20-F: IceCure Medical Secures Key FDA Breast Cancer Approval

IceCure Medical Ltd. received FDA marketing authorization for its ProSense system for low-risk breast cancer in women aged 70 and above, a significant regulatory milestone amidst ongoing financial challenges.

Summary

• IceCure Medical Ltd. is a commercial-stage medical device company focused on cryoablation systems for tumor treatment, primarily using liquid nitrogen (LN2).
• The company's flagship product, ProSense, received FDA marketing authorization on October 3, 2025, for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above.
• The American Society of Breast Surgeons (ASBrS) updated its resource guides in March 2026 to include cryoablation as a recommended treatment option for low-risk breast cancer in patients aged 70 and above with biologically low-risk tumors measuring 1.5 cm or less.
• The next-generation XSense system with CryoProbes received 510(k) regulatory clearance from the FDA and is believed to be more efficient, intuitive, and user-friendly than ProSense.
• The company is also developing a next-generation multi-probe system, MSense, for treating multiple and larger tumors.
• Total revenues for the year ended December 31, 2025, increased by 3% to $3,379 thousand, up from $3,291 thousand in 2024.
• Sales of disposables increased by 12% to $2,053 thousand in 2025, while system sales decreased by 3% to $1,326 thousand.
• Gross profit decreased by 16% to $1,226 thousand in 2025, with gross margin falling to 36% from 44% in 2024, primarily due to increased raw material and subcontractor costs.
• Operating loss decreased slightly to $15,094 thousand in 2025 from $15,696 thousand in 2024, mainly due to reduced sales and marketing expenses.
• Net loss for 2025 was $15,057 thousand, a 2% decrease from $15,318 thousand in 2024.
• As of December 31, 2025, the company had an accumulated deficit of $120,436 thousand and cash and cash equivalents of $8.9 million.
• The company's management has concluded that there are conditions that raise substantial doubt about its ability to continue as a going concern, with current cash not sufficient to fund planned operations for the next 12 months.
• A class action lawsuit was filed in Israel in July 2021, claiming a private placement of securities was made at a significant discount and had alleged defects in approval; the company believes the motion is without merit.
• The company has 46 issued patents globally, covering its technological platform and future developments.

Sentiment

Score: 4

Explanation: StockSavvy.ai views this as a mixed report. While the FDA marketing authorization for ProSense in breast cancer and positive clinical data are significant achievements, the persistent 'going concern' warning, continued operating losses, and the explicit need for substantial additional funding weigh heavily on the financial outlook. The slight revenue increase is overshadowed by declining gross margins and increased cash burn from operations.

Positives

• Received FDA marketing authorization for the ProSense system for the local treatment of low-risk breast cancer in women aged 70 and above, a significant regulatory achievement.
• The American Society of Breast Surgeons (ASBrS) updated its resource guide in March 2026 to include cryoablation as a recommended treatment option for low-risk breast cancer, supporting broader adoption.
• The ICE3 clinical trial's 5-year follow-up showed a 96.39% local recurrence-free rate for early-stage, low-risk malignant breast tumors treated with cryoablation, with no significant device-related adverse events.
• The XSense system with CryoProbes received 510(k) regulatory clearance from the FDA, offering a more efficient, intuitive, and user-friendly platform for future applications.
• Independent studies in Japan, Spain, Italy, Germany, and the Netherlands have shown positive efficacy, safety, and patient satisfaction for ProSense in treating various tumors, including breast and lung cancers.
• Cryoablation with ProSense demonstrated superior cosmetic outcomes and patient satisfaction compared to surgery in a Netherlands study.
• The company's LN2-based cryoablation technology offers competitive advantages over heat ablation, including less pain, less anesthesia, clearer image-guided visualization, deeper freezing temperatures, and more cost-effective single-probe use.
• Total revenues increased by 3% in 2025 to $3,379 thousand, driven by a 12% increase in disposable sales.
• Net loss decreased by 2% in 2025 compared to 2024, primarily due to a reduction in sales and marketing expenses.

Negatives

• The company has a limited operating history and has incurred significant operating losses since its inception, with an accumulated deficit of $120,436 thousand as of December 31, 2025.
• Management has concluded that conditions raise substantial doubt about the company's ability to continue as a going concern, as current cash is insufficient to fund planned operations for the next 12 months.
• Gross profit decreased by 16% in 2025, and gross margin declined from 44% to 36%, primarily due to increased raw material and subcontractor costs.
• Certain components for the ProSense system are no longer commercially available or are nearing end-of-life, posing risks to manufacturing and supply.
• Revenue from Japan decreased from $481 thousand in 2024 to $282 thousand in 2025, and revenue from India decreased by 71% to $120 thousand.
• The exclusive distribution agreement with Shanghai Medtronic Zhikang in mainland China expired because the distributor did not fulfill its minimum purchase target of $3.5 million by April 30, 2025.
• The company is highly dependent on third-party payors for adequate insurance coverage and reimbursement, which is not yet broad for breast cancer cryoablation in the U.S.
• The company's management team has limited experience managing a U.S. reporting company, which could divert attention and increase compliance costs.
• Geopolitical risks in Israel, where the company's headquarters and R&D are located, may adversely affect operations, workforce, and supply chain.

Risks

• Limited operating history and anticipated continued significant operating losses for the foreseeable future.
• Need to raise substantial additional funding, which may not be available on acceptable terms or at all, potentially requiring curtailment of commercialization and product development efforts.
• Management's conclusion that conditions raise substantial doubt about the company's ability to continue as a going concern.
• High dependence on the successful development, regulatory clearance, and marketing of ProSense, XSense, and future MSense systems.
• Certain components for ProSense are no longer commercially available or are nearing end-of-life, risking manufacturing disruptions and increased costs.
• Failure to maintain existing strategic relationships or identify additional distributors could decrease revenues.
• Dependence on third-party manufacturers and suppliers, making the company vulnerable to supply shortages, increased costs, and quality issues.
• Difficulties in recruiting and retaining needed additional employees and consultants due to lean staffing and intense competition.
• Risks associated with future acquisitions or strategic partnerships, including increased capital requirements, shareholder dilution, debt, and contingent liabilities.
• Intense competition in the medical device market from companies with greater financial and marketing resources.
• Commercial success is highly dependent on third-party payors providing adequate insurance coverage and reimbursement for system use.
• Potential for litigation, including product liability claims and class actions, which could be expensive and harm reputation.
• Adverse effects from security breaches, including cybersecurity incidents, on business and operations.
• Delays, suspensions, or other problems in clinical trials conducted by the company or its partners.
• Results of pre-clinical studies or early-stage clinical trials may not be indicative of future clinical trial results, and trials may not yield anticipated outcomes.
• Delays or failure to receive necessary regulatory clearances or approvals for XSense, MSense, or future products in specific countries or indications.
• Preliminary data from studies may change materially upon comprehensive review or as more data become available.
• Misuse or off-label use of products could harm reputation, lead to product liability suits, or result in regulatory investigations and sanctions.
• Products may cause or contribute to adverse medical events or malfunctions requiring immediate reporting, with failure to do so leading to sanctions or recalls.
• Inability to obtain and maintain effective patent rights or protect trade secrets could impair competitive position.
• Third-party claims of intellectual property infringement could prevent or delay development and commercialization efforts.
• Volatility in the market price of Ordinary Shares due to various factors, including clinical trial results, regulatory actions, and economic conditions.
• Future sales or issuances of Ordinary Shares could depress the market price and dilute existing shareholders.
• Potential classification as a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes, leading to negative tax consequences for U.S. Holders.
• Political, economic, and military instability in Israel, where principal operations are located, may adversely affect results.
• Termination or reduction of tax and other incentives from the Israeli government could increase costs and taxes.
• Potential requirement to pay monetary remuneration to Israeli employees for their inventions, even if rights are assigned to the company.
• Restrictions and potential payments to the Israeli Innovation Authority (IIA) if IIA-supported know-how or manufacturing is transferred outside of Israel.
• Difficulty enforcing covenants not-to-compete under Israeli law, potentially leading to increased competition.
• Provisions of Israeli law and amended articles of association may delay, prevent, or impede mergers or acquisitions.
• Difficulty for investors to enforce judgments against the company, its directors, and management due to jurisdictional constraints.

Future Outlook

The company expects operating losses and negative cash flows to continue in 2026 as it expands commercialization efforts and continues development of the MSense system. Revenue growth is anticipated to depend on physician adoption, reimbursement coverage, and patient acceptance for the newly authorized breast cancer indication. The company will likely require substantial additional capital to fund ongoing operations and development. Geopolitical risks in Israel and intense competition in the cryoablation market are expected to persist.

Management Comments

• We believe that the XSense system with CryoProbes can serve as a platform that will allow us to develop other unique CryoProbes and catheters and expand our clinical applications and is also more efficient, intuitive and user friendly compared to our existing ProSense system.
• We believe that obtaining regulatory approval for our existing and next-generation products for specific indications will help us grow our business.
• We believe that cryoablation has already started to be recognized for its true potential, and that it represents the future of treatment for certain benign and malignant tumors.
• We believe this update in the ASBrS resource guide will support broader physician adoption, expand reimbursement coverage, and accelerate commercial adoption of cryoablation as a standard-of-care treatment option.
• We believe that our LN2-based technology provides patients, medical service providers, physicians and insurers with advantages versus our competitors, especially those using heat to treat tumors.
• We believe that our cryoablation technology, and especially our LN2-based technology, has advantages over heat ablation technologies for breast tumors.
• We believe that these technological advantages will enable us to compete effectively with our competitors.
• We believe that by completing the development and initiating commercialization of our next generation XSense and future MSense systems, we will be able to compete even more effectively with our competitors.
• We believe that the Terumo Japan Agreement will accelerate the commercialization of our ProSense system and associated disposables to treat malignant breast tumors in Japan and Singapore.

Industry Context

StockSavvy.ai notes that the medical device industry, particularly in interventional oncology, is characterized by rapid technological change and intense competition. IceCure's focus on cryoablation positions it against both traditional surgical methods and other ablation technologies like RFA and MWA from major players such as Boston Scientific, Siemens Healthineers, and Hygea Medical Technology. The FDA's marketing authorization for ProSense in breast cancer, coupled with the ASBrS's updated guidelines, represents a significant step towards establishing cryoablation as a standard of care, potentially disrupting existing treatment paradigms. However, the industry also faces challenges related to reimbursement, which is critical for market adoption, and the high costs associated with R&D and regulatory approvals.

Comparison to Industry Standards

• The ICE3 trial's 5-year recurrence-free rate of 96.39% for early-stage, low-risk breast cancer compares favorably to traditional lumpectomy, which often has re-excision rates between 14% to 20%.
• A meta-analysis suggested cryoablation has the lowest complication rate among breast cancer tumor procedures, indicating a potential safety advantage over other thermal ablation techniques.
• An investigator-led randomized phase II study comparing cryoablation with RFA and MWA for CT1N0 breast cancer showed cryoablation achieved a complete ablation rate of 94%, significantly higher than RFA (33%) and MWA (72%).
• For lung cancer, a study combining SBRT with cryoablation showed a five-year local control rate of 93% and overall survival rate of 74%, which are reported as better than SBRT alone and comparable to standard surgery in similar populations (41%-52% and 82% or 67% respectively for overall survival).
• The cost of cryoablation for kidney tumors is approximately 77% of the cost of open partial nephrectomy, suggesting a cost-effectiveness advantage.
• IceCure's LN2-based technology allows deeper freezing temperatures (-150 to -170 Celsius) and faster cooling compared to argon-based technologies (e.g., Galil Medical, EndoCare), which may lead to more efficient tumor destruction and shorter procedures.
• The ability to use one probe with IceCure's technology for the same killing zone, compared to 2-3 probes often required by argon-based systems, offers cost-effectiveness and ease of use.

Management Changes

Corporate Governance

Legal Proceedings

• A motion to certify a class action was filed in Israel on July 5, 2021, against the company, its board members, controlling shareholder, and investors in a private placement. The plaintiff alleges the private placement was at a significant discount, did not reflect material information, and had defects in approval. The plaintiff estimated individual claim at approximately NIS 30,000 thousand (USD 9,404) and class action damages at approximately NIS 163,459 thousand (USD 51,241) for dilution and NIS 234,349 thousand (USD 73,464) for sales at less than market price. The company believes the motion is without merit and is currently unable to predict the likely outcome or estimate the potential financial impact.

Related Party Transactions

• On May 17, 2025, the company entered into an unsecured bridge loan agreement of $2.0 million with Epoch Partner Investments Limited, a major shareholder. The loan was repaid in full on August 18, 2025.
• Epoch Partner Investments Limited participated in an At-The-Market (ATM) facility on January 12, 2024, investing $2.5 million into Ordinary Shares.
• Epoch Partner Investments Limited committed to exercise its Subscription Rights in full and any over-subscription privilege in the Rights Offering completed on August 1, 2025, with an aggregate investment of up to $5.0 million.
• Mr. Li Haixiang, a director, has voting and dispositive power over the shares held by Epoch Partner Investments Limited, which beneficially owns 45.8% of the company's Ordinary Shares as of March 13, 2026.

Stakeholder Impact

• **Shareholders**: Face significant dilution risk from future capital raises and potential negative impact on share price due to ongoing losses and going concern warning. The concentration of ownership (48.0% by principal shareholders, officers, and directors) may limit influence of other shareholders. The FDA approval and ASBrS guidelines could positively impact long-term value if commercialization is successful.
• **Employees**: Subject to non-competition and intellectual property assignment agreements, with enforceability limitations under Israeli law. Compensation policy aims to retain and motivate, including equity-based compensation. Ronen Tsimerman's resignation as CFO creates uncertainty in leadership.
• **Customers (Hospitals, Clinics, Radiologists)**: Benefit from new FDA-authorized treatment options for breast cancer and other indications, potentially offering less invasive, less painful, and more cost-effective procedures. Adoption depends on reimbursement coverage and clinical training.
• **Suppliers/Manufacturers**: The company's reliance on a limited number of suppliers and the obsolescence of certain ProSense components pose risks to supply chain continuity and costs. Transition to XSense may impact supplier relationships.
• **Creditors**: The 'going concern' warning and need for additional funding indicate increased financial risk. The class action lawsuit also presents a potential liability.

Next Steps

• Focus on physician training, reimbursement engagement, recruitment of sales representatives, and distributor expansion for the newly authorized breast cancer indication in 2026.
• Obtain regulatory approvals for ProSense and other future systems in additional countries and for additional indications in existing countries.
• Expand recommendations for the use of products in guidelines of medical associations, such as the Society of Breast Imaging (SBI).
• Obtain Category I CPT codes and broad reimbursement coverage for cryoablation procedures in the United States, with an application for a permanent CPT Category I code expected by June 2026 for a potential effective date of January 2028.
• Extract maximum benefit from the existing CPT III code and apply for additional payments such as Transitional Pass-Through Payment (TPT).
• Negotiate reimbursement with government and private insurers and payers.
• Continue research and development efforts aimed at developing new products, including the MSense system.
• Continue efforts to obtain regulatory approval for the XSense system with CryoProbes for a variety of indications.
• Submit an application for Medical Device Regulation (MDR) approval for the XSense system with CryoProbes by the second half of 2026.
• Report a final analysis of the ICESECRET kidney cancer cryoablation study in the second quarter of 2026.
• Evaluate commercial activities in Thailand, as Terumo Thailand has not purchased minimum quantities under their distribution agreement.
• Address the expiration of the distribution agreement with Shanghai Medtronic Zhikang in China and continue sales through Beijing Turing.

Key Dates

Recommendation

IceCure Medical's recent FDA marketing authorization for ProSense in breast cancer and the supportive ASBrS guidelines are significant positive catalysts, potentially opening a substantial market. The strong clinical trial data for cryoablation across various indications further validates the technology. However, the company's persistent 'going concern' warning, substantial accumulated deficit, and explicit need for additional capital introduce considerable financial risk. While the long-term potential is notable, the immediate liquidity concerns and the challenges of broad commercialization and reimbursement in a competitive market suggest a 'hold' recommendation. Investors should monitor capital raising efforts, commercial adoption rates, and progress on reimbursement codes before considering a stronger position.

Keywords

Cryoablation, Breast Cancer, Medical Device, FDA Authorization, ProSense, XSense, Oncology, Minimally Invasive, SEC Filing, Going Concern, Clinical Trials, Regulatory Approval, Liquid Nitrogen, Tumor Treatment, Healthcare Technology