IceCure Medical (ICCM) Q1 2025 earnings summary

Executive summary

• Submitted a post-market study plan to the FDA for ProSense cryoablation in early-stage breast cancer for women aged 70+, with optimism for marketing authorization and strong interest from breast surgeons and interventional radiologists.

• Achieved continued growth in ProSense systems and disposable probe sales in North America, offsetting declines in Asia, with Europe also showing strong growth.

• Largest shareholder provided a $2 million unsecured bridge loan, enhancing financial flexibility and reflecting confidence in the business outlook.

• Multiple upcoming milestones in 2025, including regulatory filings in Japan and Israel, and new third-party data publications.

• ProSense and ICE3 study received notable recognition at major medical conferences, including ASBRS 2025.

Financial highlights

• Q1 2025 revenue was $725,000, down from $743,000 in Q1 2024, driven by growth in North America and Europe but offset by declines in Asia.

• Gross profit was $218,000 (gross margin 30%), compared to $269,000 (gross margin 36%) in Q1 2024.

• Operating expenses were $3.88 million, slightly down from $3.92 million year-over-year.

• Net loss was $3.59 million ($0.06 per share), compared to $3.61 million ($0.08 per share) in Q1 2024.

• Cash and equivalents were $6.04 million as of March 31, 2025, and $6.2 million as of May 27, 2025, including the bridge loan.

Outlook and guidance

• No material change in revenues expected before FDA marketing authorization decision; revenues and gross profits expected to remain variable as commercial scale builds.

• Post-market study will enroll 400 patients across at least 25 sites, with recruitment expected within three years.

• Anticipate regulatory filings and potential approvals in Japan (H2 2025) and Israel, plus new third-party data releases.

• U.S. sales team expansion planned following marketing authorization.