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BioE is cleared to sell cord-blood system
Federal regulators have cleared a tiny start-up's signature product.
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BioE Inc., a small biomedical company based in Vadnais Heights, said Wednesday it has won clearance from federal regulators to sell its signature product, a system that processes umbilical cord blood for use in treating a variety of diseases.
News that the Food and Drug Administration (FDA) cleared BioE's PrepaCyte processing system is a watershed event for the privately held company, which has been working with the agency for more than seven years so it could sell the system in the United States.
"It opens up a whole new market for us,'' said CEO Michael Haider. "It makes it a lot easier for cord-blood banks to acquire our product." Prior to the FDA clearance, BioE's system could only be sold on a limited basis.
BioE's product provides private and public cord-blood banks with a way to process umbilical cord blood -- the blood that remains in the umbilical cord after a baby is born and the cord is cut. Once considered medical waste, cord blood now is regarded as a rich source of stem cells.
Those stem cells can also be preserved for future uses, such as regenerative medicine projects -- regrowing body parts lost through injury or illness.
BioE estimates there are about 150 public and private cord-blood banks in the United States, plus a potentially lucrative market abroad, particularly in emerging economies, such as China and India.
Janet Moore • 612-673-7752
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