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:
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).
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.
On
May 29, 2026, Picard Medical, Inc. (the “Company”) issued a press release (the “Press Release”) featuring a letter
from Richard Fang, Chairman of the Company’s Board of Directors, addressed to the Company’s stockholders. 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.
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.
Exhibit 99.1
PICARD MEDICAL, INC. Issues
Letter to Shareholders
TUCSON, Ariz., May 29,
2026 — Picard Medical, Inc. (NYSE American: PMI) (the “Company” or “Picard Medical”), parent company of
SynCardia Systems LLC, maker of the world’s first and only total artificial heart approved by both the U.S. FDA and Health Canada,
today issued the following letter to shareholders:
Dear Shareholders,
Picard Medical, Inc. (NYSE
American: PMI) (“Picard Medical” or the “Company”), the parent company of SynCardia Systems LLC, is focused on
advancing life-saving technologies for patients with end-stage heart failure while building long-term value for our shareholders. That
mission continues to guide our strategy, and the progress we have made since 2025 — commercially, scientifically, and operationally
— gives me confidence in the direction of the Company. I want to express my excitement in that direction by giving you a recap
of our past accomplishments and our vision for the future.
A Transformational 2025
— and a Strong Start to 2026
2025 was a transformational
year for the Company. Total revenue reached $4.9 million, up 12.5%, with product revenue of $4.7 million representing 96% of total revenue.
Our initial public offering on NYSE American raised $17.4 million in net equity proceeds, and we raised an additional $9.7 million in
debt financing, ending the year with $11.5 million in cash, compared to $0.1 million at year-end 2024.
We also took meaningful steps
to strengthen and simplify our balance sheet by converting certain convertible debt, eliminating derivative liabilities, and reducing
financing-related complexity.
That momentum has continued
into 2026. First quarter revenue grew 85% to $1.2 million, and gross profit turned positive at a 24% margin, compared to a gross loss
and negative 58% margin in the first quarter of 2025. During the quarter, the Company repaid approximately $7.4 million of senior secured
debt principal in cash and settled an additional $2.1 million through equity. Subsequent to quarter end, we raised an additional $5.0
million in gross proceeds through a public offering and entered into a warrant exchange agreement that eliminated prior ratchet provisions
and further simplified our capital structure.
While we are not yet profitable,
and our auditors included a going-concern qualification in our 2025 financial statements, we believe the debt reduction, improved gross
margins, and capital structure initiatives already achieved in 2026 represent meaningful progress toward addressing those issues.
Our Product — A Life-Saving
Solution for Heart Transplant Patients
The SynCardia Total Artificial
Heart (“SynCardia TAH”) is the only FDA- and Health Canada-approved total artificial heart for end-stage biventricular heart
failure, with more than 2,100 implants performed across 27 countries, making it the most widely used and clinically established system
of its kind globally (SynCardia Systems, LLC; PMI SEC filings). The SynCardia TAH continues to support patients at leading centers including
UCSF, Cedars-Sinai, and Banner Health, and we are continuing to deepen those partnerships through dedicated clinical support and training.
The need for effective treatment
options remains significant. According to the Organ Procurement and Transplantation Network (OPTN), more than 7,500 patients are currently
on the U.S. heart transplant waiting list (OPTN/SRTR Annual Data Report 2022 – Heart). While 4,572 heart transplants were performed
in the United States in 2024, compared to 4,545 in 2023, supply remains largely unchanged despite persistent demand growth (HRSA Organ
Transplant News Release).
Many patients with end-stage
biventricular heart failure will not receive a donor heart in time. For a portion of those patients, the SynCardia TAH may represent
the only viable option for survival, and we intend to continue expanding patient access wherever possible.
The Emperor: Our Next-Generation,
Fully Implantable Heart
Our research and development
team continues to make encouraging progress on the Emperor TAH, our fully implantable, driverless, next-generation system. First-in-animal
trials began in November 2025, and the Emperor TAH has achieved pulsatile flow rates consistent with our current SynCardia TAH platform.
Earlier this year, we created improvements for a second-generation Emperor TAH and animal testing of this model was successfully completed
last week. We expect to share additional information about this animal study in the near future.
The Emperor TAH is protected
by multiple U.S. patents and a China National Intellectual Property Administration patent. Subject to successful non-clinical testing
and regulatory review, we may seek approval as early as 2028, although the regulatory process is inherently unpredictable, and there
can be no assurance regarding timing or approval outcomes.
Roadmap to Profitability
We remain focused on improving
the Company’s financial performance and believe we have a clear path toward long-term sustainability through four primary initiatives:
Gross margin expansion.
First quarter gross margin improvement to 24% is an important step forward. We intend to continue reducing per-unit costs, scaling manufacturing
capacity toward 3,000 units per year, and advancing a next-generation lower-cost driver targeted for FDA submission in late 2027.
Operational efficiency.
We are leveraging our R&D capabilities in Australia and expanding manufacturing partnerships to support a more responsive and efficient
global supply chain.
Expanded indications.
We are awaiting an FDA decision on our pending premarket approval supplement, which would expand indications to include bridge-to-candidacy
patients and remove the “imminent death” language from the indications for use. We believe approval could materially expand
the eligible patient population.
Commercial execution.
Our sales and clinical teams continue to build relationships with high-volume transplant centers across the United States, with a focus
on procedural readiness, clinical evidence, and patient outcomes.
NYSE American Listing
In May 2026, we received
notices from NYSE American regarding stockholders’ equity requirements. We have until June 7, 2026 to submit a compliance
plan, which we are actively preparing with our financial and legal advisors.
The Company has recently taken
several steps intended to strengthen its balance sheet and improve stockholders’ equity, including completing an equity financing
in May 2026, reducing outstanding liabilities through debt repayment and other settlements, implementing cost reduction initiatives,
and continuing to focus on revenue growth and gross margin improvement.
We remain committed to maintaining
our listing and acting in the long-term interests of our shareholders.
In Closing
Picard Medical stands at an
important point in its development as both a medical technology company and a public company. We believe we are advancing technologies
that have the potential to redefine treatment options for patients facing end-stage heart failure, while also building a stronger operational
and financial foundation for the future.
Every SynCardia TAH implanted
represents a patient given additional time and another opportunity for transplant or recovery. At the same time, every operational improvement,
clinical milestone, and strategic investment is intended to strengthen the Company for the long term.
Your support and confidence
are deeply appreciated. We remain committed to disciplined execution, scientific innovation, and creating lasting value for both patients
and shareholders.
Sincerely,
Richard Fang, Ph.D., MBA
Chairman of the Board
Picard Medical, Inc. (NYSE
American: PMI)
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 "believe," "expect," "intend,"
"may," "target," "commit," and similar expressions, and variations or negatives of these words.
These statements include,
but are not limited to, statements regarding: the Company’s expectations regarding its path to profitability, including gross
margin expansion, per-unit cost reductions, and scaling manufacturing capacity toward 3,000 units per year; the development,
targeted timeline for FDA submission in late 2027, and commercial potential of a next-generation lower-cost driver; the
Company’s intent to reach more patients and expand utilization of the SynCardia Total Artificial Heart at transplant centers
across the United States; expectations regarding clinical partnerships at high-volume transplant centers and their impact on
adoption; the development of the Emperor Total Artificial Heart, including expectations for sharing animal study data, seeking
regulatory approval as early as 2028, and the inherent unpredictability of the regulatory process; the Company’s expectation
of a decision from the FDA on its pending premarket approval supplement adding bridge-to-candidacy patients and the belief that
approval would materially increase the eligible patient population; the Company’s roadmap to profitability, the
Company’s plans to leverage R&D capabilities in Australia and expand manufacturing partnerships to build a more responsive
global supply chain; the Company’s intent to submit a compliance plan to NYSE American by the applicable deadline and its
commitment to maintaining its listing; the Company’s ability to regain compliance with NYSE American listing standards; and
the Company’s belief that it is redefining what is possible for patients with end-stage heart failure.
Such forward-looking statements
are subject to risks and uncertainties, which could cause actual results to differ materially from the forward-looking statements. These
risks include, but are not limited to: the Company’s ability to achieve or maintain profitability; the Company’s ability
to resolve the going-concern qualification in its financial statements; risks related to the development and regulatory approval of the
Emperor Total Artificial Heart and the next-generation driver, including the possibility that regulatory approval may take longer than
planned or may not be obtained at all; the Company’s ability to expand utilization of the SynCardia Total Artificial Heart and
obtain FDA approval of its pending premarket approval supplement; the Company’s ability to reduce per-unit costs, scale manufacturing
capacity, and improve gross margins; the Company’s ability to submit a compliance plan acceptable to NYSE American and regain compliance
with applicable listing standards; and the Company’s ability to raise additional capital and maintain adequate liquidity.
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
