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ICCM 資訊
ICCM 事件
IceCure Medical Completes First Patient Treatment in ChoICE Study
IceCure Medical has completed the treatment of the first patient in its post-marketing study, ChoICE, evaluating ProSense cryoablation for the local treatment of low-risk breast cancer. The ChoICE Study is designed to enroll approximately 400 patients across up to 30 U.S. clinical sites and generate real-world data on ProSense in its FDA cleared indication.
Medical Begins ProSense Cryoablation Clinical Study
Medical announced the enrollment of the first two patients at two U.S. clinical sites in its post-marketing study evaluating ProSense cryoablation for the local treatment of low-risk breast cancer. These initial enrollments follow the company's efforts to establish a network of U.S. clinical sites for the ChoICE Study. The ChoICE Study is designed to enroll approximately 400 patients across up to 30 U.S. clinical sites and generate real-world data on ProSense in its FDA cleared indication.
IceCure Medical Receives NMPA Approval for ProSense System
IceCure Medical has received approval, as a Class III medical device, from China's National Medical Products Administration for its ProSense system and associated cryoprobes. The NMPA approval represents an important regulatory milestone for IceCure and enables ProSense, IceCure's flagship cryoablation system, to be marketed in China in accordance with the approved registration.
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.
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