Askel Healthcare Ltd is pleased to announce that the COPLA® cartilage repair device has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). COPLA® device is intended to treat cartilage defects and to restore the function of the joint with patients with knee articular cartilage and bone defects requiring surgery.
There is an immense global unmet medical need for cartilage damage treatment that quickly restores the quality of life and mobility of patients. Successful cartilage repair has the potential to prevent further joint degradation and osteoarthritis – and, ultimately, to prevent the need for highly invasive total joint replacement operations far too soon in the patient’s life.
COPLA® is a unique way to treat joint surfaces for quick return to pain-free movement with a simple and affordable one-step surgery. COPLA® is designed to endure physiological loading after implantation, i.e., the patients are allowed to use the operated limb immediately after the surgery.
Dr. Virpi Muhonen, CEO and co-founder of Askel Healthcare, said: “We are thrilled about this recognition from the FDA. COPLA® is based on more than a decade of multidisciplinary research in the field of orthopaedics, cell biology and material science, and now our vision for the improvement of cartilage damage patient care has been recognized by the FDA. We are dedicated to bringing this much needed solution to the benefit of patients worldwide.”
“COPLA® is an exciting new product for early surgical cartilage damage treatment. It is designed to allow, for the first time, a straight-forward post-operative rehabilitation program that is convenient to the patients while enabling quick rehabilitation to physical activity. We are enthusiastically looking forward to start the clinical trial of COPLA®,” said Dr. Teemu Paatela, Director of Orthopaedics and Traumatology at Terveystalo, the largest private healthcare provider in Finland.
Askel Healthcare’s COPLA® will be introduced to first human patients in 2022, when the company starts their clinical development path with the first-in-man trial across Scandinavia. “Being part of COPLA®’s development path from the initial idea though academic research and building a MedTech start-up has been extremely rewarding. However, having this recognition and support from the FDA to bring this amazing device to everyday patient care, makes the dream of helping patient with this debilitation condition a step closer for reality,” Muhonen emphasizes.
The program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment, and review. The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA’s experts and receive feedback from the FDA. Manufacturers can also expect prioritized review of their submission.
Askel Healthcare is a Finnish privately held medical device company founded in 2017. Askel develops unique solutions for rebuilding knee joint surfaces to quickly return to pain-free and active lifestyle.
COPLA® is currently under development and not available for clinical use.
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SOURCE Askel Healthcare Ltd