ICCM — IceCure Medical Ltd

ICCM Q1 2026 Earnings Call Summary

1. Key Financial Results and Metrics:

• Revenue increased by 26% year-over-year for Q1 2026.
• North American sales surged by 84%, with U.S. sales growing by 31%.
• Growth attributed to increased system sales and higher utilization of disposable probes.

2. Strategic Updates and Business Highlights:

• The company reported a 46% increase in active accounts, rising from 13 to 19 since FDA clearance for low-risk early breast cancer treatments.
• Engagement with prestigious hospital networks and outpatient clinics is growing, with ProSense being integrated into existing workflows.
• The U.S. commercial team is expanding to support increased demand, with plans to hire additional sales representatives.
• The Choice post-market study received FDA approval, aiming to include 30 clinical and commercial hybrid sites across the U.S. to enhance adoption and generate clinical data.

3. Forward Guidance and Outlook:

• Management expects continued growth in active accounts in Q2 2026, driven by new customer acquisitions and reactivation of previously inactive accounts.
• Anticipation of additional reimbursement opportunities with the submission of a CPT1 code in June 2026, with expected approval by early 2027.
• The company is optimistic about maintaining a strong growth trajectory, supported by a robust pipeline of leads converting into sales.

4. Bad News, Challenges, or Points of Concern:

• The company faces potential risks related to the regulatory approval process for reimbursement codes, which could impact revenue timelines.
• There is uncertainty regarding the pace of new account activations and whether the growth momentum can be sustained through the traditionally slower summer months.
• Competitive pressures in the medical technology space, particularly in cryoablation, may pose challenges to market share.

5. Notable Q&A Insights:

• Management confirmed they are on schedule to activate post-market study sites, with expectations to enroll the first patient by September 2026.
• There is a focus on high-volume centers for the post-market study to enhance both commercial and clinical outcomes.
• Dr. Fine highlighted that the Choice study is expected to reconfirm positive outcomes from the ICE3 trial, which could lead to broader FDA indications.
• There was a discussion about the economic viability of treating patients outside the trial, with positive patient acceptance noted for out-of-pocket expenses related to the ProSense procedure.

Overall, IceCure Medical is experiencing significant growth and momentum in the U.S. market, driven by FDA approvals and increasing clinical engagement, while also navigating potential regulatory and competitive challenges.