By Fineline Cube Lifetech Scientific Corporation (HKG: 1302) announced that its Concave Supra (CS) integrated aortic arch triple‑branch reconstruction system has been awarded fast‑track status by China’s National Medical Products Administration (NMPA), representing the world’s first integrated solution for minimally invasive treatment of complex aortic arch aneurysms and penetrating ulcers.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Lifetech Scientific Corporation (HKG: 1302) |
| Product | Concave Supra (CS) Stent System |
| Designation | Fast‑Track Status |
| Agency | NMPA (China) |
| Indication | Complex aortic arch aneurysms and penetrating ulcers |
| Authorization Date | 10 Jan 2026 |
| Innovation | World’s first integrated triple‑branch aortic arch reconstruction; eliminates cerebral ischemia risk |
Product Profile & Innovation
- Technology: Unique concave and integrated structure enabling total endovascular aortic arch triple‑branch reconstruction
- Clinical Advantage: Eliminates cerebral ischemia risk—a major limitation of conventional techniques
- Procedure: Provides a systematic, minimally invasive, safer, and more effective solution for complex aortic arch lesions
- Technical Breakthrough: Resolves multiple technical difficulties associated with traditional endovascular approaches in the aortic arch’s complex anatomical and hemodynamic environment
- Clinical Validation: Both feasibility studies and clinical trials have demonstrated favorable safety and efficacy profiles
Market Impact & Competitive Landscape
| Parameter | China | Global |
|---|---|---|
| Aortic Arch Aneurysm Cases (Annual) | 18,000 | 55,000 |
| Penetrating Ulcers Requiring Intervention | 8,500 | 26,000 |
| Addressable Population (2027E) | 26,500 | 81,000 |
| Current Standard | Open surgery or hybrid procedures (high morbidity) | |
| Minimally Invasive Penetration | <15 % | <20 % |
| CS System Market Share Target | 40 % by 2029 | 25 % by 2030 |
| Potential Annual Revenue | ¥1.2 billion | $450 million |
- Competitive Moat: No existing integrated triple‑branch system; competitors rely on off‑label use of thoracic stent grafts with custom fenestrations, which carry 20‑30 % stroke risk
- Physician Adoption: Fast‑track status enables accelerated training at 25 Chinese cardiovascular centers; first commercial implants expected Q2 2026
- Reimbursement Pathway: Eligible for NRDL innovation channel with premium pricing (estimated ¥85,000 per procedure)
Strategic Positioning
- Pipeline Synergy: CS System complements Lifetech’s G‑iliac Pro (iliac artery covered stent) and A‑Force (abdominal aortic stent graft), creating a full‑spectrum aortic disease portfolio
- Intellectual Property: 23 granted patents covering the concave stent architecture and integrated branch delivery system; provides protection through 2038
- Global Expansion: Lifetech plans CE mark application in Q4 2026 and FDA IDE submission in 2027, targeting the $2.1 billion global complex aortic repair market
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical adoption, market penetration, and revenue forecasts for the CS Stent System. Actual results may differ due to competitive responses, regulatory approval timelines outside China, and physician training speed.-Fineline Info & Tech