The FDA has granted 510(k) clearance to Mesynthes’ Endoform Dermal Template. Endoform, a proprietary extracellular matrix biomaterial, provides a new biologic template for tissue regeneration.
Mesynthes’s Endoform technology utilises a proprietary extracellular matrix biomaterial containing a complex mixture of important biological molecules, including structural and adhesive proteins, such as collagens, elastin, fibronectin and laminin, and glycosaminoglycans.
Brian Ward, CEO of Mesynthes, said: “FDA marketing clearance for Endoform Dermal Template paves the way for commercial launch into the US dermal market and establishes our Endoform platform as a new medical biomaterial for tissue repair and reconstruction.
“In tissue regeneration, it is now well recognised that a diverse mix of extracellular matrix components is important for orchestrating a regenerative response. These components provide important structure, signals, and substrates to cells within the healing tissue. Once applied to the wound bed, the Endoform Dermal Template provides a uniquely supportive environment to guide the growth of cells and new tissue.
“Over time, Endoform is completely replaced by the patient’s own tissue. Clinically, the impact of applying extracellular matrix within a chronic wound is to restart the stalled healing process and stimulate new tissue growth in the wound bed. In acute wounds, extracellular matrix replaces lost dermis, advancing the wound healing process and reducing contracture.”
Chronic wounds are difficult to heal, require ongoing care and risk complications that can lead to amputation. The company opines that its Endoform Dermal Template provides a new tool to address this issue.