IceCure Medical has submitted final data to the US Food and Drug Administration (FDA) seeking marketing authorisation for its ProSense cryoablation system to treat early-stage T1 invasive breast cancer.

ProSense is a minimally invasive treatment intended to destroy tumours by freezing, using liquid nitrogen. This creates lethal zones for effective tumour destruction in benign and cancerous lesions, including kidney, breast, lung and liver.

The system, which is designed to enhance healthcare economics by reducing recovery time, pain, surgical risks, and complications, has already received FDA’s breakthrough designation for other indications.

IceCure said the submission included the ICE3 clinical trial results, which showed a 96.3% recurrence-free rate at five years, indicating similar outcomes to the current standard of care, lumpectomy, followed by hormone therapy.

The ICE3 trial is claimed to be the largest of its kind for liquid nitrogen-based cryoablation of low-risk, early-stage malignant breast tumours. It has demonstrated promising results, with no significant device-related adverse events reported.

The data submitted to the FDA includes a full dataset from the ICE3 five-year follow-up, a sub-analysis comparing ICE3 results with the LUMINA study, an updated PRISMA meta-analysis comparison, and real-world data from global commercial use and independent studies.

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The ICE3 trial’s outcomes align with those from the LUMINA study, which reported a 97.7% recurrence-free rate, and the PRISMA meta-analysis, which reported a 97.19% recurrence-free rate at five years.

IceCure CEO Eyal Shamir said: “We believe ICE3 is a ground-breaking study and are excited to report that the efficacy data of our minimally invasive ProSense cryoablation procedure show similar outcomes in recurrence compared to more invasive breast surgery, the current standard of care for early-stage breast cancer.

“Initial reimbursement codes are already in place and our U.S. marketing and commercial team is ready, as we await the FDA’s response.

“Driven by favourable healthcare economics combined with patient satisfaction and demand, we expect rapid adoption pending FDA granting the DeNovo Classification Request for Marketing Approval.”

Last month, IceCure obtained the Japan Patent Office’s Notice of Allowance for a patent application related to its ProSense cryoablation technology.