Organogenesis Inc announced that the US FDA has granted 510(k) marketing clearance for its FortaFlex wound dressing product, PuraPly. PuraPly is indicated for the management of acute and chronic, partial and full-thickness wounds. The product is designed using the Company's FortaFlex bioengineered matrix technology.

Organogenesis has entered into a commercialization agreement for PuraPly (formerly called FortaDerm) with Royce Medical Company. Under the agreement, Royce Medical is to market PuraPly to the US non-hospital market. Organogenesis is responsible for gaining marketing clearance and for product manufacturing, which will be performed by a third party. Commercialization is expected to begin this fall.

Dr. Michael Sabolinski, President and Chief Executive Officer, said, "This is the second product made with our FortaFlex bioengineered matrix technology to have gained FDA marketing clearance this month and is consistent with our goal of leveraging this technology to achieve a family of products. PuraPly has been licensed to Royce Medical, which will sell and market the product in the office setting."