GOING CONCERN

12 Months Ended

Dec. 31, 2025

GOING CONCERN [Abstract]

GOING CONCERN

3.

GOING CONCERN

The consolidated financial statements have been prepared on the going concern basis, which contemplates continuity of normal business activities and realization of assets and discharges of liabilities in the ordinary course of business. As of December 31, 2025, the Group incurred a net loss of $94.2 million and had net cash outflows from operating activities of $77.8 million for the financial year ended December 31, 2025. As of that date, the Group had a cash balance of $12.6 million, a net current liability position of $5.7 million and a net liability position of $0.3 million.

Subsequent to December 31, 2025, the Company completed two equity financing transactions that significantly strengthened its liquidity position. The Company completed a public offering of 40,000,000 shares of Common Stock for gross proceeds of $230 million before underwriting discounts, commissions and other transaction costs, including the underwriters’ option to purchase additional shares. In addition, the Company completed a private placement to Medtronic plc (through a wholly owned subsidiary) of 15,652,173 shares of Common Stock for gross proceeds of $90 million before transaction costs. These transactions materially improved the Company’s available cash resources.

After considering the Group’s current cash position, the proceeds from the equity financings completed subsequent to year‑end, the Group’s forecasted cash flows, and its planned operating and investment activities, management has concluded that no substantial doubt exists regarding the Group’s ability to continue as a going concern for at least 12 months from the date these financial statements are issued.