- U.S. License-Out Agreement for ‘AI Kidney’ finalized.
- Predicts 5-year kidney function using a single drop of blood.
- Aims for 5% market share of the 35.5 million U.S. chronic kidney disease patients.
- Full-stack ‘Diagnosis + Regeneration’ model to be completed by next year.

ROKIT Healthcare (KOSDAQ: 376900), a specialist in AI-driven hyper-personalized organ regeneration platforms, announced on the 17th that it has completed U.S. certification and signed a commercial license-out agreement for ‘AI Kidney,’ its proprietary AI-driven kidney disease prediction solution. The platform is scheduled for a formal commercial launch in the United States next month.

Industry experts view this move as a successful fusion of ROKIT Healthcare’s AI-driven organ regeneration platform with global diagnostic prediction capabilities, signaling that the company’s AI-driven organ diagnosis and regeneration business has entered a profitable phase. Furthermore, the deal is drawing significant attention within the AI diagnostics industry for securing a highly favorable revenue structure that goes beyond a simple technology export.

■ ‘18% Royalty’: Securing a Powerful and Stable Cash Cow

The centerpiece of this agreement is the exceptionally high 18% royalty rate. This is considered an unprecedented condition in the biotech and medical device industries, where royalty rates typically remain in the single digits.

Under the terms of the deal, ROKIT Healthcare will earn approximately $38 (50,000 KRW) in royalties per user. According to the U.S. Centers for Disease Control and Prevention (CDC), there are approximately 35.5 million chronic kidney disease (CKD) patients in the United States. ROKIT Healthcare’s immediate goal is to capture 5% of this market. This structure is expected to generate hundreds of millions of dollars in high-value revenue, serving as a robust future growth engine for the company.

Additionally, both parties plan to leverage the U.S.-certified AI-driven kidney prediction platform to expand their business globally, targeting the 700 million chronic kidney disease patients worldwide, including those in South Korea.

■ World’s First ‘5-Year Prediction’ Solution: Expected to Prevent 15% of New Dialysis Cases Annually

‘AI Kidney’ represents a paradigm shift toward ‘AI Predictive Medicine’ rather than simple diagnostics. This project was driven through certification and strategic collaboration with 20/20 Biolabs, a firm led by alumni of the world-renowned Johns Hopkins University. The solution is expected to prevent a significant portion of new kidney dialysis cases in the U.S., aligning with the objectives of the MAHA (Make America Healthy Again) policy.

The platform maximizes patient convenience by requiring only a single drop of blood. Using advanced AI algorithms, it predicts trends in kidney function and estimated Glomerular Filtration Rate (eGFR) over the next five years with high accuracy. Based on these 5-year projections, patients can manage and improve personal lifestyle factors—such as diet, blood pressure, and obesity—to prevent the decline of kidney function or the need for dialysis.

■ “Beyond Diagnosis to Regeneration”: Strategy to Maximize Enterprise Value

ROKIT Healthcare plans to integrate the vast medical data secured through this solution into its flagship AI Kidney Regeneration Platform.

By next year, the company intends to complete its ‘Full-Stack Kidney Management Model,’ which will immediately connect high-risk patients identified by AI predictive data to regenerative therapy solutions. This strategy aims to preemptively capture the global chronic kidney disease market of 700 million people by establishing a unique end-to-end system spanning diagnosis, prediction, and treatment.

“This license-out agreement proves that our AI technology is a global standard and a true game-changer,” said an official from ROKIT Healthcare. “Using the U.S. market as a springboard, we will shift the global paradigm of kidney disease from ‘post-treatment’ to ‘proactive prediction and prevention.’”