Workflow
Iberis®RDN系统
icon
Search documents
百心安-B(02185.HK)IBERIS®RDN系统在英国注册
Ge Long Hui· 2025-10-30 14:16
Core Viewpoint - The company announced that its subsidiary, Shanghai Antong Medical Technology Co., Ltd., has successfully registered the Iberis® Renal Denervation (RDN) System with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) [1] Group 1: Product Development - The Iberis® RDN System is the only globally approved renal denervation product that can be used via both transradial access (TRA) and transfemoral access (TFA) methods [1] - TRA enhances the safety, efficacy, and cost-effectiveness of RDN procedures [1] Group 2: Strategic Partnerships - The company has formed a strategic partnership with Bosheng International Group Limited to commercialize the Iberis® RDN System across multiple regions, including but not limited to EU countries, the Asia-Pacific region, and Latin America (LATAM) [1] Group 3: Regulatory Milestones - The Iberis® RDN System received its CE mark in Europe in 2016, indicating its compliance with health and safety standards [1]
百心安-B(02185.HK)IBERIS®RDN系统在瑞士完成市场准入及首例商业化手术
Ge Long Hui· 2025-10-23 11:43
Core Viewpoint - The announcement highlights the successful market entry and commercialization of the Iberis® RDN system by the company's subsidiary, Shanghai Antong Medical Technology Co., Ltd, in Switzerland, marking a significant milestone in the company's product development and market strategy [1] Group 1: Product Development - The Iberis® RDN system has completed market access and the first commercial procedure in Switzerland, performed at the University Hospital of Basel, with no reported complications or adverse events [1] - The Iberis® RDN system is the only renal denervation (RDN) product globally approved for both transradial access (TRA) and transfemoral access (TFA) methods, enhancing safety, efficacy, and cost-effectiveness [1] Group 2: Strategic Partnerships - The company has established a strategic partnership with Bosheng International Group for the commercialization of the Iberis® RDN system, covering multiple regions including the EU, Asia-Pacific, and Latin America [1] Group 3: Regulatory Approvals - The Iberis® RDN system received CE marking in Europe in 2016, indicating its compliance with health, safety, and environmental protection standards for products sold within the European Economic Area [1]
百心安-B(02185.HK):IBERIS®RDN系统产品上市会于OCC 2025会议举行
Ge Long Hui· 2025-06-03 14:43
Core Viewpoint - The announcement highlights the upcoming launch of the Iberis® RDN system, a renal denervation product developed by Shanghai Antong Medical Technology Co., Ltd., scheduled for presentation at the OCC2025 conference on May 31, 2025 [1][2] Group 1: Product Launch and Event Details - The Iberis® RDN system is set to be introduced at the 19th Oriental Cardiology Conference (OCC2025) [1] - The launch event will feature prominent medical professionals as chairs and speakers, including professors from Fudan University, Zhejiang University, and Basel University [1] - The event will be hosted by Professor Liu Jian from Peking University People's Hospital [1] Group 2: Product Features and Market Strategy - The Iberis® RDN system is the only globally approved renal denervation product compatible with both transradial access (TRA) and femoral access [2] - TRA enhances the safety, efficacy, and cost-effectiveness of renal denervation procedures [2] - The product will be jointly promoted in China by Antong Medical and Kainow Medical Technology (Wuhan) Co., Ltd., a subsidiary of United Pharmaceutical Group [2]