A New Paradigm in Fundamental Cartilage Regeneration: Sufficient with a Single Surgery
U.S. Patent Registration Complete; Poised for Developed Market Entry by 2027

ROKIT Healthcare an AI-driven personalized organ regeneration platform specialist, launched its world-first, AI-based global clinical trials for fundamental cartilage regeneration this past September, moving beyond existing treatments that merely offer simple pain relief.

ROKIT Healthcare's cartilage regeneration technology has already been validated for its efficacy and safety through multinational research. Several years ago, a study conducted with researchers from Harvard Medical School confirmed hyaline cartilage regeneration and strength recovery in large animal models, including beagles. In 2021, clinical trials on human patients in Egypt further demonstrated its effectiveness in cartilage regeneration and pain relief.

Starting in September, ROKIT Healthcare initiated this prospective, randomized controlled trial in countries including Korea, the United States, and in South America. The trial will objectively evaluate efficacy and safety by comparing a group receiving microfracture surgery alone against a group receiving microfracture surgery combined with ROKIT's AI cartilage regeneration platform. The evaluation will use multi-level clinical indicators such as MRI imaging (MOCART), histopathological analysis, and gait analysis.

The company's core technology is the world's first convergence regenerative treatment system, integrating AI analysis, autologous cell-based bio-ink technology, and 3D bioprinting to create a patch customized for each patient. This enables the regeneration of actual hyaline cartilage without immune rejection and is evaluated as a fundamental treatment paradigm that surpasses simple pain management.

This regeneration mechanism and bioprinting know-how were granted a patent by the U.S. Patent and Trademark Office (USPTO) this past June. The related AI, bioprinter, and regeneration kits have already completed medical device approvals in the U.S. and South America. European medical device approval is also expected within several months.

Accordingly, commercialization is expected to begin in approximately 10 developing countries in the first half of 2026. The company is targeting full-scale entry into developed markets, including the U.S., Europe, and Japan, starting in the second half of 2027.

Currently, the mainstream treatment for cartilage worldwide consists of injection therapies based on hyaluronic acid, PRP, and cell therapeutics. However, these methods are mostly limited to pain reduction, and their effects are short-lived, requiring repeated procedures. This leads to recurring costs and unavoidable limitations.

In contrast, ROKIT Healthcare's AI cartilage regeneration platform has already demonstrated fundamental cartilage regeneration and sustained strength in animal and human clinical studies, with findings presented at forums such as the American Academy of Orthopaedic Surgeons (AAOS). It is recognized as an innovative solution that overcomes the repetitive and incomplete nature of existing treatments, offering long-term effects with just a single surgery as the only customized regenerative therapy available.

Patients can reduce costs and achieve faster recovery with only one regenerative surgery, minimizing repetitive injections and hospital visits. Socially, this is expected to deliver medical cost savings by reducing unnecessary medical expenditures and shortening rehabilitation periods, benefiting insurance finances and national healthcare policies.

The market growth potential is also clear. According to a report by Mordor Intelligence, the global cartilage regeneration market is projected to grow from approximately USD 1.73 billion (KRW 2.39 trillion) in 2025 to USD 3.28 billion (KRW 4.53 trillion) by 2030, at a compound annual growth rate (CAGR) of 13.7%.

ROKIT Healthcare plans to rapidly lead this multi-billion dollar cartilage disease and regeneration market, driving large-scale revenue from countries worldwide. A ROKIT Healthcare spokesperson added, “ROKIT Healthcare’s cartilage regeneration technology has already been recognized for its safety and efficacy in numerous countries over several years. We are committed to contributing to the improvement of patients' quality of life and leading the global regenerative medicine market.”