This follows the agency’s 2022 denial of IceCure’s de novo classification request for its ProSense cryoablation system. The Caesarea, Israel-based company sought clearance for ProSense to treat patients with early-stage, low-risk breast cancer. FDA’s affirmative response reopens the de novo file, providing IceCure with a potential pathway to clearance.
ProSense provides a minimally invasive treatment option to destroy tumors by freezing them. It utilizes liquid nitrogen to create large lethal zones for tumor destruction in both benign and cancerous lesions. IceCure lists applications such as breast, kidney, lung and liver tumors.
The platform won FDA investigational device exemption (IDE) in April 2021. IceCure believes it could accelerate recovery while reducing pain, surgical risks and complications. With an easy, transportable design and the use of liquid nitrogen, it could offer a fast, convenient office-based procedure.
What the FDA decision means for IceCure
IceCure said the FDA found sufficient basis to reopen the de novo file. It requested the company’s full five-year dataset from the ICE3 trial. The company expects to have its five-year follow-up data from ICE3 by the end fo February. It plans to expedite data monitoring and analysis to submit the final dataset by April 2024, months ahead of its initial timeline.
Additionally, the FDA asked IceCure to submit an analysis of the data compared with data from the LUMINA study evaluating the risk of recurrence in patients with low-risk Luminal A breast cancer treated with lumpectomy surgery with adjuvant hormone therapy.
The FDA also invited the company to submit real-world data from global use of the system. This could include post-market commercial use in territories where ProSense has approval to treat breast cancer. Independent third-party studies may also qualify.
“The FDA has set a very clear path to clearance for ProSense in early-stage breast cancer, which may lead to women having a new, minimally invasive, safe, and effective treatment option,” said IceCure CEO Eyal Shamir. “We remain hopeful that final ICE3 data will be in line with our interim results and are confident that we can deliver the dataset, comparable analysis, and real-world data to the FDA in the next few months.”
