FDA Approval of GINTUIT for Oral Soft Tissue Regeneration

Organogenesis Inc., announced that the United States Food and Drug Administration (FDA) has approved GINTUIT(TM) (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen), a cell-based product that has been shown to predictably generate new and aesthetically appealing oral soft tissue (gum tissue).

The GINTUIT approval marks two important firsts: the first-ever approval of an allogeneic cell product via the Center for Biologics Evaluation and Research (CBER) arm of the FDA, and the first cell-based technology that is FDA-approved for use in the dental market.

GINTUIT is a cellular sheet that contains human fibroblasts, keratinocytes, human extracellular matrix proteins and bovine collagen. These cells produce a wide array of cytokines and growth factors, signals that allow cells to communicate with each other. These proteins are important factors for the healing and regeneration of tissue.
The GINTUIT-treated sites generated a clinically significant amount of keratinized oral soft tissue. Moreover, GINTUIT-generated gum tissue better matched the color and texture of the patient’s surrounding tissue versus traditional palatal grafting procedures. Importantly, patients overwhelmingly preferred GINTUIT over the grafting procedure when taking into consideration all aspects of treatment (surgery, recovery, appearance).

More information is available at: http://www.organogenesis.com/products/oral\_regeneration/orallcc.html

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