[Featured Stock] DreamCIS Rises on News of Medical AI Clinical Trials Possible Without MFDS Approval

DreamCIS is showing strong performance. This is interpreted as being influenced by news that clinical trials on medical devices with low risk of harm to clinical trial subjects, such as medical artificial intelligence (AI), can be conducted without approval from the Ministry of Food and Drug Safety (MFDS).

As of 10:18 AM on the 11th, DreamCIS is trading at 3,430 KRW, up 9.41% compared to the previous day.

The MFDS announced that seven bills under its jurisdiction, including the amendment to the 'Medical Device Act' which allows clinical trials on medical devices with low risk of harm to subjects to be conducted without MFDS clinical trial plan approval and even outside clinical trial institutions, have passed the National Assembly plenary session and are expected to be amended and promulgated as early as this month.

According to the Medical Device Act amendment passed that day, clinical trials like those involving medical AI, which do not directly contact research subjects but analyze subjects' medical data to produce results, will no longer require clinical trial plan approval from the MFDS.

Meanwhile, DreamCIS, established in 2000, is a CRO (Contract Research Organization) company that undertakes clinical trial research to maximize time and cost efficiency for its clients. Additionally, DreamCIS's subsidiary, 'Medip', is the leading company in Korea specializing in pharmaceutical and medical device licensing and approval. Currently, DreamCIS is known to be preparing to develop a big data-based clinical success prediction solution utilizing AI.

Choi Jae-ho, a researcher at Hana Securities, explained, “The most anticipated part is that they are preparing to develop an analytical solution that predicts clinical trial results in advance using AI, in collaboration with a leading domestic medical AI diagnostic solution company. Utilizing over 20 years of accumulated clinical big data and AI, they will provide a service that determines the success or failure of clinical trials at the preclinical to clinical transition stage.”