Sino Medical Sciences Technology Inc. (688108.SH) subsidiary's self-expanding intracranial drug-coated stent system has obtained EU MDR certification.

Sino Medical Sciences Technology Inc. (688108.SH) announced that its wholly-owned subsidiary, Sino Shenchang Medical Technology Co., Ltd. (referred to as Sino Shenchang), recently received notification from the EU Notified Body that its self-expanding, drug-coated intracranial stent system, COMETIU, has obtained the certification issued in accordance with the EU Medical Devices Regulation (EU) 2017/745 (referred to as MDR) and has achieved CE marking. After COMETIUs launch in the EU, it is still necessary to complete post-marketing registration in various countries, establish distribution channels, and gain access for hospitals and payers. The market development has significant uncertainties, and its market sales may also be influenced by uncertain factors such as EU regulatory policies, the accumulation of clinical evidence, updates to treatment standards, changes in the market environment, and fluctuations in exchange rates. The company is currently unable to predict the specific impact of these factors on its future performance. This certification is only applicable within the EU and the European Economic Area and does not constitute the basis for the registration progress or outcomes of the company's products in other countries or regions, nor does it guarantee approval for other related submissions.