IceCure(ICCM) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - IceCure Medical reported record fourth quarter sales of approximately $1.3 million, leading to total revenue from sales of $3.4 million for the full year ended December 31, 2025, reflecting significant growth driven by record unit sales and FDA clearance for ProSense [5][6][12] Business Line Data and Key Metrics Changes - The growth in sales was attributed to the positive effects of the U.S. FDA clearance for ProSense in low-risk early-stage breast cancer, which has led to broad adoption in key markets [5][6] - The company is experiencing a clear uptick in interest and engagement from patients and facilities, with expectations to close an increasing number of system sales and installations in the upcoming quarters [17][21] Market Data and Key Metrics Changes - The FDA clearance has driven demand in other markets where ProSense already has approval, particularly in Europe, leading to expanded usage for new clinical applications [12][14] - In Canada, the company submitted a Class III amended application to expand regulatory approval for ProSense to include patients aged 60 years and older, potentially impacting around 7,130 women diagnosed with low-risk breast cancer [13][37] Company Strategy and Development Direction - IceCure Medical aims to triple its U.S. commercial team by the end of the year to address growing demand and enhance market penetration [17] - The company is focusing on expanding its customer base through a post-marketing study, which is expected to accelerate the national rollout and availability of ProSense [19][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the strong global commercial momentum driven by regulatory approvals and new medical society guidelines recommending cryoablation for low-risk early-stage breast cancer [6][8] - The company anticipates that the upcoming CPT 1 code reimbursement will serve as a significant inflection point for growth, expected to be effective in early 2028 [25][41] Other Important Information - IceCure Medical is actively working with medical societies to enhance reimbursement coverage, focusing on Medicare Advantage and private payers [24] - The company has seen a record number of peer-reviewed publications and conference presentations, which are expected to further increase global exposure and demand for ProSense [15][16] Q&A Session Summary Question: Plans for reimbursement coverage beyond Medicare - Management is focusing on Medicare Advantage and private payers, with a payer outreach program in place to enhance reimbursement consistency post-FDA approval [23][24] Question: Impact of CPT I code on demand - Management believes that while CPT I will improve reimbursement, it will also serve as a critical point for accelerated growth in 2028 [25] Question: Status of post-market study sites - Management confirmed that high interest has been observed from identified sites, with ongoing efforts to meet requirements for both clinical and commercial use [29][33] Question: Regulatory approval opportunities in Canada and Japan - The Canadian submission targets patients aged 60 and above, representing over 10,000 new cases annually, while in Japan, collaboration with Terumo is underway for regulatory submission [37][39]