By Fineline Cube 
Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced market approval in Indonesia for its Iberis multi-electrode renal radiofrequency denervation (RDN) system, the only RDN product globally approved for both transradial (TRA) and transfemoral (TFA) approaches.
Regulatory Milestone & Product Profile
| Item | Detail |
|---|---|
| Company | Shanghai Bio-hearted Biological Technology (2185.HK) |
| Product | Iberis multi-electrode renal radiofrequency denervation (RDN) system |
| Approval | Market authorization in Indonesia |
| Dual-Access Innovation | Only RDN product approved for both transradial (TRA) and transfemoral (TFA) approaches worldwide |
| Clinical Advantage | TRA approach makes procedures safer, more effective, and more cost-efficient |
| Previous Licensing | Biosensors International Group holds commercialization rights for EU, Asia-Pacific, and Latin America |
Technology Differentiation & Strategic Position
- Global Uniqueness: Iberis is the sole RDN system with regulatory approval for both TRA and TFA access routes, providing physicians flexibility based on patient anatomy and procedural preferences
- Transradial Benefits: TRA approach reduces vascular complications, shortens recovery time, lowers procedure costs, and improves patient comfort compared to traditional transfemoral access
- Market Expansion: Indonesia approval marks the latest regulatory win in Bio-heart’s emerging market strategy following previous EU and Asia-Pacific partnerships
Market Context & Commercial Outlook
- Global RDN Market: Valued at $450 million in 2025, projected to exceed $2 billion by 2030 (CAGR ≈ 35%) driven by hypertension prevalence and need for drug‑resistant solutions
- Emerging Market Focus: Indonesia represents 270 million population with hypertension prevalence >30%, creating substantial addressable market for RDN therapy
- Competitive Moat: Dual‑access approval provides significant differentiation vs. Medtronic’s Symplicity Spyral and Recor’s Paradise systems, which are limited to TFA approach
- Revenue Potential: Analysts estimate Iberis could capture 15–20% of Asia‑Pacific RDN market, generating $80–120 million in annual peak sales by 2028
- Next Steps: Commercial launch in Indonesia expected Q2 2026 via Biosensors distribution network
Forward‑Looking Statements
This brief contains forward‑looking statements regarding commercial expectations, market penetration, and revenue projections for the Iberis RDN system in Indonesia and other markets. Actual results may differ due to competitive dynamics, regulatory changes, and market adoption rates for renal denervation therapy.-Fineline Info & Tech