In a recent development, the Medical Imaging Drugs Advisory Committee (MIDAC) of the U.S Food and Drug Administration (FDA) has endorsed the benefit-risk profile of LUMISIGHTTM, an optical imaging agent developed by Lumicell, Inc. This endorsement marks a significant advancement in breast cancer surgery, as LUMISIGHTTM promises to enhance the precision of lumpectomies by detecting residual cancer in real-time. The MIDAC's decision was based on a comprehensive review of LUMISIGHTTM, which is specifically designed to identify and remove residual cancer tissue during breast-conserving surgeries. Lumicell's clinical research, including data from over 350 patients in the pivotal study and safety results from more than 700 participants across six clinical trials, has paved the way for this endorsement.
Lumicell will now collaborate closely with the FDA to complete the review of LUMISIGHT's New Drug Application (NDA) and Lumicell DVS' Premarket Approval (PMA) application. This endorsement signifies a potential shift in the surgical management of breast cancer, highlighting the importance of real-time, intraoperative imaging to improve patient outcomes.
In another breakthrough, IceCure Medical Ltd. announced the successful results of its ICE3 clinical trial, which demonstrated a 96.39% recurrence-free rate for the treatment of early-stage breast cancer using cryoablation. The trial, conducted over a decade, followed patients with low-risk, early-stage malignant breast tumors using IceCure's ProSense® system. Cryoablation offers a minimally invasive alternative to traditional surgery by freezing and destroying tumors. IceCure plans to submit the full dataset to the FDA in April 2024 for marketing authorization. The ProSense® system has already been marketed globally for approved indications and is designed to reduce recovery time, pain, and surgical risks. These advancements in breast cancer surgery, both Lumicell's imaging agent and IceCure's cryoablation study, hold great promise for improving patient outcomes and expanding treatment options.
Sources:
- FDA endorsement: [f83ccb5c]
- IceCure cryoablation study: [887a5efb]