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. (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.
IceCure Medical Ltd. (NASDAQ: ICCM) filed a Form 6-K on 25 June 2025 reporting that it has furnished a press release entitled “IceCure Announces Record Date for Rights Offering for Up to $10 Million.” The press release, provided as Exhibit 99.1, is incorporated by reference into the company’s existing registration statements on Forms F-3 (Nos. 333-258660 & 333-267272) and S-8 (Nos. 333-270982, 333-264578, 333-262620 & 333-281587). The filing contains no financial statements, earnings data or detailed terms of the rights offering.
The company indicates only that a record date has been set for shareholders to participate in a rights offering of up to $10 million. If completed, this capital raise would provide additional liquidity while allowing existing shareholders to maintain proportional ownership by exercising their rights. However, subscription price, ratio, and expected closing date are not disclosed in this document. The report was signed by Chief Executive Officer Eyal Shamir.
IceCure Medical Ltd. (ICCM) has filed Amendment No. 1 to its Form F-1 to launch a non-transferable rights offering that could raise up to US$10 million. Existing holders of the company’s ordinary shares as of the July 9, 2025 record date will receive one subscription right for every share owned. Each right allows the purchase of 0.1703 of a Unit at a subscription price of US$1.00 per Unit. A full Unit comprises one ordinary share and one five-year warrant exercisable at US$1.00. Because 0.1703 of a Unit is issued per right, shareholders must aggregate at least six rights to obtain one complete Unit; holders of fewer than six shares will be unable to participate.
The subscription period runs from July 10 to 5:00 p.m. ET on July 28, 2025. Unexercised rights will expire worthless unless the company extends the offering. Investors who fully exercise their basic rights may request additional Units under an over-subscription privilege, subject to proration.
Capital Structure: If fully subscribed, IceCure will issue up to 10 million Units consisting of either 10 million ordinary shares or, at investors’ option to avoid ownership limits, 10 million pre-funded warrants (exercise price US$0.0001) plus 10 million accompanying warrants. All warrants carry a call feature that can be triggered once ProSense breast-cancer marketing authorization is publicly announced and the share VWAP equals or exceeds 300 % of the exercise price for 30 consecutive trading days.
Back-stop Commitment: Epoch Partner Investments Limited, already holding 44.04 % of IceCure’s shares, has provided a standby commitment to purchase up to US$5 million of Units through basic and over-subscription privileges.
Use of Proceeds: Net proceeds, together with existing cash and investments, are earmarked to repay a Bridge Loan ("Loan Amount") and for general corporate and working-capital purposes.
Maxim Group LLC will act as dealer-manager on a best-efforts basis, and Broadridge Corporate Issuer Solutions, LLC is the subscription agent holding investor funds in escrow until completion or cancellation of the offering.