Suture-less Trigeminal Nerve Repair Device

Micro-suturing is the current standard of care for the repair of trigeminal nerve injuries. Micro-sutured repairs are technically challenging and often inconsistent, with flaws in both fascicular alignment and spacing between severed nerve ends. Scar tissue associated with suture placement can impede axonal regeneration. Clinical need for oral surgeons: a suture-less repair solution.

Tissure™ is a degradable, hydrogel and chitosan-based nerve connector that has the adhesion and mechanical strength required to eliminate the need for suture to reconnect peripheral nerves. The product adheres to wet nerve tissue and provides over five times the adhesion energy of cyanoacrylate while also providing flexibility to stretch through range of motion without damaging nerve healing.

Current competitors in peripheral nerve repair offer largely undifferentiated collagen and polymer materials for connectors, conduits, and wraps. None of the competitors offer a suture-less alternative for a direct (non-connector) nerve repair and all of their product lines require suture to prevent migration of their product.

At the time of entry into the ITP program in 2023, the project already had a prototype and initial benchtop testing completed. At the end of the project period, design freeze and a non-GLP animal study are anticipated.

• Achieved sterile product and designed suitable packaging through moist heat sterilization while maintaining product integrity
• Design freeze anticipated Q3 2025 following completion of non-GLP animal study
• Ability to create a fully dried product that is rehydrated for 15 seconds prior to application
• Initiated non-GLP rat sciatic nerve transection study Jan 2025 to assess Tissure with and without suture

• Non-GLP rat sciatic nerve study expected to be completed Q3 2025
• 510(k) anticipated; Pre-Submission meeting will be requested Q4 2025
• Research and planning: market assessment, regulatory opinion and potential corporate partnerships
• Perform GLP rat sciatic nerve study and comparative benchtop studies with predicate device Q1 2026

• Ongoing discussion with strategic

• Wu DT et al. Tough adhesive hydrogel for intraoral adhesion and drug delivery. J Dent Res 2023
• Freedman, B et al. Degradable and removable tough adhesive hydrogels. Adv Mater 2021
• US9,387,276, US10,383,980 Interpenetrating networks with covalent and ionic crosslinks