- To date, the Company's FDA 510(k)-cleared PURE EP™
System has been used in approximately 3,000 patient cases across
the United States
- The Company has built a robust pipeline of commercial
sale prospects and expects multiple closings in first half of
2023
- New supporting clinical data to be
published
BioSig Technologies, Inc. (NASDAQ: BSGM) (“BioSig” or the
“Company”) an advanced digital signal processing technology company
delivering unprecedented accuracy and precision to intracardiac
signal visualization with its proprietary PURE EP™ System, today
issued an update to shareholders highlighting recent milestones and
ongoing company developments.
Dear Shareholders:
January 2023 marks the one-year anniversary of redefining our
product development and commercial strategies led by John Sieckhaus
and Gray Fleming, respectively. During this time, we have built new
sales and clinical teams, introduced new corporate and product
branding, launched potentially game-changing software, secured
numerous evaluations, established new research protocols, signed
purchase agreements, and created a promising revenue pipeline.
These are milestones never seen before at BioSig and we believe
there are many more exciting ones ahead.
While we are proud of the commercial progress BioSig has made
over the past twelve months, 2022 proved to be a challenging year
for the economy, and especially for Life Sciences companies like
ours. This was reflected in our valuation. History shows us that
innovative companies and technologies can prevail following
economic downturns. The sharp market declines in 2000-2002 and
2008-2009 were followed by economic recoveries where new leaders
emerged. We are confident that BioSig will be one of those
emerging leaders based on the exciting commercial, technology and
corporate activities underway in 2023.
At BioSig, we understand the importance of personalized patient
care and the economic squeeze of making every clinical decision
count. We believe that maintaining the integrity of intracardiac
signals with precision and clarity—without driving up procedural
costs—has never been more pertinent. Innovative technology will be
critical for healthcare organizations in the year ahead and we
believe BioSig’s technology is very attractive.
Recent Milestones
Despite the difficult operating environment, there were several
positives that came out of the year for the Company, our customers,
and our shareholders. Most recently, we successfully raised
approximately $3.8 mm in private placements of common stock and
warrants at what we believe were relatively attractive terms. We
will continue to try to find shareholder-friendly ways to fund the
Company as we work to grow revenue and expand our value proposition
through the ongoing development of our technology. We also received
a letter from Nasdaq notifying us that the Company has been granted
an additional 180-day period, or until May 22, 2023, to regain
compliance with the Stockholders’ Equity Requirement. Management
believes that this is sufficient time to regain compliance.
Below is a list of examples that we believe demonstrate BioSig’s
unique position within the Medtech industry and the growing
interest in our disruptive technology, the PURE EP™ System.
- On January 10, 2023, we announced that Bellin Health entered
into an agreement to acquire a PURE EP™ System. Through a formal
evaluation, Bellin reported that clear cardiac signals positively
impacted procedural efficiency resulting in cost savings per
procedure.
- Over 3,000 procedures have been performed using the PURE EP™
System with more than 80 physicians at 21 hospitals across the
United States.
- The PURE EP™ System was featured in an abstract presentation at
the 15th Asia Pacific Heart Rhythm Society (APHRS) Scientific
Session in Singapore. Results from the randomized study revealed
the PURE EP™ System’s potential to promote shorter procedural times
and higher cost savings during catheter ablation procedures.
- BioSig’s PURE EP™ System was highlighted in a peer-reviewed
case report by the Journal of Atrial Fibrillation &
Electrophysiology (JAFIB-EP). This clinical abstract detailed the
value of PURE EP™ and its groundbreaking High Frequency Algorithm
(HFA) during pulmonary vein isolation.
- A Master Research Agreement was signed with the Cleveland
Clinic to explore expanded applications for its digital signal
processing technology.
- A purchase agreement was signed with San Antonio Methodist
Hospital.
- Launched PURE EP™ software Version 6 with ACCUVIZ™ Module
highlighting the proprietary High Frequency Algorithm (HFA), a
novel feature that identifies the key frequency components of
cardiac data that can be difficult to identify within the
traditional waveform presentation.
- Cleveland Clinic, a leading Medical Center of Excellence,
agreed to evaluate the PURE EP System, and a short time later
requested a second system for evaluation.
- A purchase agreement was signed with Kansas City Heart Rhythm
Institute at Overland Park Regional Medical Center.
- The PURE EP™ System was featured at numerous conferences
including Kansas City Heart Rhythm Symposium 2022, the 17th Edition
Venice Arrhythmias 2022 Congress, and EPLive 2022.
Final Thoughts
Although 2022 was a difficult, year, we have the fortitude and
laser focus to build on the progress we have made and are energized
for what the new year brings us. We will continue to advance our
commercialization strategy and look to add more hospitals and
centers of excellence to our portfolio of PURE EP™ adopters. We are
fortunate to operate in a growing sector as the global EP market is
expected to reach $16 billion by 2028, an estimated 11.2% compound
annual growth rate. With the number of annual catheter
ablation procedures expected to grow, we believe that our PURE EP™
technology is well-positioned to set a new standard in intracardiac
visualization.
As physician advocates, we are dedicated to developing
technology that provides greater clarity and opens doors to
ingenious treatment solutions for the most challenging arrhythmias.
Collaborating with equal parts respect and humility, we are
advancing science and technology, furthering the field of
electrophysiology, and helping to solve healthcare’s greatest
challenges.
Thank you for your patience, confidence, and trust in
BioSig.
Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies,
Inc.
About BioSig Technologies
BioSig Technologies is an advanced digital signal processing
technology company bringing never-before-seen insights to the
treatment of cardiovascular arrhythmias. Through collaboration with
physicians, experts, and healthcare leaders across the field of
electrophysiology (EP), BioSig is committed to addressing
healthcare’s biggest priorities — saving time, saving costs, and
saving lives.
The Company’s first product, the PURE EP™ System, an FDA 510(k)
cleared non-invasive class II device, provides superior, real-time
signal visualization allowing physicians to perform insight-based,
highly targeted cardiac ablation procedures with increased
procedural efficiency and efficacy.
The PURE EP™ System is currently in a national commercial launch
and an integral part of well-respected healthcare systems, such as
Mayo Clinic, Texas Cardiac Arrhythmia Institute, Cleveland Clinic,
and Kansas City Heart Rhythm Institute. In a blinded clinical
study recently published in the Journal of Cardiovascular
Electrophysiology, electrophysiologists rated PURE EP™ as
equivalent or superior to conventional systems for 93.6% of signal
samples, with 75.2% earning a superior rating.
The global EP market is projected to reach $16B in 2028 with an
11.2% growth rate.1
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) 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.
1 Global Market Insights Inc. March 08, 2022.
Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road, 1st Floor
Westport, CT 06880
aballou@biosigtech.com
203-409-5444, x133
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