Cumulase™ - Recombinant Hyaluronidase
Introducing rHuPH20 - The Only Recombinant Human Hyaluronidase
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), in which the enzyme is an essential component. The enzyme strips away the hyaluronic acid that surrounds the oocyte. This allows the clinician to then perform the ICSI procedure, injecting the sperm into the oocyte.
The purity of Cumulase™ is more than 100-fold higher than the currently used animal preparations. It may reduce, if not eliminate, the risk of damage or trauma to the oocytes, and eliminates the risk of animal pathogen contamination, thereby providing a safer, purer, and more reliable alternative to bovine and ovine slaughterhouse-derived enzymes.
Cumulase™ Receives CE Mark
SAN DIEGO, Dec. 28 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Amex: HTI - News), a
development stage biopharmaceutical company developing and commercializing recombinant human
enzymes, today announced it has received CE (European Conformity) Mark approval for Cumulase(TM) for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures. The CE Mark
demonstrates that the company is in compliance with the applicable European Union (EU) directives and allows the company to market Cumulase throughout the EU. The Company anticipates launching
Cumulase early in the first quarter of 2005.
#HAL-CUM-10X: 5 vials, 100 μl conc/vial, reconstituted to 1 ml
Download : PDF Info Sheet Visit the Cumulas Web Site (http://www.cumulase.com/)
FDA released April 2005