Amend Tissue Tape™ for Oral Wound Care

An intraoral wound overlay for soft tissue that is easy to apply, remains in place for the duration of wound healing, and can be removed without causing damage to underlying tissue. Current options for oral wound care are limited to difficult to use, uncomfortable, and largely ineffective glues and resins.

Amend Tissue Tape™ is a hydrogel-based adhesive comprised of two primary elements. The hydrogel consists of an interpenetrating network of alginate and polyacrylamide. The adhesive is composed of chitosan, which forms covalent bonds across the interface. When used together, the hydrogel and adhesive adhere to wet tissue and provide over five times the adhesion energy of cyanoacrylate while also providing a long duration mechanical barrier for the wound and flexibility to stretch with the wound without damaging the underlying tissue.

There are limited products available that will safely adhere to sutured or nonsutured oral wounds. Periacryl, a cyanoacrylate-based product indicated as a dental cement, is often used off-label for wound closure. It requires a dry environment to fully set and is rigid, not stretching to accommodate movement or swelling. Amend Tissue Tape™ adheres to tissue in a wet environment, stretches with the wound, and stays in place for up to one week. This facilitates wound healing and the regenerative process.

• Upon entry to the ITP program in 2021, optimization and initial demonstration of safety and efficacy of Amend Tissue Tape was performed.
• From 2022-2023, advanced characterization and regulatory submission were made.
• In the current ITP project stage, a clinical study protocol was developed, and the clinical study will be performed following the Pre-Submission meeting in March 2025.

• Qualifications and validation complete
• Production ready
• In 2024/25, raised over $1,400,000 in private equity funding

• Perform clinical study Q2 2025
• Complete all remaining testing for 510(k) submission
• File 510(k) late summer/early fall 2025

• Continue to pursue strategic partner
  • Distribution
  • R&D

• Li et al. Tough adhesives for diverse wet surfaces. Science 2017
• PCT/US2019/055779 Bio-Inspired Degradable Tough Adhesives for Diverse Wet Environments