ROKIT HEALTHCARE, a pioneering biotech firm specializing in advanced organ regeneration, proudly announces a significant milestone. In July 2023, the company obtained the coveted certification under the European Medical Device Regulation (CEMDR) for its revolutionary “Dr. Invivo AI Regen Platform.” This certification underscores ROKIT’s commitment to advancing medical technology and patient care.
The “Dr. Invivo AI Regen Platform” marks a leap in organ regeneration and medical device innovation, fusing artificial intelligence (AI) with bioprinting. This groundbreaking approach delivers exceptional outcomes without immune responses in a short timeframe, revolutionizing organ regeneration.
Central to the platform is cutting-edge AI technology identifying affected areas, translating data into bioprinting code files. Using the patient’s own fat tissues, the kit generates a specialized regeneration-patch for transplantation. This treatment targets chronic wounds like diabetic foot ulcers (DFU), redefining skin regeneration. Dedication to diabetes foot treatment led to trials across nations, backed by recognized SCI-level journal publications.
With approvals from global medical authorities, including the U.S. FDA and the South Korean Ministry of Food and Drug Safety (MFDS), the “Dr. Invivo AI Regen Platform” gained worldwide recognition. Exported to 10 countries, including the U.S., recent CEMDR certification paves the way for ROKIT HEALTHCARE’s expansion into advanced markets.
CEMDR’s significance lies in stringent standards for medical device sales in Europe, replacing the European Medical Device Directive (MDDCE). Certified devices can be marketed in 31 countries, including the European Economic Community (EEA) and European Union (EU). Europe leads regenerative medicine with 10% annual growth.
SeokHwan You, CEO of ROKIT HEALTHCARE, states, “This certification propels us globally, extending advanced medical solutions.” A regenerative medicine leader, the company advances AI-driven regenerative medicine and bioprinting.
Established in 2012, ROKIT HEALTHCARE, a Born2Global Centre member, pioneers AI and bioprinting-based regenerative medicine. Collaborating with Seoul National University Hospital (SNUH) and Asan Hospital, it addresses chronic renal failure.
