Form 8-K

8-K — Profusa, Inc.

Accession: 0001213900-26-053535

Filed: 2026-05-08

Period: 2026-05-06

CIK: 0001859807

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0289597-8k_profusa.htm (Primary)

EX-99.1 — PRESS RELEASE (ea028959701ex99-1.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — CURRENT REPORT

8-K (Primary)

Filename: ea0289597-8k_profusa.htm · Sequence: 1

false

0001859807

2026-05-06

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

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): May 6, 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

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 ☒

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.

May 6, 2026, Profusa, Inc. (the “Company”) received a decision letter from the Nasdaq Hearings Panel (the “Panel”)

of The Nasdaq Stock Market LLC (“Nasdaq”) granting the Company an exception to continue its listing on Nasdaq, subject to

certain interim milestones and the Company’s compliance with Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”)

and Nasdaq Listing Rule 5550(b)(2) (the “Equity Rule”) in lieu of compliance with the market value of listed securities alternative

under Nasdaq Listing Rule 5550(b)(1) by July 6, 2026 (the “Decision Letter”).

The

Decision Letter further provides that during the exception period the Company must promptly notify Nasdaq of any significant events that

may affect the Company’s ability to meet the terms of the exception, and that the Panel may reconsider the terms of the exception

based on subsequent developments. The Decision Letter also notifies the Company of its right to request review by the Nasdaq Listing

and Hearing Review Council by submitting a written request for review within 15 days of the date of the Decision Letter and paying the

required fee.

The

Company is evaluating the conditions set forth in the Decision Letter and intends to take the actions necessary to seek to evidence compliance

with all applicable listing criteria within the time periods specified by the Panel. There can be no assurance that the Company will

be able to do so.

May 8, 2026, the Company issued a press release announcing the Decision Letter. 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.

Forward-Looking

Statements

This

Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of

1995, including, without limitation, statements regarding the Company’s plans and intentions to satisfy the conditions set forth

in the Decision Letter, its efforts to regain compliance with Nasdaq listing standards, the timing and outcome of any reverse stock split,

financings or other transactions, and the Company’s ability to maintain its Nasdaq listing. Words such as “anticipate,”

“believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,”

“seek,” “should,” “will,” and similar expressions are intended to identify forward-looking statements.

Forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results

to differ materially from those described in such statements, including but not limited to the Company’s ability to obtain the

required stockholder approvals, execute its compliance plan within the timeframes specified by the Panel, effect and maintain compliance

with the Bid Price Rule and other applicable listing requirements, complete anticipated transactions, and other factors described in

the Company’s filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form

10-K for the year ended December 31, 2025, and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company

undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise,

except as required by law.

Item

9.01. Financial Statements and Exhibits.

Exhibit

Description

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.

May 8, 2026

Profusa, Inc.

By:

/s/ Ben

Hwang

Name:

Ben Hwang

Title:

Chief Executive Officer

EX-99.1 — PRESS RELEASE

EX-99.1

Filename: ea028959701ex99-1.htm · Sequence: 2

Exhibit 99.1

Profusa Receives Favorable Nasdaq Listing Determination

BERKELEY, CA, May 8, 2026 (GLOBE NEWSWIRE) —

Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a digital health company pioneering the next generation

of technology platform enabling the continuous monitoring of an individual’s biochemistry, announced that, by letter dated May

6, 2026, the Nasdaq Hearings Panel granted the Company’s request to transfer the listing of its securities from The Nasdaq Global

Market to The Nasdaq Capital Market. The Company’s continued listing on Nasdaq is subject to the Company’s satisfaction of

certain interim milestones and, ultimately, the Company’s compliance with the bid price and stockholders’ equity requirements

for continued listing on the Capital Market tier by July 6, 2026.

About Profusa

Based in Berkeley, CA, 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 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. Forward-looking

statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially

from those described in such statements, including but not limited to the Company’s ability to obtain the required stockholder

approvals, execute its compliance plan within the timeframes specified by the Panel, effect and maintain compliance with the Bid Price

Rule and other applicable listing requirements, complete anticipated transactions, and other factors described in the Company’s

filings with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended

December 31, 2025, and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company undertakes no obligation

to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Contacts

Investor and Media Contacts

email: info@coreir.com

phone: 1 (212) 655-0924

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 7

v3.26.1

Cover

May 06, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

May 06, 2026

Entity File Number

001-41177

Entity Registrant Name

PROFUSA,

INC.

Entity Central Index Key

0001859807

Entity Tax Identification Number

86-3437271

Entity Incorporation, State or Country Code

Entity Address, Address Line One

626

Bancroft Way

Entity Address, Address Line Two

Suite

Entity Address, City or Town

Berkeley

Entity Address, State or Province

Entity Address, Postal Zip Code

94710

City Area Code

925

Local Phone Number

997-6925

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common

Stock, par value $0.0001 per share

Trading Symbol

PFSA

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

true

Elected Not To Use the Extended Transition Period

false

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 2 such as Street or Suite number

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine2

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 7A

-Section B

-Subsection 2

+ Details

Name:

dei_EntityExTransitionPeriod

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration