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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 25, 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 2.02. |
Results of Operations and Financial Condition. |
On
March 25, 2026, Picard Medical, Inc. (the “Company”) issued a press release announcing the Company’s financial and
operating results for the fiscal year ended December 31, 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 furnished herewith:
| Exhibit No. |
|
Description |
| 99.1 |
|
Picard Medical, Inc. Press Release dated March 25, 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 25, 2026
Exhibit
99.1
Picard
Medical Reports Full Year 2025 Financial Results
–
Revenue Growth and Continued Adoption of SynCardia Total Artificial Heart –
TUCSON,
Ariz., March 25, 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 reported
financial results for the year ended December 31, 2025. The year reflected a transformational period for the Company highlighted by revenue
growth, improved operating performance, and a strengthened balance sheet following the successful completion of the Company public listing
and related capital raises.
Key
Financial Highlights
| ● | Revenue
of $4.9 million, an increase of 12.5 percent compared to 2024 |
| ● | Product
revenue of $4.7 million representing 96 percent of total revenue |
| ● | Gross
margin was (4.1 percent) compared to (2.6 percent) in 2024 |
| ● | Operating
loss was $(13.3) million compared to $(13.7) million in 2024 |
| ● | Net
loss was $(27.0) million compared to $(21.1) million in 2024 |
| ● | Cash,
cash equivalents and restricted cash of $11.5 million at year end compared to $0.1 million
(December 31, 2024) |
| ● | $17.4
million net proceeds raised from equity financings and $9.7 million net proceeds from debt
financing during 2025 |
| ● | Conversion
of convertible debt and elimination of derivative liabilities |
Management
Commentary
“2025
was a transformational year for Picard Medical, marked by our public listing, balance sheet restructuring, and revenue growth,”
said Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical. “We strengthened our financial position while continuing
to expand adoption of the SynCardia Total Artificial Heart. We will provide additional operational updates during our business update
call on Wednesday, March 25, 2026, at 4:30 p.m. EDT.”
To
register for the live webcast of the call, go to: https://lifescievents.com/event/gjpq036k/
An
online replay will be available shortly after the call on the Company’s website, picardmedical.com, and continue to be available
for 60 days.
Financial
Results
Revenue
Total
revenue for 2025 was $4.94 million, compared to $4.39 million in 2024, representing an increase of 12.5 percent. Product revenue was
$4.75 million, while rental revenue was $0.19 million. Product revenue was driven by continued adoption of the SynCardia Total Artificial
Heart across leading transplant centers. The SynCardia Total Artificial Heart remains the most widely used and clinically established
total artificial heart system globally, with more than 2,100 implants performed to date.
Gross
Profit (Loss)
Gross
loss was $(0.2) million, compared to $(0.1) million in 2024. Gross margin was (4.1 percent) compared to (2.6 percent) in the prior year.
Operating
Expenses
Operating
expenses were $13.1 million, compared to $13.6 million in 2024. Research and development expenses were $3.0 million, and selling, general
and administrative expenses were $10.0 million.
Operating
Profit (Loss)
Operating
loss was $(13.3) million, compared to $(13.7) million in 2024.
Net
Loss
Net
loss was $(27.0) million, compared to $(21.1) million in 2024.
Liquidity
and Capital Resources
Cash,
cash equivalents and restricted cash totaled $11.5 million as of December 31, 2025, compared to $0.1 million as of December 31, 2024.
Net
cash used in operating activities was $(15.7) million, while net cash provided by financing activities was $27.1 million.
Outlook
The
Company expects to continue investing in commercialization, manufacturing scale, and product development. Additional capital will be
required to support operations and execute the Company’s business plan.
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 contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are
based on management’s current expectations, assumptions and beliefs. Forward-looking statements can often be identified by words
such as “expect,” “will,” “continue,” and “plan,” and similar expressions, and variations
or negatives of these words. These statements include, but are not limited to, statements regarding the Company’s financial condition,
future operating results, expectations for growth, capital requirements, and the Company’s outlook and plan for future investing.
They are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause actual results to
differ materially from those expressed in any forward-looking statements and are encourage to review the Company’s most recent
Annual Report on Form 10-K and other filings with the SEC for a more complete discussion of the risks and other factors that could affect
any forward-looking statements. The statements made herein speak only as of the date of this release and except as required by law, the
Company does not undertake any obligation to publicly update or revise any forward-looking statements.
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
