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IceCure Medical (ICCM) investor relations material
IceCure Medical Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary19 Nov, 2025
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.
What is the expected ramp-up for new US ProSense sites?
What is the strategy for additional reimbursement?
How will gross margin improve with increased sales?
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Next IceCure Medical earnings date
Q4 202527 Mar, 2026
Next IceCure Medical earnings date
Q4 202527 Mar, 2026
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Frequently asked questions
IceCure Medical Ltd. is a commercial-stage medical device company that focuses on the development and marketing of cryoablation systems. Utilizing liquid nitrogen-based technology, the company offers minimally invasive treatments for both benign and malignant tumors, primarily targeting applications in women's health and interventional oncology. IceCure Medical's flagship product, the ProSense Cryoablation System, destroys tumors by freezing them, providing an alternative to traditional surgical tumor removal. IceCure Medical Ltd. is headquartered in Caesarea, Israel, and its shares are listed on the NASDAQ.
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