Results from European multicentre study with follow-up of 80 Episealer® patients accepted for publication in Knee Surgery, Sports Traumatology, Arthroscopy (KSSTA)
Episurf Medical (Nasdaq: EPIS B) today announces that a manuscript with the title “Patient specific metal implants for focal chondral and osteochondral lesions in the knee – Excellent clinical results at 2 years” from a European multicentre study with 24 months’ follow-up of 80 Episealer® Knee implant patients has been accepted for publication in the scientific journal Knee Surgery, Sports Traumatology, Arthroscopy (KSSTA). The publication is expected to be available online shortly.
The study reports on the clinical outcomes for 80 patients from 9 clinics in 6 European countries, that have undergone treatment with the individualised Episealer® Knee implant for treatment of isolated focal chondral and osteochondral defects in the knee. The author group, led by Dr. med. Johannes Holz, Park-Klinik Manhagen, OrthoCentrum, Hamburg, Germany, consists of some of the most experienced Episealer® users and most knowledgeable European knee specialists, and they have followed-up their Episealer® patients and pooled their prospectively collected results.
“For us users and Episurf Medical, it is a milestone and great pleasure that our clinical data, as part of our multicentre study, impressively demonstrates the extremely successful and safe application of a new and innovative treatment concept - the Episealer® implant. We would like to take this opportunity to thank all our highly motivated colleagues and the engineers and employees of Episurf Medical for their consistent cooperation and support. We are convinced that the Episealer® implant is a fixture in the treatment of patients who are on a path towards osteoarthritis”, says Dr. med. Johannes Holz.
The authors of the publication have evaluated the clinical outcomes for the patient group using the patient reported outcome measures scoring systems KOOS (Knee injury and Osteoarthritis Outcome Score) and VAS (Visual Analogue Scale). In KOOS all measured subdomains including Pain, Symptoms, Function in daily living, Function in sports and recreation as well as Quality of life, showed significant improvements. Also, the improvement in VAS score exceeded the minimal important difference, and all results remained over time. The authors of the publication conclude that the Episealer® implants provide significant clinical and functional improvement. They also find that the study indicates that there is a definitive place for the Episealer® in the management of cartilage defects in the knee joint.
“It is important with all new devices and innovative treatments that they are properly evaluated. This study provides very important information detailing the results in 80 patients at 2 years minimum follow up. The impact and effectiveness of the Episealer® implant is impressive and I am proud to be part of this study” says Ass. Prof. Tim Spalding, University Hospitals Coventry and Warwickshire NHS Trust, UK, and co-author of the publication.
“It is particularly agreeable that previously reported clinical data in a smaller cohort and with limited number of surgeons, are upheld in this study from a number of surgeons and a number of European markets. The study is among the largest ever reported on these kinds of patients and emphasises the universal character of both problem and solution” says Prof. Leif Ryd, Senior medical advisor, 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 07.40 CEST on 15 September 2020.
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