Saudi FDA approves Apligraf for treatment of diabetic foot ulcers, chronic wounds

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.