By Fineline Cube 
Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced that its Iberis Multi-Electrode Renal Denervation (RDN) Catheter System (IberiRDN) has completed registration with the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), becoming the only RDN product globally approved for both Transradial Artery (TRA) and Transfemoral Artery (TFA) approaches, offering a safer and more cost‑efficient option for hypertension treatment.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | Iberis Multi‑Electrode Renal Denervation (RDN) Catheter System (IberiRDN) |
| Company | Shanghai Bio-heart Biological Technology (2185.HK) |
| Agency | New Zealand Medicines and Medical Devices Safety Authority (Medsafe) |
| Approval Type | Registration |
| Key Differentiator | Only RDN system globally approved for both TRA and TFA approaches |
| Previous Approval | CE Mark (Europe, 2016) |
| Geography | New Zealand (strategic Asia‑Pacific market) |
Technology Profile
- Mechanism: Multi‑electrode catheter system delivering radiofrequency energy to renal nerves to modulate blood pressure
- Dual‑Approach Innovation: Transradial Artery (TRA) approach makes RDN safer, more effective, and more cost‑efficient vs. traditional transfemoral access
- Clinical Benefits: Reduced procedure time, lower complication rates, faster patient recovery
- Global Positioning: TRA capability addresses unmet need in markets with growing preference for radial access; positions IberiRDN as premium RDN solution
Market Context & Outlook
| Metric | Value |
|---|---|
| Global RDN Market | $280 million (2024) |
| Growth CAGR | 15% (2024‑2030) |
| China Hypertension Patients | 245 million; ~10% resistant to medication (24.5 million eligible) |
| China RDN Market Potential | ¥8‑12 billion (US$1.1‑1.6 billion) by 2030 |
| New Zealand Market Size | NZ$15‑20 million (US$9‑12 million) |
| Peak Sales Forecast (IberiRDN) | ¥2.5‑3.5 billion (~US$340‑480 million) globally by 2032 |
| Next Markets | Australia (TGA filing planned Q1 2026), Japan (PMDA Q3 2026) |
- Competitive Landscape: Dominated by Medtronic’s Symplicity Spyral and Recor Medical’s Paradise; IberiRDN’s dual‑approach offers differentiation
- Strategic Value: Medsafe registration provides PIC/S GMP credibility for broader Asia‑Pacific expansion
- Reimbursement Path: New Zealand’s public health system likely to adopt RDN for resistant hypertension; PHARMAC listing expected H2 2026
Forward‑Looking Statements
This brief contains forward‑looking statements regarding IberiRDN’s market penetration, regulatory expansion, and commercial potential. Actual results may differ materially due to risks including competitive dynamics, reimbursement negotiations, and adoption rates in radial‑first markets.-Fineline Info & Tech