脉冲场消融(PFA)技术

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再融2.5亿!创新消融企业完成B轮
思宇MedTech· 2025-07-04 08:37
Core Viewpoint - Field Medical has successfully completed a $35 million Series B financing round, bringing its total funding to $75 million, aimed at advancing its FieldForce™ ablation system and initiating the VERITAS clinical trial for treating complex arrhythmias, particularly ventricular tachycardia (VT) [1][4][6]. Financing Details - Field Medical, founded in 2022 by Steven Mickelsen, focuses on developing pulse field ablation (PFA) technology for arrhythmia treatment, with its core product being the FieldForce™ ablation system [2][6]. - The Series B financing was led by BioStar Capital and Cue Growth, with participation from existing strategic investors, to support the development of the FieldForce™ system and the upcoming VERITAS clinical trial [4][6]. Clinical Trials and Research - The VERITAS clinical trial is a pivotal study designed to validate the safety and efficacy of the FieldForce™ system in treating complex arrhythmias, marking a significant step towards clinical validation [4][6]. - Field Medical has initiated its first human study, the Ventricular Catheter Ablation Study (VCAS), in May 2024, aiming to demonstrate the safety and performance of its PFA system [17][18]. Technology Overview - The FieldForce™ system utilizes innovative PFA technology designed specifically for the ventricles, aiming to provide a safer and more effective treatment option for ventricular tachycardia [10][16]. - The FieldBending technology enhances the PFA catheter's performance by improving contact force with the tissue, which is crucial for effective treatment [11][16]. Market Potential - The VT market is characterized by high clinical demand and a lack of adequate treatment tools, similar to the early stages of the atrial fibrillation market, presenting a significant opportunity for Field Medical [7][8]. - Initial data from the FieldForce system shows promising potential to transform traditional catheter ablation procedures for complex ventricular arrhythmias, possibly exceeding current care standards [22].
惠泰医疗20250703
2025-07-03 15:28
Summary of Huatai Medical Conference Call Company and Industry Overview - **Company**: Huatai Medical - **Industry**: Electrophysiology and Medical Devices Key Points and Arguments 1. **PFA Product Approval**: Huatai Medical's PFA product is expected to be approved for market launch by the end of 2024, offering differentiated advantages in general anesthesia, pressure sensing, and 3D mapping, which align closely with domestic clinical practices, potentially allowing for a competitive edge over foreign manufacturers [2][3][4] 2. **PFA Technology Advantages**: PFA technology induces myocardial cell death through high-voltage electrical pulses, providing high tissue selectivity, good safety, and reduced reliance on thermal energy, which shortens surgery time and lowers the experience requirement for operators [2][4][10] 3. **Market Growth**: The global electrophysiology market was approximately $8 billion in 2023, with a projected compound annual growth rate (CAGR) of 13% from 2024 to 2026. The atrial fibrillation market is expected to grow rapidly, with PFA technology's market share anticipated to rise from less than 5% currently to 40%-60% by 2026, and potentially 60%-80% by 2028 [2][10] 4. **Domestic Patient Statistics**: In 2022, there were 8.32 million hospitalized patients with arrhythmias in China, with a continuous increase in catheter ablation procedures. The long-term potential for PFA procedures in China is estimated to reach between 800,000 and 1.02 million cases, translating to a market size exceeding 10 billion RMB [2][11][12] 5. **Competitive Landscape**: Domestic companies like Huatai Medical, Jinjiang Electronics, and Denovo have received NMPA approval for their PFA systems, showcasing differentiated advantages that align with local clinical habits, which may lead to significant changes in the domestic electrophysiology landscape [2][6][14] 6. **Sales and Marketing Strategy**: Huatai Medical has a sales team of over 200, with a focus on PFA products. The company aims to establish a minimum of 3,000 terminal orders for the year, indicating strong promotional efforts and positive reception from doctors regarding their 3D mapping technology and product combinations [4][18] 7. **Other Business Segments**: Besides electrophysiology, Huatai Medical has strong performance in other segments, including coronary intervention with over 15% market share, peripheral intervention at about 5%, and urological stone products at around 20% [19] 8. **Future Development Directions**: The company plans to focus on expanding its product coverage in vascular access and stent markets, while also developing non-vascular intervention products, indicating a strategy for diversified growth [20] Additional Important Information - **Clinical Value of PFA**: PFA technology offers significant clinical value compared to traditional RF ablation, with faster ablation times and reduced overall procedure durations, making it more appealing to domestic physicians [17] - **Market Penetration**: The penetration of PFA technology in the Chinese market is expected to mirror that of Japan, with substantial growth potential in the coming years [12][14] - **Product Design Differences**: Domestic manufacturers have advantages in mapping, modeling, and compatibility design, with Huatai Medical's products being the only ones featuring a 3D mapping platform, which aligns with traditional RF ablation practices [15][16]
融资近3亿!创新消融企业完成A轮
思宇MedTech· 2025-04-23 07:04
报名:首届全球骨科大会 | 参会须知 报名:首届全球心血管大会 | 重磅亮点 合作伙伴征集:2025全球手术机器人大会 2025年4月21日, 脉冲场导管消融领域的创新公司 Field Medical 宣布成功完成了 4000万美元(合约 2.9亿人民币) 的A轮融资。参与本轮融资的包括行业战略投资者、风险投资公司等,多位种子轮投资者 再次投资,凸显了对公司技术的强烈信心。 # 融资详情 这笔资金将支持 完成两项初步研究: 针对心室性心动过速(VT)的VCAS研究和针对房颤(AF)的 Field PULSE研究。 同时还将继续推进Field公司商业脉冲场消融(PFA)系统的开发以及 扩大运营规模,为公司即将开展的 以VT为重点的 关键性试验VERITAS 做好准备。 Field Medical的创始人兼首席执行官Steven Mickelsen博士表示,"这笔融资是我们重新定义电生理学 家对待消融疗法方式的关键一步, 我们正在加速FieldForce ™ 消融系统的开发,努力扩大 新一代脉冲场消融(PFA)解决方案在心脏消融领域的适用范围。" Field Force是Field Medical的核心产品,是 ...
获批CE!雅培首款球囊形PFA重磅上市
思宇MedTech· 2025-03-28 06:41
报名:首届全球眼科大会 | 议程更新 报名:首届全球心血管大会 | 奖项申报 报名:首届全球骨科大会 | 奖项评选 合作伙伴征集:2025全球手术机器人大会 2025年3月27日,雅培(纽约证券交易所代码:ABT)宣布其 Volt 脉冲场消融(PFA)系统 已获得欧洲 的 CE 认证。 该公司已经开始与之前在雅培 PFA 临床试验中使用过 Volt 系统的医生合作开展商业 PFA 病例。雅培计 划2025年下半年将扩大该系统在欧洲市场的推广范围。 # Vo l t P FA 系 统 PFA 是一种非热消融技术,通过向心脏组织的靶向区域输送高能量电脉冲,破坏导致心律失常的异常电 信号。 与传统的热消融方法相比,PFA 降低了损伤邻近组织的风险,使其成为具有复杂心脏解剖结构或疾病的 患者的有吸引力的选择。 产品特点 Volt PFA的消融导管远端是一个 球囊 ,而非其他异型形状(如环形、花型等)。球囊上贴合了 8个 消融带状电极,导管能够与肺静脉前庭紧密贴合,高效地将能量直接传递至目标组织, 减少消融过程中所需的治疗应用次数。 接受Volt PFA导管(传感器增强型)微创消融手术的患者可以根据医生和医院的偏好选择 ...