MICROPORT NEURO (02172.HK): APOLLO Dream® Stent System Granted FDA Breakthrough Device Designation – World’s First Neurointerventional Drug-Eluting Stent to Receive Such Designation

NewTimeSpace · 2026/03/18 17:25 · By Boyuan Chen

NewTimeSpace: MicroPort NeuroScientific Corporation (02172.HK) announced that its independently developed APOLLO Dream® Sirolimus Targeted Eluting Stent System has recently been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).It is the world’s first balloon-expandable, rapid-exchange drug-eluting stent in the neurointerventional field to receive this designation.

NewTimeSpace News: MicroPort NeuroScientific Corporation (02172.HK) issued a voluntary announcement on March 18, 2026, announcing that its self-developed APOLLO Dream^® Sirolimus Targeted Eluting Stent System has been granted Breakthrough Device Designation by the U.S. FDA.

The APOLLO Dream^® Stent System is specifically designed for patients with symptomatic intracranial arterial stenosis who fail to respond to the best available medical therapy.

The system integrates targeted drug-eluting technology and an optimized stent mechanical structure. While providing stable vascular support and restoring cerebral blood flow, it inhibits the proliferation of vascular smooth muscle cells by releasing sirolimus targeted to the vessel wall, thereby reducing the risk of post-operative restenosis.

Compared with conventional drug-eluting stents, the system enables more precise control of drug dosage and significantly reduces total drug load. Its biodegradable drug coating helps lower the risk of long-term thrombosis.

Breakthrough Device Designation is granted to innovative medical technologies developed for diseases that are life-threatening or cause irreversible functional impairment, and that demonstrate the potential for significant clinical advantages.

This designation signifies:

The technological innovation and potential clinical value of the APOLLO Dream^® Stent System in the treatment of intracranial atherosclerotic stenosis have been recognized by an international authoritative regulatory body.

It will help accelerate the clinical development and review process of the device.

It is expected to fill the overseas market gap for drug-eluting stents in the treatment of intracranial atherosclerotic stenosis.

It lays an important foundation for the Group to advance its global strategy and accelerate entry into major international markets.

The Company stated that it will continue to advance the global clinical development and registration process of the APOLLO Dream® Stent System.

There can be no assurance that the product will be successfully commercialized. Shareholders and investors should exercise caution when dealing in the Company’s shares.

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MICROPORT NEURO 02172.HK FDA Breakthrough Device Designation