Acotec Scientific Holdings Limited announced that on November 29, 2023, the Group received the approval of IDE (Investigational Device Exemption) application from the US Food and Drug Administration (FDA) for AcoArt Litos®? Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (the "AcoArt Litos®?). An IDE refers to the exemption of medical devices from certain regulatory controls, such as prohibition on the sale of unapproved products, in order to conduct clinical trials on medical devices.

It is also an important stage in the US FDA's Premarket Approval (PMA) and 510(k) review of medical devices. The IDE approval means that the clinical research on AcoArt Litos®®? in the United States will begin after obtaining approval from the Institutional Review Board (IRB).

FDA has determined that the Company had provided sufficient data to support initiation of a human clinical study. AcoArt Litos®?? is a paclitaxel DCB used to prevent stenosis or occlusion in BTK arteries for the treatment of chronic limb-threatening ischemia with a vascular interventional approach.

AcoArt Litos ®? received the CE Marking in 2014, the US FDA "breakthrough device" designation in 2019 and the National Medical Products Administration approval for market in 2020. According to Frost & Sullivan, AcoArt Litos® of the Board.