FDA Regulatory Clearance Further Validates Cord Blood Registry's Superior Automated Stem Cell Processing Technology
AutoXpress™ System Offers Expectant Parents Highest Stem Cell Recovery Rate
SAN BRUNO, Calif. – October 9, 2007 – Cord Blood Registry (CBR), the world’s largest and most experienced cord blood stem cell bank, announced today that the FDA has issued formal 510(k) clearance of the AutoXpress™ (AXP™) stem cell processing platform. AXP is the first and only automated processing technology with FDA clearance that can process cord blood collections of any size in a closed environment using sterile materials. Published data shows AXP consistently delivers the highest stem cell recovery rates in the industry.
“Since our inception, we have been a pioneer and innovator in stem cell separation methods,” said Tom Moore, chief executive officer of CBR. “The integration of AXP technology into our operations has enabled us to increase our industry-leading stem cell recovery rates as well as our processing capacity to provide the highest-quality service to every expectant parent who elects to take advantage of the one-time opportunity to preserve these invaluable cells.”
Stem cell recovery, or cell yield, is a critical measure of quality in cord blood processing and is linked to therapeutic utility of the collection.
“As a bone and marrow transplant physician, I know firsthand that the more cells that are in a transplant sample, the greater likelihood of that cord blood collection being used successfully for transplant,” said Dr. Jennifer Willert, senior attending transplant physician and clinical professor at Rady Children’s Hospital, University of California, San Diego. “Studies have shown that a higher cord blood cell dose correlates to higher transplant survival rates and improved patient outcomes. Most treatment protocols stipulate a minimum number of cord blood cells be available in order to proceed with the transplant.”
AXP technology, developed by ThermoGenesis and distributed by GE Healthcare, is an integral part of CBR’s proprietary CellAdvantage™ system of stem cell collection, processing and storage. CBR is the first and only family cord blood bank to adopt this state-of-the-art processing technology.
About Cord Blood Registry
Cord Blood Registry® (CBR®) is the largest cord blood stem cell processing and cryopreservation service for familial use in transplantation and regenerative medicine and the most recommended cord blood bank by obstetricians. Accredited by AABB, Cord Blood Registry preserves cord blood stem cells for more than 200,000 newborns throughout the world. CBR has released more than 50 client cord blood units for specific therapeutic use, more than any other family cord blood bank. The company's research and development efforts are focused on advancing the medical therapies involving cord blood stem cells as well as the collection, processing and storage technologies to optimize quality and cell yield. Additionally, CBR facilitates collection of donated samples, available for research programs worldwide that are focused on stem cell expansion and other cell-based therapies. For more information about CBR, visit www.cordblood.com.
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