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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): October 6, 2026
HEARTSCIENCES
INC.
(Exact
name of Registrant as Specified in Its Charter)
| Texas |
|
001-41422 |
|
26-1344466 |
(State or Other Jurisdiction of
Incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
550
Reserve Street, Suite 360
Southlake, Texas | |
76092 |
| (Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s
Telephone Number, Including Area Code: (682) 237-7781
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 each exchange on which registered |
| Common Stock |
|
HSCS |
|
The Nasdaq Stock Market
LLC |
| Warrants |
|
HSCSW |
|
The Nasdaq Stock Market
LLC |
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 FD Disclosure.
On
October 6, 2026, HeartSciences Inc. (the “Company” or “HeartSciences”) issued a press release announcing
that the U.S. Food and Drug Administration has granted 510(k) clearance (K260005) for the Company’s MyoVista® wavECGTM
device as a 12-lead resting electrocardiograph, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K
(this “Current Report”).
As
previously reported, on June 23, 2026, HeartSciences, Fortitude Mining Holdings, Inc. (“Fortitude”), Fortitude Mining
HoldCo, LLC and Cordis Acquisition, LLC, entered into an Agreement and Plan of Merger (as amended, the “Merger Agreement”)
relating to their proposed business combination (the “Proposed Transaction”).
The
information provided in this Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not
be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934, as amended (the “Exchange Act”),
or otherwise subject to the liabilities of that section. Such information shall not be deemed incorporated by reference into any filing
of HeartSciences under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless
of any general incorporation language in such filing, except as otherwise expressly set forth by specific reference in such filing.
Additional
Information and Where to Find It
Communications
related to each of Fortitude and HeartSciences, their respective businesses and the Proposed Transaction may be deemed solicitation material
in respect of the Proposed Transaction. In connection with the Proposed Transaction, HeartSciences filed an amended preliminary proxy
statement on Schedule 14A with the U.S. Securities and Exchange Commission (the “SEC”) on October 6, 2026 (the “Preliminary
Proxy Statement”) and may file additional relevant materials with the SEC from time to time. Following the filing of a definitive
proxy statement with the SEC, HeartSciences will mail the definitive proxy statement and a proxy card to each shareholder entitled to
vote at the special meeting relating to the Proposed Transaction. INVESTORS AND SHAREHOLDERS OF HEARTSCIENCES ARE URGED TO READ THESE
MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE PROPOSED TRANSACTION
THAT HEARTSCIENCES HAS FILED OR MAY FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT HEARTSCIENCES
AND THE PROPOSED TRANSACTION. COMMUNICATIONS THAT DO NOT CONTAIN ALL THE INFORMATION THAT SHOULD BE CONSIDERED CONCERNING THE PROPOSED
TRANSACTION AND RELATED MATTERS ARE NOT INTENDED TO PROVIDE THE BASIS FOR ANY INVESTMENT DECISION OR ANY OTHER DECISION IN RESPECT OF
SUCH MATTERS. The preliminary proxy statement, the definitive proxy statement and other relevant materials in connection with the Proposed
Transaction (when they become available), and any other documents filed by HeartSciences with the SEC, may be obtained free of charge
at the SEC’s website at www.sec.gov. In addition, investors and shareholders may obtain free copies of the documents filed with
the SEC or by sending a request to the HeartSciences Investor Relations Department at investorrelations@heartsciences.com.
NEITHER
THE SEC NOR ANY STATE SECURITIES REGULATORY AGENCY HAS APPROVED OR DISAPPROVED THE TRANSACTIONS DESCRIBED HEREIN, PASSED UPON THE MERITS
OR FAIRNESS OF THE PROPOSED TRANSACTION OR ANY RELATED TRANSACTIONS OR PASSED UPON THE ADEQUACY OR ACCURACY OF THE DISCLOSURE IN THIS
CURRENT REPORT. ANY REPRESENTATION TO THE CONTRARY CONSTITUTES A CRIMINAL OFFENSE.
Cautionary
Note Regarding Forward-Looking Information
Communications
may contain forward-looking statements concerning HeartSciences, Fortitude and the Proposed Transaction and other matters. These forward-looking
statements generally can be identified by the use of words such as “aim,” “anticipate,” “expect,”
“plan,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,”
“goal,” “project,” “potential,” “target,” “objective,” “intend,”
and other words of similar meaning, but the absence of these words does not mean that a statement is not forward-looking. All statements
HeartSciences and/or Fortitude make in communications that do not relate to matters of historical fact should be considered forward-looking
statements.
These
forward-looking statements are based on management’s current expectations and assumptions as of the date of such communication
and are subject to a number of known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially
from those expressed or implied by such statements, which may include, without limitation, the following: the risk that the Proposed
Transaction may not be completed on the anticipated timeline or at all; the failure to satisfy the conditions to the closing of the Proposed
Transaction, including obtaining the requisite approval of the HeartSciences’ shareholders; market, macroeconomic, or other conditions
that could adversely affect either HeartSciences or Fortitude, or the combined company; risks related to the integration of the two companies
and the management of a newly public company; risks relating to Fortitude’s operations and business, including the highly volatile
nature of the price of Zcash and other cryptocurrencies; and risks relating to significant legal, commercial, regulatory and technical
uncertainty regarding digital assets generally. Additional factors that may cause actual results to differ materially from those expressed
or implied by the forward-looking statements in such communications are discussed in the Preliminary Proxy Statement, HeartSciences’
2026 Annual Report on Form 10-K, filed with the SEC on July 23, 2026, its Quarterly Report on Form 10-Q for the fiscal quarter ended
July 31, 2026, filed with the SEC on September 14, 2026, and its other reports filed with the SEC from time to time. Readers are cautioned
not to place undue reliance on these forward-looking statements. Each of HeartSciences and Fortitude expressly disclaims any obligation
to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required
by applicable law. Any forward-looking statements made in such communications are made as of the date of the communication.
Participants
in the Solicitation
HeartSciences
and Fortitude, their respective directors and executive officers, and certain executive officers of Digital Currency Group, Inc. (“DCG”),
the parent company of Fortitude, may be deemed to be participants in the solicitation of proxies from HeartSciences’ shareholders
with respect to the Proposed Transaction. Information regarding the identity of the potential participants, and their direct or indirect
interests in the Proposed Transaction, by security holdings or otherwise, is set forth in the preliminary proxy statement and other materials
that have been or may be filed with the SEC in connection with the Proposed Transaction.
In
the ordinary course of business, Fortitude currently sells or otherwise monetizes all the digital assets that it mines, including ZEC.
In addition, Fortitude and its affiliates and subsidiaries, including DCG, from time to time sell, pledge or otherwise monetize their
digital asset holdings, including ZEC. The funds received from such sales, pledges, or other monetization activities are used to fund
operating expenses and capital investments, as well as for other purposes, including to hedge exposures and realize investment gains.
No
Offer or Solicitation
Any
information contained herein is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of
an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation
of any vote or approval in any jurisdiction, pursuant to the Proposed Transaction or otherwise, nor shall there be any sale, issuance
or transfer of securities in any jurisdiction in contravention of applicable law. The Proposed Transaction will be implemented solely
pursuant to the terms and conditions of the Merger Agreement, which contain the full terms and conditions of the Proposed Transaction.
Item
9.01 Financial Statements and Exhibits
(a)
Exhibits
Exhibit
Number |
|
Description |
| 99.1* |
|
Press Release, dated October 6, 2026. |
| 104* |
|
Cover Page Interactive Data File (embedded
within the Inline XBRL document). |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| |
HEARTSCIENCES INC. |
| |
|
|
| Date: October 6, 2026 |
By: |
/s/ Andrew
Simpson |
| |
Name: |
Andrew Simpson |
| |
Title: |
President, Chief
Executive Officer and Chairman of the Board of Directors |
Exhibit 99.1
HeartSciences Receives FDA 510(k) Clearance for its MyoVista®
wavECGTM Device
Southlake, TX, October 6, 2026 (GLOBE NEWSWIRE) -- HeartSciences
Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”)
company focused on advancing electrocardiography (“ECG” or “EKG”) through the integration of artificial intelligence
(“AI”), today announced that the U.S. Food and Drug Administration (“FDA”) has granted 510(k) clearance (K260005)
for its MyoVista® wavECGTM device as a 12-lead resting electrocardiograph. The clearance covers the acquisition
and interpretation of ECG signals from adult and pediatric patients in hospitals and healthcare facilities, with interpretive statements
provided to clinicians on an advisory basis. The clearance does not include an AI-ECG algorithm.
As previously reported, HeartSciences separated the FDA submissions
for the MyoVista wavECG device and its impaired cardiac relaxation AI-ECG algorithm following updated guidance published by the
American Society of Echocardiography regarding the assessment of left ventricular diastolic dysfunction. The Company does not intend to
commercialize the device without a cleared AI-ECG algorithm and has made no commitment to, and has no timeline for, commercialization
of the device. The clearance does, however, broaden the potential options available to the Company for the device and its related intellectual
property, which the Company intends to evaluate.
Andrew Simpson, CEO of HeartSciences, said, “This clearance is
the result of several years of work by our clinical, regulatory and engineering teams, and I want to thank them for the quality and persistence
of that effort. Our commercial focus remains on MyoVista Insights, but clearance makes the device and the intellectual property behind
it a more readily realizable asset, and we will take the time to consider the best route to realizing that value.”
Proposed Transaction with Fortitude
The proposed business combination with Fortitude Mining Holdings, Inc.
(“Fortitude”), announced in June 2026 (the “Proposed Transaction”), continues to progress. The Company expects
to close the Proposed Transaction in Q4 calendar 2026, subject to customary closing conditions, including approval by HeartSciences’
shareholders.
About HeartSciences
HeartSciences is a healthcare information technology company advancing
the use of ECG/EKGs through the integration of artificial intelligence. HeartSciences’ MyoVista Insights™ Platform is a cloud-native,
vendor- and device-agnostic ECG management system designed to modernize ECG workflows and improve clinical efficiency and decision-making.
The platform’s AI-ECG marketplace is designed to deliver AI-ECG algorithms into clinical workflows across a health system’s
existing ECG equipment.
For more information, please visit www.heartsciences.com and follow
HeartSciences on X @HeartSciences.
About Fortitude
Fortitude, currently wholly-owned by Digital Currency Group, Inc. (“DCG”),
is an institutional-scale, vertically integrated venture mining platform operating across the Proof-of-Work ecosystem and anchored in
Zcash. Fortitude pairs self-mining operations with an owned data center footprint, a diversified power portfolio backed by competitive
long-term contracts, and disciplined capital allocation to identify and scale high-conviction opportunities in emerging Proof-of-Work
ecosystems, beginning with its leadership position in the Zcash network. Fortitude is led by an experienced team of operators, capital
markets professionals, and digital asset specialists with a track record of identifying and scaling high-conviction opportunities and
building privacy-preserving digital asset infrastructure.
For more information, visit www.fortitudemining.com and follow
Fortitude on X at @FortitudeCrypto
In the ordinary course of business, Fortitude currently sells or otherwise
monetizes all the digital assets that it mines, including ZEC. In addition, Fortitude and its affiliates and subsidiaries, including DCG,
from time to time sell, pledge or otherwise monetize their digital asset holdings, including ZEC. The funds received from such sales,
pledges, or other monetization activities are used to fund operating expenses and capital investments, as well as for other purposes,
including to hedge exposures and realize investment gains.
Cautionary Note Regarding Forward-Looking Information
This press release may contain forward-looking statements concerning
HeartSciences, Fortitude and the Proposed Transaction and other matters. These forward-looking statements generally can be identified
by the use of words such as “aim,” “anticipate,” “expect,” “plan,” “could,”
“may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,”
“potential,” “target,” “objective,” “intend,” and other words of similar meaning, but
the absence of these words does not mean that a statement is not forward-looking. All statements HeartSciences and/or Fortitude make in
communications that do not relate to matters of historical fact should be considered forward-looking statements.
These forward-looking statements are based on management’s current
expectations and assumptions as of the date of this press release and are subject to a number of known and unknown risks, uncertainties,
and other factors that could cause actual results to differ materially from those expressed or implied by such statements, which may include,
without limitation, the following: the risk that the Proposed Transaction may not be completed on the anticipated timeline or at all;
the failure to satisfy the conditions to the closing of the Proposed Transaction, including obtaining the requisite approval of HeartSciences’
shareholders; market, macroeconomic, or other conditions that could adversely affect either HeartSciences or Fortitude, or the combined
company; risks related to the integration of the two companies and the management of a newly public company; risks relating to Fortitude’s
operations and business, including the highly volatile nature of the price of Zcash and other cryptocurrencies; risks relating to significant
legal, commercial, regulatory and technical uncertainty regarding digital assets generally; risks relating to the commercialization of
MyoVista InsightsTM, including the rate of adoption by healthcare providers and the conversion of agreements into revenue;
and risks relating to the MyoVista wavECG device, including the Company’s ability to realize value from the device and related
intellectual property, and the recoverability of the related inventory. Additional factors that may cause actual results to differ materially
from those expressed or implied by the forward-looking statements in this press release are discussed in HeartSciences’ amended
preliminary proxy statement on Schedule 14A, filed with the U.S. Securities and Exchange Commission (the “SEC”) on October
6, 2026, in connection with the Proposed Transaction (the “Preliminary Proxy Statement”), HeartSciences’ 2026 Annual
Report on Form 10-K, filed with the SEC on July 23, 2026, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended
July 31, 2026, filed with the SEC on September 14, 2026, and its other reports filed with the SEC from time to time. Readers are cautioned
not to place undue reliance on these forward-looking statements. Each of HeartSciences and Fortitude expressly disclaims any obligation
to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required
by applicable law. All forward-looking statements are made as of the date of this press release.
Additional Information About the Proposed Transaction and Where
to Find It
This press release may be deemed solicitation material in respect of
the Proposed Transaction. In connection with the Proposed Transaction, HeartSciences has filed the Preliminary Proxy Statement and may
file additional relevant materials with the SEC. Following the filing of a definitive proxy statement with the SEC, HeartSciences will
mail the definitive proxy statement and a proxy card to each shareholder entitled to vote at the special meeting relating to the Proposed
Transaction. INVESTORS AND SHAREHOLDERS OF HEARTSCIENCES ARE URGED TO READ THESE MATERIALS (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO)
AND ANY OTHER RELEVANT DOCUMENTS IN CONNECTION WITH THE PROPOSED TRANSACTION THAT HEARTSCIENCES HAS FILED OR MAY FILE WITH THE SEC WHEN
THEY BECOME AVAILABLE BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT HEARTSCIENCES AND THE PROPOSED TRANSACTION. THIS PRESS RELEASE
DOES NOT CONTAIN ALL THE INFORMATION THAT SHOULD BE CONSIDERED CONCERNING THE PROPOSED TRANSACTION AND RELATED MATTERS AND IS NOT INTENDED
TO PROVIDE THE BASIS FOR ANY INVESTMENT DECISION OR ANY OTHER DECISION IN RESPECT OF SUCH MATTERS. The Preliminary Proxy Statement, the
definitive proxy statement and other relevant materials in connection with the Proposed Transaction (when they become available), and
any other documents filed by HeartSciences with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov. In
addition, investors and shareholders may obtain free copies of the documents filed with the SEC by sending a request to the HeartSciences
Investor Relations Department at investorrelations@heartsciences.com.
Participants in the Solicitation
HeartSciences and Fortitude, their respective directors and executive
officers, and certain executive officers of DCG may be deemed to be participants in the solicitation of proxies from HeartSciences’
shareholders with respect to the Proposed Transaction. Information regarding the identity of the potential participants, and their direct
or indirect interests in the Proposed Transaction, by security holdings or otherwise, is set forth in the Preliminary Proxy Statement
and other materials have been or may be filed with the SEC in connection with the Proposed Transaction.
No Offer or Solicitation
Any information contained herein is not intended to and does not constitute,
or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell
or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the Proposed Transaction
or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.
The Proposed Transaction will be implemented solely pursuant to the terms and conditions of the merger agreement, which contain the full
terms and conditions of the Proposed Transaction.
Investor Relations and Media Contacts:
HeartSciences
Integrous Communications
Mark Komonoski
Phone: 877-255-8483
Email: mkomonoski@integcom.us
