Wibrain Selected as Electronic Medicine R&D Institution by Ministry of Health and Welfare
Image of Wibrain's home-use electronic medicine for depression 'MindSteam' (Photo by Wibrain)
View original image[Asia Economy Reporter Chunhee Lee] Electronic medicine company Ybrain announced on the 14th that it was recently selected as a research and development institution for electronic medicine technology development in the first round of the 2022 Health and Medical Technology R&D Project, announced by the Ministry of Health and Welfare.
The selected projects are the demonstration support field project, "Clinical Field Demonstration Study of Transcranial Direct Current Stimulation (tDCS) for Patients with Depression," and the clinical trial support field project, "Multicenter Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of Transcranial Direct Current Stimulator Devices for Patients with Mild Cognitive Impairment (MCI)." With this selection, Ybrain plans to carry out these two projects until 2024 and receive approximately 2.7 billion KRW in funding.
The depression demonstration project aims to secure real-world data (RWD) from home-based treatment using Ybrain's depression electronic medicine "Mindsteem," which was approved by the Ministry of Food and Drug Safety last year, and derive real-world evidence (RWE) to pass new medical technology evaluations and lay the foundation for future reimbursement. Over a total of three years, treatment data from depression patients visiting hospitals for actual treatment will be collected to establish a foundation for advancing personalized treatment.
Mindsteem showed a remission rate of 62.8% in depressive symptoms when applied alone for 30 minutes daily over six weeks, based on multicenter clinical results conducted at six university hospitals in Korea in 2020. Considering that the remission rate of existing antidepressants was about 50%, this indicates a higher symptom improvement effect.
Yonsei University Yongin Severance Hospital participates as the lead research and development institution in the depression demonstration project. Additionally, five domestic hospitals, including Catholic Kwandong University International St. Mary's Hospital, Hallym University Chuncheon Sacred Heart Hospital, National Health Insurance Ilsan Hospital, and Myongji Hospital, collaborate as joint research and development institutions.
The clinical trial support project for MCI confirmatory trials is being conducted together with Korea University Anam Hospital, Incheon St. Mary's Hospital, and Cheonan Soonchunhyang Hospital. Through this, MCI will be added to the approval electronic medicine pipeline.
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Lee Gi-won, CEO of Ybrain, said, "Recently, government agencies have been actively introducing various projects to foster the domestic electronic medicine industry, so the outlook for the domestic electronic medicine industry is promising," and added, "Ybrain will continue to cooperate with government agencies to ensure that our active participation positively influences the electronic medicine industry."
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