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Print Edition StoriesMonday, December 21, 2009
Organogenesis seeks FDA nod for human cell-based tech
By Mass High Tech staff
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Tissue therapy company Organogenesis Inc. has sent its CelTx product, intended for gum regeneration, to the U.S. Food and Drug Administration with a Premarket Approval Application filing. It would mark the first “living cell-based technology” approved for the dental market.
The Canton-based company first tested CelTx, which contains living human cells in a collagen matrix, in clinical trials for gingival recession, the loss of a seal around teeth, bone and ligaments, which can lead to tooth decay or tooth loss.
CelTx, if approved, would eliminate the need for current gingival recession treatments, including palate grafts, which transplant tissue from one part of the mouth to another and usually leads to pain and an unmatched appearance of the gums.
More about Organogenesis
In January, the Massachusetts Life Sciences Center announced it would provide a $7.4 million grant to Organogenesis to expand the company’s facilities and accommodate its forecasted job growth. Company officials said it plans to become the “largest cell therapy manufacturing facility in the world.”
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