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.
About MicroPort NeuroScientific
MicroPort NeuroScientific (MicroPort NeuroScientific Corporation; HKEX: 2172), an associated company of MicroPort® (MicroPort Scientific Corporation; HKEX: 00853), is committed to the research and development of high-end medical devices in the field of neurological interventional treatment with solutions that currently support over 120 cerebrovascular stenting procedures every day. In the future, MicroPort NeuroScientific will continue investing more resources in innovation and development to provide more high-quality and innovative cerebrovascular and neuro-interventional solutions for physicians and patients.
More information is available at: https://www.microportneurosci.com/
Media contact：MicroPort NeuroScientific Corporation
1661 Zhangdong Rd., ZJ Hi-Tech Park
Shanghai 201218, P. R. China
Tel: (86) (21) 38954600-55200
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