# IceCure Medical Ltd. > Clarifo company profile — qualitative business description generated from > the company's filings. Financial statements, charts and ratios are > available on Clarifo (https://www.clarifo.com/en/companies/IceCure Medical Ltd.). ## Overview IceCure Medical Ltd. is a medical device company incorporated in Israel with subsidiaries in the United States, Hong Kong, and China. It develops and commercializes minimally invasive cryoablation systems that use liquid nitrogen to freeze and destroy tumors in the human body as an alternative to surgical removal. ## Products & services • ProSense® cryoablation system • Minimally invasive tumor freezing procedures • Breast cancer cryoablation applications • Regulatory and commercialization of medical devices • Clinical evidence generation and physician training - **Cryoablation systems** (70%) — Liquid nitrogen-based devices used to freeze and destroy tumors through minimally invasive procedures. - **Clinical procedures and consumables** (20%) — Disposable or procedure-related items and uses tied to installed cryoablation systems. - **Service and support** (10%) — Installation, training, and clinical support for hospitals and physicians using ProSense®. - ProSense® cryoablation system - Minimally invasive tumor freezing procedures - Breast cancer cryoablation applications - Regulatory and commercialization of medical devices - Clinical evidence generation and physician training ## Customers The company sells primarily to hospitals, clinics, and physicians that perform image-guided tumor ablation procedures. Its near-term commercial focus includes breast cancer treatment use cases, especially patients for whom a minimally invasive alternative to surgery is clinically appropriate. - **Hospitals** (primary) — Buy ProSense® systems and related support for use in oncology and breast care programs. - **Clinics and outpatient centers** (primary) — Purchase systems to offer minimally invasive cryoablation in ambulatory settings. - **Physicians and specialists** (primary) — Influence adoption by selecting cryoablation for eligible patients and performing procedures. - **Breast cancer care providers** (secondary) — Use the technology for low-risk breast cancer treatment pathways and patient management. - Hospitals purchasing systems for interventional oncology use - Clinics expanding outpatient minimally invasive procedures - Physicians seeking non-surgical tumor treatment options - Breast cancer treatment centers adopting cryoablation protocols - Patients indirectly drive demand through physician procedure referrals ## Geography IceCure is headquartered in Caesarea, Israel, and operates through subsidiaries in the United States, Hong Kong, and China. Its products have received regulatory approvals for marketing in the United States, Europe, and other territories, and the U.S. market is an important commercialization area for ProSense®. - Headquartered in Caesarea, Israel - Subsidiaries in the United States, Hong Kong, and China - Regulatory approvals in the United States and Europe - U.S. commercialization is central for ProSense® adoption - International footprint supports regulatory and market expansion ## Strategy IceCure’s strategy centers on expanding commercialization of ProSense® through regulatory clearances, physician adoption, and clinical evidence. The company is building installed base in the United States while using studies and conference presence to support broader market acceptance in breast cancer cryoablation. - **Grow the U.S. installed base** (short-term) — More installed systems support recurring procedure adoption and market visibility. - **Strengthen clinical support for cryoablation** (short-term) — Clinical evidence and guideline support help physicians adopt a new treatment modality. - **Broaden international commercialization** (medium-term) — Approvals in multiple territories create a path for geographic diversification. - Expand U.S. commercial install base - Convert regulatory clearance into physician adoption - Build clinical evidence supporting breast cancer use - Increase procedure volumes through physician engagement - Pursue approvals and commercialization in additional territories ## Risks IceCure faces the typical risks of an early commercial medical device company: adoption can be slow, reimbursement and physician practice patterns may limit procedure volumes, and additional funding may be needed to support development and commercialization. Regulatory execution, competitive alternatives, and dependence on continued clinical evidence generation are also material because the business model relies on converting approvals into routine clinical use. - **Need for additional financing** [high] — The company has accumulated losses and negative operating cash flow, and future commercialization depends on outside funding. - **Slow adoption of a new procedure** [high] — Cryoablation must win physician trust, workflow acceptance, and clinical preference versus established surgical options. - **Regulatory and indication risk** [high] — Sales depend on maintaining approvals and extending use across territories and patient groups. - **Competition from alternative therapies** [medium] — Patients and physicians may choose surgery or other ablation technologies instead of cryoablation. - Funding risk if capital markets are not available when needed - Commercial adoption risk if physicians do not switch practice patterns - Regulatory risk across multiple territories and indications - Competitive risk from surgical, thermal, or other tumor treatments - Clinical evidence risk if studies do not support broader use ## Accounting The company’s results depend heavily on judgment around revenue recognition for device sales and related commercial activities, as well as capitalization and estimation in research, development, and leasing arrangements. Because it is still scaling, investors should also watch estimates for stock-based compensation, going-concern assumptions, and any fair-value accounting tied to warrants or other financing instruments. - **Revenue recognition** — Can shift reported revenue between periods - **Going concern and estimates** — Affects disclosure and valuation of the business - **Warrant and equity instrument valuation** — Can create non-cash gains or losses - **Lease accounting** — Affects balance sheet leverage and operating expense presentation - Revenue recognition timing on device and procedure-related sales - Going-concern and liquidity assumptions affecting disclosures - Stock-based compensation and warrant valuation estimates - Lease accounting for facilities and equipment - R&D expense classification and capitalization judgments --- *Last updated: 2026-09-28T12:04:03.792170+00:00*