IceCure Achieves $3.4 Million ProSense Sales in 2025
A letter from CEO Eyal Shamir to shareholders stated, in part, "2025 was a pivotal year for IceCure - we were granted the U.S. Food and Drug Administration's marketing authorization for ProSense cryoablation for the local treatment of low-risk breast cancer with endocrine therapy in women aged 70 and above, including those who are not candidates for breast cancer surgery. This achievement has strengthened our belief that ProSense can expand patient choice, enhance care, and offer improved healthcare economics through a minimally invasive approach. This milestone marks a meaningful step toward establishing cryoablation as a new standard of care for eligible women in the United States seeking effective care without surgical removal of breast tissue. Following the FDA marketing authorization in October 2025, we have experienced and continue to experience an overwhelmingly positive response and interest in ProSense consoles and disposable cryoprobes. This has contributed to record fourth quarter results in 2025 in North America. We are particularly enthused to see systems being placed at highly regarded institutions in the United States, which we believe can further accelerate broader adoption of ProSense. Our sales team is engaged with leading hospitals, clinics, breast surgeons, and interventional radiologists currently evaluating ProSense in the U.S. Based on preliminary, unaudited estimates, IceCure delivered a 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 as we continue to execute our global commercial strategy. Our cash and cash equivalents balance as of December 31, 2025 was approximately $8.9 million. This preliminary financial information has been prepared solely on the basis of information that is currently available to, and that is the responsibility of, management. This preliminary financial information is based upon our estimates and remains subject to, among other things, the completion of IceCure's financial closing procedures and final adjustments, which may impact the results and expectations set forth above. We also saw continued advancement in the large body of data supporting ProSense for other indications. In 2025, independent investigators produced a record number of peer-reviewed publications and presentations regarding the use of ProSense for breast, musculoskeletal, and kidney cancers. We believe this expanding body of evidence is critical to long-term adoption and to supporting expanded clinical use around the world."
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- Guideline Update: The American Society of Breast Surgeons (ASBrS) is updating its treatment guidelines for benign and malignant breast tumors to include cryoablation, marking a significant step towards widespread adoption of this technology in breast cancer treatment in the U.S.
- Clinical Evidence Support: The ICE3 trial demonstrated that only 3.1% of patients treated with cryoablation and endocrine therapy experienced local recurrence within five years, showcasing the method's efficacy and safety, potentially establishing it as a new standard of care.
- Significant Market Potential: The ProSense® system targets approximately 200,000 breast cancer patients annually, particularly low-risk patients aged 70 and above, and is expected to accelerate commercial adoption and expand reimbursement coverage, enhancing treatment options for patients.
- Accelerated Industry Recognition: ASBrS will be the first medical society to include cryoablation in its guidelines just three months after FDA approval, likely prompting more surgeons to recommend this minimally invasive treatment, thereby improving patient outcomes.
- Guideline Update: The American Society of Breast Surgeons (ASBrS) is set to include cryoablation in its updated guidelines, which is expected to encourage more surgeons to recommend this minimally invasive treatment option to suitable patients, thereby enhancing treatment choices for breast cancer.
- Clinical Trial Evidence: The ICE3 trial demonstrated that only 3.1% of patients treated with cryoablation and endocrine therapy experienced local recurrence within five years, indicating that this method offers efficacy and safety comparable to lumpectomy while providing excellent cosmetic results and patient satisfaction.
- Significant Market Potential: The ProSense® system addresses an annual patient population of approximately 200,000 women with breast cancer, particularly benefiting low-risk patients aged 70 and over, and its widespread clinical adoption is anticipated to accelerate commercial uptake and expand reimbursement coverage.
- Distinct Technical Advantages: ProSense® is the first FDA-approved device for treating low-risk breast cancer via cryoablation, which minimizes surgical risks and recovery times, enhancing value for both patients and providers, and facilitating fast, convenient office-based procedures.

- FDA Approval Milestone: IceCure received FDA marketing authorization for ProSense® to treat low-risk breast cancer in women aged 70 and above, establishing it as the only on-label solution, which is expected to significantly enhance market acceptance and patient choice.
- Record Sales Performance: In 2025, IceCure achieved approximately $3.4 million in ProSense® sales in North America, marking a historic high that reflects surging market demand following FDA clearance, further solidifying the company's global commercial strategy.
- Increased Scientific Recognition: In 2025, IceCure achieved a record number of peer-reviewed publications and presentations at global conferences covering breast, musculoskeletal, and kidney cancer treatments, enhancing the clinical evidence base for ProSense® and supporting its application in other indications.
- Market Expansion Potential: ProSense® addresses an annual U.S. patient population of approximately 200,000 for breast cancer, particularly targeting 46,400 early-stage, low-risk patients aged 70 and above, indicating substantial market opportunities that are expected to drive future revenue growth and market share enhancement.

- Sales Growth Expectation: IceCure Medical anticipates a significant increase in fourth-quarter sales in North America, with preliminary data suggesting record levels, reflecting strong market demand for the ProSense® system.
- FDA Authorization Impact: Following the FDA's October 2025 approval of ProSense® for low-risk breast cancer in women aged 70 and above, interest from hospitals and medical institutions has surged, driving rapid growth in the sales pipeline.
- Market Demand Drivers: IceCure's sales team is engaging with an increasing number of hospitals and physicians, particularly orders from globally top-ranked medical institutions, which are expected to further drive market demand and enhance the company's industry influence.
- Increased Media Exposure: ProSense® has received extensive coverage in various mainstream media and healthcare industry publications, enhancing public awareness of non-surgical treatment options, which may boost patient acceptance and demand for the technology.

- International Recognition: At RSNA 2025, IceCure Medical had four independent study abstracts accepted, showcasing the effectiveness of ProSense® in 263 patients, further promoting the widespread adoption of this technology in breast cancer treatment.
- Clinical Data Support: One study demonstrated a 100% success rate in treating luminal cancers under 2.5 cm using ultrasound-guided cryoablation, indicating a safe and effective alternative for patients ineligible for surgery.
- Significant Treatment Outcomes: Another study comparing cryoablation combined with hormonal therapy to standalone treatments revealed an impressive 83.3% tumor reduction in the combination group, highlighting the added value of cryoablation.
- Increased Interest Post-FDA Approval: Following the FDA's marketing approval of ProSense® for low-risk breast cancer, IceCure Medical has observed a sustained increase in interest in the technology, indicating significant potential for broader applications in non-surgical treatment options.

- Patent Approval: IceCure has received a Notice of Allowance for a patent from the China National Intellectual Property Administration for its cryogen flow control technology related to the next-generation XSense™ cryoablation system, marking a total of 55 patents granted globally, which strengthens its market position.
- Technological Innovation: The new patent enhances the efficacy and tissue safety of cryoablation procedures through precise temperature control, utilizing sensor data to regulate cryogen flow, ensuring the desired temperature is maintained at the distal tip of catheters and probes, significantly improving treatment effectiveness.
- Market Prospects: The ProSense® Cryoablation System has received FDA marketing authorization for the local treatment of low-risk breast cancer, becoming the first medical device approved for women aged 70 and older, which is expected to drive market share growth in this segment.
- Global Expansion: IceCure's innovative technology has not only gained regulatory approval in China but also secured a patent in Japan, with applications pending in the European Union and the U.S., showcasing its potential for global market expansion and strategic significance.







