BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the
“Company”), a medical technology company committed to delivering
unprecedented accuracy and precision to intracardiac signal
visualization, announced today that Mayo Clinic-Phoenix—an existing
user of the PURE EP™ Platform—has upgraded to the Platform’s
subscription model to gain immediate access to the Company’s latest
technological advancements in cardiac arrhythmia identification.
Harnessing the power of automation, PURE EP™’s latest software
features debut unique algorithms that unlock signal data for
electrophysiologists conducting even the most challenging ablation
procedures.
- Automatic Tachycardia Characterization (ATC) alerts
electrophysiologists to heart conduction patterns that may be
difficult to detect with the naked eye or that might warrant
further evaluation.
- Near-Field Tracking (NFT) monitors changes in the local
unipolar electrogram to provide real-time tissue feedback that
assists electrophysiologists as they make their final
determinations between healthy and scarred tissue for lesion
placement during an ablation.
"Our commitment to innovation and delivering exceptional patient
care drives our ongoing collaboration with BioSig,” said Hicham El
Masry, M.D., FHRS, Cardiac Electrophysiologist at Mayo
Clinic-Phoenix. “The integration of PURE EP™'s advanced software
features further reinforces our dedication to providing the best
possible healthcare solutions for our patients. We look forward to
the positive impact this partnership will have on our cardiac
procedures."
Mayo Clinic-Phoenix is ranked as the number one hospital in
Arizona, according to the U.S. News and World Report. Within the
specialty of cardiology, heart, and vascular surgery, the
institution is ranked in the top one percent of hospitals
nationwide (33 out of 4,515 hospitals).1
With Mayo Clinic-Phoenix and Cleveland Clinic now part of the
PURE EP™ subscriber community, two out of the top three ranked
health systems in cardiology, heart, and vascular surgery have
embraced PURE EP™.2
“We are thrilled to roll out our newest, most innovative
software to one of our company’s longest standing partners. As we
continue building out PURE EP™’s software suite, customers will
have the flexibility to purchase and add enhancements that meet
their needs,” commented Gray Fleming, Chief Commercial Officer of
BioSig. “By removing the burden of ownership and maintenance, we’re
putting the latest PURE EP™ developments in physician’s hands as
they unfold—unlocking the full potential of the electrophysiology
lab.”
Leveraging full-spectrum signal data has significantly reduced
ablation procedure times. Initial evidence suggested potential
savings of approximately $418.20 per procedure using PURE EP™'s
clear signals.3 Recent independent research by Cleveland Clinic
shows PURE EP™'s unique unipolar capabilities may cut procedure
times by up to 66%.4 With the global cardiac ablation market set to
exceed $14.5 billion by 2032,5 PURE EP™ offers substantial cost
savings and efficiency gains for hospitals, improving patient
outcomes through shorter procedures.
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 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 87% 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.
- Rankings & Ratings: Mayo Clinic-Phoenix. (2023, August).
U.S. News & World Report’s 2023-24 Best
Hospitals. https://health.usnews.com/best-hospitals/area/az/mayo-clinic-6860019
- Rankings & Ratings: Mayo Clinic. (2023, August). U.S. News
& World Report’s 2023-24 Best
Hospitals. https://health.usnews.com/best-hospitals/area/mn/mayo-clinic-6610451
- Gallinghouse, G.J., et al. (2022, November). PP-069-2-AF
Reduced Time of Redo AF Ablation With PURE EP Recording System: A
Randomized Study. Asia Pacific Heart Rhythm Society Scientific
Session [Abstract]. Singapore. (55).
https://tinyurl.com/BioSigAbstractAPHRS
- 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
- Al-Ahmad, et al. (2022, September) Evaluation of a novel
cardiac signal processing system for electrophysiology procedures:
The PURE EP 2.0 study.
https://onlinelibrary.wiley.com/doi/10.1111/jce.15250
- Cardiac Ablation Market. (2022, December). Global Market
Insights.
https://www.gminsights.com/industry-analysis/cardiac-ablation
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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