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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): December 6, 2023
BioSig
Technologies, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-38659 |
|
26-4333375 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
55
Greens Farms Road, 1st Floor
Westport,
Connecticut |
|
06880 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(203)
409-5444
(Registrant’s
telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of exchange on which registered |
Common
Stock, par value $0.001 per share |
|
BSGM |
|
The
NASDAQ Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 Regulation RD Disclosure.
On
December 6, 2023, BioSig Technologies, Inc. (the “Company”) issued a letter to shareholders, which is attached hereto as
Exhibit 99.1, providing highlights on the Company’s recent developments and updates. The Company undertakes no obligation to update,
supplement or amend the materials attached hereto as Exhibit 99.1.
In
accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including
Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in
such a filing. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form 8-K is not intended to constitute
a determination by the Company that the information contained herein, including the exhibits hereto, is material or that the dissemination
of such information is required by Regulation FD.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
|
BIOSIG
TECHNOLOGIES, INC. |
|
|
|
Date:
December 6, 2023 |
By: |
/s/
Kenneth L. Londoner
|
|
Name: |
Kenneth
L. Londoner
|
|
Title: |
Executive
Chairman |
Exhibit
99.1
LETTER
TO SHAREHOLDERS
December
2023
Dear
fellow shareholders,
As
we approach the end of 2023, I want to share with you BioSig’s important achievements of the past 12 months, showcase our strengths
and strategies, address our challenges, and offer insights about the year ahead.
This
year, we completed BioSig’s business transition from a traditional medtech sales model with a technology enabling superior signal
visualization, to a subscription-based commercial model with a cardiac care platform poised to make game-changing improvements in how
electrophysiologists treat cardiac arrhythmia, a condition affecting more than six million Americans.
With
our subscription service, we debuted new PURE EP™ software features, including unique algorithms that unlock signal data for electrophysiologists
conducting even the most challenging ablation procedures. Since the launch of our version 7 (V7) software upgrade in August, two of the
top three U.S. health systems in cardiology—Cleveland Clinic and Mayo Clinic—have subscribed to our technology.
Leveraging
these successes, our primary goal for 2024 is to accelerate the adoption of our PURE EP™ Platform in existing and new target markets,
driving multiple avenues of potential value creation.
OUR
INNOVATION ENGINE
As
part of V7, our new Near Field Tracking (NFT) technology alerts the physician when to ablate tissue and when to stop ablating tissue
during an atrial fibrillation (AFib) procedure. To our knowledge, no other intracardiac signaling technology provider offers this level
of innovation.
This
functionality was developed in response to the needs communicated from leading electrophysiologists and physicians about next-level innovation
for our system. This inspired our creation of V7 NFT technology, which guides a physician through an AFib procedure and prompts when
to stop ablation to reduce risk for serious procedural complications. One such complication that EPs face is esophageal fistulas, a rare
but lethal complication with a 70% mortality risk. We believe our technology could play a critical role in reducing and/or eliminating
risk for such complications. With the highly-competitive and all-new inputs and features we have added, we expect V7 to be a significant
growth lever for our PURE EP™ Platform sales and adoption strategies.
Based
in part on our research findings, we believe that the NFT features can positively impact PURE EP™ Platform adoption around the
country. Since the V7 launch in August, followed by subsequent improvements, we’ve found that the NFT features are resonating with
a growing number of physicians at many leading hospitals due to the ease of use, effectiveness, time savings, and revenue-enhancing features—all
designed to improve workflow during the diagnosis and catheter ablation treatment for AFib. Also, with this latest software update and
the NFT features, additional reimbursement options may be applicable to hospitals when associated services are medically necessary.
DRIVING
CLINICAL EXCELLENCE
Favorable
clinical data helps drive product adoption. Data shows that our technology is well-positioned to drive clinical excellence.
Research
initiated and led by Cleveland Clinic’s world-class physician faculty was presented at this year’s Heart Rhythm Society meeting.
Our optimized ablation technique was tested in a pulmonary vein isolation (PVI) procedure, the most common catheter ablation treatment
for AFib. The results highlighted the PURE EP™ Platform’s ability to preserve raw signals that deliver real-time tissue feedback
when conducting ablation, enabling physicians to perform certain aspects of the procedure in one-third of the time as conventional methods.
Researchers
are expanding abstracts from this study into manuscripts for potential inclusion in leading scientific peer-reviewed publications. In
addition, several investigator-initiated studies are in progress at other institutions that will be presented in the second half of 2024.
We believe that the communication of this data, plus additional data from a pipeline of physician-initiated studies next year, will illuminate
the unique benefits of the PURE EP™ Platform by way of high-profile conference presentations, peer-to-peer networking, and, most
importantly, direct engagement with electrophysiologists and health centers.
A.I.
COLLABORATION
This
year, we advanced research and development for an artificial intelligence (A.I.) medical device platform through a majority-owned subsidiary,
BioSig AI Sciences, Inc. (BioSig AI) which initially began in 2019 and was later paused during the pandemic. In July 2023, we closed
a $2.2 million seed funding round for the subsidiary to support the development of this platform with certain collaborators.
The
integration of A.I. and machine learning in electrophysiology (EP) devices is powering substantial expected growth for this market, and
we intend to be a leader in developing applications of these technologies. BioSig AI’s foundational machine learning model is based
on integrated healthcare datasets, beginning with ECG and iECG data acquired by the PURE EP™ Platform. Electrophysiology-focused
technological solutions developed under the terms of the collaboration may be integrated into our PURE EP™ technology for potential
commercial application.
The
market opportunity is significant. According to Data Bridge Market Research, the market for artificial intelligence in healthcare, estimated
at $9.6 billion in 2022, is expected to reach nearly $273 billion by 2030, at a CAGR of 52% during the forecast period.1
ROBUST
IP & MANUFACTURING
Our
intellectual property is well protected. This year, we added five new patent awards, bringing our total number of patents to over 100.
These include utility patents, worldwide design patents, and U.S. and foreign utility patent applications covering various aspects of
the PURE EP™ Platform.
We
also have licenses to 11 patents and nine worldwide utility patent applications pending from the Mayo Foundation for Medical Education
and Research.
Additionally,
we have one allowed and one pending patent for BioSig AI.
During
the current quarter, we completed a manufacturing transition to Plexus, a world-class manufacturer that generates nearly half of its
over $3 billion of revenues from well-known healthcare and life sciences customers. We’re confident that Plexus will be able to
support future demands for the PURE EP™ Platform.
FINANCING
AND CAPITAL ALLOCATION
As
an early–stage commercial company, we rely on the capital markets to fund our operations. With broad market instability and economic
uncertainty over the past two years, the constrained funding environment has been incredibly challenging for early commercial-stage companies
like BioSig.
Medtech
equity financing declined 27% last year, its lowest point in seven years according to Ernst & Young, and a recent JPMorgan analyst
research report states that medtech trading this year is at the lowest levels of sentiment since the Great Recession in 2008 and 2009.2
The challenges for BioSig are real.
Despite
these headwinds, over the past 12 months, BioSig has raised over $20 million, primarily through private placements of our securities
and a recent registered direct offering.
We
are working hard to prioritize fundraising and capital allocation for commercial expansion and innovation in order to deliver durable
returns. We are committed to the conscientious use of capital to ensure funding for expanded commercialization, and we are strategic
about cost savings, especially in this current economy.
COMMITMENT
AND VISION
While
we are disappointed in the market valuation of our Company and performance of our stock this year, we remain deeply committed to improving
shareholder value through operational success. BioSig’s senior management and employees are all shareholders like you and share
the interest in durable returns.
2023
brought multiple new business leaders to our management team and our board who have delivered substantive contributions to our business
operations and strategies. We believe our software belongs in every EP lab, and we are making every effort to realize our belief.
BioSig’s
capacity for innovation is stronger than ever, and we believe our opportunities for sustainable growth are achievable. With
sound execution around our ramp-up of commercial placements and a sharp focus on building relationships
and brand awareness, we expect to deliver significant progress in the year ahead.
As
always, we greatly appreciate your interest and valued support of our mission to disrupt and uplift the industry’s standard for
cardiac care.
Sincerely,
Kenneth
L. Londoner, Chairman & CEO
1
Data Bridge Market Research. Global Artificial Intelligence in Healthcare Market – Industry Trends and Forecast to 2030.
January 2023.
2
Ernst & Young (EY), Pulse of the Industry medical technology report 2023
SAFE
HARBOR DISCLOSURE
This
shareholder letter 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. Such statements include, but are not limited to, the intended use of proceeds from the registered direct offering.
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;
(vi) difficulties in securing regulatory approval to market our products and product candidates; and (vii) market and other conditions.
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 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.
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