Organogenesis has filed a premarket approval application (PMA) with the FDA for its CelTx product, a living cellular construct for oral soft-tissue regeneration.
If approved, CelTx will be the first, living cell-based technology that is FDA-approved for use in the dental market, according to a company press release.
"This is an important milestone for Organogenesis as well as for the regenerative medicine industry, a growing field in which new research discoveries occur frequently, but product commercialization is rare," said Dario Eklund, Organogenesis vice president, in the release. "Organogenesis is proud to be forging ahead with bringing regenerative technologies like CelTx to dentists and their patients."
While Organogenesis believes that CelTx holds promise across multiple clinical applications to regenerate oral soft tissue, the company focused the initial clinical trials on regenerating new gum tissue for patients with gingival recession.
"Once approved, CelTx will allow a clinician to fully treat all compromised gums, will reduce patient pain and complications by eliminating the need for a graft, and provide a highly aesthetic clinical outcome," said Eklund. "We are looking forward to introducing what we believe will be a new therapeutic class in dentistry."
CelTx is an investigational device in the U.S. and has not yet been cleared for sale.
