The FDA has approved Gintuit, a cell-based topical product that has been shown to predictably generate new and aesthetically appealing oral soft tissue, according to Organogenesis.
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.
"This FDA approval is a significant milestone for our company, for the FDA, and for the regenerative medicine and dental surgery fields," said Geoff MacKay, president and CEO, Organogenesis. "Our second breakthrough cell-based product, Gintuit will help dental surgeons generate new gum tissue for their patients without turning to palate graft surgery."
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.
"Anyone who has experienced the discomfort of palatal graft surgery will immediately recognize the benefits of a product that has been shown to generate new gum tissue, and importantly, does not require excision of tissue from the roof of a patient's mouth," continued MacKay.
Organogenesis completed a multi-center, randomized clinical trial to determine the efficacy and safety of Gintuit to regenerate oral soft tissue in patients with gingival recession. The Gintuit-treated sites generated a clinically significant amount of keratinized oral soft tissue.
Moreover, Gintuit was considered safe and well tolerated. Gum tissue generated by Gintuit better matched the color and texture of the patient's surrounding tissue versus traditional palatal grafting procedures. Patients overwhelmingly preferred Gintuit over the grafting procedure when taking into consideration all aspects of treatment (surgery, recovery, appearance).
"Gintuit holds the promise of rewriting the rules of regeneration. Delivering a construct with living cells that can generate new tissue indistinguishable from what nature intended is unprecedented and exciting,” said Dr. Michael K. McGuire.
Organogenesis expects that Gintuit will be commercially available via a controlled market release beginning in the summer of 2012 and available to the broader U.S. market in 2013.