FDA approves biologic template for tissue regeneration

Wellington, New Zealand

- The Food and Drug Administration (FDA) has granted 510(k) clearance for Endoform Dermal Template, an extracellular matrix biomaterial manufactured by New Zealand regenerative medicine company Mesynthes.

According to the company, Endoform Dermal Template provides a “unique” biologic template for tissue regeneration. The technology utilizes a proprietary extracellular matrix biomaterial containing a mixture that includes structural and adhesive proteins such as collagens, elastin, fibronectin and laminin, and glycosaminoglycans.

Endoform Dermal Template is packaged as a sterile dry sheet in a peel pouch. The product is applied directly to the wound bed, then rehydrated, covered with a nonadherent dressing, and secured in place. It requires no special storage.

A Mesynthes press release quotes C.E.O. Brian Ward, M.D., as saying, “FDA marketing clearance for Endoform Dermal Template paves the way for commercial launch into the U.S. dermal market, and establishes our Endoform platform as a new medical biomaterial for tissue repair and reconstruction.”