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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 26, 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 26, 2025, Picard Medical, Inc. issued a press release announcing that Duffy Elmer will present in vitro data on the Emperor Total Artificial Heart at the 31st Annual Meeting of the International Society for Mechanical Circulatory Support in Vienna, Austria between December 1 and 4, 2025. 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 26, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
|
|
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 26, 2025
|
|
Exhibit 99.1
Picard Medical to Present the Next Generation Fully Implantable SynCardia Total Artificial Heart at ISMCS 2025
Tucson, Ariz. Nov. 26, 2025 - Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today announced that it will present in vitro data on the fully implantable Emperor Total Artificial Heart (TAH) at the 31st Annual Meeting of the International Society for Mechanical Circulatory Support (ISMCS 2025), held in Vienna, Austria from December 1st through 4th, 2025.
Details of the presentation are below:
Date: Thursday, December 4, 2025
Time: 14:05 Central European Time (CET).
Session: Mini Oral Session 3: Hemocompatibility and Heart/Pump Interaction
Presentation Title: “The Emperor Total Artificial Heart: A Next Generation, Fully Implantable Total Artificial Heart”
Presenter: Duffy Elmer, Engineering Project Manager, Picard Medical, Inc.
The presentation will highlight benchtop performance data from the Emperor, SynCardia’s fully implantable next generation Total Artificial Heart platform. The system uses an internal motor driven design that eliminates the need for any external pneumatic driver and is engineered to significantly improve patient mobility and quality of life.
About ISMCS 2025
ISMCS 2025 is the 31st annual global congress of the International Society for Mechanical Circulatory Support. The meeting brings together researchers, clinicians, engineers and industry leaders in mechanical circulatory support. It provides a forum to review new clinical research, discuss emerging technologies, and highlight next generation device innovations.
About Picard Medical and SynCardia
Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the SynCardia Total Artificial Heart is the most widely used and extensively studied artificial heart in the world.
For additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission at www.sec.gov.
Forward-Looking Statements
This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Registration Statement and related prospectus filed in connection with the initial public offering with the SEC. Copies are available on the SEC’s website, http://www.sec.gov.
Contact:
Investors
Eric Ribner
Managing Director
LifeSci Advisors LLC
eric@lifesciadvisors.com
Picard
Medical, Inc./SynCardia Systems, LLC
IR@picardmedical.com
General/Media
Brittany Lanza
blanza@syncardia.com