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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):
September 9, 2026
PROFUSA, INC.
(Exact name of registrant as specified in its charter)
| Delaware |
|
001-41177 |
|
86-3437271 |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
626 Bancroft Way, Suite A
Berkeley, CA 94710
(Address of principal executive offices, including
zip code)
Registrant’s telephone number, including
area code: (925) 997-6925
345 Allerton Ave.
South San Francisco, California 94080
(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, par value $0.0001 per share |
|
PFSA |
|
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 8.01 — Other Events.
On September 9, 2026, Profusa, Inc. (the “Company”)
received a letter (the “Compliance Determination Letter”) from The Nasdaq Stock Market LLC (“Nasdaq”) confirming
that the Company has demonstrated compliance with Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”) and Nasdaq Listing
Rule 5550(b)(1) (the “Equity Rule”, and together with the Bid Price Rule, the “Listing Rules”).
The Compliance Determination Letter further informed
the Company that, pursuant to Nasdaq Listing Rule 5815(d)(4)(B), the Company will be subject to a one-year Mandatory Panel Monitor (the
“Monitoring Period”). During the Monitoring Period, if the Listing Qualifications Department of Nasdaq finds the Company again
out of compliance with the Equity Rule, then, notwithstanding Nasdaq Listing Rule 5810(c)(2), the Company will not be permitted to provide
the Listing Qualifications Department with a plan of compliance with respect to such deficiency and the Listing Qualifications Department
will not be permitted to grant additional time for the Company to regain compliance with respect to such deficiency, nor will the Company
be afforded a cure or compliance period pursuant to Nasdaq Listing Rule 5810(c)(3). Rather, the Listing Qualifications Department will
promptly issue a Staff Delisting Determination. The Company may, at that time, appeal the Staff Delisting Determination pursuant to the
procedures set forth in Nasdaq Listing Rule 5815.
The Company intends to continue to monitor its
compliance with all applicable Nasdaq continued listing requirements.
Forward-Looking Statements. This Current Report on Form 8-K may contain “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. All statements
contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements,
including, but not limited to, statements regarding the Company’s ability to maintain compliance with Nasdaq listing standards,
the Company’s plans to monitor its continued compliance, and the potential consequences of non-compliance during the Mandatory Panel
Monitor period. Words such as “anticipate,” “estimate,” “expect,” “intend,” “plan,”
and “project” and other similar words and expressions are intended to signify forward-looking statements. Forward-looking
statements are not guarantees of future results and conditions but rather are subject to various risks and uncertainties. Such statements
are based on management’s current expectations and are subject to a number of risks and uncertainties, many of which are beyond
management’s control, that could cause actual results to differ materially from those described in the forward-looking statements,
as well as risks relating to general economic conditions, market conditions, interest rates, and other factors. Investors are cautioned
that there can be no assurance actual results or business conditions will not differ materially from those projected or suggested in such
forward-looking statements as a result of various factors. Please refer to the risks detailed from time to time in the reports we file
with the SEC, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC, as well
as other filings on Form 10-Q and periodic filings on Form 8-K, for additional factors that could cause actual results to differ materially
from those stated or implied by such forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events, or otherwise, unless required by law.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release dated September 15, 2026. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL Document) |
SIGNATURE
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.
| September 15, 2026 |
Profusa, Inc. |
| |
|
|
| |
By: |
/s/ Jack Stover |
| |
Name: |
Jack Stover |
| |
Title: |
Chief Executive Officer |
Exhibit
99.1
Profusa,
Inc. Receives Nasdaq Compliance Determination
Berkeley, CA, Sept. 15, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA) (the “Company”) announced today that on September
9, 2026, the Company received a letter (the “Compliance Determination Letter”) from The Nasdaq Stock Market LLC (“Nasdaq”)
confirming that the Company has demonstrated compliance with Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”) and Nasdaq
Listing Rule 5550(b)(1) (the “Equity Rule”).
The
Company remains subject to a one-year Mandatory Panel Monitor (the “Monitoring Period”). If during the Monitoring Period
the Company fails to satisfy the equity rule, the company will not be provided the opportunity to submit a compliance plan; rather, Nasdaq
will issue a delist determination, which the company may appeal by requesting a hearing. Such request would stay any further action by
Nasdaq at least until the hearing is held and any extension granted by the Panel expires.
The
Company intends to continue to monitor its compliance with all applicable Nasdaq continued listing requirements.
About
Profusa, Inc.
Based
in Berkeley, California, Profusa is a digital health company pioneering next-generation biosensor technologies, previously announced
the signing of an Option Agreement (the “Agreement”) which provides Profusa the right and option, but not the obligation,
subject to satisfaction of certain conditions, to acquire G3 Vision Labs, Inc. and its subsidiaries (“G3"). Upon option exercising,
the combined company is expected to operate as a public diagnostics company.
Forward-Looking
Statements
Certain
statements in this press release (this “Press Release”) may be considered “forward-looking statements” within
the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking
statements in this press release include, without limitation, statements regarding the Company’s ability to maintain compliance
with Nasdaq listing standards, the Company’s plans to monitor its continued compliance, and the potential consequences of non-compliance
during the Mandatory Panel Monitor period. Forward-looking statements generally relate to future events or future financial or operating
performance of Profusa. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “forecast,” “future,”
“intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,”
“project,” “propose,” “seek,” “should,” “strive,” “will,” or
“would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are
subject to risks, uncertainties, and other factors which may be beyond the control of Profusa and could cause actual results to differ
materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates
and assumptions that, while considered reasonable by Profusa and its management, are inherently uncertain. Profusa cautions you that
these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently
uncertain. There are risks and uncertainties described in the Company’s Annual Report on Form 10-K for the year ended December
31, 2025, filed with the SEC, and in other documents filed by Profusa from time to time with the SEC. These filings may identify and
address other important risks and uncertainties that could cause actual events and results to differ materially from those contained
in the forward-looking statements. Profusa cannot assure you that the forward-looking statements in this communication will prove to
be accurate.
Investor
and Media Contacts:
email:
info@coreir.com
phone:
1(212) 655-0924
