A big “step” for Askel Healthcare who was granted FDA Breakthrough Device Designation for COPLA®

We are very pleased to learn that our Finnish start-up client Askel Healthcare Ltd was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for their COPLA® cartilage repair device.

Askel Healthcare is a Finnish privately-held medical device company founded in 2017. Askel Healthcare develops unique solutions for rebuilding knee joint surfaces for patients to quickly return to pain-free and active lifestyle.

The COPLA® device is intended to treat cartilage defects and restore the function of the joints of patients with knee articular cartilage and bone defects requiring surgery.

About the FDA’s Breakthrough Devices Program

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, while preserving the statutory standards for marketing authorisation, consistent with the FDA’s mission to protect and promote public health.

The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.

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 prioritised review of their submission.

First Criterion: The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions

Second Criterion: The device also meets at least one of the following:

a. Represents Breakthrough Technology

b. No Approved or Cleared Alternatives Exist

c. Offers Significant Advantages over Existing Approved or Cleared Alternatives

d. Device Availability is in the Best Interest of Patients

The European equivalent: PRIME

In Europe, the European Medicines Agency, EMA, has an equivalent program called PRIME, although this program is not intended for medical devices but for medicines.

PRIME is a scheme launched by the EMA to enhance support for the development of medicines that target an unmet medical need. It covers medicines containing chemically, biologically, or biotechnologically derived substances and advanced therapy medicinal products (ATMPs).

This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines in order for them to optimise development plans and speed up evaluation so these medicines can reach patients earlier.

Through PRIME, the EMA offers early and proactive support to medicine developers in optimising the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicines applications. Medicine developers may also request fee waivers for scientific advice.

This will help patients benefit as early as possible from therapies that may significantly improve their quality of life.

More about COPLA®

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, 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, meaning that patients are allowed to use the operated limb immediately after surgery.

Dr. Virpi Muhonen, CEO and co-founder of Askel Healthcare, says: “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 starting the clinical trial of COPLA®,” says Dr. Teemu Paatela, Director of Orthopaedics and Traumatology at Terveystalo, the largest private healthcare provider in Finland.

COPLA® is currently under development and not available for clinical use.

It will be introduced to the first human patients in 2022 when the company starts their clinical development path with the first-in-man trial across Scandinavia. Dr. Muhonen continues: “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 to reality.”

Although COPLA® is designed for human use, it also offers a solution for dogs and horses suffering from cartilage-tissue related health problems. A research study of surgical treatment of shoulder cartilage lesions in dogs using the COPLA® is ongoing at the Veterinary Teaching Hospital of University of Helsinki. In the study, the benefit of using the COPLA® in cartilage repair surgery is compared with the conventional cleaning procedure.

*Step = Askel (in Finnish)

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SOURCE: Askel Healthcare Ltd