BioSig Technologies, Inc. (NASDAQ: BSGM) ("BioSig" or the
"Company"), a medical technology company developing a proprietary
biomedical signal processing platform designed to improve signal
fidelity and uncover the full range of ECG and intra-cardiac
signals, today announced that an article titled, "Evaluation of a
novel cardiac signal processing system for electrophysiology
procedures: the PURE EP 2.0 study" has been published in the
Journal of Cardiovascular Electrophysiology and is available
electronically with open access as of September 23, 2021, via the
Wiley Online Library.
The PURE EP 2.0 study was conducted at three U.S. hospitals:
Texas Cardiac Arrhythmia Institute at St. David’s Medical Center,
Mayo Clinic Jacksonville, and Massachusetts General Hospital.
The manuscript is co-authored by Amin Al-Ahmad, M.D., FHRS,
Bradley Knight, M.D., FHRS, Wendy Tzou, M.D., FHRS, Robert
Schaller, D.O., FHRS, Omar Yasin, M.D, Deepak Padmanabhan, M.D.,
Jason Zagrodsky, M.D., FHRS, Mohammed Bassiouny, M.D., J David
Burkhardt, M.D., FHRS, Joseph Gallinghouse Jr., M.D., FHRS, Moussa
Mansour, M.D., FHRS, Christopher McLeod, MBChB, Ph.D., FHRS and
Andrea Natale, M.D., FHRS, the Principal Investigator of the study.
The independent, blinded reviewers were Bradley P. Knight, M.D.
(Northwestern University), Wendy Tzou, M.D. (University of
Colorado), and Robert Schaller, M.D. (University of
Pennsylvania).
Intracardiac signal data of clinical interest were collected
during 51 cardiac ablation procedures using the PURE EP™ System,
the signal recording system, and the 3D mapping system at the same
time stamps. The samples were randomized and subjected to blinded,
head-to-head evaluation by three independent electrophysiologists
to determine the overall quality and clinical utility of PURE EP™
signals when compared to conventional sources. Each reviewer
responded to the same (235) signal comparisons using a 10-point
rating scale.
Results showed 93% consensus across the blinded reviewers with a
75% overall improvement in intracardiac signal quality and
confidence in interpreting PURE EP signals over the signals from
conventional sources.
Further analysis of the responses from the blinded reviewers
showed an 83% (p-value <0.001) improved confidence when
interpreting complex multi-component signals, leading to a better
understanding of the catheter position in relation to the ablation
target. Additionally, there was a 73% (p-value <0.001) improved
visualization of small, fractionated potentials increasing the
proper analysis of scar and abnormal conduction tissue
characteristics.
“In order for any new medical technology to be widely adopted
and accepted, strong, prospective clinical study results are
necessary. The results from the PURE EP 2.0 study clearly validate
the clinical importance of our technology and position the Company
for continued growth and success. We are grateful for the
many physician investigators and research staff who participated in
this study and look forward to continuing our clinical work to
advance the field of electrophysiology and bioelectronic medicine,"
commented Kenneth L. Londoner, Chairman, and CEO of BioSig
Technologies, Inc.
To date, over 60 physicians have completed over 1400 patient
cases with the PURE EP™ System across thirteen clinical sites.
About BioSig Technologies BioSig Technologies
is a medical technology company commercializing a proprietary
biomedical signal processing platform designed to improve signal
fidelity and uncover the full range of ECG and intra-cardiac
signals (www.biosig.com).
The Company's first product, PURE EP (tm) System is a
computerized system intended for acquiring, digitizing, amplifying,
filtering, measuring and calculating, displaying, recording and
storing of electrocardiographic and intracardiac signals for
patients undergoing electrophysiology (EP) procedures in an EP
laboratory.
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.
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
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