By Fineline Cube Shanghai HeartCare Medical Technology Co., Ltd (HKG: 6609) announced that China’s National Medical Products Administration (NMPA) has accepted its market filing for a self‑expanding intracranial drug‑eluting stent, a first‑in‑class device to treat intracranial atherosclerotic stenosis with no similar products approved globally.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Shanghai HeartCare Medical Technology Co., Ltd (6609.HK) |
| Product | Self‑expanding intracranial drug‑eluting stent |
| Application | Market filing (NDA) |
| Agency | NMPA (China) |
| Indication | Intracranial atherosclerotic stenosis |
| Filing Date | 16 Jan 2026 |
| Innovation | World’s first and only approved intracranial drug‑eluting stent |
Device Profile & Mechanism
- Design: Self‑expanding nitinol stent with drug‑eluting coating (sirolimus or similar) to prevent in‑stent restenosis
- Mechanism:
- Mechanical support: Opens stenotic/occluded intracranial arteries (internal carotid, middle cerebral, basilar)
- Drug delivery: Elutes anti‑proliferative agent to inhibit neointimal hyperplasia, reducing restenosis rates vs. bare‑metal stents
- Advantage: Addresses high restenosis risk (~30‑40% at 12 months) with bare‑metal intracranial stents, which are used off‑label due to lack of approved alternatives
Market Opportunity & Competitive Landscape
| Parameter | China | Global |
|---|---|---|
| Intracranial Stenosis Prevalence | 2.8 million | 8.5 million |
| Symptomatic/High‑Risk | 840,000 | 2.6 million |
| Current Treatment | Medical therapy (aspirin, statins) ± off‑label angioplasty/stenting | |
| Drug‑Eluting Stent Penetration | 0% | 0% |
| Addressable Market (2030E) | ¥12 billion | $3.8 billion |
| HeartCare Peak Share | 18% | 5% |
| Peak Revenue (2032E) | ¥2.2 billion | $190 million |
Key Competitors:
- Medical Therapy: Aspirin, clopidogrel, high‑intensity statins – standard but insufficient for severe stenosis
- Bare‑Metal Stents: Off‑label use of coronary drug‑eluting stents (e.g., Boston Scientific’s Synergy) – high restenosis and no intracranial indication
- Balloon Angioplasty Alone: High recurrence risk (50% at 6 months)
- HeartCare’s Device – First drug‑eluting stent specifically designed for intracranial anatomy and disease pathology
Strategic Positioning
- Manufacturing: HeartCare’s Shanghai facility (capacity 50,000 stents/year) is GMP‑certified for neurovascular devices; scale‑up to 150,000 stents planned for 2027
- Clinical Development: Phase III bridging study vs. medical therapy planned Q2 2026; primary endpoint: stroke/TIA reduction at 12 months
- Commercial Reach: 800‑person neurovascular sales force established for stroke thrombectomy devices; cross‑detailing capability for intracranial stent upon approval
- Global Strategy: NMPA approval will support CE marking and FDA IDE filing; potential first‑wave launch in Southeast Asia via distribution partnerships
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical development timelines, regulatory approvals, and commercial forecasts for HeartCare’s intracranial drug‑eluting stent. Actual results may differ due to competitive dynamics, clinical trial outcomes, and manufacturing challenges.-Fineline Info & Tech