Welcome to our dedicated page for IceCure Medical Ltd. SEC filings (Ticker: ICCM), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
IceCure Medical Ltd. filings document the company’s status as a foreign private issuer and its disclosures around ProSense cryoablation technology, clinical and regulatory updates, commercial activity, governance and capital structure. Form 6-K reports furnish press releases on financial and operating results, FDA-related matters, medical-conference updates and clinical data for ProSense in tumor-destruction applications.
The filing record also includes proxy materials for shareholder voting, registration-statement references on Forms F-3 and S-8, ordinary-share voting information, executive and board changes, employment and indemnification arrangements, and litigation disclosure related to a prior private placement. These filings frame ICCM’s formal reporting around its medical-device business and public-company obligations.
IceCure Medical Ltd. (ICCM) filed a Form 6-K to furnish materials for a Special General Meeting of Shareholders scheduled for 1 September 2025. Shareholders of record at the close of business on 4 August 2025 are entitled to receive notice and vote. The filing attaches three exhibits: (i) Notice of Meeting, (ii) Proxy Statement, and (iii) Proxy Card. No financial statements, earnings figures, or transaction details are included. The 6-K is incorporated by reference into the company’s effective shelf (F-3) and equity compensation (S-8) registration statements.
IceCure Medical Ltd. (Nasdaq: ICCM) filed a Free Writing Prospectus (FWP) dated 25 June 2025 in connection with its pending Form F-1 registration. The document promotes ProSense®, a liquid-nitrogen cryoablation system designed to treat benign and malignant tumors through a minimally invasive freezing procedure.
Regulatory footing: ProSense already holds FDA 510(k) clearance for kidney, liver, neurology and fibroadenoma indications, CE mark in Europe and approvals in 15 other countries including China, Brazil and India. A De Novo FDA decision for early-stage, low-risk T1 breast cancer is expected after the agency reviews IceCure’s post-market study plan; an FDA advisory panel voted favorably on benefit-risk in November 2024. IceCure’s next-generation XSense platform has separate 510(k) clearance, with a soft commercial launch targeted for Q1 2026.
Clinical evidence: The U.S. ICE3 trial (194 patients, 19 sites) showed a 96.8 % local-recurrence-free rate when ProSense was followed by endocrine therapy, no serious device-related adverse events and 100 % patient & physician cosmetic satisfaction over five years. Independent external studies reportedly corroborate these findings.
Market context: Global tumor-ablation spend is projected to rise from US$1.0 bn in 2021 to US$2.4 bn in 2028, driven by demand for less-invasive options. In 2025 the U.S. addressable cryoablation market includes about 317 k new invasive breast-cancer cases and significant kidney, liver and lung cancer populations. IceCure owns 54 patents and has secured numerous distribution agreements.
Risks & next steps: The registration statement is not yet effective; investments can only be made via the final prospectus. Marketing expansion, reimbursement upgrades beyond the current CPT III code and additional clinical studies remain forward-looking objectives.