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 unit sales and FDA clearance [5][6][12] Business Line Data and Key Metrics Changes - The growth in sales was attributed to the positive effects of U.S. FDA clearance for ProSense in low-risk early-stage breast cancer and the continued adoption of ProSense 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 during the second quarter of 2026 [17][20] 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 treatment for early-stage, low-risk invasive breast cancer in patients aged 60 and older, potentially impacting around 7,130 women annually [13][38] 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 achieve broader market penetration [17][20] - The company is focusing on increasing reimbursement coverage, particularly through the transition to CPT Category I codes, which is expected to spur additional demand and improve reimbursement rates [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that the FDA clearance and new medical society guidelines recommending cryoablation for low-risk breast cancer will significantly enhance ProSense's adoption and market presence [6][8] - The company anticipates that the post-marketing study will accelerate the national rollout and availability of ProSense, with patient enrollment expected to commence in late summer [19][20] Other Important Information - IceCure Medical has seen a record number of peer-reviewed publications and conference presentations in 2025, enhancing ProSense's reputation and driving demand for its adoption [15][16] - The company is actively working with medical societies to improve reimbursement processes and expand its market presence [20][25] Q&A Session Summary Question: Plans for reimbursement coverage beyond Medicare - Management is focusing on Medicare Advantage plans and private payers, with a payer outreach program in place to increase coverage [23][25] Question: Impact of CPT-1 code on demand - Management believes that obtaining CPT-1 will improve total reimbursement and serve as a significant inflection point for growth [26] Question: Status of post-market study sites - Management confirmed that high interest has been shown from identified sites, with ongoing work to meet requirements for both clinical and commercial use [30][34] 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 [36][38]