Organogenesis Announces FDA Approval of GINTUIT for Oral Soft Tissue Regeneration

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Posted March 12, 2012

FDA Approval Marks First-Ever CBER-Approved Allogeneic Cell-Based Product

CANTON, Mass., -- Today Organogenesis Inc., a business leader in the regenerative medicine field, announced that the United States Food and Drug Administration (FDA) has approved GINTUITTM (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.

"This FDA approval is a significant milestone for our company, for the FDA, and for the regenerative medicine and dental surgery fields," said Organogenesis President & CEO Geoff MacKay. "As a pioneer in regenerative medicine, Organogenesis continues to lead the way by ushering in a completely new therapeutic class in dentistry. 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 Mr. MacKay.

Organogenesis completed a multi-center, randomized, pivotal 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-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).

In clinical trials, GINTUIT was considered safe and well tolerated. The most common adverse reactions observed in the clinical trials (greater than or equal to 1%) included sinusitis, nasopharyngitis, respiratory tract infection, aphthous stomatitis, and the local effects of oral surgery.

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Organogenesis Announces FDA Approval of GINTUIT for Oral Soft Tissue Regeneration