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. reported that Mr. Li Haixiang resigned from its Board of Directors, effective March 17, 2026. The company stated that his resignation was not related to any disagreement regarding its operations, policies, or practices. This report is also incorporated by reference into several existing IceCure Medical registration statements on Forms F-3 and S-8.
IceCure Medical reported record 2025 sales of about $3.4M, up slightly from $3.3M, driven by growing global adoption of its ProSense® cryoablation system after FDA clearance for low-risk breast cancer. Management highlights added support from recent ASBrS medical society recommendations and rising interest from hospitals and clinics.
GAAP revenue was $3.379M, with gross profit of $1.226M and gross margin falling to 36% from 44% a year earlier as costs rose. Operating expenses declined to $16.32M, mainly from lower sales and marketing costs, while R&D and G&A increased.
Net loss narrowed slightly to $15.057M, or $0.24 per share, compared with $15.318M, or $0.30 per share. Cash and cash equivalents, including short-term deposits, grew to $8.897M as of December 31, 2025, helped by $15.539M in net proceeds from share and warrant issuances and additional warrant exercises.
IceCure Medical Ltd. files its annual report on Form 20‑F, outlining a commercial‑stage medical device business focused on minimally invasive cryoablation systems to treat tumors in the breast, lungs, kidneys, bones and other indications.
The company’s lead ProSense system received FDA De Novo marketing authorization for local treatment of low‑risk breast cancer in women aged 70 and above, and its next‑generation XSense system has 510(k) clearance. As of December 31, 2025, IceCure reports accumulated losses of $120,436 thousand, a 2025 net loss of about $15,057 thousand, negative operating cash flow of $14,574 thousand, and cash and deposits of approximately $8.9 million. Management and the auditor highlight conditions that raise substantial doubt about the company’s ability to continue as a going concern, and IceCure expects it will need substantial additional funding while facing intense competition, supply‑chain risks, regulatory hurdles, reimbursement uncertainty and extensive clinical and post‑market obligations.
IceCure Medical Ltd. files Amendment No. 1 to its Form F-3 registration statement to update the consent of Brightman Almagor Zohar & Co., a Deloitte Global Network firm, now furnished as Exhibit 23.1. The amendment states the shelf may be used "from time to time after the effective date hereof" and affirms it does not amend or restate other registration statement information.
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 $3.4 million for the year ended December 31, 2025, driven by growing demand in the U.S. and record sales in Europe. Cash and cash equivalents were about $8.9 million as of December 31, 2025. Management notes these figures may change after completion of financial closing procedures.
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.