Episurf Medical is ready to begin enrollment in the U.S. Investigational Device Exemption clinical study of the EPIC-Knee Episealer® Knee.
Episurf is in contract negotiations with additional U.S. sites, and will include participants in three European countries, as well. The study allows for additional sites, should the company want to increase the number in the coming weeks.
The randomized, controlled 180-patient IDE study is the first step for Episurf to gain U.S. premarket approval for the device. The study will evaluate Episealer vs. microfracture in the treatment of focal femoral knee chondral or osteochondral lesions.
“Impressive surgical technique, innovative and highly informative pre-surgical planning tool and quick return to weight-bearing are just some of the aspects that the U.S. surgeons highlight with the Episealer technology. ...If we can repeat the results from Europe, which we believe we can, this company has a bright future.” said Pål Ryfors, CEO.
Source: Episurf Medical