FDA conditionally approves ViaCell's IDE to evaluate fertility treatment

By Lisa Kerner

Charlotte, N.C., June 26 - ViaCell, Inc. said the Food and Drug Administration has conditionally approved its Investigational Device Exemption to evaluate ViaCyte for the cryopreservation and thawing of human oocytes for use in assisted reproductive technology.

ViaCyte's proprietary technology cryopreserves and thaws human oocytes using a choline chloride-based media to protect the cells from damage.

Enrollment in a single, pivotal clinical trial to study the safety and efficacy of ViaCyte is planned for later this year. The open-label study of up to 300 women will be conducted at multiple sites in the United States, Spain and Argentina, with live birth rate as the primary efficacy endpoint.

"Although there is evidence that oocyte cryopreservation has resulted in pregnancies and births, there is not an FDA-cleared product available today," president and chief executive officer Marc D. Beer said in a company news release.

"Our goal is to conduct a well-controlled, regulated clinical trial in order to generate data to support FDA clearance of our product for cryopreservation of oocytes."

ViaCell is a Cambridge, Mass.-based biotechnology company.

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