Update on Episurf’s MTP implant
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 1st 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.
For more information, please contact:
Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69
Email: pal.ryfors@episurf.com
About Episurf Medical
Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and individualised treatment alternatives. Episurf Medical’s Episealer® individualised implants and Epiguide® surgical drill guides are developed for treating localised cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.
The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CEST on 17 June 2025.