Shanghai Bio-heart (2185) Announces Iberis® RDN System Registration in New Zealand

Bulletin Express

Nov 26

Shanghai Bio-heart Biological Technology Co., Ltd. (2185) announced that Iberis® Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System, developed by its subsidiary Shanghai AngioCare Medical Technology Co., Ltd., has completed registration with the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).

According to the announcement dated November 26, 2025, Iberis® RDN system is currently the only renal denervation product approved globally incorporating both transradial (TRA) and transfemoral (TFA) approaches. The statement highlights that Iberis® received CE marking in 2016 and emphasizes a goal of making outpatient RDN procedures accessible worldwide.

The company also reminds investors that there is no guarantee of successful commercialization of Iberis® RDN system and advises due caution in dealing with the company’s shares.

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