Final Approval from Asan Medical Center IRB; Challenging "Zero Immunological Rejection" via Patient's Autologous Omentum-Derived Cell-Based Technology

Approximately 63% Kidney Function Regeneration Rate Achieved in Preclinical Trials with Harvard Medical School and Seoul National University

Overwhelming Efficacy Confirmed with a Roughly 70% Reduction in Kidney Fibrosis

Offering a "Life Without Dialysis" to 800 Million Chronic Kidney Disease Patients Worldwide, Planning to Cultivate South Korea as a Global Hub for Kidney Regeneration

ROKIT Healthcare (KOSDAQ 376900, CEO You Seok-hwan), an AI-driven hyper-personalized organ regeneration platform specialist, has achieved another critical milestone in the field of advanced regenerative medicine. Having obtained final approval from the Institutional Review Board (IRB) for Advanced Regenerative Medicine at Asan Medical Center, the company will officially commence the world's first human clinical surgery for kidney regeneration starting this month.

Following the approval of the advanced regenerative medicine research plan by the Ministry of Health and Welfare in late May, Asan Medical Center and ROKIT Healthcare have completed all regulatory procedures. Accordingly, autologous omentum-derived cell-based kidney regeneration surgeries will be performed on 10 patients with chronic kidney disease starting this month. The core technology applied in this surgery has already completed patent registrations in the United States, Japan, and South Korea.

This clinical trial holds immense significance as it goes beyond simple safety evaluations to directly verify the potential for kidney function recovery and tissue regeneration for the first time in the world. Because it utilizes the patient's own tissue, immunological rejection can be fundamentally blocked. Furthermore, an ultra-gap convergent technology is applied to precisely implant customized regenerative patches by combining an AI-based 3D bioprinter with state-of-the-art robotic surgery.

In particular, considering Asan Medical Center's cumulative experience of 8,000 kidney transplants and the world-class preclinical results from Harvard and Seoul National University, analysts suggest that the probability of success for this kidney regeneration clinical trial has significantly heightened.

ROKIT Healthcare’s kidney regeneration platform has already demonstrated its regenerative efficacy through preclinical trials conducted with researchers from Harvard Medical School and Seoul National University. According to the preclinical results, the kidney function regeneration rate reached approximately 63%, and a performance of about 70% reduction in kidney fibrosis was achieved. Additionally, microvascular density increased by about threefold, renal vascular resistance decreased by about 20%, and the kidney structure preservation rate was maintained at approximately 90%. These data transcend the limitations of conventional treatments focused on dialysis or transplantation, presenting a new paradigm of fundamental kidney regeneration.

An official from ROKIT Healthcare explained, "We plan to pursue rapid approval for advanced regenerative treatment as soon as this clinical trial is completed. Through this, we will not only provide a 'life without dialysis' to 800 million chronic kidney disease patients worldwide who are suffering from conventional dialysis and transplantation, but also fully activate a blue ocean strategy to cultivate South Korea into a 'global advanced regenerative medicine hub for kidney regeneration.'"