Mesynthes has filed a Premarket Notification 510(k) with the US FDA for Endoform Dermal Template for use in the treatment of chronic wounds which includes diabetic foot ulcers as well. Endoform is a extracellular matrix material that provides a unique mix of biologic macromolecules which actively promote cell proliferation and angiogenesis (blood vessel formation) to improve wound healing.
“This FDA 510(k) submission for our first product represents a major milestone in the advancement of our Endoform technology, which we believe offers unique regenerative properties for wound healing and soft tissue reconstruction,” said Brian Ward, B.V.Sc, Mesynthes Chief Executive Officer. “We hope to receive marketing clearance for this product in the United States, and file a 510(k) application for our second product, the Endoform Breast Device, by year end. This filing will help to advance partnering discussions for our lead product and also other products in our pipeline.”
Endoform technology utilizes a extracellular matrix that contains a complex mix of important biological molecules. Endoform’s authentic complexity delivers signals, architecture and substrates directly to the wound to attract host cells, support tissue repair and remodeling with minimal scarring. Endoform Dermal Template which is presented as a lyophilized product in a sterile pouch, is strong and easy to handle in a dry or hydrated state. After the wound matrix is applied to the wound bed it is rehydrated, covered with a non-adherent dressing, and secured in place. Endoform Dermal Template is available in large formats that makes it ideal for covering extensive skin deficits.