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. (Nasdaq: ICCM) is a foreign private issuer that files reports with the U.S. Securities and Exchange Commission (SEC) in connection with its liquid-nitrogen-based cryoablation systems for tumor destruction. On this page, you can review IceCure’s SEC filings, including current reports on Form 6-K that furnish press releases about regulatory milestones, clinical data, commercial progress, and corporate actions.
IceCure’s Form 6-K filings often incorporate press releases by reference into its registration statements on Form F-3 and Form S-8. These filings cover topics such as U.S. Food and Drug Administration (FDA) marketing authorization for the ProSense® Cryoablation System in low-risk breast cancer for women aged 70 and above, regulatory approvals for ProSense® in Switzerland and other markets, notices of patent allowance for technologies like cryogen flow control related to the next-generation XSense™ system, and financial and operational results for specified reporting periods.
Filings also document corporate developments, including changes in management roles and Nasdaq notifications regarding minimum bid price compliance. By reviewing these documents, investors can see how IceCure describes its minimally invasive cryoablation technology, its primary focus areas in breast, kidney, bone, and lung cancer, and the regulatory and commercial steps it reports taking to expand use of ProSense® and XSense™.
Stock Titan’s SEC filings page presents IceCure’s submissions as they are made available on EDGAR and enhances accessibility with AI-powered summaries. These summaries are designed to highlight key points from lengthy documents, such as the nature of a regulatory authorization, the scope of a patent allowance, or the main elements of a financial update. Users can quickly identify filings related to clinical milestones, regulatory approvals, capital markets activity, and other material events disclosed by IceCure Medical Ltd.
IceCure Medical reports that the U.S. FDA has approved the design of its “ChoICE” post-marketing study for the FDA-cleared ProSense® cryoablation system in low-risk breast cancer. Enrollment is expected to begin in the second half of 2026, with at least 80 patients in the first year and about 400 patients across 30 U.S. sites within 36 months.
Participating centers will both enroll patients and act as commercial sites, using cryoprobes sold exclusively by IceCure and billing an established CPT Category III code that provides about $4,000 for the facility fee. ProSense® already has FDA marketing authorization for women aged 70 and above with biologically low-risk tumors treated with adjuvant endocrine therapy.
IceCure Medical highlights new 2026 guidance from the American Society of Breast Surgeons that recommends cryoablation as an option for selected patients with biologically low-risk early-stage breast cancer. The company’s ICE3 study and a favorable FDA Advisory Panel vote helped support this update.
The guidance follows U.S. FDA marketing clearance in October 2025 for IceCure’s ProSense® cryoablation system to treat low-risk breast cancer in women aged 70 and older with tumors up to 1.5 cm who receive adjuvant endocrine therapy. ProSense® is described as the first and only FDA-cleared medical device for the treatment of breast cancer and is positioned for office-based, minimally invasive tumor destruction.
IceCure Medical furnished a Form 6-K featuring an independent, investigator-initiated study of its ProSense® cryoablation system for benign breast tumors called fibroadenomas. The PLOS One study reported a median fibroadenoma volume reduction of 80.6% about six months after treatment and 92.9% after one year.
The investigators concluded that liquid nitrogen-based ProSense® cryoablation was safe and effective, including for larger lesions treated with multiple cryoprobe relocations. IceCure estimates cryoablation could address about 63,000 fibroadenoma excision cases annually in the U.S. and believes these findings may support broader guideline updates and clinical adoption.
IceCure Medical reported completion of the last patients’ five-year follow up in its ICESECRET study of the ProSense® cryoablation system for small renal masses in kidney cancer. ICESECRET enrolled 114 patients with 138 lesions of up to 5 cm treated under CT guidance in Israel.
Previously released three-year interim data from 111 patients showed ProSense® was safe and effective, with an 88.7% recurrence‑free rate. Final analysis of the five-year data is expected in the second quarter of 2026. ProSense® is already approved for benign and malignant kidney tumors in the U.S., Europe and other countries, addressing a growing global kidney cancer burden of about 400,000 new cases annually.
IceCure Medical Ltd. announced that Chief Financial Officer Ronen Tsimerman has decided to resign after nearly a decade with the company. His resignation will take effect once a successor is appointed, and he will continue serving as CFO until then to support a smooth transition.
The company stated that his departure is not related to any disagreement over operations, policies, or practices. IceCure has begun a search for a new CFO and reports that several candidates with experience commercializing disruptive technologies have advanced to interviews with the Board of Directors.
IceCure Medical reports a strong year for its ProSense® cryoablation system, highlighted by FDA marketing authorization in the U.S. for the local treatment of low-risk breast cancer in women aged 70 and above with endocrine therapy, including those not eligible for surgery. The company says this supports its aim to make cryoablation a new treatment option for eligible patients.
Based on preliminary, unaudited estimates, IceCure delivered record ProSense® sales of approximately
The company cites a U.S. addressable patient population of roughly 200,000 women annually for breast cryoablation and highlights record scientific visibility, with independent investigators producing peer-reviewed publications and conference presentations across breast, musculoskeletal, kidney, lung cancer, and endometriosis indications.
IceCure Medical Ltd. amended its existing equity distribution agreement with Maxim Group LLC, which allows the company to offer and sell from time to time up to
The report states that this amendment is incorporated by reference into several of IceCure’s shelf and employee benefit registration statements, so any sales under the extended program would be made under those existing SEC registrations.
IceCure Medical Ltd. convened a Special General Meeting of Shareholders on January 7, 2026, where a quorum was present and shareholders approved all agenda items described in the previously distributed proxy statement.
As a result, amended and restated Articles of Association became effective immediately after the vote. The Articles formalize IceCure as a public company, define its share capital framework, and set rules for general meetings, including a quorum of at least two shareholders representing 25% of voting rights and the ability to vote by proxy or proxy statement.
The governance provisions include a staggered board structure where directors are generally appointed at Annual General Meetings, removal of directors requires a 70% majority of votes represented, and the board may fill vacancies and assign directors to board classes. The board is also authorized to adopt protective measures such as a shareholder rights plan and has broad discretion over dividends, bonus share distributions, reserve funds, and officer indemnification, exemption and insurance, all subject to applicable law.
IceCure Medical Ltd. furnished a report stating it issued a press release titled “IceCure Expected to Report Record Fourth Quarter Sales in North America Driven by Recent FDA Clearance of ProSense® Cryoablation for Low-Risk Breast Cancer.” The title indicates the company expects record fourth quarter sales in North America and directly links this to the recent FDA clearance of its ProSense cryoablation system for treating low-risk breast cancer.
The company is also incorporating most of this press release by reference into several existing Form F-3 and Form S-8 registration statements, so the same information becomes part of those offering documents from the date of this report.
IceCure Medical Ltd. reported that it issued a press release on December 5, 2025 titled “IceCure Receives Notice of Patent Allowance in China for a Novel Cryogen Flow Control to Optimize Patient Cryoablation Outcomes.” This indicates the company has received a notice of patent allowance in China for technology related to cryogen flow control, which is intended to optimize patient cryoablation outcomes.
The press release, excluding its third paragraph, is incorporated by reference into IceCure’s existing Form F-3 and Form S-8 registration statements, meaning the disclosure becomes part of those securities offering documents from the date of this report.