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Trace Biosciences Announces FDA IND Clearance for First Nerve-Specific Imaging Agent
Trace Biosciences begins Phase I trials of LGW16-03 to improve surgical safety by enabling real-time nerve visualization and potentially reducing nerve injuries, a common surgical complication.
- The U.S. Food and Drug Administration approved the IND for LGW16-03, Trace Biosciences' first nerve-specific imaging agent, recently.
- Surgeons routinely operate near critical nerves and lack approved tools to visualize nerves in real time, making accidental nerve injury a significant surgical complication for patients at risk.
- Within Trace Biosciences' nerve-targeted platform, LGW16-03 selectively binds peripheral nerves and emits near-infrared fluorescence detectable by surgical imaging systems integrated into existing workflows.
- With IND clearance, Trace will initiate a Phase I clinical study later this year in orthopedic surgery, calling it a major milestone that validates years of work.
- Following successful early clinical studies, Trace Biosciences plans to expand development across orthopedics, prostatectomy, colorectal, and head and neck surgery, but warns results face risks and uncertainties.
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Trace Biosciences Announces FDA IND Clearance for First Nerve-Specific Imaging Agent
PORTLAND, Ore., Jan. 31, 2026 /PRNewswire/ -- Trace Biosciences, Inc., a clinical-stage biotechnology company developing nerve-targeted imaging agents, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for LGW16-03, the company's…
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