- Establishes clinical network with 11 major hospitals, including Seoul National University Bundang Hospital
- Aims for commercialization and market settlement by H2 2026
- Shifting paradigm from ‘Amputation’ to ‘Regeneration’... Expected to improve national medical financial efficiency

ROKIT Healthcare (376900, CEO Seokhwan You), a company specializing in AI-driven hyper-personalized organ regeneration platforms, is accelerating its entry into the domestic market with its ‘AI-driven Diabetic Foot Regeneration Platform.’

ROKIT Healthcare has established a clinical network with 11 top-tier medical institutions nationwide, including Seoul National University Bundang Hospital, and will begin full-scale clinical trials for AI-driven diabetic foot regeneration starting this month. Through this project, the company plans to complete clinical trials by the first half of 2026 and aims to achieve commercialization and large-scale revenue in the domestic market starting in the second half of the same year.

Key medical staff from the plastic surgery and orthopedic departments of 11 major hub hospitals, including SNU Bundang Hospital, will participate in these clinical trials. The effectiveness and expertise of the trials have been maximized through the composition of a multidisciplinary medical team.

In particular, ROKIT Healthcare will utilize the ‘Innovative Medical Technology’ track for the rapid commercialization of its latest organ regeneration technology. The goal is to obtain a ‘temporary code (temporary reimbursement)’ immediately after completing clinical trials in the first half of 2026 and introduce the technology to hospitals starting in the second half of that year. Through this, the company plans to rapidly expand diabetic foot regeneration treatment using the 11 participating hospitals as hubs.

ROKIT Healthcare’s AI-driven diabetic foot regeneration technology is an advanced medical solution combining AI, bioprinting, and autologous bio-inks. The AI analyzes the patient’s wound data, and a 3D printer prints bio-ink using the patient’s own tissue to be applied to the affected area.

This technology has already proven its successful regeneration effects through thousands of clinical cases in global markets, including the U.S., Europe, South America, and the Middle East. This domestic clinical trial aims to transplant this successful global model into the Korean medical system, offering near-complete regenerative treatment with ‘a single procedure’ to thousands of patients at risk of diabetic foot amputation every year.

Due to the nature of chronic diseases, diabetic foot ulcers impose a significant burden on both patients and medical staff due to repeated hospital visits, long-term treatment, and high recurrence rates. ROKIT Healthcare’s platform is expected to drastically shorten the treatment period, thereby improving patients’ quality of life, and enhance the efficiency of national medical finances by reducing expensive chronic treatment costs and surgery fees.

An official from ROKIT Healthcare stated, “We are very pleased to be able to fully apply our AI-driven organ regeneration platform, which has already been verified worldwide, to domestic patients.” They added, “Based on the network of 11 hub hospitals nationwide, we will enhance the completeness of clinical trials to achieve medical innovation that realizes both hospital operational efficiency and patient happiness.”