Tissue Addressed:
Soft Tissue
Technology Type:
Device
Regulatory Path:
510(k)
Current Phase:
- Phase 5: IND/IDE/510(k) preparation
Principal Investigator(s):
Jamie Shaikoski, PhD (Director of R&D)
Amend Surgical
Robby Lane, MBA (Co-Founder & CEO)
Amend Surgical
Clinical Need
Current treatments for oral wounds, such as sutures, cyanoacrylate, rinses, and gels, often present application challenges, patient discomfort, and are insufficient for proper wound healing with limited protective ability against mechanical and chemical disruptions. There is a clear need for 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.
Solution
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.
Competitive Advantage
There are limited products available that will safely adhere to sutured or non-sutured oral wounds. Cyanoacrylate-based product, 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.
ITP Support
- 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 Q1 2026.
Achievements
- Qualifications and validation complete
- Production ready
- In 2024/25, raised over $4,900,000 in private equity funding
Regulatory Path
- Perform clinical study Q1 2026
- Complete all remaining testing for 510(k) submission
- File 510(k) early summer 2026
Opportunities for Partnerships
- Strategic partner sought for distribution and R&D
Key Publications & Patents
- Li et al. Tough adhesives for diverse wet surfaces. Science 2017
-
US17/283,412 Bio-Inspired Degradable Tough Adhesives for Diverse Wet Surfaces
For any questions/interests in the projects, please contact us at
translationalrc@umich.edu