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Finnish medical technology company Askel Healthcare has announced that it aims to commercialise its COPLA implant, developed to treat knee cartilage defects, in the US, as well as the European Union (EU) by 2028.
The implant is being used to treat selected patients in a clinical trial that commenced in January.
The ongoing clinical study has been designed to assess the effectiveness and safety of the implant.
The Finnish hospitals of Mehiläinen, Terveystalo and Hospital Nova of Central Finland, as well as Tartu University Hospital in Estonia, are taking part in the trial.
Additionally, the Swedish Sahlgrenska University Hospital in Mölndal is engaged in planning and analysing the trial data.
After receiving the CE mark in the EU and clearance from the Food and Drug Administration (FDA) in the US, Askel intends to commercialise the implant in both regions.
The COPLA implant is anticipated to significantly boost rehabilitation while enabling the healing of damaged knee cartilage.
According to the company, the COPLA implant facilitates full weight-bearing after surgery.
Askel Healthcare founder and CEO Virpi Muhonen said: “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 orthopaedic surgeons and patients. The journey from idea to a commercial product for a highest risk class medical device, such as COPLA, is long.”
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- Source: https://www.medicaldevice-network.com/news/askel-commercialise-copla-implant-us/
