IceCure Medical's Q1 2025: Key Contradictions in FDA Studies, Sales Strategies, and Team Expansion

FDA post-market study timeline, U.S. sales and commercial team build-out, sales strategy and pricing models, FDA response timeline, and sales team expansion are the key contradictions discussed in IceCure Medical Ltd's latest 2025Q1 earnings call.



FDA Approval and Post-Market Study:
- IceCure Medical submitted a post-market study plan to the FDA, with an expected recruitment of 400 patients across 25 sites within a 3-year period.
- This submission is a significant milestone and could potentially lead to an FDA decision on marketing authorization, enhancing the company's position in the market.

Revenue and Sales Trends:
- For Q1 2025, revenue from ProSense system and disposable probe sales was $725,000, down slightly from $743,000 in the same period last year.
- The decline was primarily due to a drop in sales in Asia, while sales in North America and Europe increased, indicating fluctuating sales across regions.

CASH Burn and Financial Health:
- As of March 31, 2025, IceCure Medical had $6.0 million in cash and equivalents, and by May 27, 2025, this was increased to $6.2 million, including a $2 million unsecured bridge loan from Epoch.
- The company raised $2.65 million in net proceeds from an at-the-market offering, reflecting their financial stability while awaiting the FDA decision.

International Expansion and Market Opportunities:
- IceCure anticipates regulatory filings and potential approvals in Japan and Israel, with Japan's breast cancer population estimated to be between 100,000 to 105,000 new cases annually.
- This international expansion could significantly increase the market opportunity for ProSense, as it aims to tap into large patient populations with early-stage low-risk breast cancer.