Trace Biosciences secures Axogen investment to advance Nerve Trace clinical trials

The Series A funding follows FDA clearance in December 2025 for Trace's lead candidate, with proceeds earmarked for Phase II and III studies toward a New Drug Application.

Summary

Trace Biosciences said Axogen, Inc. has made a strategic investment in the clinical-stage biotech as it advances Nerve Trace, a near-infrared fluorescence imaging technology designed to let surgeons visualize nerves directly and in real time during operations. The investment is part of Trace's Series A financing round, with additional investors expected to join. The company said the technology is intended to help surgeons identify and avoid nerves that would otherwise be obscured by surrounding tissue, while also helping localize and assess already injured nerves more precisely to support repair. Trace's lead candidate, Nerve Trace Dx, received FDA clearance of its Investigational New Drug application in December 2025 and has begun a Phase I clinical trial in surgical patients focused on safety and feasibility. Trace said proceeds from the investment will support Phase II and III clinical trials toward a New Drug Application. Connor Barth, Ph.D., Co-Founder and CEO of Trace Biosciences, said the investment would help advance the program through its next stage of clinical development. Michael Dale, President and CEO of Axogen, Inc., said the deal aligns with Axogen's focus on restoring peripheral nerve function by giving surgeons the ability to see nerves in real time.

Terms & Concepts
  • near-infrared fluorescence imaging: Imaging method that uses light-emitting markers to help visualize tissue during surgery.
  • Investigational New Drug application: FDA filing that allows a drug candidate to enter human clinical trials.
  • New Drug Application: Formal submission seeking FDA approval to market a drug.