BioSig Completes Enrollment in the PURE EP 2.0 Clinical Study
April 13 2021 - 9:32AM
- 51 patients undergoing elective cardiac ablation
treatments were enrolled in the trial at Mayo Clinic, Massachusetts
General Hospital, and St. David’s Medical Center
- The trial is designed to demonstrate the quality and
clinical value of the PURE EPTM signals when
compared to conventional sources of cardiac
signals. The Company expects to announce the
study results in Q3 2021
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the
“Company”), a medical technology company commercializing an
innovative signal processing platform designed to improve signal
fidelity and uncover the full range of ECG and intra-cardiac
signals, today announced it completed enrollment in the PURE EP 2.0
clinical trial.
The multi-center, prospective clinical trial was conducted at
the Texas Cardiac Arrhythmia Institute at St. David’s Medical
Center in Austin, TX, Mayo Clinic Florida Campus in Jacksonville,
FL, and Massachusetts General Hospital in Boston, MA. During the
trial, the PURE EPTM System was used in all types of arrhythmia
cases, including atrial fibrillation, ventricular tachycardia, and
atrial flutter. Atrial fibrillation, the most common arrhythmia
type affecting over 6 million people in the U.S.1, accounted
for over 40% of enrollments.
The PURE EPTM System has been awarded FDA 510(k) clearance.
The Company commenced commercialization in 2020, having recently
announced commercial sales to St. David’s HealthCare of Austin,
Texas, an HCA Healthcare-owned hospital, and Mayo Foundation for
Medical Education and Research. Clinical data, collected under the
terms of the PURE EP 2.0 study, will support the national rollout
to medical centers across the U.S.
The study aimed to establish the safe and effective use of the
PURE EPTM System and assess the quality of the PURE EPTM
intracardiac signals when compared to existing recording and
mapping systems. Collected clinical data underwent randomized,
blinded, controlled evaluation by a panel of independent
electrophysiologists to determine the clinical value of
the PURE EPTM signals. The Company has submitted a scientific
abstract for consideration by the Heart Rhythm Society. It expects
to announce the study results at the Heart Rhythm 2021 convention,
which is due to take place on July 28-31, 2021. The Company expects
to publish the full clinical study results in leading industry
publications in the second half of 2021.
In Q3 2020, the Company announced the data results recorded
during 15 atrial fibrillation ablation procedures from the PURE
EPTM System, the signal recording system, and the 3D mapping
system. The review concluded that the PURE EPTM signals were
preferred to conventional sources of intracardiac signals.
In addition to the enrolled patient data, the Company maintains
a registry of over 600 ablation procedures performed with the PURE
EPTM System at eight hospitals in the United States. This dataset
is being used to support new product development to complement the
PURE EPTM System.
"We are pleased to complete the enrollment in our flagship
clinical study. The objective of our clinical strategy is to
determine the clinical and economic benefits of the PURE EPTM
System which could include improved procedure efficacy, reduced
procedure times, and a decrease in repeat procedures,” commented
Kenneth L. Londoner, Chairman and CEO of BioSig Technologies,
Inc. “Strong clinical evidence is the foundation of our
commercial strategy. We look forward to revealing the clinical
findings from our trial in the coming months and engaging the
healthcare community in our new, targeted studies to demonstrate
the additional clinical value of our technology.”
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 EPTM 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.
1 Top 10 Things You should Know About Heart Rhythm; Scripps
Health.
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
54 Wilton Road, 2nd floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
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