Arent Fox Counsels Organogenesis, Inc. on FDA Approval of First-Ever Cell-Based Product for Oral Use
WASHINGTON, DC — MARCH 12, 2012 — Arent Fox LLP announced today that longtime client Organogenesis, Inc., an industry leader in the field of regenerative medicine, had won approval by the US Food and Drug Administration (FDA) of the bioengineered combination product, GINTUIT™ (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen), which is applied topically to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults. The approval marks the first time that the FDA’s Center for Biologics Evaluation and Research (CBER) has approved an allogeneic living cell product for therapeutic human use, and the first living cell-based technology that is FDA-approved for use in the dental market.
During stages of product development and the FDA approval process, Arent Fox’s interdisciplinary team of attorneys, scientists, regulatory personnel, and health care specialists led by partner Jamie Ravitz, worked with Organogenesis to address FDA requirements associated with this cell-based product, which was reviewed by both CBER and the Center for Devices and Radiological Health (CDRH).
GINTUIT is a living cellular sheet comprising 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 cell communicators are important factors for the healing and regeneration of tissue.
Mr. Ravitz, a partner in the firm’s food and drug practice, said, “Arent Fox is thrilled to have had the opportunity to work with Organogenesis on the FDA’s approval of GINTUIT, and we are glad to see this great result come to fruition after years of hard work. An approval of this scope is a credit to the outstanding group of medical, scientific, regulatory, and business professionals at Organogenesis.”
“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 & 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.”
For additional information, please contact Arent Fox partner James R. Ravitz at 202.857.8903 or email@example.com.