
Core Insights - IceCure Medical is awaiting FDA marketing authorization for ProSense® in early-stage low-risk breast cancer with endocrine therapy, which could position it as a first-in-class minimally invasive alternative to lumpectomy [2][8] - The company reported a sales increase for ProSense® systems and disposable probes, with total revenue rising to $3,291,000 for the year ended December 31, 2024, compared to $3,229,000 in 2023 [6][12] - Gross profit for the same period increased by 12% to $1,451,000, with a gross margin improvement to 44% from 40% year-over-year [7][12] Sales and Market Performance - Sales of ProSense® systems and disposable probes increased to $3,191,000 in 2024 from $2,955,000 in 2023, driven primarily by North American sales [6][12] - The company noted encouraging sales momentum in North America, Europe, and Japan, indicating potential for higher adoption following a positive FDA Advisory Panel decision in November 2024 [3][4] Financial Overview - Total operating expenses for the year ended December 31, 2024, increased by 2% to $17,147,000, primarily due to a 42% rise in sales and marketing expenses [11] - Research and development expenses decreased by 14% to $7,096,000, attributed to reduced development costs for the XSense™ System and the conclusion of the ICE3 study [10] - The net loss for the year increased by 5% to $15,318,000, or $0.30 per share, compared to a net loss of $14,652,000, or $0.32 per share, in the previous year [12][21] Future Catalysts - The FDA's decision on ProSense® marketing authorization is anticipated to drive further sales momentum globally [8] - Terumo Corporation, IceCure's partner in Japan, is expected to file for regulatory approval for ProSense® for breast cancer [8] - Additional third-party data on ProSense® is expected to be published in medical journals and presented at medical conferences throughout 2025 [8]