The next-generation cryoablation technology ProSense was granted breakthrough device designation to treat certain patients with T1 breast tumors.
Breakthrough device designation was granted to the next-generation cryoablation technology ProSense for use in patients with T1 invasive breast cancer as well as in patients not suitable for surgical alternatives for the treatment of their tumors, reported IceCure Medical Ltd in a press release.1
The technology uses liquid nitrogen–based cryoablation for a minimally invasive destruction of tumor cells. This designation from the FDA will allow for an accelerated review and feedback from the agency through the development process to commercialization.
“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,” Eyal Shamir, chief executive officer of IceCure, said in a press release. “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.”
Results of the ICE3 trial—which is evaluating the efficacy and safety of Prosense technology in patients who have not undergone lumpectomy for low-risk, early-stage breast cancer—were previously presented at the 2018 American Society of Breast Surgeons Annual Meeting. Women 50 years and older (median, 75 years) were enrolled if they had a single tumor no larger than 1.5 cm.
Results showed that of 146 patients receiving no other therapy for their tumor, only 1 had recurrent disease, with 103 patients being observed for almost 2 years following the intervention. There were no significant complications of treatment, with most patients returning to normal activity and many being satisfied with the results cosmetically.2
According to Shamir, the ProSense system is already approved for general minimally invasive cryoablation applications, including for kidney, liver, and benign breast tumors. Updated results of the ICE3 trial supporting the additional indication in breast cancer is set for presentation on April 30, 2021 at the American Society of Breast Surgeons Annual Meeting.
“As we continue to evaluate ProSense for the treatment of breast cancer tumors in our ICE3 clinical trial, we are grateful to the FDA’s Breakthrough Device Program,” Shamir said. “We are looking forward to continuing to work closely with the FDA to make ProSense available to the [patients with breast cancer who] can benefit from our minimally-invasive cryoablation solution.”
Of note, if the Medicare Coverage of Innovative Technology program is approved by the current administration, ProSense would be available under Medicare coverage for a 4-year duration following marketing authorization by the FDA, a requirement that may accompany all breakthrough device designations.
1. IceCure Medical Granted FDA Breakthrough Device Designation for ProSense Cryoablation System. News release. IceCure Medical Ltd. April 5, 2021. Accessed April 5, 2021. https://bit.ly/31QiERn
2. ICE3 – Promising early evaluation. IceCure Medical website. Accessed April 5, 2021. https://bit.ly/31TP3Gt