Cumulase is an ex vivo (used outside of the body) formulation of rHuPH20 to replace the bovine enzyme currently used for the preparation of oocytes (eggs) prior to in vitro fertilization (IVF) during the process of intracytoplasmic sperm injection (ICSI). The rHuPH20 enzyme is an essential component that acts to strip away the hyaluronan that surrounds the oocyte. This allows the clinician to then perform the ICSI procedure, injecting the sperm into the oocyte. The FDA considers hyaluronidase IVF products to be medical devices subject to 510(k) approval, the regulatory pathway by which Cumulase received its marketing clearance. Cumulase is currently sold through an exclusive agreement with a distributor of IVF supplies that sells directly to IVF clinics in the U.S. and European markets.
For additional information please visit the MediCult a/s corporate Web site.