The board of directors of Acotec Scientific Holdings Limited announced that the Company has recently submitted an Investigational Device Exemption ("IDE") application for AcoArt LitosTM Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (the "AcoArt Litos ") to the Center for Devices and Radiological Health of the U.S. Food and Drug Administration ("U.S. FDA"). AcoArt LitosTM is a paclitaxel drug-coated balloons (DCB) used to prevent stenosis or occlusion in below-the-knee (BTK) arteries for the treatment of chronic limb-threatening ischemia with a vascular interventional approach. The Company received the CE Marking for AcoArt Litos in 2014, the U.S. FDA "breakthrough device" designation for AcoArt Litos in 2019 and the National Medical Products Administration ("NMPA") approval for market for AcoArt Litos in December 2020, and successfully launched it in China in January 2021.

According to Frost & Sullivan, AcoArt Litos is the first domestically manufactured device receiving U.S. FDA "breakthrough device" designation.