BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the
“Company”), a medical technology company delivering unprecedented
accuracy and precision to intracardiac signal visualization,
announced today a subscription model for its PURE EP™ Platform.
Cleveland Clinic—recently ranked as number one in the Nation for
cardiology, heart & vascular surgery by U.S. News & World
Report1—is first to sign an agreement to acquire the PURE EP™
Platform under the subscription model.
BioSig has made the move to a subscription model so that
electrophysiologists and cardiology departments can access the
latest features with the ability to customize the rich suite of
PURE EP™ software capabilities to suit their needs. The proprietary
combination of hardware and software empowers electrophysiologists
with real-time, ultra-pure, cardiac signal data, with the potential
to improve arrhythmia care and procedures.
“At BioSig, we aspire to be a true partner to the
electrophysiology community; constantly advancing our technology to
push the boundaries of signal hygiene, analysis, and data
application," said Gray Fleming, Chief Commercial Officer of
BioSig. “This subscription model expands access to PURE EP™’s novel
and configurable software features as they become available and
supports operational expenditure goals by optimizing case-by-case
and day-to-day department expenses, removing the burden of
ownership and maintenance.”
The agreement follows BioSig’s exhibition at the Heart Rhythm
Society 2023 (“HRS 2023”) in May, known for being the largest
gathering of heart rhythm professionals worldwide. During the
conference, research conceptualized and spearheaded by Cleveland
Clinic’s world-class physician faculty highlighted the PURE EP™
Platform’s ability to optimize ablation procedures. The data
compared the efficacy of PURE EP™’s unipolar signal guidance to the
current standard, the Ablation Index™ for radiofrequency ablation
procedures during pulmonary vein isolation. Topline findings from
the physician-initiated research revealed a 66% reduction in
procedure time while maintaining accuracy, and enhancing precision
during PVI.2,3,4
“Cleveland Clinic approached us with the idea to conduct
research evaluating the utility and impact of our novel signal
applications. A portion of this foundational research was
presented at HRS 2023, and we were excited to collaborate with
their world-class team of electrophysiologists,” commented Zach
Koch, Principal Product Advisor of BioSig. “With a rich history of
medical innovation and breakthroughs, Cleveland Clinic has piloted
many cutting-edge cardiovascular technologies that are recognized
as the standard of care today. We are proud to witness PURE EP™ in
use at their clinic and excited to see their commitment to
innovation continue as the first subscription-based customer,
unlocking the full spectrum of clinical, operational, and economic
benefits of the PURE EP™ Platform in a fully customizable
package.”
With a comprehensive suite of tools available through the
subscription model, the PURE EP™ Platform can deliver the latest
developments in electrophysiology to physicians as they emerge,
with the flexibility to add enhancements as desired. For more
information on how PURE EP™ can enhance arrhythmia identification
and laboratory workflows, visit BioSig.com.
About Cleveland Clinic
Since 1995, no hospital in the country has ranked higher than
Cleveland Clinic in cardiac care, earning the No. 1 ranking
in U.S. News & World Report’s “2023-24 Best
Hospitals.” The Sydell and Arnold Miller Family Heart, Vascular
& Thoracic Institute at Cleveland Clinic is one of the largest
cardiovascular practices in the U.S. Considered the #1 heart
center in the nation, patients travel from all 50 states and over
135 countries to receive the expert clinical care provided by
Cleveland Clinic. The medical center’s Cardiac Electrophysiology
& Pacing Section includes over 7 EP/Cath labs and a 2,000
square foot research facility.
Cleveland Clinic is a nonprofit multispecialty academic
medical center that integrates clinical and hospital care with
research and education. Located in Cleveland, Ohio, it was founded
in 1921 by four renowned physicians with a vision of providing
outstanding patient care based upon the principles of cooperation,
compassion, and innovation. Cleveland Clinic has pioneered
many medical breakthroughs, including coronary artery bypass
surgery and the first face transplant in the United States. Among
Cleveland Clinic’s 72,500 employees worldwide are more than 5,050
salaried physicians and researchers, and 17,800 registered nurses
and advanced practice providers, representing 140 medical
specialties and subspecialties. To learn more,
visit clevelandclinic.org.
About The PURE EP™ Platform
The PURE EP™ Platform serves physicians by enabling the
real-time acquisition of raw cardiac signal data—absent of
unnecessary noise or interference inherent in traditional
approaches. By leveraging a first-of-its-kind combination of
hardware and software, the PURE EP™ Platform is designed to deliver
unprecedented intracardiac signal purity that pushes the boundaries
of cardiac arrhythmia identification, diagnosis, and treatment.
In a blinded clinical study recently published in the
Journal of Cardiovascular Electrophysiology 5,
electrophysiologists rated PURE EP™ as superior to conventional
systems for 75.2% of signal samples, with 93.6% earning a rating of
equivalent or superior. Data presented at Heart Rhythm Society 2023
demonstrated the PURE EP™ Platform’s capacity to facilitate
ablations in a third of the usual time, reducing procedure time and
improving workflow efficiencies, without sacrificing accuracy,
precision, or efficacy.
The PURE EP™ Platform is currently in a national commercial
launch and an integral part of well-respected healthcare systems,
including Mayo Clinic, Texas Cardiac Arrhythmia Institute,
Cleveland Clinic, and Kansas City Heart Rhythm Institute.
About BioSig Technologies, Inc.
BioSig Technologies is a medical technology company focused
on deciphering the body’s electrical signals, starting with heart
rhythms. By leveraging a first of its kind combination of hardware
and software, we deliver unprecedented cardiac signal clarity,
ending the reliance on ‘mixed signals’ and ‘reading between the
lines.’ Our platform technology is addressing some of healthcare’s
biggest challenges—saving time, saving costs, and saving lives.
The Company’s product, the PURE EP™ Platform, an FDA 510(k)
cleared non-invasive class II device, provides superior, real-time
signal visualization allowing physicians to perform highly targeted
cardiac ablation procedures with increased procedural efficiency
and efficacy.
An estimated, 14.4 million Americans suffer from cardiac
arrhythmias, and the global EP market is projected to reach $16B in
2028 with an 11.2% growth rate.6
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.
References
1) Rankings & Ratings: Cleveland Clinic. (2023, August).
U.S. News & World Report’s 2023-24 Best Hospitals.
https://health.usnews.com/best-hospitals/area/oh/cleveland-clinic-6410670
2) Tabaja, C., et al. (2023, May). PO-01-200 Unipolar
Signal Modification-Guided Radiofrequency Ablation.
[Abstract]. Heart Rhythm 2023, New Orleans, LA. 20(5): S187.
https://doi.org/10.1016/j.hrthm.2023.03.576
3) Tanaka-Esposito, C., et al. (2023, May). PO-03-037
Feasibility of Unipolar Signal Guided Ablation in Creating
Contiguous Lines of Conduction Block: A Proof-of-Concept Study
[Abstract]. Heart Rhythm 2023, New Orleans, LA. 20(5):
S448-S449. https://doi.org/10.1016/j.hrthm.2023.03.985
4) Yavin, H., et al. (2023, May). PO-02-002 Comparison
of Unipolar Electrogram Monitoring during Radiofrequency Ablation
in Viable and Ablated Myocardium: Loss of the S-component
[Abstract]. Heart Rhythm 2023, New Orleans, LA. 20(5):
S324-325. https://doi.org/10.1016/j.hrthm.2023.03.762
5) Al‐Ahmad, A., et al (2021, September). Evaluation of a Novel
Cardiac Signal Processing System for Electrophysiology Procedures:
The PURE EP 2.0 Study. Journal of Cardiovascular Electrophysiology,
32(11), 2915–2922. https://doi.org/10.1111/jce.15250
6) Global Market Insights, Inc. (2022, March).
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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