Trace Biosciences Inc, a US-based clinical-stage biotechnology company, announced on Saturday that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for LGW16-03, the company's first nerve-specific fluorescent imaging agent.

IND clearance enables Trace to initiate first-in-human clinical studies evaluating the safety and intraoperative performance of LGW16-03 in surgical settings.

LGW16-03 is designed to selectively bind peripheral nerves and emit a near-infrared fluorescent signal, allowing surgeons to visualise critical nerve structures in real time during surgery even when buried beneath tissues. This could help prevent accidental nerve injury during procedures such as prostatectomy, orthopaedic surgery, colorectal surgery, and head and neck surgery.

Trace plans to initiate its Phase I clinical study later this year, initially evaluating safety and feasibility in patients undergoing orthopaedic surgery. Following successful early clinical studies, the company intends to expand development across multiple surgical indications where nerve injury risk is high.