Episurf Medical (Nasdaq: EPIS B) today presents a clinical update comprising an overview of the most important European clinical trials that are ongoing for the Episealer® knee implant technology.
European multi-centre study of the Episealer® knee implant
A study with the title “Investigation of an Individualised Mini-metal Implant for Focal Cartilage Lesions in the Knee”, led by MD J. Holz at OrthoCentrum in Hamburg, follows 100 patients from nine clinics in six countries. The study is fully enrolled and 70% of the patients have passed 24 months post-surgery. Interim results for this first group are scheduled to be submitted for scientific publication in early 2020. Scientific abstracts have been accepted for presentation at several national and international clinical congresses. The results show significant improvements in clinical scores across all subdomains, and the revision rate is at a very low level. These results were recently presented at ESSKA Speciality Days in Madrid.
[KOOS data presented at ESSKA Speciality Days in Madrid]
Swedish multi-centre study, 2-years’ follow-up
A study with MD PhD A. Stålman, Capio Artro Clinic and Karolinska Institute, Stockholm, as lead investigator, is focusing on patient-reported outcome scores (KOOS and VAS). 22 patients have been subject to the 2-years follow-up and the clinical results are expected to be submitted for scientific publication in early 2020.
Swedish multi-centre study, longer term follow-up
A study with MD PhD A. Stålman as lead investigator, studying longer term follow-up (5-7 years) of the 10 first patients treated with an Episealer® implant, is ongoing. The focus is on patient-reported outcome scores (KOOS and VAS). In addition, standing X-rays will be performed in order to investigate the progression of osteoarthritis. Most of the patients have currently been examined, with final examinations to be performed shortly, and the clinical results are expected to be submitted for scientific publication in 2020.
Implant survival data
As part of Episurf Medical’s post market surveillance, Episurf is collecting data on device revision. The data will serve as a basis for cumulative revision rate analysis. A report is expected to be submitted for scientific publication during the first half of 2020.
Health economics
Ass. Prof. Lars Bernfort at Linköping University, Sweden, has developed a health economic model focusing on cost utility analysis of the Episealer®, which is used as the foundation for a health economic study. That study will be concluded once one or several of the studies above have been published and more Episealer® clinical data is available.
Comparative joint kinematic study
A comparative investigator-initiated clinical study is currently performed by Dr. Ing. P. Moewis at the Julius Wolff Institute, Charité University Hospital, Berlin. The study has the title “X-ray fluoroscopic analysis of knee joint kinematic in open and closed chain activities in patients with Episealer® Knee Implants”. 10 patients that have undergone an Episealer® procedure are followed-up and the joint mobility of the treated knee is assessed and compared with already available data from 10 healthy, non-treated knees as well as with 10 knees that have undergone total knee arthroplasty (total knee replacement). 80% of the Episealer® patients in the study have undergone examination and the remaining patients will be examined in early 2020, and clinical results are expected to be submitted for publication shortly thereafter.
EPIC-Knee: Episealer® Knee System IDE Clinical Study
A prospective, randomised, controlled, multi-centre study to evaluate the safety and effectiveness of the Episealer® knee technology compared to microfracture for the treatment of focal knee chondral or osteochondral lesions is being conducted in the US and in Europe. 180 patients will be recruited with a 2:1 randomisation of Episealer® vs microfracture. Eight European sites will participate in the study. These sites are situated in Germany, the UK and in Denmark.
“For several years, we have seen studies evaluating devices within the emerging orthopaedic segment of small implants being published. Based on the results from the European multi-centre Episealer® study, we are convinced that ongoing studies will show the strength and utility of our technology. If we can demonstrate strong clinical results, combined with fast rehab and high implant survival rates, we have met our original hypothesis that the combination of a pre-operative planning tool, individualised surgical instruments and a HA and Ti coated individualised implant delivers excellent results. This clinical pipeline is very interesting, with several important milestones in the near future” says Pål Ryfors, CEO Episurf Medical.
