Confirmed cartilage regeneration and joint function improvement in a 4-year long-term clinical trial in Egypt... Securing key evidence for European regulatory approval.
Applied for an additional indication for osteoarthritis and knee cartilage defects, with review results expected early next year.
Following successful commercialization in South America, advancing into Europe in Q1 2027... Targeting an $8.04 billion market by 2030.

ROKIT Healthcare (KOSDAQ: 376900, CEO You Seok-hwan), an AI hyper-personalized organ regeneration platform enterprise, is launching its full-scale entry into the European market with its regenerative technology for osteoarthritis cartilage.

To expand its indications into the field of osteoarthritis treatment, ROKIT Healthcare completed the application process last month for a certification amendment to add the 'knee cartilage defects' indication to its AI cartilage regeneration platform, 'Dr. INVIVO AI Regen KIT,' in accordance with the European Medical Device Regulation (CE MDR).

This is a procedure to add the cartilage indication based on the existing CE MDR certification. The review by the notified body is currently underway, and final approval is expected between late December of this year and early next year.

The core medical evidence for this indication expansion is the long-term clinical data of the AI cartilage regeneration platform accumulated over four years. ROKIT Healthcare confirmed significant cartilage regeneration and joint function improvement in a 4-year long-term human follow-up clinical trial conducted in Egypt.

According to the biopsy tissue analysis results, the regeneration and long-term maintenance of hyaline-like cartilage, similar to normal articular cartilage, were observed at the treatment site, and the WOMAC index, which comprehensively evaluates pain and joint function, was also improved. This demonstrates the potential for functional recovery of the damaged cartilage tissue itself, beyond short-term pain relief, and is expected to serve as strong clinical evidence in the European notified body's review.

Europe is ROKIT Healthcare's next strategic foothold. With a rapidly aging population leading to a surge in osteoarthritis patients, it is one of the major markets with a high unmet need for cartilage regeneration medical technology. According to Grand View Research, a global market research firm, the global cartilage repair market is projected to grow at a CAGR of 5.1%, from $5.98 billion in 2024 to $8.04 billion in 2030.

While existing osteoarthritis treatments remain largely confined to symptomatic therapies and replacements such as medication, injections, and joint replacement surgery, ROKIT Healthcare offers a fundamental AI regenerative solution combining AI-based patient-specific design, autologous tissue-derived bioink, and bioprinting.

In particular, the company has already accumulated commercialization experience with its cartilage regeneration kit in the South American market, proving the business viability and safety of the technology. Once this European CE MDR indication expansion is completed, it will establish a global cartilage regeneration business belt spanning from South America to Europe.

Upon approval, ROKIT Healthcare will launch full-scale marketing and sales targeting local medical institutions in Europe starting in the first quarter of 2027. Through this, the strategy is to foster cartilage regeneration as the second global growth axis, moving beyond skin regeneration, and to create new revenue momentum in 2027.

A representative of ROKIT Healthcare stated, "The roadmap leading from securing 4-year long-term clinical data in Egypt to the expansion of the European CE MDR indication and subsequent European commercialization is the process of verifying the clinical and commercial value of our AI organ regeneration platform in the global market. Based on solid clinical evidence, we will push forward with our entry into the European market without setbacks and connect it to substantial revenue growth."