APOLLO Dream^® Sirolimus Target Eluting Stent System Granted FDA Breakthrough Device Designation

Shanghai, China – March 29, 2026 – Recently, The board of directors (the “Board”) of MicroPort NeuroScientific Corporation (the “Company”, 2172.HK, together with its subsidiaries, the “Group”) is pleased to announce that APOLLO Dream^®  Sirolimus Target Eluting Stent System (“APOLLO Dream^®”) has been granted the Breakthrough Device Designation by the U.S. Food and Drug Administration (“FDA”).

Intracranial atherosclerotic disease (ICAD) is a leading cause of ischemic stroke worldwide and remains one of the most challenging areas in cerebrovascular therapy¹. Patients with medically refractory ICAD face limited treatment options, and effective interventional approaches to restore cerebral blood flow represent a significant unmet clinical need¹. 

APOLLO Dream^® is the Group's investigational balloon-expandable, rapid-exchange drug-eluting stent system designed to provide vascular scaffolding and restore cerebral blood flow. The Company is not aware of other devices with this specific combination of features that have received FDA Breakthrough Device Designation in this indication. The system incorporates a proprietary microgroove drug-delivery architecture: sirolimus and a bioabsorbable polymer are precisely placed into micron-sized grooves on the abluminal (vessel-wall-facing) surface of the stent, while the luminal (blood-facing) surface remains in a bare-metal state. As the polymer degrades, sirolimus is delivered to the vessel wall². APOLLO Dream^®’s drug load is lower than traditional DES³. Long-term safety outcomes are under clinical investigation⁴. 

The FDA Breakthrough Devices Program is intended to facilitate development and review of medical devices that may provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. The designation provides opportunities for early and frequent interaction with the FDA as development progresses, and represents a milestone in the regulatory strategy of the Group. The Group will continue to drive global clinical studies and registration of the APOLLO Dream^® to strengthen its global presence in neurovascular interventional therapy and benefit more patients.

Receipt of Breakthrough Device Designation does not constitute FDA approval or clearance for commercial distribution in the United States. APOLLO Dream^® remains an investigational device. Shareholders and potential investors of the Company should exercise appropriate caution when dealing in the shares of the Company.

References:

1. Hoh BL, et al. Stroke. 2024;55:305–310.

2. Lansky AJ, et al. Lancet. 2018;392(10153):1117–1126.

3. Data on file.

4. ClinicalTrials.gov Identifier: NCT04753749