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 addressed the feedback earlier received from the US FDA on the company's 510(k) submission for market clearance, and has now performed a new submission.

The Episealer® MTP technology includes patient-specific implants and instrumentation, developed to address osteoarthritis in the MTP joint of the big toe.

"This submission implies that the company has finalised the activities initiated to address FDA's previous feedback. The submission got slightly delayed because of the US federal lockdown, and it is unclear if the lockdown will have some effect on the present FDA review times. Irrespectively, we should be a step closer to clearance, and we hope to have this regulatory process finalised soon" says Katarina Flodström, CEO Episurf Medical.

For more information, please contact:

Katarina Flodström, CEO, Episurf Medical
Tel: +46 707 38 35 70
Email: katarina.flodstrom@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 above contact person, at 11:45 CET on November 18, 2025.