Organogenesis secures landmark FDA approval
By Canton CitizenCanton-based Organogenesis Inc., a business leader in the regenerative medicine field, announced last Monday that the United States Food and Drug Administration has approved Gintuit, a cell-based product that has been shown to predictably generate new and aesthetically appealing oral soft tissue.
The Gintuit approval marks two important firsts: the first-ever approval of an allogeneic cell product via the Center for Biologics Evaluation and Research (CBER) arm of the FDA, and the first cell-based technology that is FDA-approved for use in the dental market.
“This FDA approval is a significant milestone for our company, for the FDA, and for the regenerative medicine and dental surgery fields,” said Organogenesis President and CEO Geoff MacKay. “As a pioneer in regenerative medicine, Organogenesis continues to lead the way by ushering in a completely new therapeutic class in dentistry. Our second breakthrough cell-based product, Gintuit will help dental surgeons generate new gum tissue for their patients without turning to palate graft surgery.”
Gintuit is a cellular sheet that contains human fibroblasts, keratinocytes, human extracellular matrix proteins, and bovine collagen. These cells produce a wide array of cytokines and growth factors, signals that allow cells to communicate with each other. These proteins are important factors for the healing and regeneration of tissue.
“Anyone who has experienced the discomfort of palatal graft surgery will immediately recognize the benefits of a product that has been shown to generate new gum tissue, and importantly, does not require excision of tissue from the roof of a patient’s mouth,” MacKay said.
Organogenesis completed a multi-center, randomized, pivotal clinical trial to determine the efficacy and safety of Gintuit to regenerate oral soft tissue in patients with gingival recession. Patients overwhelmingly preferred Gintuit over the grafting procedure when taking into consideration all aspects of treatment (surgery, recovery, appearance).
“Gintuit holds the promise of rewriting the rules of regeneration,” said Dr. Michael K. McGuire, the lead investigator of the Gintuit pivotal trial and a pioneer in the use of tissue engineering technologies in periodontology. “Delivering a construct with living cells that can generate new tissue indistinguishable from what nature intended is unprecedented and exciting.”
Organogenesis expects that Gintuit will be commercially available via a controlled market release beginning in the summer of 2012 and available to the broader U.S. market in 2013.
The latest FDA approval comes at a time of rapid growth and development for Organogenesis. The company is currently in the midst of a major, multi-year expansion of its global headquarters, research and development, and manufacturing facilities in Canton.
“In addition to this FDA approval, the company has reached a number of important landmarks in the past 12 months,” said MacKay. “We broke ground on our new state-of-the-art regenerative medicine manufacturing facility, and we hired our 500th employee. This is truly an exciting time for our trailblazing company.”
For more information about Organogenesis, visit www.organogenesis.com.
Submitted by Organogenesis Inc.
Short URL: https://www.thecantoncitizen.com/?p=12420
Posted by Canton Citizen
on Mar 21 2012. Filed under Business.
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