HYMOVIS is a sterile, non-pyrogenic, viscoelastic hydrogel contained in a single-use syringe.
HYMOVIS is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. This results in a natural hyaluronan similar to the hyaluronan found in the synovial fluid present in the human joint. The hyaluronan in HYMOVIS is derived from bacterial fermentation.
DETAILED DEVICE DESCRIPTION: HYMOVIS is a proprietary high molecular weight hyaluronic acid (HA) based viscosupplementation intended for the treatment of pain in patients with osteoarthritis (OA) of the knee who have failed conservative nonâpharmacological therapy and simple analgesics. The device is administered as a two-injection regimen under aseptic conditions.
HYMOVIS has a hyaluronan (HYADD4) concentration of 8 mg/mL, dissolved in physiologic saline. It is supplied in a 5.0 mL syringe containing 3.0 mL of HYMOVIS. The contents of the syringe are sterile and non-pyrogenic.
HYMOVIS is engineered by modification of hyaluronan (hyaluronic acid or 'HA') with a proprietary process without chemical crosslinking and results in a highly viscoelastic hydrogel called HYADD4 with increased lubricating and shock absorption properties. The HA is derived from bacterial fermentation (Streptococcus equi).