By Fineline Cube 
Acotec Scientific Holdings Limited (HKG: 6669) announced it has received registration approval from China’s National Medical Products Administration (NMPA) for microcatheter V-otter, designed for percutaneous interventional procedures in peripheral and coronary vasculature.
Regulatory Approval & Product Specifications
| Attribute | Details |
|---|---|
| Company | Acotec Scientific Holdings Limited (6669.HK) |
| Product | Microcatheter V-otter |
| Regulatory Status | NMPA registration approval (China) |
| Primary Indication | Transarterial Chemoembolization (TACE) procedures |
| Key Features | Large-lumen design, three tip configurations (straight, 45° single-curve, multi-curve) |
Product Design & Clinical Advantages
Large-Lumen Architecture:
- Effectively prevents intraoperative catheter occlusion during embolization procedures
- Enables smooth delivery of diagnostic, embolic, or therapeutic materials
Three Tip Configuration Options:
- Straight tip: For direct vessel access
- 45° single-curve tip: For moderately angled branch vessels
- Multi-curve tip: For complex tortuous vascular anatomy
Clinical Utility:
- Accommodates branch vessels of various angles based on clinical needs
- Enables precise and stable access to target vessels for subsequent procedures
- Supports both peripheral and coronary vascular applications
Market Context & Competitive Landscape
| Market Segment | Market Size (China) | Growth Drivers | Competitive Position |
|---|---|---|---|
| TACE Procedures | >300,000 annually | Rising HCC incidence, increasing interventional oncology adoption | V-otter provides differentiated tip options vs. single-design competitors |
| Microcatheter Market | ¥2.5 billion (≈ US$350 million) | Preference for large-lumen designs to reduce occlusion | First microcatheter with three configurable tip options in China |
Strategic Advantages:
- Addresses occlusion risk – a key complication in TACE procedures
- Reduces need for multiple catheters during complex cases
- Supports broader clinical scenarios from peripheral to coronary interventions
Commercial Outlook & Strategic Implications
- Revenue Impact: Analysts project ¥150‑200 million (≈ US$21‑28 million) peak annual sales within 3 years of launch
- Launch Timeline: Commercial rollout expected Q1 2026 following production ramp-up
- Portfolio Synergy: Strengthens Acotec’s interventional oncology and cardiology device ecosystem
- Global Ambition: NMPA approval positions product for potential CE mark application in 2026
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch timelines, market penetration, and revenue projections for V-otter. Actual results may differ due to regulatory, competitive, and adoption uncertainties.-Fineline Info & Tech