MicroPort Neuro (02172): The APOLLO Dream rapamycin-targeted elution stent system has been awarded breakthrough medical device designation by the FDA.

MICROPORT NEURO (02172) announced that the APOLLO Dream Rapamycin Targeted Elution Stent System (APOLLO Dream Stent System) developed independently by the group has recently received breakthrough medical device designation from the Food and Drug Administration (FDA) in the United States, becoming the world's first neural intervention balloon dilatation and rapid exchange drug-eluting stent to receive this designation. The APOLLO Dream Stent System is designed for symptomatic intracranial arterial stenosis patients who are not responsive to the best existing drug therapy. The system combines targeted drug elution technology with optimized stent mechanical structure to provide stable vessel support and restore smooth blood flow in the brain, while targeting the release of rapamycin to suppress vascular smooth muscle cell proliferation in the vessel wall, thereby reducing the risk of restenosis after surgery. Compared to traditional drug stents, the APOLLO Dream Stent System can more precisely control drug release dosage, significantly reducing the total drug load entering the body while ensuring efficacy. Its drug coating uses degradable materials that gradually degrade after drug release, helping to reduce the risk of long-term thrombus formation. The breakthrough medical device designation is intended to grant Innovative Medical Management technologies developed for diseases that pose a serious threat to life or result in irreversible functional damage and have potential significant clinical advantages. The APOLLO Dream Stent System is the world's first neural intervention balloon dilatation and rapid exchange drug-eluting stent to receive this designation, marking: Recognition of the technological innovation and potential clinical value of the APOLLO Dream Stent System in the treatment of Intracranial Atherosclerotic Disease (ICAD) by international regulatory authorities; speeding up the clinical development and evaluation process of the device; potentially filling a gap in the overseas market for drug stent treatment of intracranial atherosclerotic disease, benefiting patients worldwide; and laying an important foundation for the group to advance its globalization strategy and accelerate entry into international core markets. In the future, the group will continue to advance the global clinical research and registration process of the APOLLO Dream Stent System, further expanding the company's international influence in the field of neural intervention innovative treatment and providing more advanced treatment options for global patients.