BioE, Inc. (Formally known as BioErgonomics) Submits 510(k) Application to FDA for Umbilical Cord Blood Processing System
11/28/2007 12:47:07 PM
ST. PAUL, Minn.--(BUSINESS WIRE)--BioE®, Inc., a biomedical company that provides enabling, high-quality human stem cells for drug discovery and therapeutic research, announced today 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. Public and private cord blood banks can easily collect these viable cells for cryopreservation and eventual transplantation in humans.