First FDA Clearance of Sterile Field Cord Blood Collection Bag
Apr 25, 2006, 21:05, Reviewed by: Dr. Priya Saxena
|"This is a significant development in cord blood collection and further demonstrates our commitment and ability to lead technological advancements in cord blood banking.”
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."
- ViaCell, Inc. (NASDAQ: VIAC) and Pall Corporation (NYSE: PLL)
Pall products are used by many of the leading cord blood transplant centers in the U.S. and its collection sets were used in the landmark Cord Blood Transplantation (COBLT) study which defines the standards on the use of stem cells from umbilical cord blood.
About Pall Corporation
Pall Corporation is the global leader in the rapidly growing field of filtration, separations and purification. Pall's business is organized around two broad markets: Life Sciences and Industrial. The Company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceutical, transfusion medicine, semiconductor, water purification, aerospace and broad industrial markets. Total revenues for fiscal 2005 were $1.9 billion. The Company headquarters are in East Hills, New York with extensive operations throughout the world. Visit Pall at www.pall.com.
About ViaCell, Inc.
ViaCell is a biotechnology company focused on enabling the widespread use of human cells as medicine. The Company is developing a pipeline of proprietary stem cell product candidates intended to address cancer, cardiac disease, and diabetes. CB001, its lead cord blood derived stem cell therapy product candidate, is being developed for hematopoietic stem cell transplantation in patients affected by a variety of cancers. In addition to its therapeutic development programs, ViaCell's Reproductive Health Business commercializes ViaCord®, a product that offers expecting families the option of preserving their baby's umbilical cord blood. The Company is working to leverage its commercial infrastructure and product development capabilities by developing ViaCyteSM, its investigational product intended to broaden reproductive choices for women through the cryopreservation of human unfertilized eggs. ViaCell is headquartered in Cambridge, Massachusetts with a processing and storage facility in Kentucky and additional research and development operations in Singapore. Additional information about ViaCell is available online at http://www.viacellinc.com.
This press release contains forward-looking statements regarding the planned introduction by ViaCell of a new sterile field collection bag and the potential advantages of such a bag. Such statements are based on management's current expectations. The introduction and market acceptance of a new collection bag is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the Company’s current expectations include, but are not limited to, unexpected delays or clinical or technical hurdles related to the use or supply of the new collection bag or unexpected data related to processing of cord blood using the bag. For more information on the risks and uncertainties associated with ViaCell and its products and programs, see the factors set forth under the heading "Risk Factors That May Affect Results" in the Company's report on Form 10-K for the year ending December 31, 2005, which is on file with the Securities and Exchange Commission. ViaCell does not undertake any obligation to update forward-looking statements.
ViaCord® and ViaCell® are federally registered trademarks and ViaCyteSM is a service mark of ViaCell, Inc.
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