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SynVitro Cumulase is a specialized formulation of recombinant human PH20 hyaluronidase (rHuPH20) designed for use in assisted reproductive technology (ART). Developed through a collaboration between Halozyme Therapeutics and MediCult (now part of CooperSurgical), it received FDA 510(k) clearance in 2006 as the first recombinant hyaluronidase product for in vitro fertilization (IVF). The product is used to facilitate the removal of the cumulus-oocyte complex and corona radiata surrounding the oocyte prior to intracytoplasmic sperm injection (ICSI). It works by enzymatically degrading hyaluronic acid, the primary component of the extracellular matrix between cumulus cells. As a recombinant human protein, SynVitro Cumulase offers a high degree of purity and eliminates the risks of pathogen transmission and immunogenicity associated with traditional animal-derived (bovine or ovine) hyaluronidase extracts.
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