The US Food and Drug Administration (FDA) has cleared Organogenesis' cell-based product, Gintuit.
Gintuit containing human fibroblasts, keratinocytes, human extracellular matrix, proteins and bovine collagen produces various cytokines and growth factors, signals which allow cells to communicate with each other, thus facilitating in healing and regeneration of tissue.
The FDA approval was based on a multi-center, randomized, pivotal clinical trial which was designed to determine the efficacy and safety of Gintuit to regenerate oral soft tissue in patients with gingival recession.
The results demonstrated that Gintuit-treated sites generated a significant amount of keratinized oral soft tissue, while Gintuit-generated gum tissue better matched the color and texture of the patient’s surrounding tissue.
Gintuit was also considered to be safe and well tolerated.
Organogenesis president and CEO Geoff MacKay said Gintuit will help dental surgeons generate new gum tissue for their patients without turning to palate graft surgery.