Trace Biosciences, a clinical-stage biotechnology company focused on nerve-targeted imaging technologies, has received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for LGW16-03. The clearance allows the company to begin first-in-human clinical trials to assess the safety and intraoperative performance of its lead imaging candidate.

LGW16-03 is a nerve-specific fluorescent imaging agent engineered to selectively bind to peripheral nerves and emit a near-infrared signal. The technology is designed to help surgeons visualize critical nerve structures in real time during surgical procedures, even when nerves are obscured beneath surrounding tissue.

Accidental nerve damage remains a common and serious surgical complication in procedures such as prostatectomy, orthopedic, colorectal and head and neck surgeries. Such injuries can lead to chronic pain, numbness, incontinence, sexual dysfunction, voice impairment or permanent functional loss, significantly affecting patient quality of life.

Connor Barth, Ph.D, Co-Founder and Chief Executive Officer of Trace Biosciences, described the IND clearance as a major milestone that validates more than a decade of scientific research aimed at improving nerve visualisation during surgery. He noted that surgeons currently lack approved real-time tools to reliably identify nerves intraoperatively and emphasised LGW16-03’s potential to enhance surgical safety and patient outcomes.

The company plans to initiate a Phase I clinical trial later this year, initially focusing on patients undergoing orthopedic surgery to evaluate safety and feasibility. Subject to positive results, Trace intends to expand clinical development into additional surgical areas where the risk of nerve injury is high.

Nirmish Singla, MD, MSCS, FACS, an urologic surgeon at Johns Hopkins Medicine and clinical advisor to Trace, highlighted the clinical need for improved nerve visualisation tools. He stated that surgeons often operate near critical nerves with limited visibility, relying heavily on anatomical knowledge and estimation. A real-time nerve imaging agent like LGW16-03, he added, could significantly reduce preventable nerve injuries and potentially transform surgical practices.

The IND approval marks the first clinical programme within Trace’s broader nerve-targeted platform, which the company aims to advance for applications in fluorescence-guided surgery, nerve repair and stimulation guidance and diagnostic imaging.