[Pangyo Bio & Medical] Emocog received approval for the IDE(investigational device exemption) for its Cogthera, digital therapeutics for people with mild cognitive impairment

A digital healthcare startup, Emocog received approval for the IDE(investigational device exemption) for its Cogthera, a software to treat people with mild cognitive impairment, from the Ministry of Food and Drug Safety. Cogthera is the very first product among other Digital therapeutics for mild cognitive impairment to receive IDE approval.

Cogthera, developed by Emocog, is a mobile-based digital treatment that can help patients with mild cognitive impairment to improve long-term memory and cognitive function. In March 2022, it was officially recognized by the Ministry of Food and Drug Safety as a medical device of cognitive therapy software.

This IDE will end in 2024. In this clinical trial stage, there will be a randomized group, double-blind group, active-controlled group, parallel-group, and multi-center study with patients suffering mild cognitive impairment. If this clinical trial is successfully completed, it will be commercialized in Korea in 2024 and can be prescribed at hospitals nationwide.

Noh Yoo-heon, co-chairman of Emocog said “The approval of this confirmation clinical trial is more meaningful in that it is the very first digital treatment for mild cognitive impairment,” “We are also planning clinical trials overseas, including pre-submission to the FDA along with domestic confirmation clinical trials.”

Emocog is a startup developing digital treatments for cognitive impairment, and the co-founders of which are experts in the fields of treatment of mild cognitive impairment and dementia patients and research on brain function improvement for more than 20 years. In recognition of its professional capabilities and the possibility of digital treatments, it has attracted a cumulative investment of about 17.5 billion won from Naver D2SF, Kakao Ventures, Stone Bridge Ventures, Green Cross Corporation, and SV Investment.

Source: Pangyo Techno Valley Official Newsroom