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BioE Submits 510(K) Application to FDA for Umbilical Cord Blood Processing System
News

BioE Submits 510(K) Application to FDA for Umbilical Cord Blood Processing System

BioE Submits 510(K) Application to FDA for Umbilical Cord Blood Processing System
News

BioE Submits 510(K) Application to FDA for Umbilical Cord Blood Processing System

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BioE®, Inc., has announced it submitted a 510(k) pre-market notification application to the U.S. Food and Drug Administration (FDA) requesting regulatory and marketing clearance for its PrepaCyte®-CB Processing System for umbilical cord blood.

PrepaCyte-CB is a sterile, three-bag, closed cell processing system used to separate and collect therapeutically important cells, including stem cells, from human umbilical cord blood. When mixed with cord blood, the proprietary reagent within PrepaCyte-CB rapidly facilitates a negative selection process.

This process causes essentially all red blood cells (RBCs) to settle to the bottom of the mixture, leaving significant quantities of viable and unmodified cells - including high yields of total nucleated cells (TNCs) and stem cells - in the upper fraction of the solution.

“The submission of our PrepaCyte-CB 510(k) application marks an important milestone for us as we progress toward providing public and private cord blood banks with a product that allows them to process and store higher-quality cord blood units,” said Carol Buchert, MT(ASCP), vice president of operations and regulatory affairs for BioE.

“Our 510(k) application is supported by clinical studies demonstrating PrepaCyte-CB’s ability to more effectively and efficiently separate therapeutically viable cells from human umbilical cord blood,” Buchert added.

Specifically, according to the results of a multi-site, comparative, in-vitro clinical study, PrepaCyte-CB significantly improves the recovery of TNCs and white blood cells (WBCs) from human umbilical cord blood when compared to a traditional hetastarch-based cord blood processing method currently utilized by many cord blood banks. Stem cells make up a portion of the total TNC recovery.

The study also demonstrated PrepaCyte-CB’s ability to remove approximately 99 percent of all unnecessary RBCs from the final processed cord blood unit. Additionally, using PrepaCyte-CB to process cord blood returns more stem cells with hematopoietic reconstitution (blood-forming) potential versus hetastarch.

“We anticipate PrepaCyte-CB and its unique cell processing capabilities will offer an attractive option to cord blood banks as they consider upgrading their cord blood processing techniques and protocols,” Buchert added.

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