Apligraf(R) Approved by Saudi Food and Drug Authority for Treatment of Chronic Wounds
By Organogenesis Inc., PRNEMonday, September 27, 2010
Diabetic Foot Ulcers a Widespread and Growing Problem in Gulf States
CANTON, Massachusetts, September 28, 2010 - Organogenesis, Inc. announced that its Apligraf(R) 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)
About Apligraf(R)
Apligraf(R) 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: 290-5.
(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.
Angelyn Lowe of Chase Communications, +1-858-273-1805, alowe at chasepr.com, for Organogenesis, Inc.
Tags: Canton, Massachusetts, Organogenesis Inc., Saudi Arabia, September 28, Switzerland