Episurf Medical

Episurf Medical (NASDAQ: EPIS B) today announces an update on the process for US market clearance for the company's Episealer® MTP big toe implant. Episurf Medical has during the spring got interactive feedback from the US FDA on the company's 510(k) submission for market clearance, that has been addressed. Progress has been made, but there are certain validation activities that are not yet fully accepted by the FDA. The company will follow the advice by the FDA on the path forward, and the company has a concrete plan for how the final questions shall be addressed.

Episealer® MTP is a patient-specific implant with patient-specific instrumentation, developed to address osteoarthritis in the 1^st MTP joint of the big toe.

"The important thing here is that we are close to reach the goal of clearance and we have now got clarity in what is needed to cross the finish line for clearance of Episealer® MTP for the US market. We see the FDA's questions as manageable, and we look forward to continuing working with them to close the last items. We are aiming for clearance before the end of this year. We are grateful for FDAs availability to us, despite going through a very turbulent time themselves" says Pål Ryfors, CEO Episurf Medical.