ICCM — IceCure Medical Ltd

Summary of IceCure Medical Ltd (ICCM) Q4 2025 Earnings Call

1. Key Financial Results and Metrics:

   • Q4 2025 sales reached approximately $1.3 million, contributing to a record annual revenue of $3.4 million for the year.
   • The growth was attributed to the U.S. FDA clearance for ProSense and increased adoption in key markets.

2. Strategic Updates and Business Highlights:

   • The FDA granted marketing authorization for ProSense in October 2025 for treating low-risk breast cancer in women aged 70 and older, as well as patients unfit for surgery.
   • The American Society of Breast Surgeons (ASBRS) now recommends cryoablation for low-risk breast cancer, enhancing ProSense's market position.
   • IceCure is expanding its customer pipeline, with significant installations in prominent hospitals and clinics, including a large university hospital.
   • The company submitted a Class III application to Health Canada to expand ProSense's approval to include patients aged 60 and older, potentially impacting over 10,000 new cases annually in Canada.
   • IceCure plans to triple its U.S. commercial team by year-end 2026 to meet growing demand.

3. Forward Guidance and Outlook:

   • The company expects to close more system sales and installations in Q2 2026, with continued growth anticipated throughout the year.
   • The post-marketing study (PMS) is set to begin onboarding sites in the next three to six months, with patient enrollment expected to commence in late summer 2026.
   • The introduction of a CPT1 code for reimbursement is anticipated to spur demand, with expected implementation by early 2028.

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

   • While the FDA clearance and ASBRS recommendation are positive, the company faces the challenge of establishing reimbursement coverage beyond Medicare, particularly with Medicare Advantage plans.
   • The sales cycle for ProSense installations can range from a few months to nine months, which may slow down the immediate revenue growth.
   • The need for ongoing regulatory approvals in international markets, such as Canada and Japan, introduces uncertainty and potential delays.

5. Notable Q&A Insights:

   • The COO, Jay LeVeigh, confirmed that while high interest exists for the PMS sites, not all agreements have been finalized, indicating a need for careful management of the onboarding process.
   • The company is actively pursuing reimbursement opportunities, particularly focusing on Medicare Advantage and private payers, to enhance coverage for ProSense.
   • Questions regarding international expansion highlighted the potential for growth in Canada and Japan, with ongoing discussions with Terumo in Japan for regulatory submission.

Overall, IceCure Medical Ltd is positioned for growth with its FDA-cleared ProSense system, bolstered by strategic endorsements and expanding market presence, despite facing challenges in reimbursement and international regulatory processes.