IceCure Medical(ICCM 2.44%) reported second-quarter 2025 results on Aug. 13, 2025, with revenue declining year-over-year to $1.25 million from $1.75 million for the six months ended June 30, 2025. The company highlighted regulatory progress for its ProSense system in breast cancer, a $10 million rights offering to strengthen liquidity, and expanding clinical validation in international markets. Key strategic updates center on the U.S. Food and Drug Administration (FDA) review, financial runway, and global adoption momentum.

FDA review advances for IceCure Medical's ProSense

The de novo marketing authorization request for ProSense is under active review by the FDA, with a comprehensive post-market study protocol submitted as requested. The FDA's requirements include a 400-patient, 30-site post-market commitment, which is shaping operational planning for the company.

"In the second quarter, we concluded a productive meeting with leadership at the FDA Center of Devices and Radiological Health regarding our de novo marketing authorization request. Importantly, the FDA requested a post-market study to be conducted after marketing authorization has been granted. The post-market study has been fully submitted to the FDA. We believe the plan reflects a comprehensive and well-structured approach. We were asked to provide additional information, which we are actively working to complete. Assuming the FDA finds the supplemental data satisfactory, we remain optimistic that approval will be granted before the end of 2025."
— Eyal Shamir, CEO

Successful FDA approval would represent a major inflection point for IceCure Medical, potentially accelerating U.S. commercial adoption and long-term revenue growth.

IceCure Medical’s rights offering strengthens financial position

As of June 30, 2025, cash and short-term deposits were $5.38 million, not including $10 million in gross proceeds from an oversubscribed rights offering that closed on August 1, 2025. Operating expenses decreased to $7.39 million from $7.68 million year-over-year for the six months ended June 30, 2025, and net loss was $6.95 million compared to $6.69 million in the prior year period.

"Recently, we strengthened our financial position with the closing of our $10 million rights offering that was significantly oversubscribed. We believe that this is a strong indicator and a vote of confidence from our shareholders. We expect this to provide a sufficient cash runway for the anticipated FDA marketing authorization decision. Our largest shareholder and a board member, Mr. Lihai Zhang of Epoch Partner Investment Limited, participated in the rights offering."
— Eyal Shamir, CEO

The successful capital raise reduces near-term liquidity risk and signals strong internal support for the company’s regulatory and commercial milestones.

ProSense clinical data drives global adoption

Peer-reviewed studies, especially from Japan, demonstrated ProSense’s long-term efficacy, including a 17-year follow-up in over 600 breast cancer patients with a 99% recurrence-free rate. The system received prominent exposure at major European and Japanese scientific meetings, fueling demand for hands-on training and real-world data presentations.

"Earlier in this quarter, ProSense was featured at the Japanese Breast Cancer Society Conference, during which a respected expert and ProSense user, Professor Fukuma, presented 17 years of data from over 600 breast cancer patients showing a 99% recurrence-free rate with cryoablation. I would like to repeat this message: 17 years of follow-up for over 600 breast cancer patients showing only a 1% recurrence, which means a 99% recurrence-free rate, which is the biggest global clinical evidence using our technology."
— Eyal Shamir, CEO

Robust international clinical evidence is supporting broader adoption of ProSense in Europe and Asia, enhancing the company’s credibility and market potential ahead of U.S. regulatory decisions.

Looking Ahead

Management expects a final FDA marketing authorization decision for ProSense before the end of 2025. Additional milestones for the second half include a Japanese regulatory filing by partner Terumo and a decision from the Israeli Ministry of Health on next-generation access. IceCure Medical also anticipates increased commercial traction and further clinical data disclosures at major European medical conferences in September 2025; no specific commercial or financial quantitative guidance was provided beyond these regulatory and strategic targets.