Shawn Fan

公司简介 杭州睿笛生物科技有限公司（简称“睿笛生物”）成立于2014年，由英美海归科学家团队创立，是一家专注于脉冲电场能量平台技术的国家高新技术企业。公司致力于微创介入高端医疗器械的研发与创新，推动脉冲电场技术在肿瘤、心血管、神经系统疾病等领域的生物医药转化应用。 愿景与使命 睿笛生物以“创新脉冲电场技术，引领精准微创治疗”为使命，持续推动全球医疗技术革新，为临床提供更安全、更有效的治疗解决方案。 核心技术与产品布局  睿笛生物依托全球领先的下一代脉冲电场消融技术平台，构建了硬件+软件协同开发能力，已布局肿瘤、房颤、慢性脑病等多个创新产品管线，并进入国家创新医疗器械特别审批通道。  肝癌纳秒刀：2024年底获中国国家药监局（NMPA）第三类医疗器械注册证，并同时获得中国NMPA & 美国FDA“突破性医疗器械”双认证。  AI+纳秒刀：2024年5月获联合国AI for Good全球峰会（日内瓦）优秀案例奖，技术获国际高度认可。 研发实力与产业化能力  研发基地：位于杭州未来科技城海创园，配备GMP万级洁净车间、高标准组装车间及完备检测实验室，并通过ISO13485质量管理体系认证。  科研合作：与浙江大学医学院附属第一医院共建“脉冲电场技术医学转化省级重点实验室”，承担国家自然科学基金、国家重大科技专项等十余项国家级科研项目。  知识产权：累计申请专利近300项，并布局PCT国际专利，加速推进CE认证，拓展欧美市场。 荣誉与资本认可 政府认定：  浙江省专精特新中小企业  杭州市准独角兽企业  杭州市企业高新技术研发中心  杭州市博士创新站  浙江省转化医学科学技术特等奖 资本支持：获知名投资机构多轮融资，彰显资本市场对公司技术前景的坚定信心。 公司网页：http://www.r-ablation.com/ Hangzhou Ruide Biotechnology Co., Ltd. – Company Profile Company Overview Hangzhou Ruide Biotechnology Co., Ltd. (“Ruide Bio”), founded in 2014 by a team of overseas returnee scientists from the UK and the US, is a National High-Tech Enterprise specializing in pulsed electric field (PEF) energy platform technology. The company is dedicated to the R&D and innovation of minimally invasive high-end medical devices, advancing the biomedical applications of PEF technology in oncology, cardiovascular diseases, neurological disorders, and other therapeutic areas. Vision & Mission Guided by its mission to “Innovate Pulsed Electric Field Technology, Lead Precision Minimally Invasive Therapy,” Ruide Bio continuously drives global advancements in medical technology, delivering safer and more effective clinical solutions. Core Technologies & Product Portfolio  Ruide Bio has established hardware-software co-development capabilities based on its globally leading next-generation pulsed field ablation (PFA) platform, with multiple innovative product pipelines in tumors, atrial fibrillation (AF), and chronic brain diseases, all entering China’s Expedited Review Pathway for Innovative Medical Devices.  NanoKnife® for Liver Cancer: Obtained Class III Medical Device Registration Certificate from China’s NMPA in late 2024, alongside dual “Breakthrough Device” designations from both China NMPA and U.S. FDA.  AI + NanoKnife®: Awarded the Outstanding Case Prize at the UN AI for Good Global Summit (Geneva, May 2024), earning international acclaim. R&D Capabilities & Industrialization  R&D Base: Located in Hangzhou Future Sci-Tech City, equipped with GMP-certified 10,000-class cleanrooms, high-standard assembly workshops, and fully integrated testing laboratories, compliant with ISO 13485 Quality Management System.  Collaborations: Jointly established the “Zhejiang Provincial Key Laboratory for Pulsed Electric Field Medical Translation” with the First Affiliated Hospital of Zhejiang University School of Medicine, undertaking over 10 national projects including the National Natural Science Foundation and Major State R&D Programs.  Intellectual Property: Filed nearly 300 patents, with PCT applications targeting US and European markets, accelerating CE certification for global expansion. Honors & Capital Recognition Government Accreditations:  Zhejiang Provincial “Specialized, Refined, Differential, and Innovative” SME  Hangzhou “Potential Unicorn” Enterprise  Hangzhou High-Tech Enterprise R&D Center  Hangzhou Doctoral Innovation Station  Zhejiang Provincial Prize for Translational Medical Science & Technology Investment & Financing: Successfully secured multiple rounds of funding from leading institutional investors, demonstrating sustained market confidence in the company’s technological trajectory. Company Website: http://www.r-ablation.com/