Kemp Dolliver's questions to IceCure Medical (ICCM) leadership • Q2 2025
Question
Kemp Dolliver of Brookline Capital Markets inquired about the specific additional information the FDA requested for the ProSense post-market study, the potential impact on the trial's budget, and the expected timeline for securing a CPT 1 code post-approval.
Answer
CEO Eyal Shamir explained that the FDA requested more details on the post-market study's execution, including a list of potential sites and a recruitment plan, to build confidence in IceCure's ability to conduct the study. CFO & COO Ronen Tsimerman added that the final budget is pending full understanding with the FDA. Regarding commercialization, Shamir confirmed plans to hire a sales team immediately after clearance and apply for a CPT 1 code, a process expected to take 12-18 months with support from five medical societies.