Brain science-based digital therapeutics (DTx) startup Beltherapeutics announced on the 8th that it has obtained the Good Manufacturing Practice (GMP) certification for medical device manufacturing and quality management standards from the Ministry of Food and Drug Safety.
Image of the digital therapeutic device (DTx) for insomnia being developed by Belt Therapeutics[Photo by Belt Therapeutics]
The MFDS GMP certification is granted to companies that strictly comply with manufacturing processes and quality management standards to ensure the quality of pharmaceuticals and medical devices. Beltherapeutics explained that through this certification, it has proven that its production facilities and management systems meet international standards and norms, allowing it to manufacture software medical devices in accordance with the "Regulations on Medical Device Items and Item-specific Grades."
Beltherapeutics is developing DTx for the treatment of insomnia and cochlear implant hearing rehabilitation using brain science and audio signal processing technology. It provides sound stimulation optimized for the patient's autonomic nervous system to improve insomnia symptoms. Based on this certification, Beltherapeutics plans to initiate clinical trials targeting insomnia patients in South Korea.
Jae-eun Lee, CEO of Beltherapeutics, said, “This GMP certification was one of the key milestones to enter DTx approval clinical trials,” adding, “We will demonstrate new possibilities for digital therapeutics with a mechanism differentiated from existing insomnia DTx.”
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