Positive results from follow-up of 30 patients in a Swedish multi-centre clinical trial of the Episealer® Knee implant
Episurf Medical (Nasdaq: EPIS B) today announces that results from a clinical study with follow-up of the 30 first patients from nine Swedish clinics show good implant safety and significantly improved patient-reported outcome scores. Follow-ups of the patients are now completed, and the principle investigator will compile the results for submission to a scientific journal. In total, 30 patients are included in the study and the average follow-up time is 55 months (24 – 86 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. Cartilage has a very limited ability to heal and the self-repairing mechanism decreases further as we age. Current standard of care, which includes various biological treatment alternatives, have shown limited effectiveness, especially with increasing age.
The Episealer® Knee implant is fully tailored to fit each patient’s unique curvature of the joint surface, the size and shape of the lesion, and underlying bone conditions. In addition to providing an individualised implant, individualised surgical instrumentation is also provided to enable correct position of the implant. The associated imaging technology visualises chondral and osteochondral defects and provides the surgeon with support in the decision making as well as being a surgery planning tool.
The objective of the prospective consecutive cohort study is to assess subjective short-term outcome and possible longer-term risks of the intervention. The study performed at Capio Artro Clinic, Stockholm, reviews the clinical outcome of 30 patients, from nine Swedish clinics, who have received an Episealer® Knee implant during the years 2012 – 2017. The mean follow-up time is 55 months. 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.
“This is the third clinical study from which we see clinical results. To date, only one of them have been published, but as previously communicated, we are expecting plenty of activity from this field during 2020. We are very happy to hear about the positive results from this independent study. The results are in line with the strong data presented from an ongoing European multicentre study, and further, confirms the results we get reported from individual surgeons who follow their patients. It takes time to get long term results and we have now come to a time point when these anticipated results can be presented, and hopefully, soon published”, 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.
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 21.45 CET on 8 March 2020.