- Approximately KRW 86 million (60%) cost savings vs. conventional skin grafting; KRW 28.5 million (20%) vs. Negative Pressure Wound Therapy (NPWT)
- Three-year longitudinal Real-World Evidence (RWE) from leading hospitals across six countries
- Broad indication validation across diabetic foot ulcers, burns, and skin cancer; zero amputation cases recorded

ROKIT Healthcare (KOSDAQ: 376900), a specialized AI hyper-personalized organ regeneration platform company, has announced landmark outcomes from its AI-driven, 3D bioprinting-based regenerative medicine platform deployed in real-world global clinical settings. Treating patients with refractory diabetic foot ulcers (DFU), burns, skin cancer, and traumatic wounds, the platform achieved a 94.9% regeneration success rate with an average treatment duration of just 7.7 weeks, marking a new paradigm in the regenerative medicine market.

These results carry particular significance as they are not derived from short-term clinical trials or controlled laboratory settings, but from three-year longitudinal Real-World Evidence (RWE), validating both the safety and commercialization potential of the technology.

According to the comprehensive analysis published in ROKIT Healthcare's Skin/Wound RWE White Paper, 94.9% of patients with refractory chronic skin wounds treated via the company's 3D bioprinting customized patch platform achieved successful healing within 12 weeks. The average healing time of just 7.7 weeks demonstrates a dramatically accelerated recovery compared to conventional treatment methods.

Furthermore, a UK cost-effectiveness model designed in accordance with NICE methodology — based on the RWE cases — confirmed that ROKIT Healthcare's AI skin regeneration platform delivers substantial cost savings: approximately KRW 86 million (60%) compared to conventional skin grafting, and approximately KRW 28.5 million (20%) compared to Negative Pressure Wound Therapy (NPWT).

The White Paper also highlights representative cases from medical institutions across six countries, including advanced healthcare markets such as the United States and Japan, further underscoring the platform's global versatility. At Nishi-Tokushukai Hospital in Tokyo, Japan, a 60-year-old female patient with a diabetic foot ulcer achieved complete healing within five weeks. At the Virginia Vascular Institute in the United States, a 65-year-old male patient with a diabetic foot ulcer received a "Healed" determination after just eight weeks.

The Egyptian Air Force Specialized Hospital recorded complete healing within five weeks, while a severe burn patient at a Turkish medical institution achieved successful skin regeneration in nine weeks. These results demonstrate consistent therapeutic efficacy regardless of country, ethnicity, or wound type — including diabetic foot ulcers, burns, and traumatic injuries.

■ Preventing Amputation and Dramatically Reducing Medical Costs — A Powerful Catalyst for Global Commercialization

Diabetic foot ulcers, when left untreated or inadequately managed, can progress to bone exposure and necrosis, ultimately necessitating amputation — a life-threatening complication. According to global health statistics, the five-year mortality rate following lower-limb amputation due to diabetic foot disease reaches 50%.

Conventional skin grafting requires harvesting healthy skin from another area of the patient's body, causing donor-site morbidity. In contrast, ROKIT Healthcare's platform provides a robust biological support environment using only a minimal amount of autologous tissue, enabling full preservation of the patient's foot — with zero amputation cases recorded throughout the entire long-term follow-up period.

Market and investment experts project that ROKIT Healthcare's three-year RWE longitudinal data will serve as a key catalyst and critical momentum driver for future global market expansion. The meaningful reduction in healing time (average 7.7 weeks) and zero amputation rate not only improve patients' quality of life but also hold significant potential to dramatically reduce the chronic disease healthcare cost burden faced by governments and insurers worldwide.

Ji Seong-mo, President of the Skin Regeneration Division, stated: "These long-term follow-up results prove that our technology is a solution that genuinely protects patients' lives and bodies in real-world global clinical settings. Building on these overwhelming commercialization metrics that have already been validated, we will accelerate rapid market penetration into key countries worldwide and firmly establish a new global 'New Standard of Care' for chronic wound treatment."