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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):
February 11, 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
Not Applicable
(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 1.01. Entry into a Material Definitive
Agreement.
On February 11, 2026, Profusa, Inc. (the “Company”)
entered into a know-how license agreement (the “License Agreement”) with Mayo Foundation for Medical Education and Research
(“Mayo”).
Under the License Agreement, Mayo granted the
Company an exclusive, worldwide license (with the right to sublicense) to certain patent rights and a non-exclusive license to related
know-how in the fields of continuous oxygen measurement tools and Critical Limb-Threatening Ischemia (CLTI), including use with the Company’s
Lumee product and future versions. The License Agreement has a term ending upon the later of the expiration of the last relevant patent
or the 15th anniversary of the first commercial sale of the last launched licensed product, after which the license becomes fully paid-up
if the Company has met its obligations.
Mayo will provide reasonable access to its investigators
to facilitate know-how transfer. Sublicensing requires Mayo’s prior written approval and must meet specified conditions.
Financial terms include royalties on net sales
of licensed products, milestone payments upon achievement of specified development and commercialization events, and a share of sublicense
income. The Company is required to provide regular royalty reports and maintain records subject to audit.
The foregoing description of the License Agreement
is a summary only, does not purport to be complete, and is qualified in its entirety by reference to the full text of the agreement, a
copy of which is filed (with certain portions redacted in accordance with Item 601(b)(10)(iv) of Regulation S-K) herewith as
Exhibit 10.1 and is incorporated herein by reference.
Item 8.01. Other Events.
On February 12, 2026, the Company issued a press
release announcing its entry into the License Agreement. A copy of the press release is filed herewith as Exhibit 99.1 to this Current
Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
| Exhibit |
|
Description |
| 10.1 |
|
Know-How License Agreement, dated February 11, 2026, by and between Profusa, Inc. and Mayo Foundation for Medical Education and Research |
| 99.1 |
|
Press Release |
| 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.
| February 13, 2026 |
Profusa, Inc. |
| |
|
|
| |
By: |
/s/ Ben Hwang |
| |
Name: |
Ben Hwang |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
Profusa and Mayo Clinic collaborate to Advance High-Impact Clinical
Applications of Oxygen Monitoring Technologies
February 12, 2026
Collaboration with Mayo Clinic aims to accelerate regulatory approval
and commercialization of Lumee™ wearable continuous tissue oxygen monitoring product
Seeking to develop and commercialize new tethered continuous oxygen
monitoring products for high impact clinical applications
BERKELEY, Calif, Feb. 12, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (“Profusa”
or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering the next generation of technology platform
seeking to enable the continuous monitoring of an individual’s biochemistry, has entered into a know-how agreement with Mayo Clinic.
The collaboration entails investigation of high impact clinical applications of Profusa’s oxygen monitoring technologies for new
product development and commercialization. Potential target indications include cardiovascular, renal, multi-organ, and orthopedic
applications, among others, where intra-organ postoperative perfusion monitoring has potential to improve clinical outcomes. The collaboration
also supports Profusa’s potential commercialization of Lumee oxygen sensing and tissue monitoring technology for critical limb ischemia
in the U.S.
Michael Kendrick, M.D., Chair of Department of Surgery at Mayo Clinic,
Rochester, Minn., said, “Oxygen is essential for cellular metabolism and tissue repair, with lack of sufficient oxygenation impairing
wound healing, increasing risk of infection, and contributing to complications common to surgery, such as leakage and anastomotic structure.
Our collaboration gives us the opportunity to leverage their innovative platform to potentially address unmet clinical challenges, including
the ability to monitor beyond subcutaneous tissue.”
“Following more than a decade of development and over $100 million
in investment, our Lumee technology enables continuous, real-time measurement of tissue oxygen directly within the body, which we believe
to be a first-of-its-kind, disruptive biochemistry monitoring platform. In addition, we are committed to continue to harness our platform
technology for innovative solutions that seek to both address large unmet clinical needs and reduce costs for healthcare systems through
earlier detection and improved disease management. We look forward to collaborating with Mayo Clinic for the U.S. commercialization
of Lumee for critical limb ischemia, and developing products to address new indications to expand our oxygen tissue monitoring technology’s
market and therapeutic reach.”, said Ben Hwang, Ph.D., Profusa’s Chairman and CEO.
Mayo Clinic has a financial interest in the technology referenced in
this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education,
and research.
About Profusa
Based in Berkeley, Calif.,
Profusa is a commercial stage digital health company led by visionary scientific founders, an experienced management team and a world-class
board of directors in the development of a new generation of tissue-integrated sensors to detect and continuously transmit actionable,
medical-grade data for personal and medical use. With its long-lasting, injectable and affordable biosensors and its intelligent data
platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians can trust and rely
on.
“LUMEE”, “PROFUSA” and the PROFUSA logo are
registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.
For more information, visit https://profusa.com.
Special Note Regarding 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
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 definitive proxy/final
prospectus relating to the business combination, which has been 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.
Contacts
Investor and Media Contacts
email: nfo@coreir.com
phone: 1 (212) 655-0924
