Alphatec Spine Comments on Untitled Letter Related to PureGen Osteoprogenitor Cell Allograft
Alphatec Holdings, Inc. (Nasdaq: ATEC) today commented on the United States Food and Drug Administration's (FDA) untitled letter dated June 23, 2011 that was sent to Parcell Laboratories, LLC regarding Alphatec Spine's PureGen Osteoprogenitor Cell Allograft product.
In the letter, the FDA raised questions in connection with Parcell's position that the PureGen product is within the classification of human cell, tissue, and cellular or tissue-based products regulated solely under Section 361 of 21 C.F.R. Part 1271. Parcell Laboratories has responded to the FDA's letter on July 21, 2011 with more complete information of the function of PureGen and how the product meets all of the criteria for being marketed under Section 361.
Dirk Kuyper, Alphatec Spine's President and CEO, stated, "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."
The PureGen Osteoprogenitor Cell Allograft has been successfully implanted in over 500 patients with no reported adverse events, complications or complaints. The product is used primarily in spinal fusion procedures for both cervical and lumbar spine. There are three controlled prospective studies currently underway to further establish the performance of the product by both academic and community-based spine surgeons.
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