Bio-heart secures Israeli registration for Iberis® RDN system, strengthening global rollout with Biosensors partnership

Bulletin Express

Jun 09

Shanghai Bio-heart Biological Technology Co., Ltd. (Bio-heart) announced that its subsidiary, Shanghai AngioCare Medical Technology Co., Ltd., has completed product registration in Israel for the Iberis® Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System (Iberis® RDN system).

The Iberis® RDN system is currently the only renal denervation product approved worldwide for use via both the transradial (TRA) and transfemoral (TFA) approaches. According to the company, the TRA route offers the potential for safer, more effective and lower-cost outpatient RDN procedures.

Commercialization is being advanced through an existing strategic partnership between AngioCare and Biosensors International Group, Ltd. The agreement covers multiple territories, including the European Union, Asia-Pacific and Latin American regions. The Israeli registration adds to the device’s CE mark, obtained in Europe in 2016, further broadening its international regulatory footprint.

Biosensors, a subsidiary of Shenzhen-listed Bule Sail Medical Co., Ltd., supports the global rollout through its combined direct sales network and distributor relationships. The company operates from its headquarters in Singapore with European operations in Morges, Switzerland.

Bio-heart cautioned that, under Hong Kong Listing Rule 18A.05, successful registration does not guarantee eventual commercial success and advised shareholders and potential investors to exercise caution when dealing in its shares.

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(Bio-heart) announced that its subsidiary, Shanghai AngioCare Medical Technology Co., Ltd., has completed product registration in Israel for the Iberis® Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System (Iberis® RDN system).</p>\n<p>The Iberis® RDN system is currently the only renal denervation product approved worldwide for use via both the transradial (TRA) and transfemoral (TFA) approaches. According to the company, the TRA route offers the potential for safer, more effective and lower-cost outpatient RDN procedures.</p>\n<p>Commercialization is being advanced through an existing strategic partnership between AngioCare and Biosensors International Group, Ltd. The agreement covers multiple territories, including the European Union, Asia-Pacific and Latin American regions. 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