ViaCell Announces ViaCyte Manufacturing Agreement With Invitrogen

Cambridge, MA - ViaCell, Inc. today announced it has entered into an agreement with Invitrogen to manufacture its ViaCyte media. ViaCyte is ViaCell's investigational product offering for use during assisted reproductive technology. The media manufactured by Invitrogen will be used in ViaCell's pivotal clinical trial to evaluate the cryopreservation and thawing of human oocytes. Financial terms were not disclosed.

"We are delighted to be working with Invitrogen to manufacture the ViaCyte media. We are confident that through Invitrogen's extensive manufacturing expertise we will produce a high quality product," said Marc D. Beer, President and Chief Executive Officer of ViaCell. "We look forward to commencing the study this quarter, which if successfully developed and approved, we believe we are well positioned to offer women a product developed and manufactured under the highest quality standards."

"We are pleased ViaCell has chosen Invitrogen to manufacture the media for ViaCyte. This is an exciting area of reproductive medicine and we look forward to supporting ViaCell as it moves this innovative product offering through pivotal testing and potentially onto the market," said Greg Lucier, Chairman and Chief Executive Officer of Invitrogen.

ViaCell plans to commence an open-label, pivotal clinical trial to evaluate safety and efficacy of its freeze and thaw media for fertility preservation in the first quarter of 2007. The trial will seek to enroll approximately 300 healthy women, age twenty-one to thirty-five, who are currently seeking fertility treatment. The primary efficacy endpoint is 50 live births. Data generated from the pivotal trial, if positive, is expected to be submitted to the FDA for 510(k) clearance of ViaCyte.

ViaCyte is an investigational product being studied for its potential 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.

SOURCE: ViaCell, Inc.