BioSig Technologies, Inc. to Receive 15 Units of PURE EP™ System from Manufacturer for Commercial Installation
July 15 2019 - 8:00AM
- New units to be prepped for next phase of targeted
commercial launch strategy
- Company includes 3 additional hospitals to its list of
medical institutions for delivery in 2019 to demonstrate the
technology
- Proprietary device is designed to record and display
high-fidelity cardiac signals with enhanced visualizations
tools
BioSig Technologies, Inc. (NASDAQ:BSGM), a medical device
company developing a proprietary biomedical signal processing
platform designed to address an unmet technology need for the
electrophysiology (EP) marketplace, today announced that it will be
receiving 15 units of its PURE EP™ System from its manufacturer in
preparation for the Company’s limited market release later this
month.
BioSig recently added 3 hospitals, including two distinguished
academic centers, to its list of medical institutions that have
agreed to receive the device in 2019 to evaluate the PURE EP™
System. These new units, which are being provided at BioSig’s
expense on a short term basis, will be used for a series of short-
and long-term (up to 180 days) external evaluation studies, which
form an essential part of a targeted commercial launch. Currently,
management is engaged with other facilities throughout the country.
These initial shipments are part of the Company’s stated plans
following the recent successful completion of initial clinical
cases at the Texas Cardiac Arrhythmia Institute in Austin, TX,
Greenville Memorial Hospital in Greenville, SC and Indiana
University School of Medicine.
“We are extremely pleased to be on track and schedule with the
initial installments of our technology, as we move into the
commercialization phase of our strategic business model,” stated
Mr. Kenneth L. Londoner, Founder, Chairman and CEO of BioSig
Technologies, Inc. “The feedback from hospitals, clinics and
physicians has been very encouraging. We have been actively
adding to our clinical, commercial, engineering and operational
teams in anticipation of the expansion of working with leading
medical centers in the U.S. We look forward to initiating
commercialization as we establish ourselves as a market innovator
in the medical technology sector.”
PURE EP™ System is an FDA approved proprietary signal
acquisition and processing technology. The device 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.
The device aims to minimize noise and artifacts and acquire
high-fidelity cardiac signals. Improving fidelity of acquired
cardiac signals may potentially increase the diagnostic value of
these signals, thereby possibly improving accuracy and efficiency
of the EP studies and related procedures.
BioSig recently announced that it has been added to the Russell
3000 Index and was allowed 33 patent claims covering its PURE EP™
System.
About BioSig TechnologiesBioSig Technologies is
a medical technology company developing a proprietary biomedical
signal processing platform designed to improve the
electrophysiology (EP) marketplace (www.biosig.com). Led by a
proven management team and a veteran Board of Directors, BioSig
Technologies is preparing to commercialize its PURE EP™ System. The
technology has been developed to address an unmet need in a large
and growing market.The Company’s first product, PURE EP™
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. The system is indicated for use under the
supervision of licensed healthcare practitioners who are
responsible for interpreting the data. This novel cardiac signal
acquisition and display system is engineered to assist
electrophysiologists in clinical decision-making during
electrophysiology procedures in patients with abnormal heart rates
and rhythms. BioSig’s ultimate goal is to deliver technology to
improve upon catheter ablation treatments for the prevalent and
potentially deadly arrhythmias, Atrial Fibrillation and Ventricular
Tachycardia. BioSig has partnered with Minnetronix on technology
development and received FDA 510(k) clearance for the PURE EP™
System in August 2018.
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) our inability to manufacture our products and
product candidates on a commercial scale on our own, or in
collaboration with third parties; (ii) difficulties in obtaining
financing on commercially reasonable terms; (iii) changes in the
size and nature of our competition; (iv) loss of one or more key
executives or scientists; and (v) 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.
Natasha Drapeau
BioSig Technologies, Inc.
Executive Vice President
54 Wilton Road, 2nd floor
Westport, CT 06880
ndrapeau@biosigtech.com
310-620-9320
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