Novel Nerve Visualization Investigational Fluorophore Receives FDA IND Approval for First-In-Human Trial
Retrieved on:
Thursday, April 15, 2021
b'NEW YORK, April 15, 2021 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved Illuminare-1, a small molecule, myelin binding agent, for their Investigational New Drug Application (IND).
Key Points:
- b'NEW YORK, April 15, 2021 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved Illuminare-1, a small molecule, myelin binding agent, for their Investigational New Drug Application (IND).
- Illuminare-1 is being developed as a surgical adjunct to improve the visualization and delineation of critical nerve structures intra-operatively in real time with the aim of avoiding serious, and potentially permanent, unintended nerve injury.
- The ultimate goal of surgery is to repair or remove damaged and/or diseased tissue while preserving vital structures, including nerves.
- "\nThe Phase 1 trial of Illuminare-1 is a dose-escalation study in up to 50 patients undergoing robot-assisted radical prostatectomy.