Imocog, Approval of Confirmatory Clinical Trial Plan for Mild Cognitive Impairment Digital Therapeutic

[Asia Economy Reporter Kim Young-won] Imocog announced on the 18th that it has received approval from the Ministry of Food and Drug Safety for the domestic confirmatory clinical trial plan (IDE) for the cognitive treatment software 'Cogthera'.

Cogthera is the first product among digital therapeutics (DTx) for mild cognitive impairment to receive approval for a confirmatory clinical trial.

Imocog is a startup developing digital therapeutics for cognitive impairment. Recognized for its expertise and the potential of DTx, it has secured approximately 17.5 billion KRW in cumulative investments from Naver D2SF, Kakao Ventures, Stonebridge Ventures, Green Cross Holdings, SV Investment, and others.

Imocog's 'Cogthera' is a mobile-based DTx that can enhance long-term memory and improve cognitive function in patients with mild cognitive impairment. In March of this year, it was officially recognized as a cognitive treatment software medical device by the Ministry of Food and Drug Safety.

The current confirmatory clinical trial is scheduled to conclude in 2024 and will be conducted as a randomized, assessor-blinded, sham device-controlled, parallel-group, multicenter study targeting patients with mild cognitive impairment. If the trial is successfully completed, domestic commercialization is planned to begin in 2024.

No Yoo-heon, co-CEO of Imocog, said, "The approval of this confirmatory clinical trial is even more significant as it is the first among mild cognitive impairment DTx." He added, "Along with the domestic confirmatory clinical trial, we are planning clinical trials overseas, including a pre-submission to the U.S. Food and Drug Administration (FDA)."

This content was produced with the assistance of AI translation services.