v3.26.1
Note 1 - Description of Business, Basis of Presentation and Management's Plan
6 Months Ended
Jun. 30, 2026
Notes to Financial Statements  
Business Description and Basis of Presentation [Text Block]

1.

DESCRIPTION OF BUSINESS, BASIS OF PRESENTATION AND MANAGEMENTS PLAN

 

Description of Business

 

Picard Systems, Inc. was originally incorporated in the state of Delaware on April 8, 2021, for the purpose of investing in and acquiring medical device companies, including SynCardia Systems, LLC (“SynCardia”) and its fully consolidated subsidiaries SynCardia Systems Australia Pty Ltd. ("SynCardia Australia") and SynCardia Systems Europe, GmbH (“SynCardia GmbH”). On September 27, 2021, Picard Systems, Inc. acquired all of the authorized and outstanding membership units of SynCardia and it changed its name to Picard Medical, Inc. (“PMI”, or collectively, the “Company”).

 

The Company is engaged in the business of designing, manufacturing, production, supply, marketing, and sale of medical device products, including the SynCardia total artificial heart for patients (“SynCardia TAH”). The SynCardia TAH is an implantable system designed to assume the full function of a failed human heart in patients suffering from advanced heart failure. SynCardia has one operating subsidiary, SynCardia GmbH, which was formed to facilitate the sale and distribution of SynCardia’s products throughout Europe.

 

Basis of Presentation and Consolidation

 

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) applicable to interim financial statements. These condensed consolidated financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2025, and the related notes which provide a more complete discussion of the Company’s accounting policies and certain other information. The condensed consolidated balance sheet as of December 31, 2025, was derived from the Company’s audited financial statements. These unaudited condensed consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s condensed consolidated financial position as of June 30, 2026, and its results of operations, changes in temporary equity and stockholders’ equity (deficit) and cash flows for the six months ended June 30, 2026 and 2025. The results of operations for the six months ended June 30, 2026, are not necessarily indicative of the results to be expected for the year ending December 31, 2026, or for any other future annual or interim period.

 

The condensed consolidated financial statements include the financial statements of PMI and its subsidiaries. All intercompany transactions and account balances between PMI and its subsidiaries have been eliminated in consolidation.

 

On July 21, 2026, PMI filed a Certificate of Amendment to its Second Amended and Restated Certificate of Incorporation with the Secretary of State of Delaware, to effect a reverse stock split of the Company’s issued and outstanding common stock, par value $0.0001 per share, at a ratio of 1-for-50 (the “Reverse Stock Split”). The Reverse Stock Split became effective commencing  July 31, 2026. Pursuant to the Reverse Stock Split, every 50 shares of the Company’s issued and outstanding common stock was automatically combined into one issued and outstanding share of common stock, with such resulting number of shares rounded up to the nearest whole share. No fractional shares were issued and the par value of the common stock remained unchanged. All historical share numbers, per-share amounts, and common stock details have been retroactively adjusted to reflect the reverse split ratio for all periods presented.

 

Going Concern, Liquidity and Managements Plans 

 

The Company has evaluated whether there are any conditions and events considered in the aggregate that raise substantial doubt about its ability to continue as a going concern for at least twelve months from the date of this report, and the near term thereafter. The Company has incurred operating losses and negative cash flows from operations for the six months ended June 30, 2026, and SynCardia has a history of operating losses dating back to its inception. The Company expects that operating losses and negative cash flows from operations will continue into the foreseeable future, and the Company will need to raise additional debt and/or equity financing to fund operations until it generates positive cash flows from operations.

 

To date, the Company’s available liquidity and operations have been financed primarily through the issuance of common stock, preferred stock, and debt. For the year ended December 31, 2025, the Company raised $9.7 million, net of repayments from the issuance of debt. For the six months ended June 30, 2026, the Company: (i) paid $0.2 million, net of borrowings, for related party debt; (ii) repaid $10.0 million of notes payable (as defined below) and convertible note payable; (iii) settled $4.7 million of Senior Secured Note through issuance of common stock, and (iv) received $3.1 million from proceeds on the issuance of common stock and warrants, net of $1.0 million cashless settlement of the Senior Secured Note. In order to proceed with the Company’s business plan, the Company will need to raise additional funds through the issuance of additional debt, equity, or other commercial arrangements, which may not be available to the Company when needed or on terms that the Company deems to be favorable. To the extent the Company raises additional capital through the sale of equity, the ownership interest of its current stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting the Company’s ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures, or declaring dividends. If the Company is unable to obtain sufficient financial resources, its business, financial condition, and results of operations may be materially and adversely affected. The Company may be required to delay, limit, reduce or terminate parts of its strategic business plan or future commercialization efforts. There can be no assurance the Company will be able to obtain financing on acceptable terms. Therefore, based on the Company’s current financial condition and expected future cash flows, there is substantial doubt about the Company’s ability to continue as a going concern for at least twelve months from the date of these financial statements issued. The financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities and reported expenses that may be necessary if the Company is unable to continue as a going concern.