Aroa Biosurgery has received EC Certification for its Endoform® Dermal Template (“EDT”), which allows the company to market and sell this device in the European markets.
EDT is an intact extracellular matrix to treat acute and chronic wounds such as diabetic and venous ulcers. EDT is available as sheets in a range of sizes and does not require physician fixation. EDT is accessible to all healthcare providers across the continuum of care.
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.
EDT is marketed through a global marketing partnership with Hollister Inc. EDT received FDA 510k clearance in 2010 and was launched in the USA in 2013 through Hollister Inc. By 2016, over two million units have been sold in USA. The company will now be able to commercialise EDT in European markets with the receipt of a CE mark.