, Sept. 28
/PRNewswire/ -- Organogenesis, Inc. announced that its Apligraf® bilayered living cellular construct has been approved for the treatment of diabetic foot ulcers and other chronic wounds by the Saudi Food and Drug Authority (SFDA) of the Kingdom of Saudi Arabia
. Apligraf is a living cell based product used by physicians to heal chronic wounds in patients in the U.S. and around the world.
"With diabetes being a widespread and growing medical problem in Saudi Arabia and other Gulf States, the incidence of Diabetic Foot Ulcers is expected to increase," explained Dr. Damien Bates, M.D., Ph. D., F.R.A.C.S. (Plast.), and Chief Medical Officer at Organogenesis. "The prevalence of diabetes is now nearly 14% and expected to increase to 19% by 2030, the highest incidence in the Middle East nations."
The Kingdom of Saudi Arabia, with a population of more than 29 million, is the largest and most affluent of the Gulf Co-operation Council countries. It has built one of the most comprehensive healthcare systems in the Middle East.
Diabetic foot ulcers are open wounds that, for a variety of reasons, fail to heal by the body's own systems. The lifetime risk of a person with diabetes developing a foot ulcer could be as high as 25%. The International Diabetes Federation reports that 285 million people around the world suffer from diabetes.
Apligraf was the first bioengineered cell based product to receive U.S. FDA approval for chronic wounds. Clinical studies have shown that Apligraf in combination with a standard therapy is more efficient in healing diabetic foot ulcers or venous leg ulcers than standard therapy alone.(i,ii)
Apligraf® contains two layers of human living cells: an outer protective layer of differentiated keratinocytes and an inner layer of fibroblasts in a collagen matrix. When placed on a wound previously unresponsive to treatment, Apligraf provides cells, collagen matrix and other proteins that provide a covering that has been demonstrated to promote healing. In multiple controlled clinical studies, Apligraf has been shown to be an effective and safe wound care treatment, superior to conventional treatments.
About Organogenesis, Inc.
Having pioneered the field, Massachusetts based Organogenesis, Inc. is a leading regenerative medicine company focused in the areas of bioactive wound healing, oral regeneration and biosurgery. 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.
(i) Veves A, Falanga V, Armstrong DG, Sabolinski ML. Diabetic Foot Ulcer Study Group. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care 2001; 24: 2905.
(ii) Falanga V, Sabolinski M. A bilayered living skin construct. (APLIGRAF) accelerates complete closure of hard-to-heal venous ulcers. Wound Rep Reg 1999; 7:210-207.
SOURCE Organogenesis, Inc.