Askel Healthcare has reached an important milestone towards marketing authorization of the COPLA® implant in EU and the USA

23 Mar 2023
www.prnewswire.com
Clinical Study
Finnish medical technology company Askel Healthcare is developing a new method to treat knee cartilage defects. Askel Healthcare's COPLA® implant is expected to significantly accelerate rehabilitation and enable healing of damaged knee cartilage. From the beginning of January, COPLA® implant is available for selected patients as part of a clinical trial. Three Finnish and one Estonian hospital are participating in the trial. The company is aiming to commercialize the product in the United States and EU by 2028.
HELSINKI, Finland, March 23, 2023 /PRNewswire/ -- Knee pain is very common. It is estimated that every fourth 40-year-old person suffers from knee pain. The most common cause of knee pain is osteoarthritis, which is typically caused by untreated knee cartilage damage. Cartilage does not have the capacity to repair itself and so far, there is no treatment available that enables fast rehabilitation and that can reliably repair the damaged joint surface. Globally the number of patients suffering from knee osteoarthritis is over 650 million, and the number has doubled in the last 30 years.
Since 2017, Askel Healthcare has been developing a biodegradable implant for surgical treatment of cartilage damage in the knee. In the clinical trial that started in the beginning of 2023, patients with knee cartilage defects are for the first time treated with Askel's COPLA® implant. Askel's goal is to commercialize the implant in the US and EU by 2028 and prior to that gain the needed regulatory approvals, i.e., the CE-mark in EU and clearance by the United States Food and Drug Administration (FDA).
The COPLA® implant enables immediate full weight-bearing after surgery, which is expected to accelerate the rehabilitation process and enable cartilage healing. The ongoing clinical trial evaluates the effectiveness and safety of the implant. Three Finnish and one Estonian hospital are participating in the study. The participating hospitals are Mehiläinen, Terveystalo, Hospital Nova of Central Finland, and Tartu University Hospital in Estonia. The Swedish Sahlgrenska University Hospital in Mölndal is also involved in planning and analyzing the results.
"We want to significantly simplify and speed up the rehabilitation of patients with knee cartilage defects and help them return to a pain free and active life. I am very pleased to see how well the COPLA® implant has been received by both orthopedic surgeons and patients. The journey from idea to a commercial product for a highest risk class medical device, such as COPLA®, is long. Reaching this clinical phase is also an very important milestone for our financing and it impacts our next funding round taking place in the spring. For the first time we are able to help people suffering from knee pain – this has been our main goal from the very beginning," said
Virpi Muhonen, PhD, Founder and CEO of Askel Healthcare. Muhonen is one of the inventors of the COPLA® implant, whose scientific career in the crosstalk of cell biology and orthopedics led to the development of the implant and founding of Askel.
"The history of cartilage repair comprises from many chapters. Recently one of the most common methods have been the Autologous Matrix-Induced Chondrogenesis (AMIC) where a collagen membrane is glued onto the damaged area in combination with microfracturing. The COPLA® implant is in principle used similarly. The benefit of the COPLA® implant compared to other existing products is in its structure, which makes it possible to apply several layers of implants and then put immediate full weight on the treated joint. This speeds up patient recovery following the treatment. I look forward to the findings of these clinical trials," said
Mikko Kirjavainen, MD, an orthopedic and traumatology surgeon at Sports Mehiläinen.
"The cartilage damage and related knee pain made my favorite hobbies, basketball and running, impossible. I hope that the cartilage implant allows me to get back to activities that involve running and jumping. The cartilage implant surgery went as planned, and the rehabilitation is off to a great start. My goal is to get back to the basketball court in the upcoming fall," said
Aki Salo, who is one of the patients participating in the trial and who had a knee surgery in February 2023 at Mehiläinen.
Additional information:
Askel Healthcare, CEO Virpi Muhonen
Tel. +358 40 489 3840
Mehiläinen Plc, MD
Mikko Kirjavainen, orthopedic and traumatology surgeon, Chief Physician at sports Mehiläinen
Tel. +358 40 077 0699
Askel Healthcare is a Finnish medical technology company set to transform surgical knee cartilage treatment and recovery. Our mission is to keep people in motion through our universal COPLA® implant, which is a ground-breaking innovation for the repair of knee cartilage defects.
Mehiläinen Group is a well-known and highly valued private provider of social and healthcare services, offering comprehensive high-quality services in Finland and internationally. 113-year-old Mehiläinen is a rapidly developing and growing leader in the industry. Mezilamines invests in the possibilities of digitalisation and the effectiveness and quality of care in all its business areas.
Mehiläinen serves 2.1 million customers annually, and services are produced at over 820 locations by more than 33,000 employees and private practitioners. Internationally, Mehiläinen provides healthcare services in Sweden, Germany, and Estonia, as well as digital healthcare software solutions through its subsidiary BeeHealthy.
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