BioSig Announces Physician-Initiated Research Protocol at The Kansas City Heart Rhythm Institute
July 21 2022 - 10:00AM
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the
“Company”) a medical technology company advancing electrophysiology
workflow by delivering greater intracardiac signal fidelity through
its proprietary signal processing platform, today announced that
Dhanunjaya DJ Lakkireddy, MD, Medical Director for the Kansas City
Heart Rhythm Institute, will initiate a research protocol analyzing
the signals acquired by the PURE EP(T.M.) System during
Radiofrequency (RF) ablation.
The single center study at Overland Park Regional Medical Center
and officially registered with clinicaltrials.gov [NCT05464537],
will include 30 participants with paroxysmal atrial fibrillation
(AF) undergoing pulmonary vein isolation (PVI). The study aims to
build on previous research that claims the loss of the negative
component of the unipole during PVI can serve as a tool for
achieving durability with overall lesser procedure time and no
significant increase in adverse events. AF recurrence will be
examined at 6 and 12-months post-procedure.
“Positive results from this study could substantially emphasize
the value of the PURE EP System in the EP lab by decreasing
procedural cost specific to both time and product spend,” commented
Gray Fleming, Chief Commercialization Officer, BioSig Technologies,
Inc.
Dr. Lakkireddy is a board-certified, fellowship-trained
cardiologist specializing in electrophysiology. With more than 15
years of experience, he has specialized interest in complex
arrhythmia management for all types of arrhythmias conditions. The
Company recently announced that Overland Park Regional Medical
Center (OPRMC) has signed an agreement to purchase the Pure
EP(T.M.) System under the terms of the Company's new leasing
program. This represents BioSig's first national purchasing
agreement since announcing The Company's new commercial structure
and clinical support teams.
About The Kansas City Heart Rhythm Institute
The Kansas City Heart Rhythm Institute brings the highest quality
clinical care, research and arrhythmia education to Kansas City and
the surrounding area. With eight practicing Electrophysiologists,
the Kansas City Heart Rhythm Institute has three Electrophysiology
clinics in the greater Kansas City area as well as outreach
locations in four major hospitals.
About Overland Park Regional Medical
CenterOverland Park Regional Medical Center is a licensed
343-bed facility offering acute medical care services to patients.
Cardiovascular programs at OPRMC have received certification from
The American Association of Cardiovascular and Pulmonary
Rehabilitation (AACVPR). OPRMC's clinician and physician experts
excel in a wide range of interventional cardiology practices and
complex electrophysiology procedures, including Complex Arrhythmia
Management (AF, VTACH, PVC, SVT), Convergent AF Ablation (with C.T.
surgeon and E.P.), Leadless Pacemakers & Internal Cardiac
Defibrillators, and Left Atrial Appendage Closure.
About BioSig TechnologiesBioSig 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(T.M.) System, is a novel
signal processing and acquisition platform designed to extract
advanced diagnostic and therapeutic data that enhances physician
workflow and increases throughput. PURE EP(T.M.) was engineered to
address the limitations of existing EP technologies by empowering
physicians with superior signals and actionable insights.
The Company is in a national commercial launch of the PURE
EP(T.M.) System. The technology is in regular use in some of the
country’s leading centers of excellence, including Mayo
Clinic, and Texas Cardiac Arrhythmia Institute at St. David’s
Medical Center.
Clinical data acquired by the PURE EP(T.M.) System in a
multi-center study at centers of excellence including Texas Cardiac
Arrhythmia Institute at St. David’s Medical Center was
recently published in the Journal of Cardiovascular
Electrophysiology and is available electronically with open access
via the Wiley Online Library. Study results showed 93% consensus
across the blinded reviewers with a 75% overall improvement in
intracardiac signal quality and confidence in interpreting PURE
EP(T.M.) signals over conventional sources.
Forward-looking StatementsThis 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) market conditions and the Company’s intended
use of proceeds, (ii) the geographic, social and economic impact of
COVID-19 on our ability to conduct our business and raise capital
in the future when needed, (iii) our inability to manufacture our
products and product candidates on a commercial scale on our own,
or in collaboration with third parties; (iv) difficulties in
obtaining financing on commercially reasonable terms; (v) changes
in the size and nature of our competition; (vi) loss of one or more
key executives or scientists; and (vii) 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, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x13
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