BY SEAN WHOOLEYIceCure Medical (Nasdaq:ICCM) announced today that it submitted final data to the FDA requesting marketing authorization for its ProSense system.
Caesarea, Israel-based IceCure designed ProSense to deliver cryoablation that treats breast cancer in a 20-40-minute outpatient procedure. It seeks FDA authorization for treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy.
ProSense already holds FDA breakthrough device designation and has clearance in the U.S. for other indications. Those include treating benign tumors of the breast, and tumors in the kidney and liver.
However, the FDA in 2022 denied IceCure’s de novo classification request for ProSense to treat patients with early-stage, low-risk breast cancer. In January of this year, the FDA agreed to reopen the de novo file. An affirmative response from the FDA provided IceCure with a potential pathway to clearance.
The company submitted a five-year follow-up dataset from the ICE3 study and a sub-analysis as well. Real-world data, including post-market commercial use and independent third-party study results, went to the FDA as well.
ICE3 evaluated the liquid nitrogen-based cryoablation of low-risk, early-stage malignant breast tumors. Five-year recurrence-free rates (96.3%) fell in line with expectations and showed similar outcomes to lumpectomy (97.7%), the current standard of care. IceCure also reported no significant device-related adverse events or complications in the final ICE3 analysis.
“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,” said IceCure CEO Eyal Shamir. “Driven by favorable healthcare economics combined with patient satisfaction and demand, we expect rapid adoption pending FDA granting the DeNovo Classification Request for Marketing Approval.”