康沣生物-B(06922):冷冻粘连治疗系统的一次性使用冷冻探头变更注册获得国家药监局批文

智通财经
Aug 07

智通财经APP讯,康沣生物-B(06922)公布,继该集团的冷冻粘连治疗系统,该集团的呼吸介入产品之一,的其他部件(即一次性使用冷冻探头)于2024年1月9日获得国家药品监督管理局授出的批文后,一次性使用冷冻探头注册变更为冷冻探头已于2025年8月5日获得国家药监局授出的批文。

在获得国家药监局授出的该等批文后,该集团的冷冻粘连治疗系统商业化路径将更加完善,冷冻探头将以一次性及重复使用的产品特性对相关适应症进行全面覆盖。

冷冻粘连治疗系统采用亚临界制冷技术及控压传热技术进行快速冷冻粘连,将用于气道内异物、黏液、血液凝块和坏死组织的冷冻去除以及支气管和肺部组织的冷冻活检。

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