By Fineline Cube Blue Sail Medical Co., Ltd (SHE: 002382) announced that its Lithonic coronary intravascular shockwave therapy system has received CE qualification in the European Union (EU), clearing the device for commercialization across member states. The system was developed by Blue Sail’s cardiovascular subsidiary, Biosensors Interventional Technologies Pte. Ltd.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Blue Sail Medical Co., Ltd (002382.SZ) |
| Product | Lithonic coronary intravascular shockwave therapy system |
| Developer | Biosensors Interventional Technologies Pte. Ltd (subsidiary) |
| Certification | CE Mark (European Union) |
| **Indication | Intravascular lithotripsy (IVL) for severely calcified stenotic lesions |
| **Approval Date | 14 Jan 2026 |
| **Technology | Electrohydraulic shockwave generation |
Device Profile & Mechanism
- Principle: Intravascular lithotripsy (IVL) delivers high‑pressure acoustic waves to severely calcified coronary lesions
- Mechanism of Action:
- Electrohydraulic effect: Electrodes generate shockwaves in an electrolyte solution
- Shockwave propagation: Pressure waves precisely released within the vessel to modify calcified plaques
- Clinical Advantage: Enables stent expansion in lesions resistant to conventional balloon angioplasty
- Safety Benefits: Reduces risks of vessel perforation and no‑reflow complications vs. rotational atherectomy
Market Impact & Competitive Landscape
| Parameter | EU Market | Global Market |
|---|---|---|
| Calcified Coronary Lesions (Annual) | 280,000 | 1.4 million |
| IVL‑Eligible Cases | 95,000 | 480,000 |
| Current IVL Penetration | 18% | 12% |
| IVL Market Value (2030E) | €450 million | $2.1 billion |
| Lithonic Peak Share | 8% | 5% |
| Peak Revenue (2032E) | €36 million | $105 million |
Key Competitors:
- Shockwave Medical – IVL market leader with Shockwave C2 (70% share)
- Fastwave Medical – Magnum IVL system (in development)
- Lithonic – First Chinese‑developed IVL system with CE mark; competitive pricing advantage (20‑30% below Shockwave)
Strategic Positioning
- Manufacturing: Blue Sail’s Suzhou facility (ISO 13485 certified) will produce Lithonic for EU markets; FDA IDE application planned for Q3 2026
- Commercial Launch: EU rollout targeted for Q2 2026 through Biosensors’ distribution network (covers 15 EU countries)
- Reimbursement Strategy: CE mark enables national reimbursement pathways; seeking NUB innovation status in Germany for premium pricing
- Pipeline Extension: Lithonic platform being adapted for peripheral artery disease (PAD) and renal denervation indications
Forward‑Looking Statements
This brief contains forward‑looking statements regarding CE certification benefits, market penetration, and revenue forecasts for Lithonic. Actual results may differ due to competitive responses, pricing pressures, and regulatory challenges in non‑EU markets.-Fineline Info & Tech