Maintains 80.3% of normal kidney function at 4 weeks post-attachment of the AI hyper-personalized kidney regeneration patch.
Confirms functional regeneration of the kidney through 'direct GFR measurement technology' established with Harvard Medical School.
Achieves 80.3% functional recovery compared to normal in an extreme 5/6 nephrectomy injury model leaving only 1/6 of the kidney.
Maximizes expectations for successful human clinical trials and delayed dialysis in patients with moderate renal failure, considering human-minipig physiological similarities.

ROKIT Healthcare (KOSDAQ 376900, CEO You Seok-hwan), an AI hyper-personalized organ regeneration platform enterprise, has successfully demonstrated the "substantial functional regeneration" of its kidney regeneration patch through quantitative figures in large animal clinical trials.

Until now, the greatest challenge in preclinical studies of chronic kidney disease (CKD) has been the difficulty of directly and repeatedly measuring transcutaneous GFR (tGFR) on an hourly basis in animal models.

The existing indirect estimate based on blood creatinine (eGFR) has a so-called 'creatinine blind spot,' where it appears normal even when kidney function is damaged by 50% or more, limiting the precise verification of actual kidney functional regeneration and dynamic changes.

Through collaboration with Professor Joseph V. Bonventre's research team at Harvard Medical School, ROKIT Healthcare tackled this challenge head-on by establishing a chronological 'kidney tGFR measurement technology' for the first time in Korea using a domestic mini-pig model.

This holds significant meaning as it evaluates changes in kidney function with quantitative figures beyond simple histological improvement, by directly administering a specific contrast agent to precisely track the actual filtration rate of the kidney per minute.

■ Functional numerical recovery to 80.3% of normal function in just 4 weeks in an extreme injury model leaving only 16.7% of the kidney

Currently approved renal failure treatments or dialysis therapies only slow down the decline of residual kidney function or maintain the status quo, and there has been no treatment to fundamentally restore irreversibly damaged kidney function.

ROKIT Healthcare's research team developed and applied the '5/6 nephrectomy mini-pig model,' which most closely resembles human end-stage renal disease. This is an extremely severe injury research model that removes 83.3% (5/6) of the entire kidney, leaving only 1/6 (16.7%). It is a harsh model where a significant number of large animals typically die within the first week.

Based on the final efficacy dataset analyzed at 4 weeks post-procedure, a higher recovery of kidney function was confirmed in the test group compared to the untreated group.

When the tGFR of the normal control group (G1, Sham), whose kidneys were not resected after laparotomy, was set as the baseline of 100% (1.52 mL/min/kg), the test group (G3) attached with ROKIT Healthcare's AI hyper-personalized kidney regeneration patch after identical 5/6 resection recorded an average glomerular filtration rate of 80.3% (1.22 mL/min/kg).

On the other hand, the untreated control group (G2), which underwent 5/6 resection without any treatment, remained at 61.2% (0.93 mL/min/kg). The G2 group experienced a sharp drop in function, with 40% dying in the first week.

This marks a 31.2% improvement compared to the untreated control group (G2), directly and indirectly suggesting that the AI hyper-personalized kidney regeneration platform suppressed the decline in kidney function after 5/6 nephrectomy and restored severely damaged kidney function back to a normal trajectory.

■ 'Complete Separation' excluding statistical noise and cross-validation between Korea and the US

The most notable indicator in this data is the achievement of 'Complete Separation' between the test and control groups. The lowest tGFR value (1.11) among the individuals in the test group (G3) with the regeneration patch was higher than the highest value (1.04) among the untreated control group (G2).

The data distributions of the two groups were completely separated without a single overlap. The highest responding subject (ID: KF-52) recorded a tGFR of 1.39, reaching 91% of normal kidney function.

These results align perfectly with the preclinical results of the mouse unilateral ureteral obstruction (UUO) model previously conducted with the Harvard Medical School research team, holding great significance as cross-validation has been successfully completed in both small and large animal models in Korea and the US.

According to academic indicators of translational research across species, the kidney's physiological efficacy confirmed in the pig model is maintained at about 90.3% in humans. When applied to patients with severe chronic renal failure (GFR 30-50 range), this leads to the conclusion that there is a very high possibility of a substantial improvement in the glomerular filtration rate by about 30% upon human application.

An increase in a patient's GFR from 30 to 39, 40 to 52, or 50 to 65 scientifically proves that it is possible to reverse and preserve the chronic kidney disease stage itself, preventing lifelong hemodialysis or delaying the initiation of dialysis by at least 4 to 5 years.

A ROKIT Healthcare official stated, "It is highly meaningful in renal failure research that Harvard Medical School and Korean researchers simultaneously proved the functional regeneration of the kidney with quantitative figures through direct GFR measurement technology." The official added, "Securing a strong early signal in large animals of 80.3% recovery compared to normal in just 4 weeks in an extreme model with only 1/6 of the kidney remaining will serve as a crucial milestone. This proves in advance the safety and efficacy of the world's first AI hyper-personalized kidney regeneration human clinical trials currently underway at major medical institutions in Korea."