HAII Corporation’s “Repeech” Gains U.S. Approval for Key Clinical Trials

South Korea’s Digital Health Innovation Advances Toward Global Expansion

HAII Corporation, a South Korean digital health company, has obtained approval to conduct clinical trials in the United States for its speech rehabilitation digital therapeutic, “repeech.” This approval comes from the Institutional Review Board (IRB) at Mass General Brigham (MGB), a leading medical institution in the U.S. The approval process, which began in November 2023, took ten months to complete and marks a crucial step toward U.S. regulatory clearance for “repeech.”

Focused Research and Development

The “repeech” therapeutic has been developed over the past three years, specifically designed to aid speech recovery in stroke patients. This project was supported by the Korea Health Industry Development Institute (KHIDI) as part of the 2022 Healthcare Technology R&D initiative. With millions of people suffering from strokes annually and nearly half experiencing speech issues, “repeech” aims to offer an effective solution for rehabilitation.

International Collaboration

The IRB approval was secured through the collaborative efforts of HAII’s research team in South Korea and experts from the MGH Institute of Health Professions (IHP) in the U.S. The team, which includes Dr. Kathryn Connaghan, Dr. Jordan R. Green, and Dr. Bridget Perry, played a key role in preparing clinical data and managing the approval process. Jinwoo Kim, CEO of HAII, expressed gratitude for the support from the MGH IHP team and emphasized the importance of this achievement in advancing their clinical trials in the U.S.

“This process was both challenging and rewarding. I extend my sincere thanks to Dr. Green and the MGH IHP team for their trust in our innovation and their dedication to securing this critical approval. With this milestone, HAII is fully committed to advancing clinical trials in the U.S. and pursuing final FDA clearance. We remain steadfast in our mission to bring South Korean digital therapeutics to the global stage,” he said. 

HAII plans to complete the FDA Q-submission and product updates by the end of 2024, with U.S. clinical trials expected to start in 2025. Additionally, HAII has received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) to conduct a multicenter clinical trial across five locations, including Ewha Womans University Seoul Hospital. These trials are set to begin in the second half of the year.

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