IceCure Corporation Reports Second Quarter Earnings of 2025 in a Public Transcript
IceCure Medical Ltd, a company specializing in minimally invasive cancer treatments, is gearing up for several significant milestones in the second half of 2025.
The company recently raised $2.65 million in net proceeds from the sales of 2,127,961 ordinary shares under their at-the-market offering facility. This funding, coupled with the $10 million in gross proceeds from a rights offering that closed on August 1, will strengthen IceCure's financial position, enabling them to continue executing across their regulatory, clinical, and commercial activities.
One of the key regulatory milestones is the pending FDA marketing authorization for their ProSense cryoablation system. Although the system has not yet received approval in the U.S. for treatment of early-stage, low-risk breast cancer in women aged 70 and over combined with adjuvant endocrine therapy, IceCure has submitted a comprehensive post-market study plan in response to the FDA’s request. The FDA has asked for additional information on this plan, which IceCure is actively working to provide. The company remains optimistic that approval will be granted by the end of 2025, assuming the supplemental information satisfies the FDA.
In the meantime, ProSense is already approved for breast cancer and other indications in Europe, with growing adoption supported by clinical trial results. IceCure plans to commercialize the device in the U.S. starting in 2026 upon FDA clearance.
Recruitment and commercialization planning are underway for a U.S. launch post-clearance, including developing a commercial team and identifying sites that will serve as both study and early commercial users.
The net loss for the six months ended June 30, 2025, was $6.95 million, or $0.12 per share, compared to $6.69 million, or $0.14 per share, in the same period last year. Operating expenses for the same period were $7.39 million, down from $7.68 million in 2024, due to spending optimization efforts. Revenue for the six months ended June 30, 2025, was approximately $1.25 million, down from $1.75 million in 2024, due to a shipment delay of over $200,000 in Q2 2025 caused by the Israeli-Iran conflict.
IceCure Medical expects key value-driving milestones in the second half of the year, including a final FDA marketing authorization decision, submission of a regulatory filing in Japan for ProSense, and a decision from the Israeli Ministry of Health on their next-generation access.
The company will also have a stronger presence at major conferences in September, including at the European Society of Breast Imaging and the Cardiological and Interventional Radiology Society of Europe. Management, including Eyal Shamir (CEO), Ronen Tsimerman (Chief Financial Officer and Chief Operating Officer), will be presenting at these conferences.
Additional data releases may be coming from independent study models on ICE3, including from trials in Italy and Brazil. The application for a CPT1 code will commence upon FDA clearance, with an expected process duration of 12 to 18 months and support from five specialist societies.
IceCure Medical's ProSense cryoablation system offers a minimally invasive alternative to lumpectomy for approximately 46,000 eligible women annually in the U.S., making it a significant opportunity for the company.
[1] FDA requests additional information for post-market study [3] IceCure submits post-market study plan to FDA [5] IceCure sees significant opportunity for ProSense in U.S. market
- IceCure Medical Ltd will actively work to provide the additional information requested by the FDA for their post-market study plan.
- Upon receiving the FDA's acceptance, IceCure has planned to submit a regulatory filing in Japan for their ProSense cryoablation system.
- IceCure Medical expects a decision from the Israeli Ministry of Health on their next-generation access in the second half of the year.
- Besides attending major conferences, IceCure's management will present at the European Society of Breast Imaging and the Cardiological and Interventional Radiology Society of Europe.
- With FDA clearance, IceCure Medical sees a significant opportunity to offer their ProSense cryoablation system to approximately 46,000 eligible women annually in the U.S. market.
