HAII Corporation (HAII Corp.), a leading digital medicine company from South Korea, announces that its speech rehabilitation digital therapeutic, “repeech,” has received Institutional Review Board (IRB) approval for confirmatory clinical trials in the United States from the prestigious Mass General Brigham (MGB). This milestone achieved just 10 months after the initial application in November 2023, represents a significant advance in the development and potential regulatory approval of cutting-edge digital therapeutics.
Revolutionizing Speech Recovery
Developed over the past three years with meticulous research and planning, repeech is designed to support the rehabilitation of speech disorders following a stroke. This development was made possible through a project sponsored by the Korea Health Industry Development Institute (KHIDI) under the “2022 Healthcare Technology R&D project” supported by the Korean government. Each year, approximately 15 million people worldwide suffer from strokes, with 40-50% experiencing speech impairments that require therapeutic intervention.
The IRB approval was secured through the close collaboration between HAII’s research team in South Korea and the MGH Institute of Health Professions (IHP) research team HAII’s team prepared the necessary clinical data, while the MGH IHP team expertly managed the IRB application process, led by distinguished experts Dr. Kathryn Connaghan, Dr. Jordan R. Green, and Dr. Bridget Perry from the Department of Communication Sciences and Disorders.
Jinwoo Kim, CEO of HAII, expressed his appreciation, stating, “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 US and pursuing final FDA clearance. We remain steadfast in our mission to bring South Korean digital therapeutics to the global stage.”
HAII is on track to complete the FDA Q-submission and finalize product enhancements by the latter half of 2024, with plans to initiate clinical trials in the US by 2025.
In addition to the IRB approval in the US, HAII has also secured approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for a multicenter confirmatory clinical trial, granted in early February of this year. This trial, which will be conducted across five clinical sites, will have Ewha Womans University Seoul Hospital as the primary site. The company is poised to begin these trials in the second half of the year.
Through these strategic initiatives, HAII is making substantial strides in the globalization of South Korean digital therapeutics, with further developments eagerly anticipated.
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