Presented by: Connor Barth PhD
Trace Biosciences

Introduction

Nerve damage impacts ~8% of all surgical outcomes worldwide, incurring undue pain, loss of function, and high costs to healthcare systems. Conventional intraoperative nerve detection uses anatomical knowledge and white light (WL) visualization. However, nerves can be difficult to identify by conventional methods. Fluorescence-guided surgery (FGS) offers a potential means for enhanced intraoperative nerve identification and preservation.

Materials

We have developed novel near-infrared (NIR) nerve-specific fluorophores that provide excellent nerve contrast with the ability to identify buried and invisible nerve structures. Additionally, we have characterized the nerve visualization performance in canine prostate models and resected human specimens to support clinical utility for prostatectomy.

Results

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Several lead candidates of our novel fluorophores displayed bright NIR nerve-specific fluorescence contrast. The lead NIR nerve-specific fluorophore, BCP-T108-35, enabled buried nerve visualization in a swine iliac nerve where conventional WL visualization was insufficient for nerve identification during robotic surgery. Our lead agents also demonstrated compatibility with the da Vinci Firely system to produce high contrast nerve visualization in cavernous nerves following administration to canine prostate and resected human prostate tissue, validating utility for improved nerve identification during prostatectomy.

Conclusion

FGS has the potential to eliminate intraoperative nerve damage. Work is underway towards an investigational new drug application to the FDA for first-in-human clinical trials with our nerve specific fluorophores. Upon successful translation, this technology will provide enhanced visualization of nerves intraoperatively, to improve outcomes in nerve sparing prostatectomy surgery.

Funding

NIH Grant Funded: Clinical Translation of Near Infrared Nerve-Specific Fluorophores for Nerve-sparing Prostatectomy (R44CA247639)

Lead Authors

Nathan McMahon, PhD
Trace Biosciences

Co-Authors

Lei Wang, PhD
Trace Biosciences

Summer Gibbs, PhD
Trace Biosciences