Date: Mar 12, 2012 Author: Ira Kantor Source: Boston Herald (
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Organogenesis Inc. of Canton, a leader in the regenerative medicine field, announced today its product, Gintuit, which is designed to form new gum tissue for dental patients, has been approved by the U.S. Food and Drug Administration.
Gintuit marks the first-ever approval of an allogenic cell product via the FDA’s Center for Biologics Evaluation and Research, and the first cell-based technology FDA-approved for use in the dental market, the company said.
Organogenesis CEO Geoff MacKay said the FDA approval was “a significant milestone” for the company.
“Our second breakthrough cell-based product, Gintuit, will help dental surgeons create new gum tissue for their patients without turning to palate graft surgery,” MacKay said.
Gintuit is a cellular sheet containing human fibroblast and extracellular matrix proteins, as well as bovine collagen.
The company added Gintuit is expected to be commercially available via a controlled market release beginning this summer, and available to the broader U.S. market next year.
The announcement comes as Organogenesis continues work on its $63 million expanded regenerative manufacturing facilities in the Bay State