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SOURCE Organogenesis Inc.
CANTON, Mass., Oct. 21, 2013 /PRNewswire/ -- The Galien Foundation, a foundation which fosters, recognizes and rewards excellence in scientific innovation to improve the state of human health, has nominated Organogenesis Inc.'s newest FDA approved product, GINTUIT™ (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) for the seventh annual Prix Galien USA Awards in the "Best Biotechnology Product" category.
The Prix Galien Award, which recognizes the technical, scientific and clinical research skills necessary to develop innovative medicines and devices, is considered the biomedical industry's highest accolade.
"Biopharmaceutical research cannot exist without those who are willing to push innovation and extract understanding and attention in the details," remarked Bruno Cohen, Chairman of the Galien Foundation. "We are proud to honor those in the field who exemplify these values; the same values that the Galien Foundation continually upholds, distinguishing these awards as the best in the world."
"As a pioneer and a commercial leader in the emerging field of regenerative medicine, we are proud that GINTUIT is the first regenerative medicine product to be nominated for the Prix Galien," said Dario Eklund, Vice President, Oral Regeneration and Biosurgery, Organogenesis Inc.
GINTUIT is no stranger to "firsts." The product received a first-cycle FDA approval as a combination product (biologic-device) in March of 2012. Its FDA-approval signified the first-ever approval of a manufactured allogeneic cell construct via the Center for Biologics Evaluation and Research (CBER arm of the FDA). GINTUIT is also the first cell-based technology that is FDA-approved for use in the dental market.
The Prix Galien Award Ceremony will be held this week in New York City on October 22. The Prix Galien USA Committee, composed of nine individuals who are majority Nobel Laureates, will evaluate nominees as Best Biotechnology Product, Best Pharmaceutical Agent, and Best Medical Technology approved by the U.S. Food and Drug Administration (FDA) during the past 5 years.
About the Galien Foundation
The Galien Foundation fosters, recognizes and rewards excellence in scientific innovation to improve the state of human health. Our vision is to be the catalyst for the development of the next generation of innovative treatment and technologies that will impact human health and save lives.
The Foundation oversees and directs activities in the USA for the Prix Galien, an international award that recognizes outstanding achievements in improving the human condition through the development of innovative therapies. The Prix Galien was created in 1970 in honor of Galen, the father of medical science and modern pharmacology. Worldwide, the Prix Galien is regarded as the equivalent of the Nobel Prize in biopharmaceutical research.
For more information visit www.galienfoundation.org.
GINTUIT is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults. GINTUIT is not intended to provide root coverage. The most common adverse reactions observed in the clinical trials (=1%) included sinusitis, nasopharyngitis, respiratory tract infection, aphthous stomatitis, and the local effects of oral surgery.
For more information, visit www.gintuit.com.
About Organogenesis Inc.
Having pioneered the field, Massachusetts-based Organogenesis Inc. is a world leading regenerative medicine company focused in the areas of bio-active wound healing and oral regeneration. 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.
For more information, visit www.organogenesis.com.
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