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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):
March 20, 2026
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
March 20, 2026, Picard Medical, Inc. (the “Company”) issued a press release announcing that the Company will participate in
the American College of Cardiology’s Annual Scientific Session & Expo to be held March 28 to March 30, 2026, in New Orleans,
Louisiana. 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 March 20, 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, 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: March 20, 2026
Exhibit 99.1
Picard
Medical / SynCardia to Present its Next-Generation Emperor Total Artificial Heart Technology at the
American College of
Cardiology’s Annual Scientific Session
Poster presentation and conference exhibit will feature early preclinical data on the
Company’s fully implantable, autoregulating artificial heart platform
TUCSON,
Ariz., March 20, 2026 — Picard Medical, Inc. (NYSE American: PMI) (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 it will be presenting a poster consisting of new preclinical data related to its next-generation Emperor Total
Artificial Heart at the American College of Cardiology (ACC)’s Annual Scientific Session & Expo (ACC.26) to be held in New
Orleans, Louisiana from March 28 to March 30, 2026.
Abstract Poster Presentation – ACC.26
|
● |
Title: THE EMPEROR TOTAL ARTIFICIAL HEART: A FULLY IMPLANTABLE, AUTOREGULATING SOLUTION FOR ADVANCED HEART FAILURE |
|
● |
Date and Time: Sunday, March 29, 2026 | 11:00 a.m. – 12:00 p.m. |
|
● |
Location: Posters, Hall E |
|
● |
Presenter: Duffy Elmer, Engineering Project Manager, SynCardia LLC |
The poster will present early engineering and preclinical evaluation of the Emperor Total Artificial Heart, which is being developed as a fully implantable electromechanical artificial heart system intended to preserve the physiological autoregulation and hemodynamic performance of the currently approved SynCardia Total Artificial Heart while enabling fully implantable operation.
Exhibition Information
At ACC.26, SynCardia will also exhibit at booth #2554 throughout the conference.
Conference attendees are invited to visit the booth to meet with SynCardia’s engineering and clinical teams, and to learn more about the FDA approved SynCardia Total Artificial Heart, including its clinical use as a bridge to transplant for patients with advanced biventricular heart failure. Company representatives will also be available to discuss the design, development progress, and future clinical direction of the fully implantable Emperor Total Artificial Heart platform. The Company’s participation in the conference will provide an opportunity for clinicians, researchers, and industry participants to learn about SynCardia’s current clinical technology as well as its next-generation artificial heart development program.
Mr. Elmer, Engineering Project Manager, SynCardia LLC and presenter at the conference, commented, “The Emperor Total Artificial Heart represents the next evolution in total artificial heart therapy. The system is being designed to combine a fully implantable architecture with physiologic autoregulation in order to preserve the proven hemodynamic performance of the SynCardia Total Artificial Heart while enabling fully implantable long-term support. By building on the reliability and clinical experience of the SynCardia platform, the Emperor program aims to expand treatment options and improve mobility and quality of life for patients with advanced heart failure. We look forward to informing clinicians about this at the upcoming ACC conference.”
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 circulatory 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
