#Israel #Caesarea #IceCure Medical #ProSense® #Eyal Shamir

IceCure Medical Reports Record Sales and Market Progress

On January 12, 2026, IceCure Medical Ltd. (NASDAQ: ICCM), known for its innovative cryoablation technology, announced remarkable developments to its shareholders via a letter from CEO Eyal Shamir. The company reported unprecedented sales figures for ProSense®, its leading product, designed to treat low-risk breast cancer. This achievement comes in the wake of FDA marketing authorization, which has significantly bolstered demand in the United States and Europe.

Strong Performance and Market Demand

The FDA granted authorization for ProSense® as the first on-label minimally invasive treatment option targeted at women over 70 with low-risk breast cancer. This pivotal milestone has not only expanded treatment options for patients but has also demonstrated the potential to enhance overall healthcare economics. There are approximately 200,000 women annually in the U.S. eligible for cryoablation treatment, highlighting the expansive market opportunity right at IceCure's doorstep.

The initial response to ProSense® in the U.S. has been overwhelmingly positive, showcased by approximately $3.4 million in ProSense® sales during the year ending December 31, 2025. This surge in sales reflects not just the product's innovative design but also its growing adoption among healthcare professionals and institutions, including reputable hospitals and clinics across the U.S.

In Europe, similar patterns have emerged, demonstrating record sales attributed to the FDA clearance and steady adoption rates. The increasing number of placements at high-acclaim institutions suggests a burgeoning enthusiasm around IceCure's technology.

Enhancing Clinical Visibility

IceCure's achievements are not confined to commercial sales. In 2025, the company recorded the highest number of peer-reviewed publications and conference presentations by its principal investigators, underscoring a growing body of clinical evidence supporting the efficacy of ProSense® across various cancer types, including breast, musculoskeletal, and kidney cancers. These publications are crucial in promoting the product's adoption and affirming its effectiveness through independent research validates the treatment's safety and efficacy.

Strategic Goals for 2026

Looking ahead, IceCure remains committed to sustaining momentum through strategic initiatives aimed at further clinical validation and commercialization efforts. Several objectives have been outlined for 2026, including:

• - Expansion of U.S. Market Reach: The company anticipates continued growth in ProSense® system and cryoprobe sales as market acceptance increases.
• - Reimbursement Developments: Potential additional coverage options for ProSense® procedures based on received authorizations, including a CPT III code increase effective January 2026.
• - Regulatory Approvals: The forthcoming request for breast cancer clearance in Japan underscores IceCure's ambition to extend its global footprint.
• - Ongoing Independent Studies: An ongoing effort to produce more peer-reviewed research will provide further credibility to the ProSense® technology and its applications.
• - Pursuit of Strategic Partnerships: IceCure will explore opportunities for collaboration to accelerate growth and capitalize on recent advancements.

In conclusion, IceCure Medical’s progress in 2025 underscores its commitment to transforming cancer treatment with innovative solutions like ProSense®. The milestones achieved thus far signal an optimistic future for IceCure as it plans to enhance healthcare measures for patients requiring effective and less invasive treatment alternatives. As we step into 2026, the company looks forward to further achievements that will benefit patients and healthcare providers alike.

Stay updated with IceCure as it paves the way for advanced cancer treatment technologies.