BioSig Technologies, Inc. Issues Shareholder Letter with Corporate Update on Recent Achievements
May 11 2022 - 8:30AM
- To date, Company's FDA 510(k) cleared PURE EP(TM)
system has completed over 2,200 patient cases with 75 physicians at
17 hospitals across the United States
- The Company adds new executives to
accelerate sustained commercial momentum developing a national
installed base of the PURE EP systems
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 issued a Letter to Shareholders providing highlights on the
Company's recent developments and updates.
Recent Company highlights include:
- The growth of its PURE EP(TM) System from its first-in-human
surgical procedures in 2019 to completing over 2,200 patient cases
with 75 physicians at 17 hospitals across the United States.
- BioSig strengthened its management with a new commercialization
team led by industry veteran Gray Fleming, Chief Commercial
Officer, who spent 18 years with St. Jude Medical.
- The rollout of a two-phase approach for purchase, lease, or
rental options for PURE EP and a new go-to-market strategy for
commercialization.
- Launch of its new NOVA-5 software at the Heart Rhythm Society
Convention on April 29, 2022. NOVA-5 offers greater customization
and smarter workflows with the aim of further driving clinical
adoption.
- Recapped the successful completion of its first blinded
clinical trial in 2021 and published those results in a leading
peer-reviewed journal. Titled "Evaluation of a novel cardiac signal
processing system for electrophysiology procedures: The PURE EP 2.0
study," the study was conducted at three leading medical centers
across the United States: St. David's Medical Center (TCAI), Mayo
Clinic, and Massachusetts General Hospital.
- A snapshot into Biosig's financing included no debt and
positioning in a global electrophysiology device market which,
according to Grand View Research, could reach $12.2 billion by 2026
and expand at a growth rate of approximately 12%.
"We have made great strides on multiple fronts and
felt it was an important time to communicate to our shareholders
the strength of our business and the initiatives we are executing
that have served as the foundation for our growth trajectory," said
Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.
"We strongly believe in the value of our technology and are now
supported with both peer-reviewed clinical data and third-party
economic data, proving the value of what we have built. We are
eager to continue working on our new commercialization strategy,
seeing the impact of our new NOVA-5 software has, and all our
initiatives we are undertaking to drive shareholder value and
expand PURE EP."
To view the Company's Shareholder Letter in its
entirety, please visit: Presentations :: BioSig Technologies, Inc.
(BSGM).
The PURE EP(TM) is an FDA 510(k) cleared
non-invasive class II device that aims to drive procedural
efficiency and efficacy in cardiac electrophysiology. To date, 75
physicians have completed more than 2,200 patient cases with the
PURE EP(TM) System.
Clinical data acquired by the PURE EP(TM)
System in a multi-center study at Texas Cardiac Arrhythmia
Institute at St. David's Medical Center, Mayo Clinic Jacksonville,
and Massachusetts General Hospital 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(TM) signals over conventional
sources.
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 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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