IceCure Medical Ltd Q3 FY2025 earnings call

• FDA granted marketing authorization for their system to treat low-risk breast cancer, validating years of clinical research and positioning them in minimally invasive breast cancer care. The indication covers ~46,000 women in the US over 70 with tumors up to 1.5 cm or on endocrine therapy, plus ~88,000 non-surgical or unwilling surgical patients and ~63,000 women with benign breast tumors.
• Encouraging response from US clinicians, with growing interest and plans to expand commercial sites. Submitted post-market study protocol to FDA and in interactive communication to finalize it.
• Global interest in ProSense, with Switzerland added to approved countries, and a Brazilian medical delegation visiting. Terumo plans to submit regulatory application for ProSense in Japan in H1 2026.
• Innovation progress: Net generation probation system approved in Israel, secured patent allowance in US and Japan. Featured at medical conferences and partnered with Karig Hospital for training.
• Strong clinical validation with 13 independent studies in breast cancer and data in lung cancer and endometriosis.

For the 9 months ended September 30, 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024. Revenue decreased by $316,000 due to a drop in sales in Japan, other Asian territories, and North America, partially offset by an increase in Latin America. Gross profit for the 9 months ended September 30, 2025, was $626,000 compared to $134,000 in the prior year period, resulting in a gross margin of 30% versus 43% in 2024. Total operating expenses decreased to $11.5 million for the 9 months ended September 30, 2025, from $12.2 million a year ago. Net loss for the period was $10.8 million or $0.18 per share, similar to the prior year's net loss of $10 million or $0.22 per share.

• Revenue and gross profits may continue to vary quarter-to-quarter as the company builds commercial scale sales.
• Cash, cash equivalents, and short-term deposits position the company strongly to execute regulatory, clinical, and commercial initiatives. Raised $10 million via rights offering and ~$5.87 million via market offering, boosting cash balance.
• Expect post-market study approval by end of year/early next year, with plan to recruit first patient by summer 2026 and reach 80 patients by end of 2026.

Q: Where's the status with the FDA for approval of the post-market study?

A: We submitted the protocol to the FDA and started interactive communication to finalize it. The official protocol with all elements has been submitted to the FDA.

Q: Update on the 30 sites for the post-market study?

A: About 20 sites identified, working on clinical protocol, statistical analysis plan, and claim database. Expect final approval by end of year/early next year, with first patient recruited by summer 2026 and 80 patients by end of 2026