IceCure Medical (ICCM) investor relations material

Executive summary

• Achieved FDA marketing authorization for ProSense cryoablation system for low-risk breast cancer, especially in women aged 70+ and those not suitable for surgery, positioning the company as a leader in minimally invasive care.

• Addressable U.S. market estimated at over 200,000 patients annually, including those not eligible for surgery and benign tumor cases.

• Strong global interest and expansion, with recent regulatory approvals in Switzerland and Israel, and a distribution agreement in Brazil.

• Multiple independent clinical studies validated ProSense efficacy across breast, lung, and endometriosis, reporting high survival, recurrence-free, and patient satisfaction rates.

Financial highlights

• Revenue for the nine months ended September 30, 2025, was $2.1 million, down from $2.42 million year-over-year, mainly due to lower sales in Japan, Asia, and North America, partially offset by growth in Latin America.

• Gross profit was $626,000 (30% margin), compared to $1,034,000 (43% margin) in the prior year period; non-GAAP gross margin was 30% versus 40% year-over-year.

• Operating expenses decreased to $11.5 million from $12.2 million year-over-year, reflecting reductions in R&D and sales/marketing, partially offset by higher G&A expenses.

• Net loss was $10.81 million ($0.18 per share), nearly unchanged from $10.84 million ($0.22 per share) in the prior year.

• Cash and equivalents were $10 million as of September 30, 2025, rising to $11.8 million by October 31, 2025, after successful capital raises.

Outlook and guidance

• Expectation of continued revenue and gross profit fluctuations as commercial activities ramp up post-FDA clearance.

• U.S. commercial rollout expected to accelerate with increased ProSense installations and a post-market study involving 30 clinical sites, pending FDA review.

• Anticipate broader patient access and higher facility reimbursement rates starting January 2026, with reimbursement for procedures expected to increase from $3,800 to over $4,000.

• Terumo Corporation plans to submit a regulatory application for ProSense in Japan in the first half of 2026.