- Clinical verification conducted even during wartime, proving robustness of remote-support technology
- Expected expansion into regenerative treatments for diabetic foot ulcers and burns

ROKIT Healthcare (KOSDAQ 376900, CEO Seokhwan You), an AI hyper-personalized organ regeneration platform company, has received approval for the final pilot study required for reimbursement entry from Clalit Fund, Israel’s largest national health insurance provider.

Based on its existing EU Medical Device Regulation (EU-MDR) certification, the company successfully passed Israel’s regulatory review and has now entered the final stage to evaluate reimbursement cost structures and treatment efficiency. Following the pilot study, national insurance coverage across Israel is expected to accelerate.

ROKIT Healthcare has previously demonstrated the safety and effectiveness of its technology through collaboration with Sheba Medical Center, the largest medical institution in the Middle East. The company donated the world’s first AI-driven organ regeneration bioprinter to Sheba Medical Center, which has since been used to achieve strong clinical outcomes in treating burns, wounds, and diabetic foot ulcers.

In particular, the company’s AI remote-support system proved its stability even under wartime conditions, underscoring the value of its “crisis-responsive organ regeneration platform.”

The upcoming pilot study will be conducted at several major Israeli hospitals, including Sheba Medical Center, Meir Medical Center, Beilinson Medical Center, and Soroka Medical Center.

Israel presents significant market potential. According to the International Diabetes Federation (IDF), approximately 10% of Israeli adults have diabetes, totaling around 530,000 patients.

A ROKIT Healthcare representative stated, “Approval from the Clalit Fund is a major milestone toward national insurance adoption. It is especially meaningful as it confirms the safety and efficiency of our technology even in wartime conditions,” adding, “This achievement will accelerate our expansion into the global organ regeneration market.”