BioSig Technologies, Inc. (NASDAQ: BSGM) ("BioSig" or the
"Company"), a medical technology company committed to delivering
unprecedented accuracy and precision to intracardiac signal
visualization, today announced a workforce reduction, intended to
reduce annual cash burn by 50%. The Company is reducing its
internal workforce, which is expected to be completed by January
31. The Company is also shifting its business model and seeks to
partner with organizations for sales distribution and clinical
support of its PURE EP™ Platform.
"BioSig is at an important juncture, and we are taking steps to
streamline our corporate structure. We are grateful to those
employees who are affected by the impact of these changes. Their
hard work and dedication were integral to bringing the PURE EP™
Platform to where it is today," said Ken Londoner, Chairman and CEO
of BioSig.
Since its launch in Q4 2023, PURE EP™'s Near-Field Tracking
(“NFT”) has increased customer interest and usage at some of the
country's largest and leading medical centers and health systems.
This usage has also illustrated the need for increased clinical
support as the Company seeks to install its PURE EP™ Platform in
additional accounts. The Company is looking to partner with
well-established electrophysiology companies and distributors that
already have clinical staff in the hospital setting.
"After a strategic review, we are adjusting the business model
to ensure that we have an economical clinical infrastructure as we
expand the recently released version 7 software featuring NFT,"
said Fred Hrkac, Executive Vice President of BioSig, who joined the
Company on November 2, 2023. Mr. Hrkac has a 32-year career in
medical device and electrophysiology business expansion for
industry bellwethers.
Physicians from world-renowned medical centers, including
Cleveland Clinic in Cleveland, OH, Mayo
Clinic in Phoenix, AZ, Overland Park Regional
Medical Center in Overland Park, KS, and Texas
Cardiac Arrhythmia Institute in Austin, TX, have completed
more than 100 cases using PURE EP™'s NFT algorithm.
Researchers from Cleveland Clinic presented topline clinical
findings on the value of tissue-based science and methodology
behind NFT at the Heart Rhythm 2023 convention held last May. Those
findings evidenced a 66% reduction in ablation time when using the
PURE EP ™ Platform, among other benefits. Looking ahead,
in collaboration with several early adopters, the Company is
quantifying the efficacy and safety benefits of NFT and
investigating expanded applications for the NFT software.
BioSig will continue to work closely with its physician partners
to potentially integrate its hardware and software in today's labs
to provide seamless functionality.
To learn more about PURE EP™'s growing suite of proprietary
software-based features, click here.
About The PURE EP™ PlatformThe PURE EP™
Platform serves physicians by enabling the real-time acquisition of
raw cardiac signal data—absent of unnecessary noise or interference
inherent in traditional approaches. By leveraging a
first-of-its-kind combination of hardware and software, the PURE
EP™ Platform is designed to deliver unprecedented intracardiac
signal purity that pushes the boundaries of cardiac arrhythmia
identification, diagnosis, and treatment.
In a blinded clinical study recently published in the Journal of
Cardiovascular Electrophysiology,1 electrophysiologists rated PURE
EP™ as superior to conventional systems for 75.2% of signal
samples, with 87% earning a rating of equivalent or superior. Data
presented at Heart Rhythm Society 2023 demonstrated the PURE EP™
Platform's capacity to facilitate ablations in a third of the usual
time, reducing procedure time and improving workflow efficiencies,
without sacrificing accuracy, precision, or efficacy.
The PURE EP™ Platform is currently in a national commercial
launch and an integral part of well-respected healthcare systems,
including Cleveland Clinic, Mayo Clinic, Texas Cardiac Arrhythmia
Institute, and Kansas City Heart Rhythm Institute.
About BioSig Technologies, Inc.BioSig
Technologies is a medical technology company focused on deciphering
the body's electrical signals, starting with heart rhythms. By
leveraging a first-of-its-kind combination of hardware and
software, we deliver unprecedented cardiac signal clarity, ending
the reliance on 'mixed signals' and 'reading between the lines.'
Our platform technology addresses some of healthcare's biggest
challenges—saving time, costs, and lives.
The Company's product, the PURE EP™ Platform, an FDA 510(k)
cleared non-invasive class II device, provides superior, real-time
signal visualization, allowing physicians to perform highly
targeted cardiac ablation procedures with increased procedural
efficiency and efficacy.
An estimated 14.4 million Americans suffer from cardiac
arrhythmias, and the global EP market is projected to reach $16B in
2028 with an 11.2% growth rate.2
Forward-Looking StatementsThis press release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. 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) BioSig’s ability to regain
compliance with and meet the continued listing requirements of the
Nasdaq Capital Market to maintain listing of its common stock; (ii)
the geographic, social, and economic impact of pandemics or
worldwide health issues on BioSig’s ability to conduct its business
and raise capital in the future when needed; (iii) BioSig’s
inability to manufacture its products and product candidates on a
commercial scale on its own, or in collaboration with third
parties; (iv) difficulties in obtaining financing on commercially
reasonable terms; (v) changes in the size and nature of BioSig’s
competition; (vi) loss of one or more key executives or scientists;
(vii) BioSig’s cost reduction plan and associated workforce
reduction or other cost-saving measures not reaching the targeted
reduction of cash burn by 50%; and (viii) difficulties in securing
regulatory approval to market BioSig’s products and product
candidates. For a discussion of other risks and uncertainties, and
other important factors, any of which could cause BioSig’s actual
results to differ from those contained in forward-looking
statements, see Biosig’s filings with the Securities and Exchange
Commission (“SEC”), including the section titled “Risk Factors” in
BioSig’s Quarterly Report on Form 10-Q, filed with the SEC on
November 14, 2023. 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, except as required by
law.
1 Al-Ahmad, et al. (2022, September) Evaluation of a novel
cardiac signal processing system for electrophysiology procedures:
The PURE EP 2.0 study.
https://onlinelibrary.wiley.com/doi/10.1111/jce.15250
2 Cardiac Ablation Market. (2022, December). Global Market
Insights.
https://www.gminsights.com/industry-analysis/cardiac-ablation
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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