Product Safety

PriMatrix has been rigorously validated to assure biocompatibility and product sterility.

PriMatrix Biocompatibilty Summary
Test Performed Standard Result
Cytotoxicity, MEM Elution ISO 10993-5 No evidence of causing cell lysis or toxicity
Sensitization, Maximization ISO 10993-10 No evidence of causing delayed dermal contact sensitization
Acute Intracutaneous Reactivity ISO 10993-10 No evidence of significant irritation
Acute Systemic Toxicity ISO 10993-11 No mortality or evidence of systemic toxicity
Genotoxicity, AMES Bacterial Reverse Mutation ISO 10993-11 Nonmutagenic to Salmonella typhimurium test strains TA98, TA100, TA1535, TA1537, and Escherichia coli strain WP2uvrA
Hemolysis, Modified
ASTM Direct Contact Method
ISO 10993-3 Nonhemolytic
Hemolysis, Modified
ASTM Extraction Method
ISO 10993-4 Nonhemolytic
Surgical Muscle Implantation,
4 & 12 Weeks
ISO 10993-6 Macroscopically and microscopically classified as a nonirritant

For additional information please download and reference the PriMatrix Safety Profile data sheet.