Positive FDA Meeting Outcome
IceCure Medical had a positive high-level meeting with the FDA, leading to a request for a post-market study plan, which is seen as a positive signal for ProSense marketing authorization.
Interest from Medical Community
There was significant interest in ProSense at the American Society of Breast Surgeons 2025 meeting, with many surgeons expressing interest in participating in the post-market study.
Strong Regional Sales Growth
Revenue in North America increased by 11% and in Europe by 60% year-over-year despite an overall slight decline in total revenue.
Financial Support from Largest Shareholder
The company secured a $2 million unsecured loan from its largest shareholder, providing financial flexibility while awaiting FDA decisions.