SuperBrain DEX, a device for treating mild cognitive impairment developed by domestic digital therapeutics (DTx) corporations ROWAN, has received item approval from the Ministry of Food and Drug Safety. It is the 11th DTx in Korea.
According to ROWAN on the 25th, SuperBrain DEX is tablet PC–based cognitive training software designed so that patients with mild cognitive impairment can train cognitive function at home for seven days a week over a total of 16 weeks, without visiting a hospital after a prescription.
DTx are medical devices that use software to prevent, manage, and treat disease instead of pills or injections. As with new drugs, they must prove therapeutic efficacy through exploratory and confirmatory clinical trials to receive approval from the Ministry of Food and Drug Safety. Patients can use them with a doctor's prescription.
Mild cognitive impairment, the early stage of dementia, is a high-risk group with a higher chance of progressing to dementia. Among healthy older adults, 1% to 2% progress to dementia each year, but among patients with mild cognitive impairment, 10% to 15% progress each year. Conversely, this stage is also the golden time for treatment to prevent dementia progression.
ROWAN equipped SuperBrain DEX with an algorithm that analyzes each patient's cognitive status and degree of improvement and automatically recommends training. Even among patients with mild cognitive impairment, personalized training tailored to individual differences is possible, and it features an intuitive user interface (UI) and automatic difficulty adjustment so older adults can use it easily.
This item approval was based on clinical trial results conducted at 12 tertiary general hospitals nationwide, including Seoul St. Mary's Hospital, Korea University Guro Hospital, Ewha Womans University Seoul Hospital, and Ajou University Hospital, involving 140 patients with mild cognitive impairment aged 50 to 85. The study found that after 16 weeks, cognitive function scores improved significantly compared with the control group.
The research team said, "SuperBrain DEX not only improves cognitive function but also showed meaningful improvements in activities of daily living (K-IADL) and in a dementia progression indicator (CDR-SB)," adding, "This proves it is a digital therapeutic with real clinical effect, beyond a simple training app."
SuperBrain DEX extended hospital-centered treatment into the home. Because older patients can continue treatment without repeated hospital visits, it is highly useful for those in areas with limited medical access or for patients with mobility challenges.
A company official said, "This approval is significant in that it confirmed the effectiveness of digital therapeutics in the domestic mild cognitive impairment field through a large-scale clinical trial, established an elderly-friendly home-care model, and broadened the prospects for future reimbursement and adoption in clinical settings."