GINTUIT™ (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) for Oral Soft Tissue Regeneration

Healthy gum (gingival) tissue is important for good oral health, whether it be around teeth, implants or dentures. The type of gum tissue that is best suited to maintaining good health and withstanding the effects of food and tooth brushing is known as keratinized gingiva (KG) or keratinized tissue (KT).

Loss of sufficient amounts of keratinized gum tissue can cause soft tissue inflammation and cannot be resolved by oral hygiene procedures alone. In order to increase the amount of keratinized gum tissue, dental surgeons often use palatal grafting procedures. These procedures require surgical excision of tissue from the roof of a patient’s mouth, which is then surgically placed on the patient’s gums. While these techniques are effective, there are significant drawbacks including: (1) pain and morbidity, (2) limited tissue to treat all areas requiring intervention, and (3) unappealing aesthetics due to poor color and texture match.

GINTUIT™ will help dental surgeons generate new gum tissue for their patients without turning to palatal graft surgery. GINTUIT is a thin cellular sheet made of human fibroblasts, keratinocytes, human extracellular matrix proteins and bovine collagen. These cells produce a wide array of cytokines and growth factors, which are signals that allow cells to communicate with each other. These proteins are important factors for the healing and regeneration of tissue.

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 that better matched the color and texture of the patients’ 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 (≥1%) included sinusitis, nasopharyngitis, respiratory tract infection, aphthous stomatitis, and the local effects of oral surgery.

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.

About GINTUIT™

GINTUIT™ is manufactured using living cells isolated from human skin (fibroblasts and keratinocytes) and grown together with bovine collagen in a highly-controlled laboratory setting for 20 days.

GINTUIT 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.

For additional information, please contact:

Organogenesis Customer Support
Email: gintuitcs@organo.com
Telephone: 1-888-943-8245, Option 2