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FDA Authorizes Device for Bone Marrow Stem Cell Preparation

The ThermoGenesis Corporation, which manufactures automated blood processing systems and disposable products that are used in the manufacture, preservation and delivery of cell and tissue therapy products, including the processing and storage of adult stem cells, announced today that it has received FDA authorization to begin marketing its MarrowXpress (MXP) device. The MXP is used for the preparation of the adult stem cell concentrate that is derived from bone marrow, and as such the device is applicable both in intraoperative and clinical laboratory settings.

In June, ThermoGenesis submitted a pre-market notification application to the FDA, which subsequently determined that the MXP is exempt from pre-market notification requirements and instead will be subject to regulation that governs laboratory equipment which is designated for specific medical utilization. According to Dr. William Osgood, CEO of ThermoGenesis, “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. In anticipation of this authorization, we have initiated discussions with an orthopedic surgery group, vascular surgeons, and leading academic medical centers not only in the U.S. but also in Europe and Asia, and we look forward to begin placing this device in the clinical setting in the near future. We believe this positions ThermoGenesis to significantly participate in what will ultimatel represent a multi-billion dollar market opportunity in regenerative medicine.”

Bone marrow is the leading source for adult stem cells that are currently in clinical trials for the treatment of a variety of diseases which include, most predominantly, ischemic heart disease, peripheral artery disease, diabetes and blood disorders. According to the U.S. Centers for Disease Control and Prevention, approximately 24 million people in the U.S. alone are known to have heart disease, while approximately 16.2 million people have peripheral artery disease and another 15.8 million people suffer with diabetes. Such statistics for the U.S. comprise nearly half of all documented cases of these diseases worldwide. While the MXP is specifically designed for the processing of stem cells from bone marrow, similar technologies are also being developed with applications to adult stem cells that are derivable from blood and fat.

According to Dr. John Chapman, Vice President of Research and Development and Scientific Affiars at ThermoGenesis, “We are confident that the users of this technology will value the unique capability of this device to achieve significantly improved recovery of the 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. 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.”

This latest FDA authorization of a newly patented medical device represents merely one more example of the explosive growth that is occurring in the regenerative medicine industry, not only in regard to the biological materials themselves, such as the stem cells, that are used, but also in regard to the electronic machinery and engineering that are helping to drive the medical advancements, and for which there is also an increasing global market.

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