Core Viewpoint - Bluefan Medical is set to achieve significant milestones in 2025, particularly in its cardiovascular business, which is expected to return to profitability after previous losses due to national procurement policies and global health events [1] Group 1: Financial Performance - The cardiovascular business is projected to generate approximately 1.4 billion yuan in sales for 2025, representing over a 24% increase from the previous year, positioning the company among the industry leaders [2] - Despite a one-time valuation loss of about 120 million yuan related to its investment in Suzhou Tongxin Medical Technology, the core operations of the cardiovascular division remained profitable, demonstrating strong resilience and growth potential [2] Group 2: Investment Opportunities - The company’s investment in Suzhou Tongxin Medical, a leader in the artificial heart sector, is expected to yield substantial returns as the company has submitted its prospectus for an IPO on the Sci-Tech Innovation Board [3] - The core product of Suzhou Tongxin, the CH-VAD, is the first fully magnetic levitation left ventricular assist device approved in China, with significant clinical implantation success, indicating a strategic investment payoff for Bluefan Medical [3] Group 3: Product Development and Market Expansion - Bluefan Medical has made significant strides in product approvals across various cardiovascular segments, including coronary intervention and structural heart disease, enhancing its revenue generation capabilities [4] - The company has received multiple product approvals, including the coronary artery balloon dilation catheter and the coronary artery scoring balloon, which strengthen its market position in the "intervention without implantation" trend [4] - The company’s overseas subsidiary has achieved CE certification for the Lithonic coronary intravascular shockwave therapy system, marking a significant international market entry and reinforcing its global competitive edge [5] Group 4: Sales and Market Strategy - The company has ranked highly in the latest national procurement results for high-value medical consumables, which is expected to enhance its market share in the domestic coronary intervention sector [7] - Bluefan Medical is actively building a "self-research + agency" platform to facilitate the international expansion of domestic innovative medical devices, establishing itself as a key player in the global market [8] - Collaborations with various domestic and international firms are being leveraged to create a robust platform for Chinese innovative medical devices to enter overseas markets [8] Group 5: Overall Growth and Future Outlook - 2025 is identified as a pivotal year for Bluefan Medical, with breakthroughs in profitability, product offerings, and international expansion, positioning the company for high-quality growth and enhanced overall value [8]

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。 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。集团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。 百心安-B(02185)发布公告，最近，本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 肾动脉射频消融导管系统(Iberis RDN系统)已在印度尼西亚注册。该注册得到柏盛国际集团有限公司(柏 盛)及安通的共同支持。 ...

华福证券此前发布研报称，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。 本文源自：智通财经网 智通财经获悉，百心安-B(02185)现涨超4%，截至发稿，涨4.13%，报6.56港元，成交额118.24万港元。 消息面上，百心安此前公告，附属公司上海安通医疗科技有限公司研发的Iberis 多极肾动脉射频消融导 管系统已在新西兰完成注册。Iberis RDN系统是全球唯一获准使用经桡动脉方法和经股动脉入路方法的 肾神经阻断产品。 ...

华福证券此前发布研报称，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。 智通财经APP获悉，百心安-B(02185)现涨超4%，截至发稿，涨4.13%，报6.56港元，成交额118.24万港 元。 消息面上，百心安此前公告，附属公司上海安通医疗科技有限公司研发的Iberis 多极肾动脉射频消融导 管系统已在新西兰完成注册。Iberis RDN系统是全球唯一获准使用经桡动脉方法和经股动脉入路方法的 肾神经阻断产品。 ...

消息面上，百心安此前公告，附属公司上海安通医疗科技有限公司研发的Iberis多极肾动脉射频消融导 管系统已在新西兰完成注册。Iberis RDN系统是全球唯一获准使用经桡动脉方法和经股动脉入路方法的 肾神经阻断产品。 华福证券此前发布研报称，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。 百心安-B(02185)现涨超4%，截至发稿，涨4.13%，报6.56港元，成交额118.24万港元。 ...

Core Viewpoint - The announcement highlights the registration of the Iberis RDN system in New Zealand, marking a significant milestone for the company in the renal denervation market [1] Company Summary - The Iberis RDN system, developed by the company's subsidiary Shanghai Antong Medical Technology Co., Ltd., has received approval from New Zealand's Medicines and Medical Devices Safety Authority (Medsafe) [1] - The Iberis RDN system is the only renal denervation 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 renal denervation procedures [1] - The company's ultimate goal is to provide outpatient renal denervation surgeries for patients worldwide [1] - The Iberis RDN system received CE marking in Europe in 2016, indicating its compliance with European health, safety, and environmental protection standards [1]

Core Insights - The company Baixinan-B (02185) announced that its subsidiary, Shanghai Antong Medical Technology Co., Ltd. (Antong), has successfully registered the Iberis Renal Denervation (RDN) system with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) [1] - Antong has formed a strategic partnership with Bosheng International Group Ltd. for the commercialization of the Iberis RDN system across multiple regions, including the EU, Asia-Pacific, and Latin America [1] - The Iberis RDN system is the only RDN product globally approved for both transradial access (TRA) and transfemoral access (TFA), enhancing safety, efficacy, and cost-effectiveness of the procedure [1] Company Overview - Bosheng is a Bermuda-registered company and a subsidiary of Shenzhen Stock Exchange-listed Blue Sail Medical Co., Ltd. (stock code: 002382), focusing on cardiovascular business [2] - Bosheng operates globally with its headquarters in Singapore and European headquarters in Morges, Switzerland, aiming to meet healthcare needs through a combination of direct sales and a global distribution network [2] - The company is committed to supporting medical education and advancing patient care by organizing training courses, scientific summits, and related activities at international and national levels [2]

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]

Core Viewpoint - The announcement highlights the successful market entry and first commercial procedure of the Iberis RDN system in Switzerland, marking a significant milestone for the company and its strategic partner [1] Group 1: Product Development and Approval - The Iberis RDN system, developed by Shanghai Antong Medical Technology Co., Ltd., has completed market access and the first commercial surgery in Switzerland [1] - The 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] - The company aims to provide outpatient RDN surgeries for patients worldwide [1] Group 2: Strategic Partnerships - Antong has formed a strategic partnership with Bosheng International Group, covering multiple regions including EU countries, Asia-Pacific, and Latin America (LATAM) for the commercialization of the Iberis RDN system [1] - The collaboration is expected to support the broader distribution and adoption of the Iberis RDN system in various international markets [1] Group 3: Safety and Efficacy - The first commercial procedure at Basel University Hospital reported no complications or adverse events, indicating a positive initial outcome for the Iberis RDN system [1] - The TRA method utilized in the procedure is noted to make RDN safer and more effective compared to traditional methods [1]

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].