Digital healthcare startup Emocog has received approval from the Ministry of Food and Drug Safety for a domestic confirmatory clinical trial (IDE) for cognitive therapy software ‘Cogthera’. Cogterra is the first digital therapy for mild cognitive impairment (DTx) to receive confirmatory clinical trial approval.
CogThera, developed by Imocog, is a mobile-based digital treatment that can enhance long-term memory and improve cognitive function in patients with mild cognitive impairment. In March 2022, it received formal confirmation as a medical device (cognitive therapy software) from the Ministry of Food and Drug Safety.
This confirmatory clinical trial is scheduled to be completed in 2024 and will be conducted in the form of a randomized, evaluator-blinded, sham device-controlled, parallel group, multicenter study targeting patients with mild cognitive impairment. If this clinical trial is successfully completed, domestic commercialization will begin in 2024 and it will be available for prescription at hospitals nationwide.
Noh Yoo-heon, co-CEO of Imocog, said, “This confirmatory clinical trial approval is more meaningful in that it is the first digital treatment for mild cognitive impairment,” adding, “We are conducting pre-submission to the FDA along with domestic confirmatory clinical trials. “We are also planning clinical trials.”
Meanwhile, Imocog is a startup developing digital treatments for cognitive impairment, and its co-founders are experts with over 20 years of experience in treating patients with mild cognitive impairment and dementia and researching brain function improvement. Recognized for its professional capabilities and potential as a digital therapeutic agent, it has secured a cumulative investment of approximately 17.5 billion won from Naver D2SF, Kakao Ventures, Stone Bridge Ventures, Green Cross Holdings, and SV Investment.
Source: Pangyo Techno Valley Official Newsroom
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