Organogenesis Inc. filed a pre-market approval application with the Food & Drug Administration for its CelTx oral tissue regeneration product.
The Canton, Mass.-based firm said the CelTx product is a living cellular construct designed to help heal the gums of patients with gingival recession. It’s made of human fibroblasts, keratinocytes and extracellular matrix proteins.
If the FDA clears the product, which is now approved only as an investigational device, Organogenesis said it would be the first living, cell-based technology approved for use in the dental market. The company hopes to expand the product across a number of clinical applications for gums.
The PMA application is based on a pivotal clinical trial that showed “a statistically and clinically significant gain in the amount of keratinized oral soft tissue,” according to a press release. The regenerated gums were a better color and texture match to existing gums than tissue transplanted from the palate, which is the most common treatment for gingival recession.
Organogenesis‘ flagship product, Apligraf, is a circular patch with skin-like dermal and epidermal layers, about the diameter of a hockey puck and a quarter of a millimeter thick. It’s made using epidermal fibroblasts and dermal keratinocytes from the donated samples, which are seeded into a collagen solution. As they develop, they mimic the growth of actual human skin — minus hair follicles, blood vessels and, mercifully, sweat glands — stimulating the production of protein and growth factors that spur the patient’s own cells into action to heal damaged tissue.