IceCure Medical has received a favourable recommendation for its ‘ProSense’ Cryoablation System from the Medical Device Advisory Committee Panel of the US Food and Drug Administration (FDA).
Leveraging liquid nitrogen to target benign and malignant lesions, the ProSense system is said to offer a less invasive approach to killing tumours.
Nine panellists voted in favour, noting that the device’s benefits “outweigh the risks” when used as per the proposed indications to treat early-stage low-risk invasive breast cancer patients, combined with cryoablation and adjuvant endocrine therapy.
Despite five panellists voting against it, three of them noted that additional FDA special controls could have “swayed their opinion in favour”.
The positive vote was based on the data from IceCure's ICE3 trial and other inputs.
The non-randomised, multi-centre ICE3 study in the US assessed liquid nitrogen-based cryoablation of low-risk, early-stage, small breast tumours breast tumours as a surgery substitute.
It enrolled 194 subjects with a mean age of 74.9 years and tumour sizes between 2.8mm–14.9mm.
Conducted across 19 sites, the trial reported a 4.3% ipsilateral breast tumour recurrence (IBTR) rate at five years and a 96.7% breast cancer survival rate.
For the subset of 124 subjects who underwent cryoablation and endocrine therapy, the IBTR rate was 3.7%, indicating a 96.3% recurrence-free rate.
Based on the latest recommendation, the company now anticipates receiving marketing authorisation from the FDA for the system in the first quarter of 2025.
IceCure Medical CEO Eyal Shamir said: "This is a significant milestone on the path towards the marketing authorisation of ProSense cryoablation in the US for early-stage low-risk breast cancer and I believe a critically important development for women seeking an alternative to lumpectomy.
“We expect the FDA's decision, based on the advisory panel's recommendation, in the first quarter of 2025. Our US sales and distribution team is ready to support doctors and patients in the event of a successful marketing authorisation for ProSense in breast cancer."
