IceCure Medical reports 36% sales growth in first nine months of 2024

IceCure Medical (ICCM) reported financial results as of and for the nine months ended September 30. Sales of ProSense consoles and disposable probes increased by 36%. Gross profits increased by 41%, while non-GAAP gross profits grew by 104%. Gross margins increased to 43%, while non-GAAP gross margin increased to 40%, compared to 27% in the same period in 2023. On November 7, the U.S. FDA Medical Device Advisory Committee Panel voted in favor of ProSense’s benefit-risk profile in early-stage low risk breast cancer. Near-Term Value Enhancing Catalysts: The FDA will review and evaluate the Advisory Panel’s recommendation and is expected to make a final decision regarding marketing authorization of ProSense in early-stage, low risk breast cancer with endocrine therapy in the first quarter of 2025. Interim results of the company’s ICESECRET, a prospective, multicenter, single-arm clinical trial of ProSense for the cryoablation of kidney cancer, are expected to be released in December 2024. Terumo Corporation, IceCure’s partner in Japan, is expected to file for regulatory approval of ProSense for breast cancer in Japan in 2025, with the aim of receiving regulatory clearance. The company expects that additional third-party data on ProSense will be published in medical journals and presented at prestigious medical conferences throughout 2025.