[8-K] Picard Medical, Inc. Reports Material Event

Rhea-AI Filing Summary

Picard Medical, Inc. reported that its wholly owned subsidiary, SynCardia Systems LLC, has completed the first in vivo implantations of the Emperor Total Artificial Heart. This marks an important clinical milestone for the company’s artificial heart technology, moving it from development toward real-world use in living subjects.

The announcement was made through a press release furnished as an exhibit to this current report. The disclosure is informational and is stated as being furnished rather than filed under securities laws, which limits how it is incorporated into other regulatory documents.

Insights

Medical device and SEC disclosure analyst

Picard reports first in vivo use of its Emperor artificial heart.

Picard Medical states that SynCardia Systems LLC, its wholly owned subsidiary, has completed the first in vivo implantations of the Emperor Total Artificial Heart. Moving a total artificial heart into implantation in living subjects is a key step in the clinical development path for a complex medical device, following earlier lab and preclinical work.

The event is communicated via a press release furnished as an exhibit to a current report, which indicates a focus on timely transparency rather than detailed financial disclosure. The report does not provide revenue figures, cost data, or regulatory status, so the direct financial impact is not quantified here. Future company communications may clarify how these implantations relate to broader clinical programs or commercialization plans.

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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): November 19, 2025

Picard Medical, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-42801		86-3212894
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

1992 E Silverlake
Tucson AZ, 85713

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (520) 545-1234

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		PMI		The NYSE American, 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 November 19, 2025, Picard Medical, Inc. issued a press release announcing that SynCardia Systems LLC, its wholly owned subsidiary, completed the first in vivo implantations of the Emperor Total Artificial Heart. A copy of the press release is furnished as Exhibit 99.1 and incorporated by reference herein.

The information in this report and the exhibits attached hereto shall not be deemed to be “filed” for purposes of the Securities Exchange Act of 1934 (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 Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

The following exhibits are being filed herewith:

Exhibit No.		Description
99.1		Picard Medical, Inc. Press Release dated November 19, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURE

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.

Picard Medical, Inc.
By:	/s/ Patrick NJ Schnegelsberg
	Name:	Patrick NJ Schnegelsberg
	Title:	Chief Executive Officer

Dated: November 19, 2025

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FAQ

What did Picard Medical (PMI) announce in this 8-K filing?

Picard Medical announced that its wholly owned subsidiary, SynCardia Systems LLC, completed the first in vivo implantations of the Emperor Total Artificial Heart.

Which Picard Medical subsidiary performed the Emperor Total Artificial Heart implantations?

The first in vivo implantations were completed by SynCardia Systems LLC, a wholly owned subsidiary of Picard Medical, Inc..

What is the Emperor Total Artificial Heart mentioned by Picard Medical (PMI)?

The Emperor Total Artificial Heart is Picard Medical’s artificial heart technology developed through its subsidiary SynCardia Systems LLC, which has now been implanted in vivo for the first time.

How was the Emperor Total Artificial Heart milestone disclosed by Picard Medical?

Picard Medical disclosed the milestone through a press release, which was furnished as Exhibit 99.1 to this current report.

Does this Picard Medical 8-K filing include financial or earnings data?

The report focuses on the clinical milestone of first in vivo implantations of the Emperor Total Artificial Heart and does not include earnings or detailed financial data.

Is the press release about Picard Medical’s Emperor Total Artificial Heart considered filed with the SEC?

The company states that the information in this report and its exhibits is furnished, not “filed,” and is not automatically incorporated into other securities law filings.