Hi, Mabi Speech Disorder Rehabilitation DTx 'Lipich' Launches Confirmatory Clinical Trial in the US

Digital therapeutics (DTx) specialist Hai recently announced on the 13th that it has signed a contract with the MGH School of Health Professions in Boston, Massachusetts, USA, to conduct a confirmatory clinical trial of Hai's dysarthria speech rehabilitation DTx, 'Repeech,' in the United States.

Hai's digital therapeutic device (DTx) for speech rehabilitation of dysarthria, 'LipiChi' [Photo by Hai]

The clinical trial scheduled for next year will be conducted in two phases, divided into the first and second halves of the year. In phase 1, preparations for the clinical trial in the US, including obtaining Institutional Review Board (IRB) approval, will be completed by the first half of the year. Phase 2 will begin in the second half of 2024, with full-scale clinical trials including patient recruitment.

Hai's Repeech for post-stroke dysarthria rehabilitation was developed after more than three years of planning and research. Globally, 15 million stroke patients occur annually, and 40-50% of them have speech impairments requiring rehabilitation.

Separately from the US clinical trial with MGH, Hai completed the confirmatory clinical trial application to the Korean Ministry of Food and Drug Safety earlier last month. Once the product is commercialized, it is expected to greatly aid speech rehabilitation for the 300,000 to 400,000 dysarthria patients occurring annually in Korea.

Jinwoo Kim, CEO of Hai, said, “We thank MGH and the research team for highly evaluating our product and taking on the clinical trial.” He added, “Repeech has laid the foundation for global expansion this year, and through clinical trials next year and the year after, we aim to obtain US regulatory approval by 2026.”

This content was produced with the assistance of AI translation services.