Core Viewpoint - 百心安-B's stock price increased by over 4% following the announcement of the successful market entry and commercialization of the Iberis RDN system in Switzerland [1] Group 1: Company Developments - 百心安-B's subsidiary, Shanghai Antong Medical Technology Co., Ltd., has successfully completed the first commercial procedure using the Iberis RDN system at Basel University Hospital [1] - The procedure reported no complications or adverse events, indicating a positive outcome for the initial commercialization [1] - Antong has formed a strategic partnership with Bosheng International Group to commercialize the Iberis RDN system across multiple regions, including the EU, Asia-Pacific, and Latin America [1] Group 2: Product Information - The Iberis RDN system is the only renal denervation (RDN) product globally approved for both transradial access (TRA) and transfemoral access (TFA) methods [1] - The TRA method enhances the safety, efficacy, and cost-effectiveness of RDN procedures [1] - The ultimate goal of the company is to provide outpatient RDN surgeries for patients worldwide, with the Iberis RDN system having received CE marking in Europe in 2016 [1]

截至本公告日期，Iberis RDN系统是全球唯一获准使用经桡动脉方法(TRA)和经股动脉入路方法(TFA)的 肾神经阻断(RDN)产品。TRA使RDN更安全、更有效、更便宜。公司的最终目标是为全球患者提供门诊 RDN手术。安通已于2016年于欧洲取得Iberis RDN系统的CE标志。 安通与柏盛就Iberis RDN系统的商业化达成战略伙伴关系，相关合作涵盖多个地区，包括但不限于欧盟 国家、亚太地区及拉丁美洲(LATAM)地区。 百心安-B(02185)发布公告，最近，公司附属公司上海安通医疗科技有限公司(安通)研发的Iberis多极肾 动脉射频消融系统(Iberis RDN系统)在瑞士完成市场准入及首例商业化手术。该手术由巴塞尔大学医院 进行。概无有关并发症或不良事件的报导。该案例得到柏盛国际集团有限公司(柏盛)及安通的共同支 持。 ...

Core Viewpoint - The stock of Baixinan-B (02185) has seen a significant increase, with a rise of over 14% during trading, currently reported at 8.70 HKD, with a trading volume of 109 million HKD. This surge is attributed to positive developments in the renal denervation (RDN) market, particularly following Boston Scientific's acquisition of SoniVie for 600 million USD and updates to hypertension treatment guidelines by major American health organizations [1]. Company Summary - Baixinan's Iberis RDN system is the only globally approved device that offers both transradial (TRA) and transfemoral access for RDN, providing a significant first-mover advantage in the market [1]. - The company has established strategic partnerships with Yuan Da Health and other international entities, which are expected to accelerate its commercialization efforts [1]. Industry Summary - The RDN procedure is emerging as a new therapeutic approach for uncontrolled and resistant hypertension, with a projected market size in China exceeding 10 billion RMB by 2032, according to Frost & Sullivan [1]. - Recent updates from the American College of Cardiology and the American Heart Association have included RDN in their IIb level recommendations for hypertension treatment, indicating a growing acceptance and potential for clinical application [1]. - The proposed national coverage decision by the Centers for Medicare & Medicaid Services (CMS) in the U.S. is expected to significantly expedite the clinical promotion and application of RDN if approved [1].

Core Viewpoint - Baixinan-B (02185) has seen a significant increase of over 10%, currently up 13.5% at HKD 8.83, with a trading volume of HKD 106 million [1] Group 1: Market Developments - Boston Scientific is set to acquire SoniVie for a total price of USD 600 million by March 2025, indicating a strong entry into the RDN market [1] - The American College of Cardiology and the American Heart Association updated hypertension treatment guidelines in August, incorporating RDN as a Class IIb recommendation [1] - The proposed national coverage decision for RDN by the Centers for Medicare & Medicaid Services (CMS) in July, if approved, will significantly accelerate clinical adoption [1] Group 2: Industry Insights - Percutaneous renal denervation (RDN) is a new therapeutic device for uncontrolled and resistant hypertension [1] - According to Frost & Sullivan, the market size for RDN in China is expected to exceed RMB 10 billion by 2032 [1] - Baixinan's Iberis RDN system is the only globally approved device that can perform RDN via both transradial (TRA) and transfemoral approaches, providing a significant first-mover advantage [1] Group 3: Strategic Partnerships - Baixinan has established significant strategic partnerships with Yuan Da Health and various countries for commercial acceleration [1] - The Iberis RDN system has been included in health insurance coverage in Germany and France, further supporting Baixinan's commercialization efforts [1]

该行指出，经皮去肾交感神经术（RDN）是针对未控及顽固高血压器械新疗法。根据灼识咨询，预计 2032 年中国 RDN 年市场规模超过 100 亿元人民币。该行指出，百心安 Iberis RDN 系统是全球唯一获批 上市能兼具经桡动脉（TRA）和经股动脉双入路 RDN，先发优势显著，国内已与远大健康、海外多国 家地区联合蓝帆柏盛达成重磅战略合作；德国、法国已将 Iberis RDN 纳入医保，当前正为百心安商业 化加速起点。 华福证券发布研报称，2025年3月波士顿科学以总价6亿美元收购SoniVie积极入局RDN赛道；8月美国心 脏病学会和美国心脏协会更新高血压治疗指南并将RDN纳入指南IIb级推荐；美国医保(CMS)7月发布的 RDN国家覆盖决定拟议稿，后续若通过，临床推广应用将大幅提速。 智通财经APP获悉，百心安-B(02185)再涨超10%，截至发稿，涨13.5%，报8.83港元，成交额1.06亿港 元。 ...

Core Viewpoint - Baixinan-B (02185) has seen a nearly 10% increase in stock price, currently trading at 7.85 HKD, with a transaction volume of 11.7587 million HKD, following a strategic partnership announcement with Bluestar Medical (002382) for the Iberis RDN system [1] Company Summary - Baixinan has established a "going abroad" cooperation with Bluestar Medical, leveraging its platform capabilities and industry reputation [1] - The Iberis RDN system has achieved commercialization in countries such as Germany, Spain, and Italy, with Germany and France including it in their healthcare insurance [1] - The Iberis RDN system is the only one globally approved for both transradial (TRA) and transfemoral access routes, providing a significant first-mover advantage [1] Industry Summary - Percutaneous renal denervation (RDN) is a new therapeutic device for uncontrolled and resistant hypertension [1] - According to Frost & Sullivan, the annual market size for RDN in China is expected to exceed 10 billion RMB by 2032 [1] - The inclusion of the Iberis RDN system in the healthcare insurance of Germany and France is expected to accelerate Baixinan's commercialization efforts [1]