- Based on 4-year clinical white paper, official regulatory consultations planned with the FDA and major global agencies in collaboration with Prof. Lattermann of Harvard Medical School, President of ICRS
- High data credibility secured through objective, precision medical analysis by leading domestic and international cartilage regeneration specialists

▲ Biopsy Tissue Microscopic Observation Images

ROKIT Healthcare (KOSDAQ: 376900), a specialist in AI-driven personalized organ regeneration platforms, has publicly disclosed the 4-year long-term follow-up clinical outcomes of its AI-based 3D bioprinting cartilage regeneration platform.

Going beyond a conventional 4-year medical analysis, these results demonstrate the regeneration of true Hyaline-like Cartilage through biopsy tissue analysis, and the company is now moving toward global commercialization following objective validation by leading domestic and international institutions.

4-Year Long-Term Follow-Up Biopsy Confirms True Hyaline Cartilage Regeneration

Conventional treatments using stem cells or cartilage injections have well-known limitations — over time, regenerated tissue tends to be fibrocartilage, which is prone to degeneration and wear. However, longitudinal clinical research conducted on patients who underwent cartilage regeneration surgery at Assiut University Hospital in Egypt four years ago confirmed that the tissue regenerated in patients treated with the ROKIT Healthcare platform was not simple scar tissue, but true hyaline cartilage — identical to normal cartilage — as revealed by precision medical analysis and 4-year biopsy specimens.

Histological analysis (Safranin O positivity, Type II Collagen expression) and evaluation of degenerative markers (MMP-3, MMP-9), conducted under special biopsy research approval, confirmed that four years post-surgery, true hyaline cartilage regeneration, structural stability, and an established anabolic microenvironment for self-maintenance were all present.

Data Credibility Maximized Through Objective Precision Medical Analysis by World-Leading Cartilage Regeneration Specialists

The most significant differentiator of this 4-year long-term clinical dataset is the high level of credibility achieved through independent, third-party objective analysis conducted by top university hospital faculty in the field of cartilage regeneration in Korea.

In a previous media interview, Prof. Jang Jong-beom of the Department of Orthopedic Surgery at Seoul National University Bundang Hospital stated: "Hyaline cartilage regeneration has been an unsolved challenge that countless medical scientists have failed to overcome. ROKIT Healthcare's AI cartilage regeneration platform is a groundbreaking technology capable of regenerating cartilage that closely resembles true hyaline cartilage, solving the fundamental problem that has eluded the field until now."

Prof. Ryu Dong-jin of the Department of Orthopedic Surgery at Inha University Hospital also emphasized: "In a clinical environment where direct tissue biopsy of regenerated cartilage is extremely difficult, the confirmation of hyaline cartilage — not fibrocartilage — regenerated to a thickness of 2mm or more is clinically highly valuable and represents an unparalleled body of evidence."

MRI-based cartilage assessment scores (MOCART 2.0), independently evaluated by a third-party institution, showed continuous improvement from an average of 70 at Year 1 to 82.86 at Year 4. The WOMAC pain index dropped sharply from 10.00 (severe pain) pre-surgery to 1.71 (near pain-free) at 4 years post-surgery (p=0.0006), and the KOOS composite score improved significantly from 48.38 pre-surgery to 80.34 at Year 4 (p=0.0038).

In conclusion, the regenerated cartilage has engrafted and integrated with the surrounding normal cartilage as true hyaline cartilage, and patients continue to maintain a pain-free, normal quality of life four years after the procedure.

Consultations with ICRS President Underway… Official Regulatory Discussions with U.S. and Major Countries' Approval Agencies to Begin

ROKIT Healthcare announced that, based on the official clinical white paper consolidating the 4-year long-term clinical data, the company plans to initiate formal regulatory consultation procedures with approval agencies in the United States and key global markets, in close collaboration with Prof. Lattermann of Harvard Medical School — a world-renowned authority and President of the International Cartilage Regeneration Society (ICRS).