Organogenesis announced that the FDA has approved Gintuit (allogeneic cultured keratinocytes and fibroblasts in bovine collagen), a cell-based product for generating new and aesthetically appealing oral gum tissue. Gintuit is the first-ever allogeneic cell product and the first cell-based technology approved for use in the dental market.
Safety and efficacy of Gintuit to regenerate oral soft tissue in patients with gingival recession was determined in a multi-center, randomized, pivotal clinical trial. The Gintuit-treated sites generated a clinically significant amount of keratinized oral soft tissue. Also, Gintuit-generated gum tissue better matched the color and texture of the patient’s surrounding tissue vs traditional palatal grafting procedures.
Gintuit is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults. Gintuit is expected to be commercially available via a controlled market release beginning in the summer of 2012 and available to the broader US market in 2013.
For more information visit www.organogenesis.com.