BIOHEART-B: IBERIS® RDN system registered in the UK

Zhitong
2025.10.30 14:16
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BIOHEART-B announced that its subsidiary Antong's Iberis® RDN system has been registered with the MHRA in the UK. This system is the only renal denervation product approved for use via the radial artery and femoral artery access globally. Antong has reached a strategic cooperation with Baisheng International Group, planning to promote this product in multiple regions, with the ultimate goal of providing outpatient RDN procedures for patients worldwide

According to the Zhitong Finance APP, BIOHEART-B (02185) announced that recently, its subsidiary Shanghai Antong Medical Technology Co., Ltd. (Antong) has completed the registration of the Iberis® Radiofrequency Ablation Catheter System (Iberis® RDN System) with the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. This registration is jointly supported by Baisheng International Group Limited (Baisheng) and Antong.

Antong and Baisheng have reached a strategic partnership for the commercialization of the Iberis® RDN System, with related cooperation covering multiple regions, including but not limited to EU countries, the Asia-Pacific region, and Latin America (LATAM).

As of the date of this announcement, the Iberis® RDN System is the only renal denervation (RDN) product globally approved for use via the transradial approach (TRA) and the transfemoral approach (TFA). TRA makes RDN safer, more effective, and more affordable. The group's ultimate goal is to provide outpatient RDN procedures for patients worldwide. Antong obtained the CE mark for the Iberis® RDN System in Europe in 2016.

Baisheng is a company registered in Bermuda. Baisheng is a subsidiary of Blue Sail Medical Co., Ltd. (stock code: 002382), which is listed on the Shenzhen Stock Exchange, and one of the business entities under its cardiovascular business segment. Baisheng's operations span the globe, with its headquarters located in Singapore and its European headquarters in Morges, Switzerland. By combining a direct sales network with a global distribution network, Baisheng is committed to meeting the needs of the healthcare sector and is dedicated to supporting genuine medical education, advancing medical progress, and improving patient care through regular training courses, scientific summits, seminars, and related activities held at international forums and national levels. Baisheng also participates in major cardiology conferences worldwide in a manner that complies with all ethical and legal requirements