[Edaily Reporter KIM SAE-MI ] #ROKIT HEALTHCARE Inc. presented the results of preclinical studies on its kidney regeneration patch at the American Society of Nephrology, but the key figures were identical to the interim results released five months ago. While the company emphasized that it had confirmed the potential to protect kidney function in collaboration with researchers from Harvard Medical School, it did not clearly disclose the number of animals used in the experiments or data supporting the therapeutic effects.

According to the biotech industry on the 28th, ROKIT HEALTHCARE Inc. presented the preclinical results of its kidney regeneration patch—developed in collaboration with a research team led by Professor Joseph Von Ventre of Brigham and Women’s Hospital, affiliated with Harvard Medical School—during the corporate presentation program at the American Society of Nephrology (ASN Kidney Week 2026) held in Denver, U.S., on the 23rd (local time).

In this study, kidney damage was induced by blocking the ureter—the urinary tract in mice—and then a regenerative patch made from the omentum, a mesh-like tissue in the abdomen, was implanted. The company stated that in 62.5% of the patch treatment group, the glomerular filtration rate (GFR)—which indicates the kidney’s ability to filter waste products—was maintained or improved.

Different explanations for the same figure… What is the basis for the “62.5%” calculation?

A key point to note in this announcement is how much progress the study has made since the interim results were released last May.

On May 26, ROKIT HEALTHCARE Inc. announced preclinical interim results from a joint study with Harvard, stating that kidney function was maintained or regenerated in 62.5% of the patch-treated group. At this conference, held approximately five months later, the company again presented the same 62.5% figure as a key achievement. While interim results and subsequent analyses may align, whether the same effect was confirmed in additional experiments is a separate matter.

In this presentation, the company also introduced results from kidney tissue analysis and experiments using other animal models. However, it did not specify the scope of the research data added since May or whether the entire study has been completed.

Meanwhile, the explanation for the 62.5% figure has also changed. On September 3, the company announced that the glomerular filtration rate (GFR) of the damaged kidneys was preserved at approximately 62.5%. In contrast, in May and October, it explained that kidney function was maintained or improved in 62.5% of the animals to which the patch was applied. The extent to which kidney function was preserved and the proportion of animals in the total group that showed an effect are different metrics. It is necessary to verify the criteria used to calculate each figure.

The scale of the experiment is also unclear. A securities filing submitted to the U.S. Securities and Exchange Commission (SEC) in June by Rokit America, ROKIT HEALTHCARE Inc.’s U.S. subsidiary, outlined plans to conduct a study involving 78 mice over approximately six months.

However, based solely on the data disclosed in this announcement, it is difficult to determine the actual number of animals used in the analysis or the specific number of mice out of the total from which the 62.5% figure was derived. Nor was it specifically stated how far the originally planned study had progressed.

2% Increase in GFR vs. 26–33% Decrease in Control Group… What Are the Results of the Intergroup Comparison?

The experimental results released by ROKIT HEALTHCARE Inc. demonstrate the potential for protecting kidney function.

According to the company, mice with the kidney regeneration patch showed an average 2% increase in glomerular filtration rate (GFR), while those without the patch experienced a 26–33% decrease. KIM-1, a marker indicating the degree of kidney damage, was also approximately 95% lower in mice with the patch compared to the control group.

Based on these figures alone, the kidney condition of the mice with the patch appeared to be better. However, to determine whether this difference is due to the patch’s effect rather than chance, we need data on the number of mice used in the experiment, individual measurement results, and statistical data directly comparing the two groups.

It is also necessary to examine the statistical data released by the company last May. At that time, the p-value for mice without the patch was 0.0061, while the p-value for mice with the patch was 0.3945. The p-value is a statistic used to determine whether an observed difference could have occurred by chance; generally, a value below 0.05 is considered to indicate a statistically significant difference.

However, if these figures are the result of comparing kidney function in each group before and after the experiment, caution is needed in interpreting them. This is because it could mean that while kidney function deteriorated significantly in the mice without the patch, no significant change was observed in the mice with the patch.

While this suggests the patch may have prevented a decline in kidney function, it does not in itself prove a therapeutic effect. A direct verification is needed to determine whether the difference in changes in kidney function between mice with and without the patch is statistically significant. It is difficult to confirm such a comparison based solely on the currently available data.

$280,000 for Harvard Joint Research… $4,000 Participation Fee for U.S. Conference Presentation

The

joint

research conducted with Harvard Medical School researchers was carried out as a corporate-sponsored study funded by ROKIT HEALTHCARE Inc.

According to the research agreement disclosed to the U.S. SEC, ROKIT HEALTHCARE Inc. and Rokit America entered into a Sponsored Research Agreement with Brigham and Women’s Hospital last March. Under the agreement, the total research grant amounts to $282,939, equivalent to approximately 378 million won.

The principal investigator is Professor Bonventre, a leading authority in the field of kidney disease who previously served as president of the American Society of Nephrology. The agreement also stipulates that the hospital’s research team will conduct and oversee the study.

Corporate-sponsored research is a form of industry-academia collaboration commonly used in the development of new drugs and medical technologies. Therefore, the credibility of the research results cannot be dismissed solely based on the fact that funding was provided. However, when evaluating the research outcomes, the funding relationship must also be taken into account.

In a recent interview published on the YouTube channel “Growth Research,” Professor Bonventre assessed the research results as promising yet unexpected. ROKIT HEALTHCARE Inc. shared the interview video on its official channel on the 27th.

There is also speculation that the presentation at the American Society of Nephrology differed in nature from a typical research abstract presentation.

On the 23rd, ROKIT HEALTHCARE Inc. announced that its Chief Technology Officer (CTO), Inadan, would present the research findings at the American Society of Nephrology’s “Innovation Stage.”

According to the official exhibition guide published by the American Society of Nephrology, the “Innovation Stage” is part of “Innovation Avenue,” a new corporate exhibition program launched this year. For a participation fee of $4,000 (approximately 5.35 million won), the program provides exhibition space, a presentation monitor, and a 20-minute presentation opportunity. Eligible participants include startups and companies that have not exhibited at the conference in the past three years; the conference organizers review applications for eligibility.

Furthermore, a review of the official academic abstracts released by the American Society of Nephrology reveals that Professor Bonventre is listed as a co-author on three studies related to renal safety biomarkers, chronic kidney disease in children, and diabetic kidney disease. ROKIT HEALTHCARE Inc.’s research on the kidney regeneration patch was not included among these. This means that the research achievements introduced by the company and the official academic abstracts in which Professor Bonventre participated as a co-author represent separate presentations.

Edaily requested an explanation from ROKIT HEALTHCARE Inc. regarding the scope of the research, the results of the statistical analysis, and the nature of the presentation at the American Society of Nephrology, but had not received a response as of the time of this article’s publication.