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Last month, the Company announced it had submitted a 510(k) pre-marketnotification application to the FDA. Upon its review, the FDA determined thatthe device was exempt from the agency's pre-market notification requirementsand will instead be regulated as laboratory equipment labeled for a specificmedical 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 fromumbilical cord blood.
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"This notification that we can immediately begin marketing our MXP deviceis a major regulatory milestone for the Company and particularly excitingsince we received this notification just several weeks after filing oursubmission, and since it follows by less than a month from having received theCE-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 cellsstudied in regenerative medicine clinical trials for treating several largepatient population diseases and injuries including blood disorders, ischemicheart diseases, peripheral artery diseases, and diabetes. According to thelatest statistics, there are 24 million people in the U.S. Centers for DiseaseControl and Prevention with heart disease, 16.2 million with peripheral arterydisease, and 15.8 million with diabetes. Worldwide statistics would be morethan twice these amounts.
In addition, bone marrow stem cells are currently processed in a number oforthopedic and vascular surgeries inside and outside the U.S. Outside theU.S., stem cell treatments for ischemic heart disease are practiced andreimbursed by insurance companies.
"In anticipation of this authorization, we have initiated discussions withan orthopedic surgery group, vascular surgeons, and leading academic medicalcenters not only in the U.S. but also in Europe and Asia, and look forward tobegin placing this device in the clinical setting in the near future. Webelieve this positions ThermoGenesis to significantly participate in what willultimately represent a multi-billion dollar market opportunity in regenerativemedicine," Osgood added.
"We are confident that the users of this technology will value the uniquecapability of this device to achieve significantly improved recovery of thestem cells from bone marrow meaning that less marrow will need to be collectedfrom their patients to obtain the same number of stem cells," said Dr. JohnChapman, Vice President of Research and Development and Scientific Affairs."While the initial marketing application for the MXP will be for bone marrowprocessing, both at point-of-care and in a laboratory, we will continue ourexploration of the use of this technology platform for other sources of adultstem cells including mobilized peripheral blood and adipose tissue stem cellprocessing," Chapman added.
About ThermoGenesis Corp.
ThermoGenesis Corp. (www.thermogenesis.com) is a leader in developing andmanufacturing automated blood processing systems and disposable products thatenable the manufacture, preservation and delivery of cell and tissue therapyproducts. These products include:
-- The BioArchive(R) System, an automated cryogenic device, is used bycord blood stem cell banks in more than 25 countries for cryopreserving andarchiving cord blood stem cell units for transplant.
-- AXP(TM) AutoXpress Platform (AXP(TM)) is a proprietary family ofautomated devices that includes the AXP a
