BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the
“Company”), a medical technology company delivering unprecedented
accuracy and precision to intracardiac signal
visualization, announced today the release of new software
features for the PURE EP™ Platform. The novel software features
were successfully leveraged for the first time during patient cases
conducted at the Kansas City Heart Rhythm Institute
(“KCHRI”).
Building on the FDA-cleared platform's proprietary combination
of advanced hardware and software, PURE EP™'s latest software
debuts two new features designed to harness the power of
automation, empowering electrophysiologists to identify subtle
details in cardiac arrhythmias that are difficult to observe with
the naked eye. The new features include:
- Near-Field Tracking (NFT) automatically
monitors changes in the local unipolar electrogram to provide
real-time tissue feedback and characterization; helpful information
for electrophysiologists as they make their final determinations
between healthy and scarred tissue for lesion placement.
- Automatic Tachycardia Characterization (ATC)
now alerts electrophysiologists in real-time to subtle changes in
tachycardia conduction patterns, complementing its existing
capability to monitor tachycardia rate changes that may warrant
further evaluation.
“With these new features, we enhance PURE EP™’s existing
capabilities, providing electrophysiologists with pure,
unadulterated cardiac signals in real time,” said Zachary Koch,
Principal Advisor of Product Development at BioSig. “These latest
features demonstrate our commitment to provide full-spectrum
visibility and data analysis of intracardiac signals to enhance
clinical decision-making.” The latest software upgrade builds on
existing foundation of PURE EP™ proprietary features which
include:
- PURE ZONE™ visibility of intracardiac signals
at high frequency and low amplitude, which provides valuable
information for electrophysiologists on heart tissue
characterization and localization.
- High Frequency Algorithm (HFA) automatically
detects and eliminates radiofrequency interference (signal
components >200 hertz), directing electrophysiologists’ focus on
what truly matters—vital intracardiac signals.
- TRUSOURCE™ Analysis & Report for real-time
detailed case insights.
Research initiated and led by Cleveland Clinic's world-class
physician faculty was presented at this year’s Heart Rhythm Society
meeting. The findings validate PURE EP™’s ability to deliver clear,
stable, trusted unipolar signals, suggesting the potential of an
optimized radiofrequency technique to treat arrhythmias. The
physician-initiated data revealed a 66% reduction in procedure time
while maintaining accuracy, and enhancing precision.1,2,3
Given the mean cost of operating room time is approximately $37
per minute, PURE EP™ demonstrated potential cost savings of
approximately $418.10 per procedure, per data presented at the Asia
Pacific Heart Rhythm Society Scientific Session in 2022.4
Considering electrophysiologists conduct an estimated 75,000
ablations annually in the U.S.,5 PURE EP™, by extension, presents
potential healthcare cost savings of over $30 million a year.
“PURE EP™’s capabilities have already been instrumental in
improving our workflows,” said Dhanunjaya “DJ” Lakkireddy, M.D.,
Executive Medical Director at the KCHRI. “The incorporation of
advanced features with PURE EP™ uphold our commitment to quality
patient care while also introducing a higher level of automation,
unlocking time efficiencies and more effective utilization of
resources in laboratory procedures.”
With this latest software update, and the use of the NFT
feature, additional reimbursement options are applicable when
associated services are medically necessary. 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 study6 recently published in the
Journal of Cardiovascular Electrophysiology6, 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.7
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) 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
2) 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
3) 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
4) 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
5) Mansour, M., et al. (2017, February). The Impact of First
Procedure Success Rate on the Economics of Atrial Fibrillation
Ablation. JACC: Clinical Electrophysiology, 3(2), 129–138. doi:
10.1016/j.jacep.2016.06.002.
https://pubmed.ncbi.nlm.nih.gov/29759385/
6) 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
7) 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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