In order for us to obtain permission from the Ministry of Food and Drug Safety, the technical stability and effectiveness of the device was reviewed and passed by the Korea Institute of Medical Device Safety Information (NIDS), a second-level review organization, and then we had applied for permission from the KFDA based on the related data, the processing period is 5 days, and when the license is issued, it will be used at a medical institution.

Technical document review is the most important procedure for medical device approval. Even after preparing and submitting considerable data, the safety of the patient and the effectiveness of the device must be perfect during the review process, so it takes a considerable amount of time to be reviewed after several supplements.

The ACPi V100 model is an upgrade of the Anyfusion V100 model to the level of an anticancer drug preparation system, and it is mostly the same technology as the Anyfusion V100 technical document, so it passed without undergoing several supplements.

Equipment and kit approvals have been completed, and demos will be held in hospitals this week.

Demos are scheduled to be held at 6-7 local hospitals and 5-6 hospitals in Seoul and the metropolitan area from December 2020 to January 2021.

It is expected to be an opportunity to be freed from the difficulties and dangers of anticancer drug makers due to toxicity.

Except for 28 countries that use CSTD, which has improved ease of dispensing, most markets and Korea do not have a way to avoid toxic exposure and dispensing risk by directly dispensing by humans (pharmacists), so the need for anti-cancer drug preparation equipment is high.

If the need is verified through demos of several hospitals, it is expected that most hospitals at domestic and abroad will use it.

We will do our best to make equipment useful to users, and to be an opportunity to be freed from the risk of preparing anticancer drugs.

Thank you.