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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 17, 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 17, 2026, Picard Medical, Inc. (the “Company”) issued a press release announcing that a 29-year-old patient had been
sustained entirely by the SynCardia Total Artificial Heart while waiting for more than four years for a donor transplant. The patient
was implanted with the SynCardia Total Artificial Heart on September 2, 2021 and underwent a successful heart transplant on February
24, 2026 after over 1,600 days of continuous artificial heart support. 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 furnished herewith:
| Exhibit No. |
|
Description |
| 99.1 |
|
Picard Medical, Inc. Press Release dated March 17, 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 17, 2026
Exhibit
99.1
Picard
Medical / SynCardia Announce Successful Four-Year Bridge to Transplant with
SynCardia Total Artificial Heart Support
--
29-year-old patient supported for more than 1,600 days on the SynCardia Total Artificial
Heart before receiving a donor heart transplant
--
TUCSON,
Ariz., March 17, 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 that a 29-year-old patient successfully received a donor heart transplant after living for more than four years
supported entirely by the SynCardia Total Artificial Heart.
The
patient was implanted with the SynCardia Total Artificial Heart on September 2, 2021, after developing severe biventricular
heart failure. The device replaced the pumping function of both sides of the heart, maintaining circulation while the patient awaited
a donor organ. After 1,636 days of continuous artificial heart support, the patient underwent a successful heart transplant on
February 24, 2026.
“The
challenge in advanced heart failure is often the time required to find a suitable donor organ,” said Patrick NJ Schnegelsberg,
Chief Executive Officer of Picard Medical. “This case demonstrates how the SynCardia Total Artificial Heart can sustain critically
ill patients for extended periods, allowing them to live at home while awaiting heart transplantation.”
Total
artificial heart therapy is indicated as a bridge to transplant for patients with irreversible biventricular heart failure who
cannot be supported with isolated left ventricular assist device therapy. By replacing both ventricles and all four native heart
valves, the SynCardia Total Artificial Heart restores circulation and hemodynamic stability while patients await donor organ availability.
More
than 2,100 SynCardia Total Artificial Heart implants have been performed worldwide in patients with advanced biventricular heart
failure, with the longest documented patient support exceeding eight years on device.
While
individual outcomes may vary, extended duration support cases continue to inform clinical practice and illustrate the potential
for long term mechanical circulatory support in carefully selected patients.
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
