More than 650 million people suffer from knee osteoarthritis
One of the main factors causing knee osteoarthritis is untreated knee cartilage defects
The Copla knee cartilage implant repairs cartilage tissue of the injured knee and allows full body weight on the operated leg immediately after surgery and therefore enables faster recovery to a normal active life
A fundraising campaign of Askel Healthcare is planned for this spring
Finnish medical technology company Askel Healthcare (“Askel”) is developing a new method for the treatment of cartilage defects in the knee using its Copla implant. The implant has recently reached the clinical trial stage. As a part of this pilot trial the world’s first Copla implant surgery in humans was conducted in January at Tartu University Hospital.
According to Virpi Muhonen PhD, founder and CEO of Askel Healthcare, three Finnish hospitals are participating in the clinical trials in addition to Tartu University Hospital. The company aims to receive the necessary approvals for marketing in the European Union and the United States by 2028.
"Reaching the stage of clinical trials is an important milestone in our commercialization process. For the first time, we can help people who suffer from knee pain caused by cartilage defects. This has been our main goal since the beginning," she added.
According to Muhonen, Askel Healthcare wants 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. Getting to the clinical trial stage is a huge milestone and also very important for our next fundraising campaign which starts this spring,” she said.
Muhonen is one of the inventors of the Copla implant whose scientific career in orthopedic cell biology led to the development of the implant and founding of Askel Healthcare. 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 at the beginning of this year, 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, receive the required regulatory approvals, i.e., the CE-mark in the EU and clearance by the United States Food and Drug Administration (FDA).
Knee pain is very common. It is estimated that every fourth person over the age of 40 suffers from knee pain. The most common cause of knee pain is osteoarthritis, which is often 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.
The Copla implant allows full weight-bearing on the leg immediately after surgery, which helps to speed up the recovery process and allow the cartilage to heal.
The ongoing clinical trial is evaluating the effectiveness and safety of the implant. Tartu University Hospital is the only Estonian hospital participating in the study. Finnish hospitals Mehiläinen, Terveystalo and Hospital Nova of Central Finland are the participating hospitals from Finland. In addition, the Swedish Sahlgrenska University Hospital in Mölndal is involved in planning and analyzing the results.
Background: The world's first Copla implant surgery
The world's first surgery of a human knee using the innovative Copla implant was performed at the Tartu University Hospital this January.
According to a member of the operation team, Dr. Kaspar Tootsi from Tartu University Hospital’s Orthopaedics Clinic, cartilage is a tissue with a special structure that has a very poor recovery potential. "Usually, a defect remains on the surface of the injured cartilage, which does not heal, or is partially filled with fibrocartilage. To fill the defect, it is possible to use a collagen scaffold with microfracture, which allows the access and nesting of the stem cells in the defect. Copla is an implant belonging to this group."
According to Dr Tootsi, what makes Copla innovative is its special composition and structure, which allows the use of several layers when filling a defect.
"While with other implants the recommended recovery period with crutches is about two months, with Copla, immediate full body weight support is allowed on the operated leg. This creates the conditions for a significantly faster recovery. In the future, the field of use of Copla will certainly be wider, but within the current clinical trial, we are using it for a single cartilage defect in the knee joint, if there are no signs of established osteoarthritis."
About Askel Healthcare
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.