Results from Swedish multi-centre clinical trial with follow-up of 30 Episealer® patients accepted for scientific publication
Episurf Medical (Nasdaq: EPIS B) today announces that results from a clinical study with follow-up of the 30 first Episealer® patients from nine Swedish clinics has been accepted for publication in the scientific journal Cartilage. The publication is expected to be available online shortly. The study reports on good implant safety and significantly improved patient-reported outcome scores. In total, 30 patients are included in the study and the average follow-up time is 55 months (subjective outcome scores at 24 months, survival data at 24 – 86 months, mean of 55 months).
The Episealer® Knee implant is intended for treatment of focal cartilage and osteochondral defects on the femoral side of the knee joint. These defects often imply severe pain, which significantly can impact the patient’s quality of life. Current standard of care, which includes various biological treatment alternatives, has shown limited effectiveness, especially with increasing age.
The study is a prospective consecutive cohort study, with the objective to assess subjective short-term outcome and possible longer-term risks of the Episealer® intervention. The study results are compiled by principle investigator MD PhD A. Stålman at Capio Artro Clinic, Stockholm. The patients in the study received an Episealer® Knee implant during the years 2012 – 2017. Of the 30 patients, one patient has undergone revision to a partial knee prosthesis. The patient-reported outcome scores EQ5D VAS (EuroQoL Visual Analogue Scale), VAS-pain (Visual Analogue Scale) and KOOS (Knee injuries and Osteoarthritis Outcome Score) all show significant improvements.
”Again, we note that the satisfactory clinical results previously reported are corroborated, now in a new Swedish study. Further, the risk of revision is again shown to be low. It all points to the Episealer® being a reliable and effective mode of treatment for these “GAP-patients” (being too old for biological cell treatment and too young for a knee prosthesis)” says Prof. Leif Ryd, Senior medical advisor of 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.
This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CEST on 30 September 2020.
Tags: