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Sep 7, 2024

The Memo: ArthroSave Revolutionizing Joint-Preserving Treatment of End-Stage Knee Osteoarthritis

Newsletter - ArthoSave

Under the direction of Co-Founder and CEO Karianne Lindenhovius, ArthroSave is revolutionizing the treatment of end-stage knee osteoarthritis with its joint-preserving solution. The company’s mission is to improve painful osteoarthritic joints, allowing patients to return to an active way of life. ArthroSave is able to regenerate painful joints and preserve the original knee joint, postponing a knee prosthesis to a later age and preventing complex and expensive revision surgery later in life. This results in reduced healthcare costs and improved patient quality of life.

Origin Story

ArthroSave was born from an unexpected discovery during Lindenhovius’ Co-Founder’s medical practice. Lindenhovius recalls, “While treating a patient who required ankle joint distraction for medically necessary reasons, my Co-Founder, Peter van Roermund, noticed something remarkable: the patient, who coincidentally also suffered from osteoarthritis and a very painful ankle joint, experienced significant pain relief and regained mobility following the procedure.” At that time, he realized that joint distraction could potentially encourage repair in arthritic joints.

Years later, a pivotal moment occurred when a policeman with knee osteoarthritis entered van Roermund’s practice. Lindenhovius explained, “The patient knew they needed a knee prosthesis, but doing so would end the patient’s active duty and confine him to office work.” Drawing from his earlier success with ankle joints, van Roermund proposed applying the same distraction technique to the knee. Lindenhovius said, “They decided to try it, recognizing that it was a low-risk surgery that could potentially eliminate or postpone the need for a prosthesis—and it was successful. So that’s how the first patient started.”

ArthroSave was founded in 2016 and is based in the Netherlands. Lindenhovius further explained, “We are based in Culemborg, a small city close to the academic medical center in Utrecht. We are a spin-off company from the academic university medical center.”

The Current Landscape

The current standard of care for severe knee osteoarthritis is knee replacement. Although this approach is generally effective in relieving pain and restoring function, it is not universally successful. Approximately 20% of patients report ongoing pain or dissatisfaction with their treatment. Furthermore, knee replacement is an invasive surgery with recovery time, and the implant will eventually wear out, particularly in younger, more active patients.

Lindenhovius explained, “When you are 65 years old, it’s okay to have a knee prosthesis because you will survive the lifetime of the prosthesis. But when you get it too young, you do survive it and need to have a complex and expensive revision surgery later in life, which is less effective and often results in invalidation.”

Inside the Innovation

ArthroSave’s flagship product, KneeReviver, offers a unique approach focusing on joint preservation and soft tissue regeneration rather than joint replacement. Lindenhovius remarked, “We all know osteoarthritis is a progressive disease. It always gets worse. But we can turn that situation around by stopping the degeneration and starting the regeneration of the knee joints—and that’s very special and unique. With the KneeReviver, we will postpone knee replacement surgery for ten more years.”

The KneeReviver is a bilateral device composed of two purpose-built fixators on either side of the knee, fixed with eight standard half-pins. Lindenhovius explains, “The pins are placed extra-articular, meaning they don’t interfere with the knee joints, which is very important because every interference you create risks future damage. Another advantage is that the KneeReviver is a temporary six-week treatment without leaving any implants behind, and after that, your knee starts to regenerate.”

Lindenhovius emphasized the significance of this breakthrough innovation, stating, “No one has ever thought about cartilage to repair, and that’s what we do. Everyone wants to understand the mechanism of action behind that. So far, animal studies have shown that biomarkers reflecting joint degradation do decrease, while biomarkers related to joint regeneration do increase. We know that during joint distraction, an intermittent fluid pressure oscillation is stimulated in the joint, and that allows for the nutrition of the cartilage; however, we don’t yet know the exact mechanism of action. Because the clinical benefit is so big, we can already start selling without knowing the exact working principles.”

A prospective two-year follow-up study of the KneeReviver showed significant clinical and structural improvement over two years. The total Western Ontario and McMaster University Osteoarthritis Index showed a clinically relevant improvement at one and two years (+26 and +24 points, respectively). Additionally, the minimum radiographic joint space width improved over one and two years (+0.5 mm and +0.4 mm, respectively), as did the physical Short-Forn 36 (+10 points). Before treatment, 42% of patients used pain medication. Two years post-treatment, only 23% of patients used pain medication.

Lindenhovius adds, “Long-term data is showing that the knee prosthesis can be postponed for nine years in 48% of the cases, where there is no obvious total WOMAC difference between survivors and failures. We conclude that the initial joint space width that can be seen on the X-ray and is created with joint distraction is predictive of long-term success. MRI analyses are showing that knee joint distraction provides cartilage repair, showing a structural benefit still after ten years.”

Progress and Milestones

ArthroSave is making significant strides toward commercializing its flagship product. In the last several years, ArthroSave finalized the first KneeReviver clinical trial with promising clinical results, obtained a CE marking, and successfully operated on patients on a small scale.

In 2023, ArthroSave raised €2.6M to enable the company to perform additional clinical trials, accelerate its commercial strategy, and introduce the KneeReviver to the international orthopedic market.

Lindenhovius stated, “Earlier this year, we started a 1,200-patient randomized control trial in the Netherlands to get the KneeReviver reimbursed. That is a huge achievement and will continue for the coming one to two years.”

Looking ahead, ArthroSave looks to increase its presence in European markets and expand to the US. Lindenhovius added, “Currently, we are preparing an FDA approval, and we are working to fund this next exciting stage for the company.”

Market Insights

Knee replacements, or knee arthroplasties, are the most common orthopedic procedure performed each year. According to LSI’s Global Surgical Procedure Volumes database, approximately 3.8 million knee arthroplasties were performed in 2023. Of these, approximately 80% of procedures are total knee replacements, a major orthopedic procedure becoming more common in younger adults. The challenge with treating adults under the age of 65+ is that the lifespan of current knee implants is 15 to 20 years. 

Due to current limitations in knee replacement surgical techniques and materials, approximately 375,000 knee revision surgeries were performed in 2023. These procedures are projected to increase at a CAGR of 6.2%, reaching an estimated 506,000 procedures by 2028. 

Join Us At LSI Europe ‘24

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