The FDA questioned whether PureGen is within the classification of human cell, tissue and cellular or tissue-based products that the FDA regulates. Alphatec Spine and Parcell Laboratories plan on working with the FDA to address its questions about PureGen and will share the clinical outcomes gathered to date.
PureGen Osteoprogenitor Cell Allograft has been successfully implanted in more than 500 patients, primarily during lumbar and cervical spine fusions, and no adverse events have been reported.
Read the release about PureGen.
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