[Hinews] On October 16, Rokit Healthcare (376900), a South Korean biomedical company, announced that its AI-driven autologous tissue regeneration therapy for diabetic foot ulcers has been officially approved for reimbursement by public insurance at a major U.S. tertiary hospital outpatient department (HOPD). This marks the first time an AI-based regenerative treatment has been recognized within the U.S. public insurance framework, specifically under the Current Procedural Terminology (CPT) code system.

Rokit’s diabetic foot treatment, which leverages AI to personalize tissue regeneration, achieves an average regeneration success rate of 82% with a single procedure. Compared to traditional treatments such as amputation or chronic wound care, this approach reduces treatment costs to approximately one-quarter of conventional methods. With an estimated 1.6 million diabetic foot patients annually in the United States, this technology promises significant cost savings for the healthcare system.

Rokit Healthcare CI (Photo provided by Rokit Healthcare)
Rokit Healthcare CI (Photo provided by Rokit Healthcare)


The insurance approval is expected to accelerate Rokit’s market entry into regions with high insurance barriers, including the Middle East and Europe, following its success in South America. Health authorities in these regions are likely to evaluate the economic and clinical benefits of autologous tissue regeneration therapy based on the U.S. precedent.

Looking ahead, Rokit Healthcare plans to sequentially commercialize its AI-powered hyper-personalized organ regeneration platform for skin, cartilage, and kidney applications across the U.S., Europe, and Middle East markets. This insurance milestone is seen as a pivotal step toward transforming the medical economics of regenerative medicine.
“This is the first instance of AI-driven regenerative medicine being integrated into the U.S. public insurance system,” said Seok-Hwan You, CEO of Rokit Healthcare. “We anticipate this will accelerate global insurance approvals and usher in a new era of personalized treatment through our hyper-personalized regeneration platform.”

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