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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):
April 22, 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. |
The following information
is intended to be furnished under Item 2.02 of Form 8-K, “Results of Operations and Financial Condition.” This information
shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, (the “Exchange Act”),
or incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, whether made before or after the date
of this report, regardless of any general incorporation language in the filing. In a press release dated April 22, 2026, Picard Medical,
Inc. (the “Company”) announced preliminary unaudited top-line revenue results for the Company’s first quarter ended
March 31, 2026. The full text of the press release is furnished herewith as Exhibit 99.1 to this report.
| Item 9.01. |
Financial Statements and Exhibits. |
The following exhibits are being furnished herewith:
| Exhibit No. |
|
Description |
| 99.1 |
|
Picard Medical, Inc. Press Release dated April 22, 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: April 22, 2026
Exhibit 99.1
Picard
Medical / SynCardia Reports Revenue Growth
Based on Top-line Results for the First Quarter 2026
– Growth driven by increased U.S. demand and pricing –
TUCSON, Ariz., April 22, 2026 — Picard Medical, Inc. (NYSE American: PMI) (“Picard Medical” or the “Company”), parent company of SynCardia Systems, LLC, (“SynCardia”) maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today announced preliminary, unaudited top-line revenues for the first quarter ended March 31, 2026.
Revenue rose 79.9% to $1.1 million for the three months ended March 31, 2026, from $0.6 million for the three months ended March 31, 2025, reflecting higher utilization of the SynCardia Total Artificial Heart (“STAH”) and increased driver rental income.
Growth was driven by higher STAH sales, which was due to favorable reimbursement and economic conditions in the United States. The Company also implemented pricing adjustments for its driver rental program during the quarter, contributing to higher recurring revenue.
Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical, said, “Our preliminary revenue growth reflects progress across our commercial and operational initiatives, as well as increased utilization of our total artificial heart as a bridge to transplant. We remain focused on expanding patient access, supporting clinical partners, and advancing development of our next generation fully implantable total artificial heart platform.”
The revenue information in this release constitutes selected preliminary, unaudited financial data based on information available as of the date hereof and remains subject to the completion of the Company’s quarter-end financial close process and review. The Company’s independent registered public accounting firm has not audited, reviewed, or performed any procedures with respect to this preliminary financial data. Actual results may differ materially from these preliminary estimates.
Picard Medical expects to file its full financial results in its Quarterly Report on Form 10-Q with the Securities and Exchange Commission on or before May 15, 2026, and investors should review those materials for a comprehensive presentation of the Company’s results of operations and financial condition.
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 STAH 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 (the “SEC”) at www.sec.gov.
Forward-Looking Statements
This
press release includes 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 that involve risks and uncertainties. Forward-looking statements
are statements that are not historical facts. Forward-looking statements can often be identified by words such as “remain,”
“expand,” “expect” and “advance,” 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, expanding patient access, supporting clinical partners, and advancing development of our next generation fully
implantable total artificial heart platform. 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. Additional information
about the Company, including risk factors that may affect the Company’s business, financial condition, and results of operations,
is contained in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K and Quarterly Reports
on Form 10-Q, which are available free of charge on the SEC’s website at http://www.sec.gov and on the Company’s investor
relations website at https://picardmedical.com/.
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