IceCure Medical Ltd Q1 FY2026 earnings call

• Regulatory and Clinical Milestones

• Received FDA clearance for ProSense use in low-risk early-stage breast cancer, driving accelerated commercial momentum in the U.S. and increased global interest
• Gained FDA approval for the Choice post-market study in Q1 2026, which will enroll 30 hybrid clinical-commercial sites and 80 total patients, with the first patient planned to be enrolled by September 2026 and full patient completion expected by March 2027
• Submitted an amendment to Health Canada for breast cancer indication clearance, and expects a final approval decision by the end of 2026
• Updated American Society of Breast Surgeons guidelines now recommend cryoablation for patients with biologically low-risk breast cancer

• Commercial Progress

• Active U.S. accounts grew 46% from 13 to 19 after FDA clearance, with growth coming from both new customer acquisition and reactivation of previously inactive accounts that waited for regulatory clearance
• Large U.S. hospital networks, regional systems, and outpatient clinics are increasingly integrating ProSense, which does not require new infrastructure or complex workflow changes
• U.S. medical conferences following FDA clearance generated far more qualified leads than in 2025, with growing physician demand for information and hands-on training
• Approximately half of current active U.S. sites plan to participate in the Choice post-market study, and the company is prioritizing high-volume locations for the remaining 15 study sites
• ProSense already has an established CPT code covering facility costs of ~$4,000 per procedure; the company plans to submit for a CPT1 code for physician reimbursement in June 2026 and has also applied for transitional pass-through payment that could add $9,000 per procedure if approved
• FDA clearance has boosted global interest across Europe, Asia, and the Americas, even in markets where ProSense already had regulatory approval for breast cancer

• Reimbursement Progress

• Existing CPT code covers facility fees of ~$4,000 per procedure
• CPT1 code submission for physician reimbursement planned for June 2026, with a decision expected in early 2027 and potential implementation in 2028
• Transitional pass-through payment application filed, which could add $9,000 per procedure if approved by early 2027

• Non-Breast Business Activities

• Outside the U.S. (where commercial focus is centered on breast cancer), ProSense is already routinely used to treat tumors in other organs including kidney and lung, with growing clinical research activity in these indications

Aggregate total revenue for Q1 2026 grew 26% year-over-year. The North America product/geographic segment saw 84% year-over-year sales growth, while the U.S. sub-segment specifically grew 31% year-over-year. Growth was driven by both new ProSense system sales and increasing disposable probe sales, with disposable probe volume rising at both new and existing active customer sites. No separate absolute financial values or revenue contribution percentages for other segments were provided in the transcript.

• Management expects continued growth in the number of active U.S. accounts during Q2 2026
• The Choice post-market study remains on schedule: first patient enrollment is planned for September 2026, with all 80 patients expected to be enrolled by March 2027
• Health Canada approval for the breast cancer indication is expected by the end of 2026
• The CPT1 code application for physician reimbursement will be submitted in June 2026, with approval expected in 2027 for implementation on January 1, 2028
• Management expects sequential quarter-over-quarter commercial growth in 2026, with Q2 expected to be a strong quarter, and full-year growth driven by conversion of the expanding lead pipeline into system sales
• The growing pipeline of qualified leads is expected to convert to sales through the end of 2026 and into early 2027, supporting durable long-term growth

• All forward-looking statements related to commercial growth, regulatory approvals, and reimbursement are subject to inherent risks and uncertainties, many of which are outside of the company's control, as detailed in the company's 2025 Form 20-F filing with the SEC
• Conversion of the current lead pipeline to sales may take longer than expected, as customer purchasing processes require business plan development and internal approval
• Approval of CPT1 reimbursement and transitional pass-through payment is not guaranteed, and lack of full reimbursement could limit commercial adoption outside of clinical studies
• Turumo's submission to Japan's PMDA may slip slightly from the original June 2026 target to early Q3 2026, with regulatory outcome still uncertain
• Commercial adoption of ProSense outside of the Choice post-market study depends on patient willingness to cover out-of-pocket costs before full reimbursement is available, and long-term patient acceptance rates are still unproven at scale

Q: When do you expect to reach 30 Choice post-market study sites, and are you currently on schedule to meet study timelines? What is the status of the Health Canada submission amendment and approval timeline? / A: Since FDA approved the study protocol in March 2026, the company has already started contracting with sites across the U.S. and has made strong progress. The study remains on schedule to enroll the first patient by September 2026 and complete 80 total patient enrollments by March 2027. For Health Canada, the company has already responded to all informal technical feedback received, and still expects a final approval decision by the end of 2026.

Q: How do you approach commercial use of ProSense before the CPT1 physician reimbursement code is approved, and what is patient acceptance of out-of-pocket costs for commercial procedures outside of clinical trials? / A: Many providers offer commercial procedures in an office-based setting where transitional pass-through reimbursement does not apply. Providers disclose expected out-of-pocket costs directly to patients; because the total procedural cost is relatively low, most patients can manage these expenses. To date, all offered commercial patients have agreed to move forward with the procedure, though commercial volume is still ramping up following FDA clearance.

Q: Will the CPT1 code submission be completed on schedule in June 2026, and what cadence of system placements should be expected through 2026? / A: The CPT1 application package is in final preparation and will be submitted within 2-4 weeks of the call (on track for the June 2026 target), with approval expected in 2027 for a January 1, 2028 effective date. While the company does not provide detailed sales guidance, it expects Q2 2026 to be a strong quarter, with sequential quarter-over-quarter growth for the full year. Post-FDA clearance, many previously pending leads have become actionable, with growth momentum expected to build throughout 2026.

Q: What clinical outcomes and benefits does the company expect to generate from the Choice post-market study? / A: The Choice post-market study will generate real-world clinical data that reconfirms the positive outcomes seen in the ICE3 registrational trial. The patient population selected for the study matches the group that saw the best outcomes in ICE3, so management expects very strong results that can support future FDA expansion of ProSense's approved indication.