IceCure Medical today said it received FDA breakthrough device designation for its ProSense cryoablation system.
ProSense is a liquid nitrogen-based cryoablation system that is a minimally invasive treatment for cancer tumors. It is designed for use in the treatment of TI invasive breast cancer or in patients not suitable for surgical alternatives for treating breast cancer.
“We are thrilled to receive the breakthrough device designation from the FDA for our lead asset, ProSense, based on promising clinical outcomes in multiple clinical studies to date. ProSense has successfully demonstrated the potential to be an exceptionally safe and effective minimally invasive cryoablation approach to tumor destruction. We believe receipt of this designation is a testimony to the potential of ProSense to become the new gold standard for cryoablation tumor therapy,” CEO Eyal Shamir said in a news release.
As part of the breakthrough device program, the Medicare Coverage of Innovative Technology (MCIT) program could provide Medicare coverage for devices like the ProSense for a four-year duration starting the day of FDA marketing authorization of the device. IceCure Medical said it would still be required to apply for CPTI codes under regular approval procedures to receive reimbursement after the four-year provisional coverage period.
“The addition of the breakthrough device designation builds on a series of successful regulatory milestones. ProSense has already received FDA approval for general minimally-invasive cryoablation applications, including for kidney, liver and benign breast tumors. IceCure is further pursuing FDA-specific approval for breast cancer with its ongoing ICE3 clinical trial, the largest controlled multilocation clinical trial in the U.S. for liquid nitrogen-based cryoablation of small, low-risk, early-stage malignant breast tumors. We are excited to have updated interim results of the ICE3 trial presented at the upcoming American Society of Breast Surgeons Annual Meeting on April 30,” Shamir said.