Aroa Biosurgery has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s Endoform® Silver Dermal Template, which allows the company to market and sell this device in the USA.
Endoform Silver Dermal Template (Endoform Silver) is an advanced antimicrobial version of Aroa’s EDT wound care product. This product will be primarily used for chronic wounds where healing has stalled.
Aroa’s EDT wound care product is marketed through a global marketing partnership with Hollister Inc. EDT was launched in the USA in 2013 through Hollister Inc. Over two million units have been sold in USA. The company will now be able to commercialise an antimicrobial version of EDT in the USA and anticipate the launch of the new device in the first quarter of 2018.
Brian Ward, chief executive of Aroa Biosurgery says “This device will broaden our wound care portfolio and will allow Aroa to provide a more comprehensive and complementary advanced wound care offering in the USA.”
EDT is an intact extracellular matrix to treat acute and chronic wounds such as diabetic and venous ulcers. This device is built using Aroa Biosurgery’s proprietary Endoform platform derived from ovine forestomach matrix. Endoform is a building block that serves as the underlying architecture for a wide range of medical devices. Read more about the Endoform platform here.