The company has previously 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.
ThermoGenesis’s MarrowXpress (MXP) device is a derivative of the company’s AutoXpress Platform that is used to volume reduce and collect stem cells from umbilical cord blood.
John Chapman, vice president of R&D and scientific affairs, at ThermoGenesis, said: “While the initial marketing application for the MXP will be for bone marrow processing, both at point-of-care and in a laboratory, we will continue our exploration of the use of this technology platform for other sources of adult stem cells including mobilized peripheral blood and adipose tissue stem cell processing.”