Alphatec Holdings Inc. (NSDQ:ATEC) subsidiary Alphatec Spine responded to the FDA’s Untitled Letter challenging the status of the PureGen stem cell-based bone regeneration product developed with partner Parcell Laboratories.
Parcell received the warning letter late last month stating that the PureGen product was miscategorized and that the company needs a biologics license to continue developing the product because it "is dependent on the metabolic activity of living cells for its primary function and is not intended for autologous use or allogeneic use in a first or second degree blood relative."
Alphatec responded to the agency’s inquiry with more information supporting the product’s existing classification. Thus far PureGen has been regulated entirely under Part 1271 of Section 361 of Title 21 of the Code of Federal Regulations, deeming it within the classification of human cell, tissue, and cellular or tissue-based products.
The FDA alleges that the product doesn’t meet all of the criteria for that classification and that PureGen should be regulated as a drug under the Federal Food, Drug & Cosmetic Act and as a biologic under the Public Health & Welfare Act, according to the agency’s letter.
Parcell must produce either a biologics license or a sponsor must have an investigational new drug application in effect in order for PureGen to continue development, the agency wrote.
"Both Alphatec Spine and Parcell Laboratories are fully committed to work closely and collaboratively with the FDA to address the questions related to the PureGen product. We look forward to discussing the PureGen product with the FDA and sharing our clinical outcomes to date," Alphatec Spine president & CEO Dirk Kuyper said in prepared remarks.