The Saudi Food and Drug Authority (SFDA) has granted approval for Organogenesis' treatment of diabetic foot ulcers and other chronic wounds, Apligraf.
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Apligraf is a living cell based product used by physicians to heal chronic wounds in patients in the US and around the world.
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.
The company said that in multiple controlled clinical studies, Apligraf has been shown to be an effective and safe wound care treatment, superior to conventional treatments.
Organogenesis claims that Apligraf was the first bioengineered cell based product to receive US Food and Drug Administration approval for chronic wounds.
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