'Dementia DTx' Imocog, Certified as 'Innovative Medical Device Company' by Ministry of Health and Welfare

Digital healthcare startup Imocog announced on the 27th that it has become the first digital therapeutics (DTx) company to obtain the Ministry of Health and Welfare's certification as an 'Innovative Medical Device Company.'

Imocog logo (left) and certification mark for innovative medical device companies
[Photo by Imocog]

The Ministry of Health and Welfare's Innovative Medical Device Company certification system is established under the 'Medical Device Industry Promotion and Innovative Medical Device Support Act' to certify and support companies with excellent research and development capabilities and achievements, aiming to foster and revitalize the domestic medical device industry. Imocog was certified as a promising 'Innovative Leap-type Company' based on its innovative technology.

Founded in 2021, Imocog is a bio digital healthcare platform company developing dementia solutions covering the entire cycle from prevention to diagnosis and treatment. 'Cogthera,' being developed as a DTx for treating mild cognitive impairment patients, received approval for a confirmatory clinical trial plan in the domestic mild cognitive impairment field last September and is currently conducting clinical trials. The company has also established a subsidiary in Germany to accelerate overseas clinical trials and global market entry, with plans to expand into markets such as the United States, Asia, and Japan.

Through this certification, which is valid for three years from the designation date, Imocog will be able to use the Innovative Medical Device Company certification mark and receive various policy supports. Companies selected as innovative medical device companies can benefit from preferential use of government support projects and government policy financing, awards for excellent companies, fee reductions when using technology services in advanced complex zones, support for joint research with overseas medical institutions and companies, and overseas clinical trial support, among other policy benefits.

Yooheon Noh, CEO of Imocog, stated, “We will accelerate our overseas expansion based on this certification and policy support,” adding, “We will do our best to be recognized for our innovative technology and lead the market not only in Korea but also in the United States and Europe.”