By Fineline Cube 
Beijing Balance Medical Technology Co., Ltd. (SHA: 688198) announced that its expanded polytetrafluoroethylene (ePTFE) pericardial membrane has received NMPA registration approval, ending China’s reliance on imported products for cardiac surgery.
Regulatory Approval & Product Specifications
| Attribute | Details |
|---|---|
| Company | Beijing Balance Medical Technology Co., Ltd. (688198.SH) |
| Product | ePTFE pericardial membrane (0.1mm thickness) |
| Regulatory Status | NMPA registration approval (China) |
| Indication | Repair or reconstruction of pericardium during cardiac surgery |
| Market Impact | Ends foreign monopoly, eliminates import dependence |
Product Profile & Clinical Application
Design Features:
- 0.1mm thickness: Ultra-thin ePTFE membrane for precise cardiac applications
- Material: Expanded polytetrafluoroethylene (ePTFE) for biocompatibility and durability
- Use Case: Implanted during open-heart procedures to repair/reconstruct damaged pericardial tissue
- Function: Protects the heart post-surgery
Clinical Need:
- Standard practice in open-heart surgery to implant pericardial membranes
- Current domestic market monopolized by foreign companies
- Long-standing reliance on imports for this critical cardiac surgery component
Market Context & Competitive Landscape
| Market Segment | Current Status | Market Size (China) | Post-Launch Outlook |
|---|---|---|---|
| Pericardial Membranes | 100% import dependence | ~¥500 million (≈ US$70 million) annually | Balance-Medical becomes first domestic supplier |
| Cardiac Surgery Devices | Foreign dominance | High-growth sector | Potential for additional product line extensions |
| Import Substitution | Critical national priority | Government-backed initiative | Eligible for preferential procurement policies |
Strategic Significance:
- First Domestic Supplier: Ends decades of import reliance for ePTFE pericardial membranes
- Cost Advantage: Expected 20-30% price reduction vs. imported counterparts
- Supply Security: Reduces vulnerability to global supply chain disruptions
- Technology Transfer: Demonstrates advanced biomaterials manufacturing capability in China
Manufacturing & Commercial Strategy
- Production: Balance-Medical’s GMP-certified facility in Beijing
- Quality Standards: Meets ISO 13485 and NMPA requirements for implantable devices
- Launch Timeline: Commercial rollout expected Q2 2026 following production scale-up
- Pricing Strategy: Competitive pricing to undercut imports while maintaining margins
- Reimbursement Path: Class III medical device designation supports inclusion in hospital procurement catalogs
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial launch execution, market penetration, and manufacturing capacity for Balance-Medical’s ePTFE pericardial membrane. Actual results may differ due to regulatory, competitive, and adoption uncertainties.-Fineline Info & Tech