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ViaCell Expands Study Sites in ViaCyte Pivotal Trial

ViaCell, Inc. (Nasdaq: VIAC) today announced it expects to expand the number of U.S. clinical sites participating in its ViaCyteSM pivotal trial from three to eight. ViaCyte is an investigational product intended to broaden reproductive options for women through the freezing and thawing of human oocytes (eggs). The FDA has approved ViaCell’s Investigational Device Exemption (IDE) supplement supporting the expansion of its U.S. clinical trial sites. The pivotal trial commenced in March 2007 and is expected to be completed in 2009.

“There is great enthusiasm behind this program through our clinical investigators and the reproductive endocrinologist community. By expanding the number of sites in the U.S. we increase access to our trial and gain broader insight from opinion leaders on the value of our egg freezing product candidate,” said Marc D. Beer, President and Chief Executive Officer of ViaCell. “Egg freezing is an emerging area and we believe we are on the forefront of offering a technology to women who need to extend or protect their fertility.”

The primary objective of the pivotal study is to determine the efficacy of the ViaCyte media for the cryopreserving and thawing of human oocytes. The open-label study will also evaluate safety. Women seeking in vitro fertilization (IVF), diagnosed with male factor infertility, are eligible to enroll. The primary efficacy endpoint is live birth rate and 50 live births must be achieved. Approximately 300 healthy women, age 21-35, who are currently seeking fertility treatment, are expected to enroll in the study. Participants in the study will undergo traditional IVF. After the eggs are retrieved, oocyte cryopreservation will be performed using ViaCyte. The oocytes will be thawed following storage in liquid nitrogen and subsequently inseminated. Embryos will be transferred to the subject’s uterus using a non-surgical procedure. Additional information about the trial is available online at http://www.clinicaltrials.gov.

About ViaCyte

ViaCyte is an investigational product intended to broaden reproductive options for women through the cryopreservation and thawing of human oocytes. The oocyte is a large cell with a high content of water, historically making it difficult to freeze. ViaCell’s proprietary technology to cryopreserve and thaw human oocytes uses a choline chloride-based media designed to protect the cells from damage during the freezing process with the goal of making it possible to successfully store and thaw oocytes for future use. There is currently no FDA-cleared product for oocyte cryopreservation.