- A shift from “amputation-centered treatment” to “regeneration-centered care”
- Laying the foundation for national health insurance reimbursement following domestic clinical validation
- A new therapeutic alternative for approximately 17,000 diabetic foot patients in Korea

ROKIT Healthcare (KOSDAQ 376900, CEO Seokhwan You), a leader in AI-driven hyper-personalized organ regeneration platforms, has received approval from the National Evidence-based Healthcare Collaborating Agency (NECA) to initiate clinical trials for its AI-powered regenerative therapy for diabetic foot ulcers.

With this approval, ROKIT Healthcare’s innovative medical technology—“3D bioprinting-based wound treatment using autologous micronized adipose tissue”—becomes the first AI bioprinting-based innovative medical procedure to be applied in Korean clinical settings.

A company representative stated, “ROKIT Healthcare’s diabetic foot regeneration platform has demonstrated safety through clinical trials in five countries, and 82% of patients showed regeneration with just a single treatment. As the technology is already covered by public insurance systems in the U.S. and Latin America, we expect positive outcomes in Korea as well.”

This technology targets patients with chronic diabetic foot ulcers unresponsive to conventional treatment. Using an AI-based bioprinter, a personalized autologous adipose-derived regenerative patch is implanted directly into the wound to protect tissue and promote regeneration—representing an advanced, AI-guided hyper-personalized organ regeneration therapy.

A key advantage is its efficiency: the entire procedure is completed in a single operating room within a short timeframe, without requiring hospitalization, offering substantial time and economic benefits for both patients and clinicians.

According to the Health Insurance Review & Assessment Service, approximately 17,000 diabetic foot patients were treated in Korea last year, and about 1,000 individuals undergo lower-limb amputation annually. Studies indicate that nearly 50% of amputees die within five years.

Once diabetic foot ulcers progress, amputation has historically been the only remaining option. Therefore, if this cutting-edge technology becomes a standard of care, it is expected to provide a meaningful alternative for limb preservation among diabetic foot patients.

A company representative noted, “The introduction of a regenerative therapy for diabetic foot represents a symbolic shift from the traditional amputation-centered paradigm to one focused on restoring tissue and vasculature.” The spokesperson added, “By shortening the prolonged healing period that often leads to retirement, long-term care, and depression, we expect this therapy to significantly reduce the medical and social welfare burden associated with repeated hospitalizations, complication management, and extended rehabilitation.”

They concluded, “The initiation of domestic clinical trials marks the beginning of formal evaluation and recognition of a technology already actively used in overseas clinical settings. We will devote our full efforts to shifting the long-held assumption that amputation is inevitable for diabetic foot patients—toward a future of regeneration without amputation, and to building strong medical evidence to support national health insurance coverage.”

▲ Photos of the actual treatment process using ROKIT Healthcare’s AI-driven diabetic foot regeneration platform