IceCure Medical Ltd Q4 FY2025 earnings call

Regulatory and Society Impact - U.S. FDA marketing authorization of ProSense in October 2025 for low-risk breast cancer in women age 70 and over and non-suitable for surgery. - American Society of Breast Surgeons’ (ASBRS) 2026 statement recommends cryoablation as an option for selected patients with biologically low-risk early-stage breast cancer. ### Customer Pipeline and Installations - Growing pipeline of customers including medical clinics and hospitals converting to signed contracts, deliveries, and installations of ProSense. Examples include Thomas Hospital and prominent hospitals in the Southeast and highly regarded medical institutions with ProSense systems. ### Global Momentum - FDA clearance widens demand in other markets where ProSense already has approval for breast cancer, increasing confidence and adoption internationally, especially in Europe. - Submitted Class III amended application to Health Canada seeking to expand regulatory approval for ProSense in treatment of early-stage, low-risk invasive breast cancer in patients aged 60 years and older. - Evidence-based data and peer-reviewed presentations/abstracts enhancing ProSense’s reputation, with clinical programs promoted on social media. ### U.S. Commercial Activity - Three factors converging to accelerate adoption in U.S.: FDA-cleared, established reimbursement, ASBRS guidelines. - Increasing U.S. commercial organization to address demand, aiming to triple commercial team by end of year. - Post-marketing study (PMS) with 30 sites required, majority identified, onboarding to commence in 3 - 6 months, all 30 to be opened by end of next year, patient enrollment to commence in late summer with 20% by next year.

In the twelve months ended December 31, 2025, the company had a record fourth quarter of sales of approximately $1.3 million, leading to a record revenue from sales of $3.4 million for the full year. Growth was driven by record-year sales reflecting the positive effect of the U.S. FDA clearance in low-risk early-stage breast cancer and continued growth and adoption of ProSense in key markets. Revenue contribution details not explicitly broken down by specific product segments other than ProSense-related sales.

Forward-Looking - Expect to close increasing number of system sales and installations during second quarter of 2026 with continued growth in subsequent quarters. - Post-marketing study onboarding to commence in 3 - 6 months, all 30 sites to be opened by end of next year. - Patient enrollment in PMS slated to commence in late summer with 20% enrollment by this time next year. - Anticipate CPT1 code reimbursement response by early 2027 with CPT1 going effective in early 2028. - Believe CPT1 will be an important point for faster growth starting from early 2028.

Q: Could you walk through a little more detail with regard to your plans to get reimbursement coverage beyond Medicare?

A: Jay LeVeigh mentioned they have a payer outreach program approaching private payers, focusing on Medicare Advantage program, and continuing to work on increasing payments and transitioning to CPT1.

Q: As you proceed with getting CPT1 code in place, do you see that as spurring significant additional demand, or is it really just a matter of getting better reimbursement based on what you have seen so far in the market?

A: Eyal Shamir said they believe CPT1 will be an important point at which IceCure Medical Ltd will be able to grow much faster and higher starting from early 2028.

Q: On the 30 hybrid commercial clinical sites, can you get a little more specific? Have you identified at least 20 or 25? And then talk a little bit about the ramp.

A: Jay LeVeigh said they identified the sites, have high interest from sites across the U.S., not all agreements signed yet related to PMS, but have confidence in moving forward fast with those sites.

Q: Announced filing in Canada for regulatory approval, hoping to get that before the end of this year. Can you talk about the opportunity there? And update on Japan.

A: Jay LeVeigh said submitted for ICE3 indication in Canada for 60 and above, representing over 10,000 new cases annually. In Japan, working with Terumo, Terumo started process with PMDA, had first general consultation with positive outcomes with comments to address, planning another discussion and formal submission immediately after.