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Organogenesis Files Premarket Approval Application For CelTx

CelTx, a living cellular construct for oral soft tissue regeneration

Organogenesis has filed a Premarket Approval Application (PMA) with the FDA for its CelTx, 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, said the company.

While Organogenesis believes that CelTx holds promise across multiple clinical applications to regenerate oral soft tissue (also known as gums), it focused the initial clinical trials on the use of CelTx to regenerate new gum tissue for patients with gingival recession.

CelTx is an investigational device in the US and has not yet been approved for sale. Patients preferred CelTx over the grafting procedure when taking into consideration all aspects of treatment (surgery, recovery, appearance). It is upon these data that the PMA is based, said the company.

Dario Eklund, vice president of oral regeneration and bio-surgery at Organogenesis, said: “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. Organogenesis is proud to be forging ahead with bringing regenerative technologies, like CelTx, to dentists and their patients.”

“We designed CelTx to address these shortcomings. 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. We are looking forward to introducing what we believe will be a new therapeutic class in dentistry.”