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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): May 15, 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 May 21, 2026, Picard Medical, Inc. (the “Company”) announced
financial 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 3.01. |
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing. |
On May 15, 2026, the Company
received a written notice (the “May 15 Notice”) from the NYSE American LLC (the “NYSE American”) indicating that
the Company is not in compliance with the NYSE American continued listing standards set forth in Section 1003(a)(i) of the NYSE American
Company Guide (the “Company Guide”), which requires a listed company to have stockholders’ equity of at least of $2.0
million if it has reported losses from continuing operations and/or net losses in two of its three most recent fiscal years. The May 15
Notice states that the Company reported a stockholders’ deficit of approximately $1.4 million as of March 31, 2026 and has incurred
losses from continuing operations and/or net losses in its three most recent fiscal years ended December 31, 2025.
Additionally, as previously disclosed, on May
8, 2026, the Company received a notice that it was not in compliance with Section 1003(a)(ii) (the “May 8 Notice,” and together
with the May 15 Notice, the “Notices”). In connection with the Notices, the
Company must submit a plan (the “Plan”) to the NYSE American by June 7, 2026, advising of actions it has taken or will take
to regain compliance with the continued listing standards by November 8, 2027.
The Company is preparing its Plan in accordance
with the June 7, 2026 deadline. If NYSE American accepts the Company’s Plan, the Company will be able to continue its listing during
the Plan period and will be subject to continued periodic review by the NYSE American staff. If the Plan is not submitted, not accepted,
or is accepted but the Company is not in compliance with the continued listing standards by November 8, 2027, or if the Company does not
make progress consistent with the Plan during the Plan period, the Company will be subject to delisting procedures as set forth in the
Company Guide.
The Notice has no immediate effect on the listing
or trading of the Company’s common stock, which will continue to trade on the NYSE American under the symbol “PMI” with
the added designation of “.BC” (which was applied following the May 8 Notice). The Notice does not affect the Company’s
ongoing business operations or its reporting requirements with the SEC.
| Item 7.01. |
Regulation FD Disclosure. |
On May 21, 2026, the Company issued a press release disclosing receipt of the Notices and the specific continued listing standards that the Company has fallen
below. A copy of the press release is furnished as Exhibit 99.1 and incorporated herein by reference.
The information included in Item 7.01,
including the exhibit hereto, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the
Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any
filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date
hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific
reference in such filing
| Item 9.01. |
Financial Statements and Exhibits. |
The following exhibits are being filed herewith:
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release, dated May 21, 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: May 21, 2026
Exhibit 99.1
Picard
Medical / SynCardia Reports First Quarter 2026 Financial Results
– Gross profit turns positive; Company executes significant
debt reduction –
– Responds to NYSE American continued listing
notice –
TUCSON, Ariz., May 21, 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, reported financial results for
the first quarter ended March 31, 2026.
“We continue to make progress across both our commercial and
strategic priorities,” said Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical Inc. “During and the quarter,
we improved gross margin performance, reduced outstanding debt obligations, strengthened our capital structure, and continued advancing
development of the Emperor Total Artificial Heart alongside expansion of our SynCardia commercial activities.”
Mr. Schnegelsberg added, “The quarter was highlighted by year-over-year
revenue growth, a return to positive gross profit, and strengthening the Company’s balance sheet through significant debt reduction,
while the Company continued to invest in research and development, manufacturing, and clinical support initiatives across its Total Artificial
Heart platform.”
First Quarter 2026 Financial Highlights
Revenue grew 85% to $1.2 million for the first quarter of 2026 compared
to $0.6 million in the first quarter of 2025, reflecting increased utilization of the SynCardia Total Artificial Heart and continued growth
in U.S. commercial activity. Product revenue increased 54% to $0.9 million, while Freedom Driver rental revenue grew to $0.2 million from
$7,000 in the prior year period. Gross profit improved to $0.3 million, reflecting a gross margin of 24%, compared to a gross loss of
$0.4 million and a negative 58% margin in Q1 2025. Net loss was $7.6 million, including significant non-cash charges related to debt settlement
and fair value adjustments.
Balance Sheet and Capital Structure
During the quarter, the Company took several actions to reduce leverage
and strengthen its capital structure. The Company repaid approximately $7.4 million of a senior secured note due 2028 (the “Senior
Secured Note”) principal in cash, settled an additional $2.1 million of principal of the Senior Secured Note through the issuance
of 1.4 million shares of the Company’s common stock (the “Common Stock”), and repaid approximately $0.9 million of related-party
debt. The warrant liability decreased from approximately $7.8 million to approximately $4.7 million, reflecting a reduction in the fair
value of outstanding warrants driven by fluctuating changes in the Company's stock price and volatility during the quarter.
Subsequent to quarter end, the Company completed a public offering
in May 2026, raising gross proceeds of $5.0 million. The Company also entered into a warrant exchange agreement replacing 7.0 million
existing warrants at a $2.675 exercise price with 10.0 million new warrants at a $0.35 exercise price, eliminating the prior ratchet provisions
and simplifying the capital structure. The remaining Senior Secured Note balance was substantially reduced through a combination of cash
payments, equity settlements, and a cashless transaction to approximately $1.3 million.
NYSE American Listing Standards Notices
As previously disclosed on a Current Report on Form 8-K, filed with
the Securities and Exchange Commission on May 11, 2026, on May 8, 2026 the Company received a written notice from the NYSE American LLC
(the “NYSE American”) notifying it of non-compliance with Section 1003(a)(ii) of the NYSE American Company Guide (the “Company
Guide”), which requires listed companies to maintain stockholders' equity of at least $4.0 million if losses from continuing operations
and/or net losses have been reported in three of the four most recent fiscal years. The determination was based on reported stockholders'
equity of approximately $3.8 million as of December 31, 2025, and losses from continuing operations and/or net losses in three of its
four most recent fiscal years.
On May 15, 2026, the Company received a second written notice from
NYSE American, notifying it of non-compliance with Section 1003(a)(i) of the Company Guide, which requires stockholders' equity of at
least $2.0 million if such losses have been reported in two of the three most recent fiscal years. The determination was based on a reported
stockholders' deficit of approximately $(1.4) million as of March 31, 2026, and losses in two of the three most recent fiscal years.
Pursuant to Section 1009 of the Company Guide, the Company has until
June 7, 2026 to submit a compliance plan outlining steps to regain compliance by November 8, 2027 (the “Plan”). The Company
is actively preparing the Plan with its financial and legal advisors and intends to submit the Plan by the deadline.
The notices do not have an immediate effect on the listing or trading
of the Common Stock on NYSE American. In accordance with NYSE American procedures, a “.BC” indicator has been appended to
the Company’s trading symbol to indicate the status of the Common Stock as “below compliance.”
Operational and Strategic Update
During the first quarter of 2026, the Company advanced execution across
its core operational priorities.
Commercial activity remained focused on expanding patient access to
the SynCardia Total Artificial Heart at transplant centers across the United States. Utilization of the Freedom Driver rental program
increased meaningfully during the quarter, contributing to rental revenue growth and expanding the Company's recurring revenue base. Clinical
support and training initiatives continued across certified U.S. transplant centers, with targeted engagement at high-volume accounts
to support procedural readiness and patient outcomes.
On the product development front, the Company continued investment
in next-generation driver technologies and the Emperor Total Artificial Heart, its fully implantable, driverless artificial heart currently
in development and targeting a 2028 clinical study launch.
The Company also continued strengthening quality systems and operational
infrastructure to support scalability, regulatory compliance, and Medical Device Single Audit Program readiness.
Outlook
The Company remains focused on expanding utilization of the SynCardia
Total Artificial Heart, advancing development of the Emperor Total Artificial Heart, its next generation fully implantable artificial
heart, targeting a 2028 clinical study launch, improving manufacturing efficiency, and strengthening its commercial and financial position.
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
“continue,” “remain,” “expand,” “advance,” “target,”
“intend” 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 expanding
utilization of the SynCardia Total Artificial Heart and expanding patient access at transplant centers across the United States;
advancing development of the Emperor Total Artificial Heart and targeting a 2028 clinical study launch; improving manufacturing
efficiency; strengthening the Company’s commercial and financial position and capital structure; continued investment in
next-generation driver technologies; the Company’s intent to submit a compliance plan to NYSE American by the applicable
deadline; and the Company’s ability to regain compliance with NYSE American listing standards. 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
