Second UCSF artificial heart bridge case for Picard Medical (NYSE: PMI)

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Picard Medical, Inc. filed an 8-K to share a clinical milestone for its SynCardia Total Artificial Heart. UCSF Health successfully supported a male patient in his twenties with advanced biventricular heart failure for 119 days on the device before a heart transplant on March 14, 2026.

This is the second of five UCSF patients successfully bridged to transplant using the SynCardia Total Artificial Heart, underscoring its role for end-stage heart failure patients awaiting donor organs. SynCardia’s system is described as the only commercially available total artificial heart in the United States and Canada, with more than 2,100 implants across 27 countries.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

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Accepted by SEC EDGAR 03/19/2026 - 08:16 AM

FAQ

What did Picard Medical (PMI) announce in its latest 8-K filing?

Picard Medical reported that UCSF Health used the SynCardia Total Artificial Heart to support a young patient with advanced biventricular heart failure for 119 days before a successful heart transplant, highlighting a notable bridge-to-transplant case and growing clinical experience with the technology.

How long was the UCSF patient supported by Picard Medical’s SynCardia Total Artificial Heart?

The UCSF patient was supported for 119 days with the SynCardia Total Artificial Heart before undergoing heart transplantation. This extended support period illustrates the device’s role in maintaining full circulatory function for end-stage heart failure patients while they wait for a suitable donor organ.

How many UCSF patients have been bridged to transplant with the SynCardia Total Artificial Heart?

The filing notes that this case is the second of five UCSF Health patients successfully bridged to heart transplantation using the SynCardia Total Artificial Heart, emphasizing accumulating experience at that center with total artificial heart therapy in advanced biventricular heart failure.

What regulatory approvals does the SynCardia Total Artificial Heart from Picard Medical have?

The SynCardia Total Artificial Heart is described as the world’s first total artificial heart approved by both the U.S. Food and Drug Administration and Health Canada, and as the only commercially available artificial heart in the United States and Canada for end-stage heart failure patients.

How widely has Picard Medical’s SynCardia Total Artificial Heart been used globally?

The company reports more than 2,100 SynCardia Total Artificial Heart implants at hospitals across 27 countries. This volume suggests broad clinical adoption and provides a substantial real-world experience base for this mechanical circulatory support technology in end-stage heart failure.

Does Picard Medical’s 8-K include forward-looking statements about SynCardia?

Yes. The company states that the press release contains forward-looking statements subject to risks and uncertainties, and directs readers to the Risk Factors section of its registration statement and related prospectus filed for its initial public offering for more detail on these potential risks.

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 19, 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 19, 2026, Picard Medical, Inc. (the “Company”) issued a press release announcing that a patient had been sustained by the SynCardia Total Artificial Heart while waiting 119 days for a donor transplant. 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 19, 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 19, 2026

Exhibit 99.1

Picard Medical / SynCardia Highlight Second Successful
Total Artificial Heart Bridge to Transplant at UCSF Health

Case highlights young patient supported for 119 days with the SynCardia Total Artificial

Heart before successful heart transplantation

TUCSON, Ariz., March 19, 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 highlighted a case reported by UCSF Health in which a patient in his twenties with advanced biventricular heart failure was successfully bridged to heart transplantation using the SynCardia Total Artificial Heart. The patient, a male in his twenties, received the SynCardia Total Artificial Heart on November 15, 2025 to restore full circulatory support while awaiting a donor heart. After 119 days of support with the device, the patient underwent a successful heart transplant on March 14, 2026.

This case represents the second of five patients at UCSF Health who have been successfully bridged to transplantation using the SynCardia Total Artificial Heart, highlighting the role of total artificial heart therapy in supporting patients with advanced biventricular heart failure while they await a donor organ.

“We are pleased to have performed our second successful redo sternotomy, total artificial heart explant and heart transplant at UCSF and are happy to report that the patient is recovering well,” said Amy G. Fiedler, MD, Associate Professor of Cardiac Surgery and Surgical Director of Heart Transplantation and Mechanical Circulatory Support at the University of California San Francisco. “Our program values its partnership with SynCardia and the ability to bridge some of the sickest patients to successful heart transplantation.”

Cases such as this demonstrate the growing experience with total artificial heart therapy at leading transplant centers such as UCSF Health.

“We congratulate the physicians and care teams involved and are proud the SynCardia Total Artificial Heart provided critical time while this patient awaited transplantation. Adoption at leading transplant centers reflects the growing need for advanced mechanical circulatory support for patients with end-stage heart failure,” said Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical.

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

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

4 documents

Press Releases

EX-99.1 EXHIBIT 99.1 11.5 KB