European multicentre study initiated for 5 years’ follow-up of Episealer® Knee patients
Episurf Medical (Nasdaq: EPIS B) today announces the initiation of an investigator-initiated European multicentre study with 5 years’ follow-up of 50 Episealer® Knee patients. The study is a continuation of the European multicentre study, from which 2 years’ follow-up results were published in September 2020 (Holz, J. et al, Patient‑specific metal implants for focal chondral and osteochondral lesions in the knee; excellent clinical results at 2 years, KSSTA online 2020).
The interim study from 2020 concluded that the results indicate that there is a definitive place for the Episealer® device in the management of a focal chondral or osteochondral defect affecting the distal femur. The study sponsor, investigator Associate Professor Tim Spalding, University Hospitals Coventry and Warwickshire NHS Trust, UK, will now perform the 5 years’ follow-up together with surgeons from 8 additional clinics in 6 European countries. Preliminary results from the follow-up are expected during the fourth quarter of 2021, while full results are expected in early 2022.
“This study can be performed thanks to the study group's engagement and persistent follow-up of their patients, and we appreciate the initiative taken by Mr Tim Spalding. There has previously been a focus on 2 years’ data for the Episealer® patients. We are happy to now be in a position to get results from a large group of patients that have had their implants for 5 years. Recent publications with strong 2 years’ results have been very useful in Episurf’s dialog with healthcare providers, customers, and authorities in our markets. We are confident that the 5 years’ results will provide even stronger evidence in support of the Episealer®, showing that the technology is reliable over time” says Pål Ryfors, CEO Episurf Medical.
For more information, please contact:
Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69
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.