Replies to post #21298 on CBA Florida Inc. (fka CBAI)

[upoldman45]

CONTACT
Jon Zurbey or Jeremy Baier
Haberman & Associates
612.372.6446
612.372.6461
[e-mail]
[e-mail]
BioE RECEIVES FDA 510(K) CLEARANCE FOR CORD BLOOD PROCESSING SYSTEM
PrepaCyte-CB available immediately to public and private cord blood banks seeking simple and
cost-effective method to separate potentially therapeutic cells and stem cells from cord blood
PrepaCyte-CB only cord blood processing system of its kind cleared by FDA;
milestone adds to Minnesota’s long history of cord blood leadership
ST. PAUL, Minn. . Jan. 14, 2009 . BioE®, Inc., a biomedical company that provides enabling cord blood stem cell
tools and technologies, announced today it received 510(k) clearance from the U.S. Food and Drug Administration (FDA)
for its PrepaCyte®-CB Processing System for umbilical cord blood.
PrepaCyte-CB provides public and private cord blood banks a simple and cost-effective method for processing
umbilical cord blood to obtain potentially therapeutic cells . total nucleated cells (TNCs) and CD34+ hematopoietic
stem/progenitor cells . for eventual transplantation in humans. Available immediately, PrepaCyte-CB is the only cord
blood processing system of its kind cleared by the FDA.
“We are excited about PrepaCyte-CB’s ability to improve the quality and bankability of cord blood units during a
time of rapid growth for cord blood utilization in transplantation,” said Gayl Chrysler, vice president of cellular therapies
and clinical affairs for BioE.
“The benefits of PrepaCyte-CB were so readily apparent during BioE’s clinical study that it was an easy decision
to switch to this new processing platform,” said Donald Hudspeth, BSCLS, MT(ASCP), general manager and international
projects manager for Cryobanks International, a public and private cord blood bank in Alamonte Springs, Fla. and BioE
clinical study participant. “PrepaCyte-CB enables us to process cord blood units safely and reliably, control costs, and
consistently obtain quality cord blood units with greater transplantation potential due to increased TNC and CD34+ stem
cell recoveries.”
PrepaCyte-CB Quality
. PrepaCyte-CB recovers high yields of TNCs, mononucleated cells (MNCs) and CD34+ hematopoietic
stem/progenitor cells from human umbilical cord blood, according to the results of BioE’s multi-site, in-vitro clinical
study

[upoldman45]

hope you guys seen this