CAMBRIDGE, Mass.--(BUSINESS WIRE)--ViaCell, Inc. (Nasdaq: VIAC) announced today that it has received FDA approval of its investigational device exemption (IDE) supplement for its ViaCyteSM pivotal clinical trial. The pivotal study will evaluate ViaCyte, an investigational product being studied for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology. FDA approval of the IDE supplement allows the Company to enroll women into the study and commence in vitro fertilization treatment, or IVF. Previously, the FDA disapproved the IDE supplement. In doing so, the FDA asked ViaCell to respond to questions related to the specifications and sourcing of certain raw materials used in the manufacturing of the ViaCyte media. All questions have been addressed and no conditions are outstanding.
