Core Viewpoint - The company has received approval from the National Medical Products Administration (NMPA) in China for its core product, the BroncAblate intelligent radiofrequency ablation system, marking a significant step in the commercialization of the world's first bronchoscopic radiofrequency ablation device for lung cancer treatment [1][2]. Group 1 - The BroncAblate intelligent ablation system consists of the BroncAblate intelligent catheter and the main unit, which is the first device confirmed through large-scale, high-quality clinical studies for bronchoscopic lung cancer radiofrequency ablation [1]. - The system allows real-time monitoring of the ablation area, including temperature and impedance, providing a visual representation of the treatment process and enabling intelligent adjustment of output power for stable and controllable radiofrequency energy delivery [1]. - The device aims to achieve better ablation efficacy with minimal damage and fewer complications for patients, enhancing the overall treatment experience [1]. Group 2 - The BroncAblate intelligent catheter, when connected to the main unit, utilizes saline infusion to effectively reduce impedance and deliver radiofrequency energy precisely to the tumor center in the lungs, resulting in a minimally invasive intervention for lung tumors [2]. - This innovative approach fills a global gap in the field of targeted micro-invasive therapies for lung cancer, offering significant benefits over traditional methods [2].

肺癌是全球面临的重大公共卫生问题之一，国家癌症中心公布的2022年数据显示，我国肺癌新发病例数 为106.06万例，是我国恶性肿瘤的"第一杀手"。尽管现有治疗手段多样，但这些治疗手段却面临适用人 群相对狭窄，且并发症多、治疗效果不佳等问题，BroncAblate智衡上市为患者提供超微创介入治疗解 决方案，打破了传统治疗的困境僵局。 堃博医疗-B(02216)发布公告，公司核心产品，自主研发的全球首款经自然腔道射频消融肺癌治疗器械 ——BroncAblate智衡一次性使用肺部射频消融导管(下称BroncAblate智衡)正式获得中国国家药品监督管 理局(NMPA)批准在中国上市，引领肺癌治疗进入超微创介入治疗时代。 BroncAblate智衡为全球首款通过临床研究验证的经自然腔道肺癌射频消融介入治疗器械，由公司自主 研发，通过关键技术创新，解决了此前肺部射频消融过程中，由于肺部含气量大、阻抗过高难以持续稳 定能量输出、消融范围受局限的技术难题，实现经自然腔道(支气管)将射频介入治疗导管精准送达肺部 病灶中心，通过射频消融灭活肿瘤组织，带来微创、可重复的肺部肿瘤精准靶向超微创介入疗法，成功 填补该领域的全球空白。 ...