Before starting human clinical trials, Askel conducted extensive testing to prove the product’s safety. The company is now in the clinical phase. Its first-in-human Pilot Trial, involving 20 patients across three countries, is ongoing and has shown exceptionally strong initial results. The one-year data demonstrates safety in humans, the benefits of early weight-bearing enabled by the implant, and excellent early functional outcomes. The next major step for the company is to initiate the Pivotal Trial (up to 250 patients) required for market authorisations.
There is a tremendous need for better ways to treat cartilage defects, and the COPLA® Cartilage implant has been developed to meet this need. Osteoarthritis is a major global problem, affecting millions of people worldwide. Approximately one third of the general population has cartilage defects in the knee, although not all cause symptoms. Among athletes, the prevalence is even higher: up to 50%. Untreated knee cartilage defects are well-documented as a risk factor for osteoarthritis, the most common degenerative joint disease globally(1-2). As cartilage damage is known to predispose patients to osteoarthritis, it is critically important to find better solutions for early repair.
Today, surgeons lack effective methods to treat cartilage defects optimally, leaving total joint replacement as the final option: often after patients have endured years of pain and reduced mobility. The COPLA® Cartilage implant was developed together with top-tier orthopaedic surgeons to address this gap and provide a solution for early cartilage repair.
Askel has a proprietary, scalable, in-house manufacturing facility capable for global production of the implant. The process uses Askel’s patented technology and the in-house manufacturing ensures implants of the highest quality. The COPLA® Cartilage implant has been granted Breakthrough Device Designation by the FDA. This designation recognises that the implant provides a more effective treatment for irreversibly debilitating conditions than currently available devices. Through the Breakthrough Devices Program, Askel benefits from ongoing interaction and feedback from FDA experts during the development process, significantly reducing regulatory risk.
Askel’s vision is to become the global standard in surgical cartilage repair. The company’s next steps are to complete its clinical programme, achieve EU and US market authorisations, and partner with leading strategic players to bring the COPLA® Cartilage implant to patients worldwide.
1) Uyen-Sa D., et al. Increasing Prevalence of Knee Pain and Symptomatic Knee Osteoarthritis. Ann Intern Med. 2011 Dec 6; 155(11): 725–732.
2) Flanigan D., et al. Prevalence of Chondral Defects in Athletes' Knees: A Systematic Review. Med Sci Sports Exerc. 2010. Oct; 42(10): 1795-801.