China-based Shanghai Bio-Heart Biological Technology Co., Ltd (HKG: 2185) has announced receiving ethical approval from Ruijin Hospital’s Hainan branch for its Iberis multi-electrode renal radiofrequency denervation (RDN) system. The company is on the brink of applying for clinical emergence use with the Hainan Medical Products Administration and Hainan’s health commission.
Product Profile
Bio-Heart Bio’s RDN product previously obtained CE certification from the European Union in 2016. This certification indicates that the product meets the necessary safety and performance standards, positioning it for potential approval in the Bo’Ao Lecheng Medical Tourism Pilot Zone, in accordance with relevant policies. The Iberis system is designed to treat hypertension through renal denervation, offering a minimally invasive alternative to traditional therapies.
Future Implications
The ethical approval from Ruijin Hospital’s Hainan branch marks a significant step forward for Bio-Heart Bio in expanding its presence in the Chinese market. The company’s Iberis RDN system is poised to benefit from the growing demand for innovative medical devices in the region, particularly in the treatment of hypertension. This development underscores Bio-Heart Bio’s commitment to advancing medical technology and improving patient outcomes.-Fineline Info & Tech
