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Organogenesis Inc. Release: Cutting-Edge Technology Brings Major Advance to Patients Lacking Healthy Gum Tissue


4/8/2013 10:33:46 AM

INDIANAPOLIS, April 8, 2013 /PRNewswire/ -- Patients lacking healthy gums now have an advanced, living cell-based product available to help the body generate new tissue. Jay R. Beagle, D.D.S., M.S.D., a leading periodontist who has been practicing for over two decades in Indianapolis, Indiana, was chosen as one of the first periodontists in the country to be trained to use this novel, regenerative medicine product GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen).

(Photo: http://photos.prnewswire.com/prnh/20130408/NE90055 )

GINTUIT is the only product available that has been proven to generate new oral soft tissue, or gum tissue. It works with the patient's own body to produce the amount and type of gum tissue that should naturally occur.

Prior to GINTUIT, patients and dental specialists had limited treatment options to manage mucogingival conditions, characterized by a loss of the protective gum tissue that surrounds teeth and dental implants, which could result in tooth or implant loss. Since gum tissue will not regenerate on its own, patients have had to resort to invasive surgical procedures, including repositioning gum tissue, removing tissue from one part of the mouth to another, or using outside materials to shape the gums. While commonly used, these procedures can be painful and the results are not always aesthetically pleasing since the replacement tissue does not match the affected site.

"GINTUIT is the first new treatment option in years focused on soft tissue, transforming our ability to provide quality care for patients suffering from various conditions caused by missing or deficient gums," said Dr. Beagle. "By using living cells to work with the patient's own cells, GINTUIT addresses the limits of currently available treatments and provides a much more patient-friendly option that results in natural-looking gums and an easier, less painful recovery. I am pleased to be among the dental specialists that can currently offer this treatment to my patients, and look forward to my continued work with the product."

GINTUIT was recently approved by the U.S. Food and Drug Administration (FDA) and represents the first cell-based product that is FDA-approved for use in the dental market.

It is currently available to patients in a controlled market release program by leading dental specialists across the country. The product was developed and is manufactured by Organogenesis Inc. (Canton, MA), a pioneer in regenerative medicine.

"We are thrilled to have a periodontist of Dr. Beagle's caliber as part of the GINTUIT controlled market release and appreciate his dedication to using transformative technology to improve patient care," stated Dario Eklund, Vice President, Oral Regeneration and Biosurgery. "We believe that GINTUIT will make an important impact on how dental specialists can address the loss of healthy tissue for their patients by providing predictable and aesthetically pleasing results."

About GINTUIT
GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) 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. GINTUIT is not intended to provide root coverage.

Important Safety Information:

GINTUIT should not be used if an active infection is present and when there is a known allergy to bovine collagen. In clinical trials, the most common adverse events reported were nasopharyngitis, respiratory tract infection, sinusitis, and upper respiratory tract infections.

Transmission of infectious diseases is a theoretical possibility. The long-term potential for oral mucosal cancers to arise from, or in response to, this product is unknown.

About Organogenesis Inc.
Having pioneered the field, Massachusetts-based 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. For more information, visit www.organogenesis.com.

CONTACT: Angelyn Lowe, +1-857-233-8715, alowe@organo.com

SOURCE Organogenesis Inc.



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