FOR IMMEDIATE RELEASE
1/08/07
Technology Represents First FDA Cleared System for Cord Blood Processing
Cambridge, MA (January 8, 2007) ViaCell, Inc. (Nasdaq: VIAC) today announced that it is integrating automation into its existing closed processing system at its processing laboratory for ViaCord®, a product offering that allows expectant families the opportunity to preserve their baby’s umbilical cord blood for potential use by the child or related family member. The automation technology is the SEPAX Cord Blood Processing System from Biosafe SA, a closed and sterile processing system that efficiently harvests stem cells from cord blood in a large-scale processing environment. SEPAX is the only FDA cleared cord blood processing system. Biosafe received FDA clearance in January 2007 and European CE mark approval in 2001.
“Each cord blood unit varies in volume and cell count. As a result, we believe the SEPAX automation technology, in combination with our long-standing closed processing system, will allow us to continue offering all families a high quality product with the efficiency required to meet increasing demand for ViaCord,” said Jim Corbett, President of ViaCell Reproductive Health. “SEPAX, together with our exclusive FDA-approved collection bag, provides families advanced technology during every step of the cord blood banking process.”
Mr. Corbett added, “SEPAX is a proven technology with a proven transplant record. The SEPAX system is widely used in Europe and elsewhere with over 100,000 units processed using this technology, from which hundreds of transplants have been performed.”
“We are very pleased to have one of the largest and most respected family cord blood banks adopting the SEPAX System,” said Claude Fell, President and Chief Executive Officer of Biosafe SA. “SEPAX has earned a reputation for safety and performance over a number of years of routine operation in leading stem cell processing facilities and hematology laboratories around the world.”
About ViaCord®
ViaCord is a product offering that allows expectant families the opportunity to preserve their baby’s umbilical cord blood for potential use by the child or a related family member. ViaCord recently launched the first and only FDA cleared cord blood collection bag suitable for use in a sterile field. In addition, ViaCord uses multi-compartment cryobags as part of its closed processing system to ensure that cells are processed in a manner that meets U.S. FDA regulations designed to prevent contamination and error. Cells stored in cryobags have been used in more than 99% of all cord blood transplants. Stem cells derived from umbilical cord blood are currently a treatment option for over 40 diseases, including cancers such as acute lymphoblastic leukemia and Non-Hodgkins lymphoma, certain bone marrow failure syndromes such as severe aplastic anemia and neuroblastoma, certain blood disorders such as sickle cell anemia and other metabolic diseases such as Hurler syndrome. Studies have shown that umbilical cord stem cell transplants from a related donor have a significantly higher survival rate than transplants from an unrelated donor.
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About ViaCell
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.
About Biosafe
Biosafe is a privately-held company based in the Lake Geneva region of Switzerland. Biosafe, through its Sepax technology, is the world’s leading supplier of automated cord blood processing systems and is present in over 30 countries. The Sepax System is used by a majority of Netcord members, an organization that brings together internationally-renowned public cord blood banks.
Further information about Biosafe and the Sepax System is available at www.biosafe.ch or +41 22 365 2727. The Sepax System is distributed in N. America by GenesisBPS - www.genesisbps.com or 866-71-BLOOD (25663) or 201-708-1400.
This press release contains forward-looking statements regarding the anticipated future demand of the ViaCord business and expected impact of the SEPAX system. These statements are based on management's current expectations. The growth of the ViaCord business 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: the impact of competition in the umbilical cord preservation industry, the impact of any potential adverse outcome in pending patent infringement litigation related to the cord blood preservation business, and any other unexpected material issues, delays or failures in the collection, processing or storage of umbilical cord blood by the Company. The Company’s ability to achieve expected benefits from use of the SEPAX system may be impacted by a number of factors, including unexpected technical hurdles or other problems or issues that may arise during implementation and use. For more information on the risks and uncertainties associated with the Company, its financial performance, its products and programs, and pending litigation, see the factors set forth under the heading "Risk Factors That May Affect Results" in the Company's Quarterly Report on Form 10-Q for the quarter ending September 30, 2006, which is on file with the Securities and Exchange Commission and which factors are incorporated herein by reference. ViaCell does not undertake any obligation to update forward-looking statements.
ViaCell® and ViaCord® are federally registered trademarks and ViaCyteSM is a service mark of ViaCell, Inc. All other trademarks are those of the respective owners.
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