LacertaMatrix

LacertaMatrix is a single-use, sterile wound dressing made from porcine gelatin and alligator-derived hyaluronic acid. It provides a moist wound healing environment and biodegradable scaffold for tissue formation, indicated for management of partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, surgical wounds, trauma wounds, and draining wounds.

The subject device uses porcine gelatin and alligator-derived hyaluronic acid in a matrix sheet form, sterilized by E-beam at SAL 10⁻⁶, available in sizes 6.25–100 cm², with endotoxin <20 EU/device and confirmed non-pyrogenic status. The predicate (Aroa Symphony) uses ovine collagen and bacterial-derived hyaluronic acid, sterilized by ethylene oxide, with sizes 1–400 cm². Both share the same intended use and provide moist wound healing with scaffold function.

Testing per ISO 22442-3 (viral inactivation), ISO 11137-1/2 (sterilization validation), USP <85> and ANSI/AAMI ST72 (bacterial endotoxin), ISO 10993 series (cytotoxicity, sensitization, irritation, acute/subacute toxicity, pyrogenicity, implantation, genotoxicity), full-thickness porcine wound healing study, and human repeat insult patch test (HRIPT) and skin prick test.