Organogenesis Inc., a business leader in the regenerative medicine field, has received the United States Food and Drug Administration (FDA) approval for its Gintuit (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 Ginuit 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, Ginuit will help dental surgeons generate new gum tissue for their patients without turning to palate graft surgery."

Ginuit 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, pivotal clinical trial to determine the efficacy and safety of Ginuit to regenerate oral soft tissue in patients with gingival recession. The Ginuit-treated sites generated a clinically significant amount of keratinized oral soft tissue. Moreover, Ginuit-generated gum tissue better matched the color and texture of the patient's surrounding tissue versus traditional palatal grafting procedures. Importantly, patients overwhelmingly preferred Ginuit over the grafting procedure when taking into consideration all aspects of treatment (surgery, recovery, appearance).

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

“Healthy gingiva or gum tissue is important for protecting teeth and dental implants. The loss of keratinized gingiva is a very common, yet serious, problem,” said Dr Michael K McGuire, the lead investigator of the Ginuit pivotal trial and a pioneer in the use of tissue engineering technologies in periodontology. “Ginuit 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.”

Organogenesis expects that Ginuit 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.

The latest FDA approval comes at a time of rapid growth and development for Organogenesis. The company is currently in the midst of a major, multi-year expansion of its global headquarters, research and development, and manufacturing facilities in Massachusetts.

"In addition to this FDA approval, the company has reached a number of important landmarks in the past twelve months," said Mr. MacKay. "We broke ground on our new state-of-the-art regenerative medicine manufacturing facility, and we hired our 500th employee. This is truly an exciting time for our trailblazing company."

Ginuit 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. Ginuit is not intended to provide root coverage.

The most common adverse reactions observed in the clinical trials (=1%) included sinusitis, nasopharyngitis, respiratory tract infection, aphthous stomatitis, and the local effects of oral surgery.

Organogenesis Inc. is a world leading regenerative medicine company focused in the areas of bio-active wound healing and oral regeneration. The company's mission is to bring the medical marvel of regenerative medicine products to patients and to standardize their use in everyday medical care.