Organogenesis files a PMA with the FDA for its CelTx living cell-based technology

Organogenesis, Inc. announced today that it has filed a Premarket Approval Application (PMA) with the U.S. Food and Drug Administration (FDA) for its CelTx(TM), 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.

A pioneer in the field, Organogenesis is the world's first regenerative medicine company to successfully commercialize and mass produce profitable living cell-based products. "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," explained Dario Eklund, Organogenesis Vice President, Oral Regeneration and Bio-surgery. "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 (also known as gums), the company focused the initial clinical trials on the use of CelTx to regenerate new gum tissue for patients with gingival recession. Gingiva (gums) forms a crucial seal around teeth and the supporting structures around them (bone and ligaments). Gingival recession is the loss of this protective seal, making teeth susceptible to bacteria that can lead to decay and potential tooth loss.

Clinicians currently have limited options to correct gingival recession. Most commonly they perform a free gingival graft, in which tissue is taken from the roof of the mouth (palate) and is transplanted to the gum in order to prevent further recession. This procedure is performed approximately 500,000 times per year in the U.S. Drawbacks to free gingival graft procedures include pain and morbidity (at the site of the palate graft), insufficient tissue to treat all sites requiring treatment and often unappealing aesthetics due to poor color and texture match of the graft to the adjacent gums.

"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," continued 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 approved for sale.

Earlier this year, Organogenesis completed a multi-center, randomized, pivotal clinical trial to determine the efficacy and safety of CelTx to regenerate oral soft tissue in patients with gingival recession. The CelTx-treated sites demonstrated a statistically and clinically significant gain in the amount of keratinized oral soft tissue. Moreover, the CelTx-regenerated gum tissue better matched the color and texture of the patient's surrounding tissue vs. the grafting procedures. Importantly, patients overwhelmingly 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.

Michael K. McGuire, DDS, the lead investigator of the CelTx trial and a pioneer in the use of tissue engineering technologies in periodontology noted, "CelTx, more than any other product on the horizon, holds the promise of rewriting the rules of regeneration. Implanting a construct with living cells that can generate new tissue that leaves no trace that a periodontal surgeon has been there is exciting. If approved, CelTx will allow us to broaden our scope of practice and, importantly, provide our patients with a predictable and highly aesthetic outcome."