#Israel #Caesarea #IceCure Medical #Cryoablation #ProSense®

IceCure Medical Reports Financial Results for H1 2025

On August 13, 2025, IceCure Medical Ltd. (NASDAQ: ICCM) disclosed its financial and operational results for the first half of 2025, showcasing the company's ongoing commitment to innovation in minimally-invasive cryoablation technology. IceCure, known for its ProSense® system, aims to provide a non-surgical alternative for tumor removal by freezing, marking a significant advancement in cancer treatment options.

Financial Overview

In the six months ending June 30, 2025, IceCure generated revenues of $1.25 million, a decline from $1.75 million during the same period in 2024. The drop was primarily attributed to delays in product shipments due to geopolitical tensions affecting international deliveries, specifically the Israel-Iran conflict. Despite this, the company recorded strong support from its shareholder base, successfully completing a $10 million rights offering that was oversubscribed by a factor of two.

The company reported a gross profit of $349,000, down from $799,000 a year earlier. The decline in gross margin, from 46% to 28%, underscores the challenges faced during this period. Nonetheless, IceCure remains optimistic about future growth and continued adoption of ProSense® in key markets.

Operational Insights

A noteworthy highlight was IceCure's constructive dialogue with the U.S. Food and Drug Administration (FDA) regarding the marketing authorization request for ProSense® in treating early-stage, low-risk breast cancer in women aged 70 and older. This demographic accounts for approximately 46,000 patients annually in the U.S. The FDA has outlined that a post-market study will be required post-authorization, reflecting the agency's commitment to ongoing data collection for new medical treatments.

Eyal Shamir, CEO of IceCure, expressed optimism about the FDA's response and the growing momentum for ProSense® in Europe, attributing this trend to the positive outcomes from the ICE3 study and ongoing independent research.

A pivotal point for IceCure's commercial strategies includes strategic rollouts at global events focused on breast imaging and interventions. ProSense® is slated for presentation and workshops at significant conferences, which are expected to bolster its visibility and usage among medical professionals.

Looking Ahead

IceCure has set ambitious milestones for the remainder of 2025, including additional regulatory approvals in diverse markets such as Japan, where partner Terumo Corporation plans to file for authorization of ProSense®. Furthermore, IceCure's next-generation XSense™ system is awaiting approval from the Israeli Ministry of Health.

As clinical data continues to evolve, independent researchers are expected to leverage findings from the ICE3 study for their own trials, with initiatives like the PRECISE trial in Italy, further indicating a rising interest in cryoablation as a treatment modality in oncology.

Conclusion

Despite the challenges faced in H1 2025, IceCure Medical has demonstrated resilience and commitment to advancing its innovative technology for the betterment of patients. As regulatory pathways are navigated and commercial strategies are implemented, the company positions itself at the forefront of minimally-invasive cancer treatment innovations. The coming months are critical as stakeholders watch for FDA decisions, ongoing clinical trials, and the broader adoption of ProSense® in both the U.S. and international markets. IceCure continues to push forward, ensuring both patient safety and effective treatment remain at the core of its mission.