Organogenesis Inc. Files PMA for CelTx(TM) for Oral Soft Tissue
Published: Dec 21, 2009
CANTON, Mass., Dec. 21 /PRNewswire/ -- 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.
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.
"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."
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.
CelTx(TM) is a living cellular construct comprised of human fibroblasts, keratinocytes and extracellular matrix proteins. Studies suggest the living cells found in CelTx produce a wide array of growth factors and cytokines that in turn stimulate the patient's own cells to regenerate new gum tissue that is clinically relevant and aesthetically appealing.
About Organogenesis, Inc.
Having pioneered the field, Massachusetts based Organogenesis, Inc. is a world leading regenerative medicine company focused on soft tissue repair within three major areas: bio-active wound healing, oral regeneration and bio-surgery. The company's mission is to bring the medical marvel of regenerative medicine products to patients and to standardize their use in everyday medical care. Organogenesis recently established European headquarters located in Switzerland, as well as announced an expansion of its U.S. headquarters. For more information, visit www.organogenesis.com.