By Fineline Cube 
Shanghai Bio‑Heart Biological Technology Co., Ltd. (HKG: 2185) announced that its subsidiary, Shanghai AngioCare Medical Technology Co., Ltd., has secured registration with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the Iberis Multipolar Renal Denervation Catheter System (Iberis RDN System). The system, the only RDN device globally cleared for both Transradial Approach (TRA) and Transfemoral Artery (TFA) access, is now positioned for broader commercialization across the European Union, Asia‑Pacific, and Latin America through a new partnership with Biosensors International Group, Ltd.
Key Highlights
- MHRA Registration – The Iberis RDN System has met all UK regulatory requirements, enabling immediate availability to UK clinicians and patients.
- Global Partnership – AngioCare and Biosensors have agreed to collaborate on commercialization across multiple regions, leveraging Biosensors’ extensive global distribution network.
- Dual‑Access Advantage – TRA offers a safer, more effective, and cost‑efficient approach to renal denervation; the Iberis system’s unique dual‑access capability positions it as the only product that can meet diverse clinical preferences worldwide.
- Regulatory Milestone – The device previously received a CE mark in 2016 (ATON) and now adds the UK MHRA endorsement, solidifying its status as a leading RDN solution.
About the Iberis RDN System
- Multipolar Catheter – Delivers precise, multi‑point renal nerve ablation in a single session.
- Transradial & Transfemoral Compatibility – Allows clinicians to choose the most appropriate vascular access based on patient anatomy and operator skill.
- Clinical Efficacy – Early‑phase studies demonstrate durable blood‑pressure reductions and a favorable safety profile.
Strategic Implications
- Market Expansion – UK approval opens the door to the largest single‑market RDN demand in Europe, creating a launchpad for further EU, APAC, and LATAM penetration.
- Competitive Edge – By offering both TRA and TFA, Iberis differentiates itself from competitors that support only one access route.
- Revenue Growth – The partnership with Biosensors is expected to accelerate sales velocity and expand the system’s global footprint.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech