Icecure Medical Ltd（ICCM）資訊與事件ICCMIcecure Medical Ltd

IceCure Medical Enters Exclusive Distribution Agreement with Scovas Medical

IceCure Medical announced that it has entered into an exclusive distribution agreement with Scovas Medical for the distribution of IceCure's ProSense cryoablation systems in the Netherlands for breast cancer and interventional oncology. Under the Agreement, Scovas will serve as IceCure's exclusive distributor for ProSense in the Netherlands for an initial term with a view towards negotiating a further longer-term agreement, subject to the agreement of the parties. The Company believes that entering into the initial Agreement with Scovas supports market development, clinical education, and physician access in a country with strong interventional radiology expertise and a growing interest in minimally invasive procedures that support de-escalation of cancer care.

IceCure Medical Receives Approval for Low-Risk Breast Cancer Study

IceCure Medical announced that the Institutional Review Board of West Cancer Center & Research Institute in Germantown, Tennessee, has granted approval for the company's post-marketing study for ProSense cryoablation in the local treatment of low-risk breast cancer. The approval advances the study and enables patient enrollment, which is expected in the coming weeks. The results from the company's ICE3 clinical trial demonstrated that ProSense cryoablation followed by endocrine therapy achieved a 3.1% rate of local recurrence in women with early-stage, low-risk breast cancer. 99.1% of patients and 97% of physicians that responded to a survey reported high rates of satisfaction with the cosmetic outcomes. These results supported the FDA's marketing authorization for ProSense in selected patients aged 70 years and above.

IceCure Medical Highlights Clinical Role of Cryoablation in Breast Cancer Treatment

IceCure Medical highlighted two recent peer-reviewed publications by U.S. experts that reinforce the growing clinical role of cryoablation in breast cancer treatment de-escalation. A new review cites ProSense's FDA marketing authorization, its inclusion in updated American Society of Breast Surgeons guidelines and "encouraging" outcomes from the five-year ICE3 clinical study, while a second publication extends the clinical discussion of cryoablation to axillary lymph node metastases for both curative and palliative care. The first article highlights ProSense's authorized use in selected early-stage, low-risk breast cancers in women aged 70 and older, and ongoing studies including IceCure's ChoICE post-marketing trial. The second article notes that cryoablation can be performed safely with high technical success and low complication rates, and for both curative and palliative care, expanding the clinical discussion of cryoablation beyond the primary tumor to regional nodal disease.