Shanghai Bio-heart Biological Technology Co., Ltd. (2185) announced that a subsidiary of the company, Shanghai AngioCare Medical Technology Co., Ltd., in collaboration with Biosensors International Group, Ltd., has successfully registered the Iberis® Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System (Iberis® RDN system) with the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
According to the announcement, Iberis® RDN system is approved for both transradial and transfemoral approaches, and it previously received CE marking in Europe in 2016. The registration is part of a broader strategic partnership between AngioCare and Biosensors that encompasses commercialization in multiple regions, including the European Union, the Asia–Pacific region, and Latin America.
The company notes that there is no guarantee Iberis® RDN system will be successfully developed and marketed, and shareholders and potential investors are advised to exercise due care when dealing in its shares.