (v) changes in the size and nature of our competition; (vi)
loss of one or more key executives or scientists; and (vii)
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. Kawasaki K. Megan, Cleary J. David, Correa de Sa D. Daniel,
Calame R. Susan, Dillon M. Christopher, Tsai H. Mitchell, (2019)
Abstract 9552: Understanding the Costs Associated with Cardiac
Ablations. Circulation, 2019;140:A9552.
www.ahajournals.org/doi/10.1161/circ.140.suppl_1.9552
2. "Late-Breaking Clinical Trials II: Innovation
Boulevard: Pulsed AF: First Human Experience and Acute
Procedural Outcomes Using A Novel Pulsed Field Ablation
System" [Friday, May 8, 2020 at 11:00 a.m. EST]
3. 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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