Sino Medical Sciences Technology Inc.

SinoMed's COMETIU Stent System Faces Regulatory Setback in China Despite FDA Breakthrough Designation

- China's National Medical Products Administration rejected SinoMed's market application for COMETIU, the world's first self-expanding intracranial drug-coated stent system designed to treat intracranial atherosclerotic stenosis. - The regulatory rejection caused SinoMed shares to plummet 17.2% following the announcement, despite the device previously receiving FDA Breakthrough Device Designation in August. - COMETIU targets patients with intracranial atherosclerosis, a condition where over 70% of cases with intracranial vascular stenosis cannot be cured by drugs alone. - SinoMed plans to continue discussions with Chinese regulators while advancing global commercialization efforts and conducting pivotal clinical trials in the United States.