Shift in US advanced regenerative medicine policy: AI image analysis and 3D bioprinting increasingly adopted into official coding system
Expansion from diabetic foot ulcers to 'total skin regeneration'… targeting skin cancer, breast cancer reconstruction, and chronic wounds
US serviceable obtainable market (SOM) projected to surge approximately 8-fold from 1.5 million to 11.95 million patients

ROKIT Healthcare (KOSDAQ 376900, CEO Suk Hwan You), an AI-driven hyper-personalized organ regeneration platform company, announced that the American Medical Association (AMA) has recently updated its 'CPT (Current Procedural Terminology) Category III Codes.' This update establishes the entire lifecycle of advanced regenerative medicine as official medical procedure codes in the US, signaling a significant shift in local regulatory and policy frameworks.

Consequently, the US market adoption of ROKIT Healthcare’s pioneering technologies—encompassing AI image analysis, digital simulation, 3D bioprinting, and patient-specific skin and cartilage regeneration scaffold transplantation—is expected to gain substantial momentum.

The newly introduced codes specifically include: 1044T-1049T (harvesting and application of autologous/heterologous skin constructs), 1030T-1035T (patient-specific digital 3D modeling, digital simulation, and computational analysis), and 0559T-0562T (anatomical 3D printing models and surgical guides).

With the codes for 3D printing-related nasal/skin regeneration and the harvesting/transplantation of autologous/heterologous skin constructs having taken effect on the 1st of this month, a medical and legal foundation has been established. This allows the scope of regenerative medicine insurance claims in the US to expand beyond existing diabetic foot ulcer (DFU) treatment to the broader field of total skin reconstruction and regeneration, including skin cancer reconstruction, breast cancer reconstruction, and severe chronic wounds.

Previously, ROKIT Healthcare’s primary target in the US was severe diabetic foot ulcer (DFU) patients, numbering approximately 1.5 million. However, driven by these US policy changes—including the new CPT code listings—the total skin regeneration Serviceable Obtainable Market (SOM) eligible for Medicare and public/private insurance coverage is projected to skyrocket to 11.95 million patients, an approximate 8.0-fold increase. This expanded market encompasses 7 million severe chronic wound patients, 3.3 million severe skin cancer reconstruction patients, and 150,000 severe breast cancer reconstruction patients. Furthermore, this provides an objective basis to request additional medical device reimbursements for advanced AI modeling and bioprinting, which are currently not included in the US diabetic foot ulcer regeneration insurance fee schedule.

In tandem with this, the code for 'acellular scaffold transplantation for knee cartilage defects,' scheduled to take effect in January next year, aligns precisely with the core indication of ROKIT Healthcare’s leading AI cartilage regeneration technology. If ROKIT Healthcare successfully completes the FDA Early Feasibility Study (EFS) / Expedited Access Pathway (EAP) process for cartilage regeneration—slated for submission in the second half of this year—it will be highly significant as the foundation to swiftly link and claim insurance codes is already preemptively established in the US. The total number of arthritis patients requiring cartilage regeneration in the US is estimated to be approximately 32 million.

This expansion of CPT codes allows US hospitals to officially record clinical, diagnostic, and treatment costs utilizing ROKIT Healthcare’s AI organ regeneration platform, building a solid foothold for full-scale medical insurance reimbursement in the future.

An official from ROKIT Healthcare stated, "This shift in US policy, including the creation of the new AMA CPT codes, is a major milestone demonstrating that organ regeneration technology merging AI and 3D bioprinting is being recognized as an official procedure in the US medical field. We will proceed with commercialization procedures without hitch through close cooperation with the world's leading authoritative institutions, and effectively pre-occupy the multi-billion dollar US organ regeneration market."