- Kidney function regenerated in 62.5% of subjects; safety confirmed
- Efficacy of patented technology targeting chronic kidney disease (CKD) treatment validated
- Preclinical trial led by world-renowned nephrologist Professor Joseph V. Bonventre

ROKIT Healthcare (KOSDAQ: 376900), a specialist in AI-driven personalized organ regeneration platforms, has received official validation of the efficacy and safety of its 'AI and Omentum-Based Kidney Regeneration Platform' from researchers at Harvard Medical School, one of the world's most prestigious medical institutions.

The findings offer new hope for approximately 800 million renal failure patients worldwide who have had no fundamental treatment options and have been entirely dependent on dialysis or organ transplantation. The results are particularly significant as they officially validate the efficacy of a patented, proprietary technology poised to disrupt the chronic kidney disease (CKD) treatment market, valued at hundreds of trillions of Korean won.

Harvard Medical School researchers confirmed a groundbreaking reversal of kidney function decline using the glomerular filtration rate (GFR), the key indicator of kidney function. In the experiment, the control group receiving acellular treatment showed complete collapse of kidney function (p=0.0061), while 62.5% of subjects in the ROKIT Healthcare omentum patch transplant group demonstrated regeneration and preservation of kidney function.

The omentum patch group recorded a p-value of 0.3945, providing academic and statistical validation that the decline in kidney function had halted and that preservation and regeneration had occurred. The kidney regeneration technology has already been granted patents in major countries including South Korea, Japan, and the United States, securing exclusive intellectual property rights.

A key advantage of this treatment approach is that immune rejection is fundamentally minimized, as it utilizes the patient's own omentum tissue in combination with AI and 3D bioprinting technology. The Harvard research team officially affirmed an exceptional safety profile, stating that "not a single adverse event or safety issue was observed in connection with the procedures and transplantation processes." This significantly strengthens the prospects for the success of future human clinical trials.

The interim results of this preclinical trial were led directly by Professor Joseph V. Bonventre, the world's foremost authority in nephrology — the first to discover the kidney injury biomarker 'KIM-1,' who also successfully cultured stem cell-based 'mini kidneys' and elucidated the mechanisms of chronic renal failure. The global credibility and impact of the published data are accordingly recognized at the highest international level.

Building on Harvard Medical School's preclinical data and four years of domestically accumulated kidney regeneration data, ROKIT Healthcare plans to accelerate the world's first kidney regeneration pilot clinical trial and advance its pipeline for global commercialization starting in the second half of this year.

The company previously published a paper on the alleviation of kidney fibrosis and safety in South Korea in 2022. In the second half of this year, it plans to complete the world's first domestic pilot clinical surgery targeting patients with stage 3–4 chronic kidney disease (CKD). The company will then pursue large-scale global human clinical trials centered in South Korea and the United States, and accelerate the commercialization of its 'AI-driven autologous organ regeneration medical platform.'

A ROKIT Healthcare spokesperson expressed the company's ambition, stating: "Through this Harvard Medical School validation, we have effectively eliminated the technological risks we have faced and secured biological validity. Using our entry into human clinical trials in the second half of this year as a launchpad, we intend to emerge as the definitive game changer in the next-generation regenerative medicine market."