Thermogenesis's MarrowXpress is a 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 Platform 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.
"We are confident that the users of this technology will value the unique capability of the MarrowXpress to achieve significantly improved recovery of stem cells from bone marrow meaning that less marrow will need to be collected from their patients to obtain the same number of stem cells," said Dr. John Chapman, Vice President of Research and Development and Scientific Affairs. "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," Chapman added.
Adapted from the Thermogenesis announcement.
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