Q4 2025 Icecure Medical Ltd Earnings Call Transcript
Key Points
- Icecure Medical Ltd (ICCM) reported record fourth-quarter sales of approximately $1.3 million, contributing to a total annual revenue of $3.4 million for 2025.
- The U.S. FDA clearance for ProSense in treating low-risk early-stage breast cancer has significantly boosted sales and adoption in key markets.
- The American Society of Breast Surgeons (ASBrS) now recommends cryoablation for selected patients, which could serve as a significant catalyst for ProSense adoption.
- ProSense is the first and only FDA-cleared medical device for breast cancer treatment, providing a competitive advantage in the U.S. market.
- Icecure Medical Ltd (ICCM) is experiencing strong global commercial momentum, with increased demand and expanded market presence in Europe and other international markets.
- The company's VP in sales North America was unable to join the call due to connectivity issues, potentially impacting the communication of sales strategies.
- The FDA's requirement for other companies to submit full follow-up data for cryoablation systems may delay market competition but also indicates a complex regulatory environment.
- The sales cycle for ProSense systems can take several months, which may slow down revenue realization.
- The transition to CPT 1 reimbursement is not expected until early 2028, which could delay optimal reimbursement rates.
- The post-marketing study requires onboarding 30 sites, which is still in progress and may take time to complete, potentially delaying broader adoption.
Good morning, and thank you for standing by. (Operator Instructions) Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Michael Polyviou. Please go ahead.
Thank you, Ella, and welcome to IceCure Medical's conference call to review the financial results as of and for the 12 months ended December 31, 2025, and provide an update on recent operational highlights. You may refer to the earnings press release that we issued earlier this morning. Participating on today's call is IceCure Medical's CEO, Eyal Shamir. The company's VP in sales North America, Shad Good is not able to join due to connectivity issues, so I will read his prepared statement. Shay Levav, the company's COO, will be available during the Q&A portion of the call.
Before we begin, I'll now take a moment to read a statement about forward-looking statements. The call and the question-and-answer session that follows it contain forward-looking statements within the meaning
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