First and Only Natural Silk Protein Injectable For Tissue Bulking
U.S. FDA cleared for vocal fold medialization and vocal fold insufficiency
INTENDED USE:
Silk Voice® is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice® injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the mid-line for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.
Scientific Publications
2018
A novel silk-based vocal fold augmentation material: 6-month evaluation in a canine model
The authors present an in vivo investigation in an in vivo model to evaluate the biocompatibility and migration tendency of a novel Silk-HA against a commercial CaHA-CMC filler.
STUDY EXTENSION: 12-MONTH IN VIVO EVALUATION
Results showed that Silk-HA provides immediate medialization of the treated vocal fold, lasting for a minimum of 12 months in vivo. The novel delivery system for Silk-HA enabled the user to observe a bird’s-eye-view of the entire bulking procedure.
Histomorphologically, Silk-HA and CaHA-CMC both demonstrate similar inflammatory responses. The Silk-HA was shown to remain at the site of injection in all twelve subjects, whereas CaHA-CMC demonstrated migration into the retropharyngeal lymph nodes in three of the twelve implants.
In the current vocal fold model, the Silk-HA material compares favorably in terms of longevity and immune response to CaHA-CMC. The lack of migration of the Silk-HA material demonstrates promising potential to address the unmet needs for vocal fold injection in the clinic.
Injectable Silk Protein Microparticle-based Fillers: A Novel Material for Potential Use in Glottic Insufficiency
The authors report a novel, silk protein-based injectable filler. This formulation was engineered with the intention of vocal cord injection augmentation. This injectable filler leverages the unique properties of silk protein's superior biocompatibility, mechanical tunability, and predictable degradation. The initial formulation and mechanical properties are discussed.
