Rokit Healthcare, a long-term regenerative medicine platform company, recently announced that changes in advanced regenerative medicine policies in the U.S. are expected to increase its effective target market by approximately eight times.
Industry sources reported on Monday that the American Medical Association (AMA) has officially designated the entire regenerative medicine process as a medical procedure code in its recent update of the Current Procedural Terminology (CPT) Category III Codes. AMA CPT codes are used to record medical services, surgeries, and tests performed by hospitals or healthcare providers for health insurance claims and administrative processing.
The new specific codes include 1044T-1049T (harvesting and application of autologous heterologous skin structures) and 1030T-1035T (patient-specific digital 3D models, digital simulations, and computational analysis).
These changes are expected to boost the local application of Rokit Healthcare’s core technologies, including artificial intelligence (AI) image analysis, digital simulation, 3D bioprinting, and patient-customized skin and cartilage regeneration scaffold implantation.
The introduction of codes related to 3D printing and skin regeneration procedures, effective from July 1, has established a medical and legal basis for expanding insurance claims for regenerative medicine in the U.S. This expansion now covers skin cancer regeneration, breast cancer reconstruction, and severe chronic wounds, broadening the scope beyond diabetic foot skin regeneration.
Previously, Rokit Healthcare’s primary target in the U.S. was approximately 1.5 million patients with severe diabetic foot ulcers (DFUs). Following this policy change, the total effective market for skin regeneration, including severe chronic wounds and skin cancer reconstruction eligible for Medicare and other insurance coverage, is projected to surge to 11.95 million – an eightfold increase.
Furthermore, the upcoming code for acellular scaffold implantation for knee cartilage defects, set to take effect next January, aligns with Rokit Healthcare’s AI-driven cartilage regeneration technology. If the FDA’s Expanded Access Program (EAP) for cartilage regeneration is successfully completed as planned in the second half of this year, it will pave the way for swift insurance code linkage and claims in the U.S.
A Rokit Healthcare spokesperson stated that the establishment of these AMA CPT codes and the shift in U.S. policy represent a significant milestone in recognizing AI and 3D bioprinting-integrated regenerative technologies as official medical procedures. They emphasized their commitment to advancing commercialization through collaboration with leading global institutions and capturing a significant share of the multi-billion-dollar U.S. regenerative medicine market.
In related news, Rokit Healthcare plans to invest approximately 15 billion KRW (about 10.1 million USD) in research, development, and clinical expansion this year. Last month, they also appointed Dr. Inadan, a renowned researcher from a world-class institution, as their new Chief Technology Officer.