FDA Marketing Authorization for ProSense
The FDA granted marketing authorization for IceCure Medical's ProSense system to treat low-risk breast cancer, positioning the company at the forefront of minimally invasive breast cancer care.
Significant Addressable Market
ProSense addresses a potential market of approximately 200,000 patients annually in the U.S., including 46,000 women over 70 diagnosed with low-risk breast cancer, 88,000 patients not eligible for surgery, and 63,000 women with benign breast tumors.
International Expansion and Interest
Global interest is growing following FDA approval, with recent regulatory approval in Switzerland and plans for expansion in Japan with Terumo Corporation.
Financial Position Strengthened
IceCure Medical raised $10 million from a rights offering and $5.87 million from a market offering, bringing the cash balance to $11.8 million as of October 31, 2025.
Operational Cost Optimization
Total operating expenses decreased to $11.5 million from $12.2 million, reflecting efforts to optimize spending while executing commercial and regulatory strategies.