Led by Co-Founder & CEO Virpi Muhonen, Askel Healthcare is transforming knee cartilage repair with their COPLA® Cartilage Implant. Backed by promising clinical trial results and FDA Breakthrough Device Designation, the company is advancing toward market authorization, aiming to set a new global standard in orthopedic care.

Origin Story

Askel Healthcare’s journey began over a decade ago, driven by a shared vision to revolutionize the treatment of knee cartilage defects. In 2009, a notable Finnish orthopedic surgeon and professor, Ilkka Kiviranta, assembled a multidisciplinary research group with a clear clinical goal: to develop a universal, affordable, and patient-friendly solution for knee cartilage defects that would regenerate cartilage tissue with long-term, clinically sustainable results.

The research project, based at the Universities of Helsinki and Tampere in Finland, brought together experts in orthopedic surgery, tissue engineering, cell biology, and materials science. Among this pioneering group were Dr. Virpi Muhonen, an expert in orthopedic cell biology, and Dr. Anne-Marie Haaparanta, a specialist in biomaterials for medical applications. Both would go on to become the co-founders of Askel Healthcare.

Reflecting on the origins of the company, Co-Founder & CEO, Virpi Muhonen explains, "We were part of this incredible team that was focused not just on academic research, but on creating something that could truly make a difference in patients' lives. After years of rigorous research, the idea for our COPLA® cartilage implant emerged, and we knew it had the potential to help millions suffering from knee pain."

"We took COPLA from an academic innovation to a clinical-stage product," Muhonen recalls. "Our goal was to create a solution that not only addressed the clinical challenges of cartilage lesions but also provided a practical, scalable treatment that could improve the quality of life for patients globally."

Since its inception, the product concept behind COPLA® has led to four scientific publications and one Ph.D. thesis, solidifying its foundation in both research and clinical application. Today, Askel Healthcare is in the clinical phase, with the first patients already benefiting.

The Current Landscape

Cartilage lesions, especially in the knee, present a significant clinical challenge. These injuries, if left untreated, often lead to the progressive development of osteoarthritis—a debilitating degenerative joint disease that severely impacts a patient’s quality of life. The current standard of care for treating these lesions is fraught with limitations, often failing to deliver the long-term outcomes that patients need.

"Unfortunately, all these first-line surgical treatments have poor long-term outcomes," explains Muhonen. "Patients who suffer a traumatic knee injury, often undergo procedures like microfracturing, cartilage grafting, or simple cleaning of the damaged area, but these solutions are not enough. They provide temporary relief, but the underlying issue remains unresolved."

In the United States alone, approximately 750,000 knee cartilage repair operations are performed annually. Most of these—around 600,000—are first-line treatments such as microfracturing and cleaning procedures. Despite the high volume of surgeries, the outcomes are often disappointing. Patients are frequently left with persistent pain, limited mobility, and a significant risk of requiring additional surgeries down the line.

“If these cartilage lesions are not treated effectively, they inevitably worsen, leading to osteoarthritis," Muhonen continues. "The problem is that current treatments do not regenerate the damaged cartilage effectively. They might provide some short-term relief, but eventually, these patients face the possibility of a total knee replacement."

The market is crowded with various surgical techniques and products, yet many of these solutions fall short, particularly when it comes to long-term success. "There are cell therapies available, but they are expensive and require multiple operations. Allografts are another option, but they are limited by the availability of donor materials," Muhonen notes. "And while total knee arthroplasty is an option, it’s not ideal for younger patients who are still active and not ready for such a drastic measure."

"Our focus is on making the whole category of surgery better," says Muhonen. "We aim to provide a solution that offers real, sustainable results for patients who deserve to get back to the activities they love without the constant fear of recurring pain or further surgeries."

Inside the Innovation

Askel Healthcare’s innovative solution, the COPLA® Cartilage Implant, is designed to address the fundamental issues that plague current treatment options, offering a more effective and patient-friendly alternative for cartilage repair.

"The COPLA Cartilage Implant is made of biodegradable polymers, creating a three-dimensional environment that allows cartilage tissue to heal," explains Muhonen. "What sets COPLA apart is its ability to enable immediate weight-bearing post-surgery. Patients can move freely without any weight-bearing restrictions, which is not only convenient but crucial for the healing process."

The innovation behind COPLA lies in its ability to harness the body's natural mechanisms for cartilage regeneration. "Mechanical loading is the key signal for cartilage to regenerate," Muhonen continues. "Without this, the body produces scar tissue instead of healthy cartilage. COPLA creates the perfect environment for this mechanical loading to occur, ensuring that the new cartilage tissue is of high quality, leading to better long-term results."

COPLA is also designed with simplicity in mind, making it an attractive option for surgeons. "It's incredibly easy to use," Muhonen notes. "The implant can be cut to size with surgical scissors and delivered either arthroscopically or through open surgery. We’ve made sure that it integrates seamlessly into existing surgical procedures, which helps in reducing operation time and complexity."

Progress and Milestones

Askel Healthcare has made impressive progress in the development and clinical testing of the COPLA® Cartilage Implant. "Our focus has always been on building a solution that addresses the unmet needs in cartilage repair, and the results we’re seeing now validate our approach,” says Muhonen.

In June 2024, Askel Healthcare presented the results from their first-in-human Pilot Clinical Trial at the 9th Joint Preservation Congress in Warsaw. The trial, which involved the initial ten patients, successfully met its primary safety endpoint with no implant-related complications. 

The trial also provided promising preliminary efficacy data. All patients were able to achieve full, unrestricted weight-bearing immediately after surgery—an achievement that sets COPLA apart from other treatments. By six months, significant improvements in knee function and pain levels were observed, with patients reporting high satisfaction and a marked improvement in their quality of life.

"The early results are incredibly promising," Muhonen noted. "By week six, patients are taking almost 9,000 steps, a significant improvement compared to other methods where patients are typically just beginning to take their first crutch-free steps. This early mechanical loading is crucial for cartilage regeneration and long-term success."

In parallel with their clinical advancements, Askel Healthcare has also strengthened its intellectual property portfolio. The company was recently granted its first patent for the COPLA® technology, validated as a Unitary Patent covering 17 EU countries, with additional protection extended to key markets including the UK, Spain, and Switzerland.

Looking ahead, Askel Healthcare plans to start a pivotal trial for market authorization next year, with the goal of securing FDA clearance by 2030. The company is also in the process of raising a €20 million Series A round, supported by up to €10 million equity option from the EIC Fund.

Market Insights

Askel’s solution is much needed. The number of patients requiring cartilage defect repair is expected to exceed the growth of the elderly (65+ years old) demographic, which has been the historical demographic primarily undergoing in need for cartilage defect repair. LSI’s Global Surgical Procedure Volumes database projects that knee arthroscopies are projected to increase at a CAGR of 4.6%, from an estimated 3.9 million procedures in 2023 to approximately 4.9 million procedures in 2028. Knee arthroscopy volumes will grow in excess of the 65+ population as adults under the age of 65 are expected to drive procedure growth and market demand. 

According to LSI’s Market Analysis and Projections (MAP) database, the global orthobiologics market was valued at $6.1 billion in 2023. As knee arthroscopy volumes are one of the primary leading indicators for market growth, LSI projects that the orthobiologics market will increase at a CAGR of 3.1% from 2023 to 2028. 

Orthobiologics, like Askel’s COPLA implant, represent a vital solution, particularly for adults under the age of 65 who are not ideal candidates for the far more invasive knee replacement procedure. 

Join Us At LSI Europe ‘24

Virpi Muhonen has been selected to present at LSI Europe ‘24 this September 16th-20th in front of hundreds of global medical technology companies. Join us in welcoming Virpi to the event in Sintra, Portugal where she will share the latest updates on Askel Healthcare’s technology and development.