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 and the continued broad adoption of the product 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 [16][19] 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 - The company aims to triple its U.S. commercial team by the end of the year to align with growing momentum and demand, focusing on broader penetration across the U.S. market [16][19] - IceCure is also working on obtaining CPT-1 code reimbursement to cover physician costs, 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 accelerate adoption and validate ProSense's role in modern breast cancer care [6][7] - The company anticipates that the post-marketing study will significantly accelerate the national rollout and availability of ProSense, with patient enrollment expected to commence in late summer [18][19] Other Important Information - The company highlighted the importance of independent studies and peer-reviewed publications in enhancing ProSense's reputation and driving demand for its adoption in breast cancer care [14][15] - IceCure is actively participating in medical conferences to engage with its target audience and promote ProSense for breast cancer treatment [11][12] Q&A Session Summary Question: Plans for reimbursement coverage beyond Medicare - Management indicated that they are focusing on Medicare Advantage programs and private payers, with a payer outreach program in place to increase reimbursement consistency [23][25] Question: Impact of CPT-1 code on demand - Management believes that obtaining CPT-1 code will improve total reimbursement and serve as a significant inflection point for growth [26] Question: Status of post-market study sites - Management confirmed that all 30 sites for the post-market study have been identified, with high interest from those sites to also serve as commercial sites [29][34] Question: Regulatory approval in Canada and Japan - The company submitted for regulatory approval in Canada for patients aged 60 and above, representing over 10,000 new cases annually, and is working with Terumo in Japan for formal submission to PMDA [38][39]