iQflow's Wearable Artificial Pancreas 'iQpatch X' Receives MFDS IDE Approval

[Asia Economy Reporter Hyunseok Yoo] Wearable drug delivery solution specialist EOPLO announced on the 9th that it has received approval from the Ministry of Food and Drug Safety for the investigational device exemption (IDE) of the sensor-detachable wearable artificial pancreas ‘EOPatch X’.

Following the IDE approval, EOPLO will conduct a study evaluating efficacy, safety, and other indicators on more than 100 type 1 diabetes patients at nine general and tertiary hospitals in Korea. EOPLO stated that after obtaining approval from each hospital’s Institutional Review Board (IRB), the clinical trial will begin around January and be completed by December. The company also said it plans to apply for medical device product approval after the clinical trial is completed.

Currently, only two artificial pancreas solutions have been commercialized with approval from the U.S. Food and Drug Administration (FDA): those from Medtronic and Tandem. These products are based on conventional insulin pumps with infusion lines, which cause considerable inconvenience in use, yet the number of users has significantly increased since commercialization. As a next-generation solution, the wearable pump-based artificial pancreas without infusion lines has not yet received final approval anywhere, so if ‘EOPatch X’ is commercialized, significant sales growth is expected.

Previously, EOPLO was the second in the world and the first in Korea to commercialize the wearable insulin pump ‘EOPatch.’ Since April, it has started domestic sales through Huons’ Hu:On Diabetes Care EOPatch Mall, and after obtaining European certification in May, it is currently being exported to Europe through Menarini. Additionally, EOPLO signed a supply contract worth approximately 45 billion KRW with Indonesia’s PT. PNS, preparing to enter the ASEAN region, and is also negotiating exports to several regions including China, the Middle East, and South America.

Kim Beommin, head of the Pan-Government Medical Device Research and Development Project Group, said, “We are very pleased that EOPLO’s ‘EOPatch X,’ which is receiving close support for early productization through the Pan-Government R&D coordination project, has received IDE approval from the Ministry of Food and Drug Safety.” He added, “As the wearable artificial pancreas ‘EOPatch X’ is a global leading product with no domestic or international commercialization cases yet, the Pan-Government project will support the entire process including clinical trials, manufacturing approval, overseas certification, and export support for rapid productization and market entry.”

Meanwhile, the ‘Pan-Government R&D Coordination’ is a program operated jointly by the Ministry of Food and Drug Safety and the Pan-Government project group to enable rapid productization of medical devices. In September, EOPLO was selected for the ‘Pan-Government R&D Coordination’ project after being recognized for the early productization potential of ‘EOPatch X’ by the Pan-Government project group and the Ministry of Food and Drug Safety, receiving administrative and technical support for product commercialization.

Kim Jaejin, CEO of EOPLO, said, “We expect to secure meaningful data from this domestic approval clinical trial by the end of next year,” and added, “Our goal is to complete the main domestic clinical trial by 2022 and launch the sensor-detachable wearable artificial pancreas system domestically by the end of 2023.” He continued, “Based on the clinical trial results, we will work harder to commercialize the product in regions with high demand for wearable artificial pancreas such as the U.S. and Europe, aiming to increase sales and generate profits.”

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