- Two-track strategy combining AI organ regeneration surgery and organ-enhancing injections aims to reshape regenerative medicine
- Company targets the fast-growing global AI chronic pain and organ function improvement market

ROKIT Healthcare (KOSDAQ: 376900), a leader in AI-driven hyper-personalized organ regeneration, announced that it will launch AI-FRESH (Activated Fibrin-based tissue REgeneration System for Healing) on the 21st. AI-FRESH is a next-generation activated fibrin tissue regeneration platform developed to complement the company’s AI-based organ regeneration surgical solutions across skin, cartilage, kidney, and heart indications.

By integrating AI-FRESH with its existing AI surgical regeneration platform, ROKIT Healthcare establishes a dual-track portfolio of “AI organ regeneration + organ function enhancement.” This combined approach is positioned to reinforce the company’s leadership as a global first mover and comprehensive solutions provider in regenerative medicine.

AI-FRESH operates by collecting a patient’s own blood, separating and activating key components, and using AI-based imaging and clinical data to precisely identify areas associated with pain or functional decline. The activated solution is then injected around damaged tissue to promote both pain relief and tissue remodeling.

A ROKIT Healthcare spokesperson stated, “AI-FRESH is an end-to-end AI platform encompassing diagnosis, processing, injection, and follow-up care. Because blood composition, inflammation patterns, and tissue status differ greatly among individuals, AI-FRESH enables true hyper-personalization—this is its core differentiator.”

Initial indications include diabetic foot ulcers and partial rotator cuff tears with chronic pain. When used alongside the company’s AI surgical regeneration platform, AI-FRESH is expected to significantly shorten pre- and postoperative recovery periods.

Beginning next year, ROKIT Healthcare plans to expand indications across orthopedics, dermatology, and plastic surgery, including:
- Knee osteoarthritis
- Sports injuries such as tennis elbow and Achilles tendinitis
- Facial scar and skin regeneration
- Adjunctive treatment for hair loss

Given the size of the domestic and global markets for diabetic foot and other chronic conditions, AI-FRESH is expected to support strong commercial growth. Its ability to be administered repeatedly, combined with minimal invasiveness and relatively low treatment cost, enhances accessibility for patients. The platform also addresses the growing unmet needs driven by population aging and chronic pain prevalence worldwide.

Following the Korea launch, the company plans to seek regulatory approvals first in markets with more flexible pathways, such as Latin America and the Middle East. ROKIT Healthcare will then proceed with CE-MDR submission in Europe and FDA clearance in the United States, pursuing a coordinated global rollout starting next year.

The spokesperson added, “Regenerative medicine has traditionally focused on reconstructing organs through surgery. AI-FRESH introduces an adjunct platform that integrates surgery with injections, allowing patients to recover more quickly, more naturally, and at lower cost. With this addition, ROKIT Healthcare is establishing itself as the only company offering an AI-powered, end-to-end solution for both organ regeneration and pain/function management.”