By Fineline Cube Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced it has received regulatory approval for its multi-electrode renal radiofrequency denervation (RDN) system, Iberis, in Israel.
The Iberis RDN System is the world’s only platform approved for both transradial access (TRA) and transfemoral access (TFA), offering physicians flexibility in procedural approach. The transradial method enhances safety, efficacy, and cost-effectiveness compared to traditional transfemoral approaches.
Regulatory Status & Global Footprint
| Region | Approval Status | Date |
|---|---|---|
| Israel | Approved | Jun 2026 |
| European Union | Approved | Previously |
| Indonesia | Approved | Previously |
| Thailand | Approved | Previously |
| Additional Markets | Under Review | Ongoing |
Product Innovation & Clinical Advantages
- Dual-Access Platform: Only RDN system globally approved for both TRA and TFA approaches
- Transradial Benefits:
- Reduced vascular complications
- Faster patient recovery
- Lower procedural costs
- Enhanced patient comfort
- Technology: Multi-electrode radiofrequency ablation system for precise renal nerve modulation
- Indication: Treatment of resistant hypertension
Commercial Strategy & Partnership
Shanghai Bio-heart has established a strategic licensing agreement with Biosensors International Group, Ltd., a Singapore-based medical device manufacturer, granting commercialization rights for the Iberis RDN System across:
- European Union
- Asia-Pacific region
- Latin America (LATAM)
- Additional territories
This partnership leverages Biosensors’ established distribution infrastructure and regulatory expertise to accelerate market penetration in key global regions.
Market Outlook
- Hypertension Prevalence: Affects approximately 1.3 billion people globally, with 10-20% classified as treatment-resistant
- RDN Market Growth: Projected to reach $2.1 billion by 2028, driven by aging populations and improved clinical evidence
- Competitive Position: Iberis’ dual-access capability provides unique differentiation in an increasingly competitive RDN landscape
- Reimbursement: Israeli approval paves the way for healthcare system adoption and potential reimbursement discussions
Forward-Looking Statements
This brief contains forward-looking statements regarding regulatory approvals, market opportunities, and commercial expectations. Actual results may differ due to regulatory, competitive, and market adoption risks.-Fineline Info & Tech