INITIAL APPLICATION WILL BE FOR USE IN POINT-OF-CARE BONE MARROW PROCESSING
RANCHO CORDOVA, Calif., July 14 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. (Nasdaq: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, today said it has received authorization from the FDA to begin marketing its MarrowXpress (MXP) device for use in a clinical laboratory setting or intraoperatively for preparation of a cell concentrate from bone marrow.
Last month, the Company announced it had submitted a 510(k) pre-market notification application to the FDA. Upon its review, the FDA determined that the device was exempt from the agency's pre-market notification requirements and will instead be regulated as laboratory equipment labeled for a specific medical use. The device is a derivative of the Company's AutoXpress(TM) (AXP(TM)) Platform that is used to volume reduce and collect stem cells from umbilical cord blood.
"This notification that we can immediately begin marketing our MXP device is a major regulatory milestone for the Company and particularly exciting since we received this notification just several weeks after filing our submission, and since it follows by less than a month from having received the CE-Mark enabling us to market the device in the European Community," noted Dr. William Osgood, Chief Executive Officer.
Bone marrow derived stem cells are the dominant source of stem cells
studied in regenerative medicine clinical trials for treating several large
patient population diseases and injuries including blood disorders,
ischemic heart diseases, peripheral artery diseases, and diabetes.
According to the latest statistics, there are 24 million people in the U.S.
|SOURCE ThermoGenesis Corp.|
Copyright©2008 PR Newswire.
All rights reserved