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Organogenesis Files PMA for CelTx(TM) for Oral Soft Tissue Regeneration
Date:12/21/2009

te 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."

About CelTx(TM)


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SOURCE Organogenesis, Inc.
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