IceCure Medical Ltd (Nasdaq: ICCM), a developer of minimally-invasive cryoablation technology, announced on Friday that it received a positive vote from the FDA's Medical Device Advisory Committee Panel, with 9 out of 14 panelists supporting the benefit-risk profile of its ProSense Cryoablation System for treating early-stage low-risk invasive breast cancer.
Panelists in favor indicated that ProSense's benefits outweigh its risks when combined with adjuvant endocrine therapy. Three dissenting voters noted that adequate special controls could have swayed their support.
The panel's decision was informed by data from IceCure's ICE3 study and comparisons to lumpectomy, as well as testimonies from patients, advocates and healthcare professionals.
ProSense offers a minimally invasive alternative to traditional surgery, leveraging liquid nitrogen to destroy tumours effectively.
A final FDA decision on ProSense's marketing authorization is anticipated in Q1 2025.
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