Regulatory Progress for ProSense
IceCure concluded a productive meeting with the FDA regarding de novo marketing authorization for ProSense, with optimism for approval before year-end 2025. The FDA requested a post-market study, which has been fully submitted and awaits feedback.
Increased Adoption in Europe
ProSense has seen a positive shift in adoption in Europe for breast cancer cryoablation, driven by ICE3 results and growing clinical evidence. The technology was featured prominently in several high-impact medical forums.
Successful $10 Million Rights Offering
IceCure strengthened its financial position with a $10 million rights offering that was significantly oversubscribed, providing a sufficient cash runway for the anticipated FDA decision.
Strong Clinical Results in Japan
17 years of data from over 600 breast cancer patients in Japan showed a 99% recurrence-free rate with cryoablation, demonstrating significant clinical success.