Table 6: Biocompatibility Testing Performed on the P4HB Suture Fiber.

Tests ForMethodResultsRemark

CytotoxicityMEM elutionPassedNo evidence of cell lysis or toxicity
CytotoxicityAgarose overlayPassedNo evidence of cell lysis or toxicity
Irritation and sensitizationIntracutaneous reactivity with saline and sesame oil extractsPassedNo evidence of significant irritation
Irritation and sensitizationMaximization sensitization with saline and sesame oil extractsPassedNo evidence of delayed dermal sensitization
Systemic toxicityAcute systemic toxicity with saline and sesame oil extractsPassedNo evidence of systemic toxicity
Systemic toxicityMaterial-mediated pyrogenicityPassedNonpyrogenic
Genotoxicity, carcinogenicity, and reproductive toxicityBacterial reverse mutation study with saline and ethanol extractsPassedNonmutagenic
Genotoxicity, carcinogenicity, and reproductive toxicityChromosomal aberration in CHO cellsPassedNot genotoxic
Genotoxicity, carcinogenicity, and reproductive toxicityMouse micronucleus study with saline and sesame oil extractsPassedNot genotoxic. No evidence of cellular toxicity.
Local effects after implantationSubchronic implantationPassedNonirritant
Local effects after implantationChronic implantationPassedNonirritant
Interaction with bloodIn vitro hemolysis with saline extractPassedNonhemolytic