Note 2 – Liquidity and Going Concern

These condensed unaudited interim financial statements were prepared on a going concern basis. The going concern basis assumes that the Company will continue in operation for the foreseeable future and will be able to realize its assets and discharge its liabilities and commitments in the normal course of business.

The Company has incurred operating losses and negative cash flows from operations since its inception. For the six months ended June 30, 2026, the Company had a net loss of $38.8 million and had an accumulated deficit of $196.6 million as of June 30, 2026. Additionally, the Company has generated negative cash flows from operations for the six months ended June 30, 2026.

Since inception, the Company has financed its activities principally from the issuance of preferred stock, debt financing arrangements, revenue from sales of the Vivistim System and net proceeds from the IPO completed in May 2026. The Company believes that its operating losses and negative operating cash flows will continue into the foreseeable future. There can be no assurance that the Company’s products will generate sufficient revenue for the Company to achieve profitable operations.

Based on its current operating plan, the Company expects to continue to incur significant expenditures to increase awareness and adoption of the Vivistim System, support research and development activities, including regulatory affairs and clinical studies, scale its commercial operations and infrastructure, and operate as a public company. In prior reporting periods, the Company concluded that recurring operating losses, negative cash flows from operations, and future expenditures raised substantial doubt about its ability to continue as a going concern. In May 2026, the Company completed its IPO and received net proceeds of approximately $134.0 million. As a result of the additional liquidity provided by the completed IPO, management concluded that the existing cash and cash equivalents are sufficient to fund its operations and meet its obligations for at least one year from the date these condensed unaudited interim financial statements are issued. Accordingly, management concluded that the conditions and events described above do not raise substantial doubt about the Company’s ability to continue as a going concern.

If future revenue is not sufficient or if sufficient funds on acceptable terms are not available when needed, the Company may be required to curtail planned activities to significantly reduce its operating expenses. Failure to manage discretionary spending or raise additional financing, as needed, may have a material adverse effect on the Company’s future viability and results of operations.