By Fineline Cube 
Jenscare Scientific Co., Ltd. (HKG: 9877) announced that it has submitted the registration application for CE mark of JensClip, its transcatheter mitral valve repair (TMVr) system, in the European Union. The company also confirmed that its China registration application has been submitted and accepted.
Regulatory Submission Status
| Item | Detail |
|---|---|
| Product | JensClip Transcatheter Mitral Valve Repair (TMVr) System |
| Company | Jenscare Scientific Co., Ltd. (9877.HK) |
| EU Regulatory Path | CE mark application submitted |
| China Regulatory Path | Registration application submitted and accepted |
| Indication | Severe mitral regurgitation |
| Key Markets | European Union, China |
Device Innovation & Technical Features
JensClip incorporates several proprietary design elements aimed at improving procedural safety and ease of use:
| Feature | Description | Clinical Advantage |
|---|---|---|
| Claw‑Wedge Mechanical Locking | Secure fixation at any angle | Stable leaflet coaptation, reduced tension |
| Diamond‑Shaped Valve Clip | Facilitates retrieval and repositioning | Enhanced procedural safety, operator flexibility |
| Integrated Release Mechanism | Single‑step detachment process | Shortens operation time, reduces procedural risk |
| Global Patent Protection | Innovative design patent‑protected | Market exclusivity, competitive moat |
The device is designed to effectively mitigate mitral regurgitation through reliable leaflet capture while minimizing the learning curve for interventional cardiologists.
Market Opportunity & Disease Burden
Mitral Regurgitation (MR) Prevalence:
- EU: ~4.5 million patients with moderate‑to‑severe MR; ~500,000 new severe cases annually
- China: ~8 million patients; diagnosis rate <15%
- Treatment Gap: Only 2‑3% of eligible patients receive transcatheter repair due to limited device availability and physician training
TMVr Market Projections:
- EU Market Size: €1.2 billion (2025), growing at 12% CAGR
- China Market Size: ¥3.5 billion (2025), projected to reach ¥12 billion by 2030
- JensClip Revenue Potential: Peak sales of ¥800 million‑1.2 billion (EU + China) by 2032, assuming 8‑12% market share
Competitive Landscape
| Device | Company | Regulatory Status | Key Features | Market Position |
|---|---|---|---|---|
| MitraClip | Abbott | CE/FDA/NMPA approved | Gold standard; established data | Dominant (>80% share) |
| Pascal | Edwards Lifesciences | CE/FDA approved | Independent leaflet capture | Emerging competitor |
| JensClip | Jenscare Scientific | CE pending, China under review | Enhanced retrieval, integrated release | First domestic TMVr (China) |
| ValveClamp | Pulse Medical | China approved | Clip‑based; limited data | Early‑stage domestic |
Strategic Advantage: JensClip’s patented diamond‑shaped design and integrated release differentiate it from first‑generation devices, potentially reducing procedure time by 15‑20% compared to MitraClip.
Regulatory Pathway & Commercial Strategy
EU Timeline:
- CE Submission: Dec 2025
- Notified Body Review: 12‑18 months (expected approval Q2 2027)
- Market Entry: H2 2027 via specialty distributor network
China Timeline:
- NMPA Submission: Accepted Q4 2025
- Innovative Device Pathway: Potential for priority review (12‑15 months)
- Domestic Preference: Eligible for Volume‑Based Procurement (VBP) and DRG reimbursement incentives
Manufacturing: Jenscare’s Suzhou facility (capacity: 5,000 units/year) expected to achieve CE certification by Q1 2027, enabling parallel EU/China supply.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding JensClip’s regulatory approval timelines, market penetration, revenue projections, and competitive positioning in the EU and China TMVr markets. Actual results may differ due to regulatory review outcomes, competitive responses, and market adoption rates..-Fineline Info & Tech