Neonatology
First FDA Clearance of Sterile Field Cord Blood Collection Bag
By ViaCell, Inc.
Apr 25, 2006, 21:05

ViaCell, Inc. (NASDAQ: VIAC) and Pall Corporation (NYSE: PLL) announced today the first U.S. Food and Drug Administration clearance of a cord blood collection bag suitable for use in a sterile field. Pall and ViaCell collaborated on the development and design of the new collection bag. ViaCell has exclusive rights to the new collection bag for family cord blood banking and expects to introduce it as part of its ViaCord� collection kit. The new sterile field bag will give families and their health care providers the ability to more safely and easily collect umbilical cord blood from newborns, even when born by cesarean section.

Umbilical cord blood is a valuable source of stem cells used to treat more than 40 life threatening diseases including a wide range of cancers, immune deficiencies and genetic disorders. Collection of cord blood is a critical first step in the process of preserving a baby's umbilical cord blood to meet these and other future medical needs. It is important that the collection kit simply and aseptically collect as much blood as possible since larger units for cord blood generally produce more viable stem cells.

�I believe the new ViaCord collection bag provides a significant benefit to the obstetrician,� said Yoni Branhard, M.D., Vice Chairman of the OB-GYN Department, Lenox Hill Hospital, New York City. �This is an innovative initiative in cord blood banking. The sterile bag gives my colleagues and me the comfort that, no matter how we deliver a child � vaginally or by cesarean - we are collecting the cord blood in a high quality manner.�

Collecting blood from the umbilical cord of babies born by cesarean section, unlike vaginal births, must be done in a sterile surgical field. There are about 1.2 million cesarean sections performed in the U.S. each year, representing about 30 percent of all births. Since not all cesarean births are planned, ViaCell intends to include the new sterile field bag in its ViaCord collection kit provided to all expectant families who decide to preserve their baby's umbilical cord blood. Expectant parents and medical professionals will then have the optimal tools to collect their infant's cord blood, no matter the type of birthing situation.

Karen A. Foster, Vice President, ViaCord Processing Laboratory, said, "We are excited by our collaboration with Pall in developing this innovative bag that allows us to continue offering families the highest quality product. This is a significant development in cord blood collection and further demonstrates our commitment and ability to lead technological advancements in cord blood banking.�

"Our agreement with ViaCell is another milestone in Pall's development and customization of tools to help make cell therapy routine, safe and simple," says Judy Angelbeck, PhD, Senior Vice President, Pall New Technologies. "We are proud to work with ViaCell as they are committed to the highest standards of cord blood collection, processing and storage for family cord blood banking."

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