恒旭资本投资的励楷科技Skathi™远端通路导管获得美国FDA批准

2022-06-12

2022年6月,励楷科技Skathi™远端通路导管获美国食品药品监督管理局FDA 510(k) 上市许可。

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Skathi™远端通路导管作为励楷科技自主研发生产的首个成功商业化产品,此前已在2021年7月获NMPA批准于中国上市,并在一年不到的时间里,以稳定优异的临床性能,得到了众多国内神经介入医师的充分肯定。此次获美国FDA 510(k)上市许可的导管产品为励楷科技美国分公司生产及销售,产品设计和生产工艺与国内一致,展现了其过硬的产品性能和励楷高标准的生产体系,同时也彰显了励楷科技成熟高效的技术平台与放眼全球的战略布局。

     

2021年至今,恒旭资本先后参与励凯科技B轮及B+轮融资。励楷科技最大的亮点,不仅在于优秀的创始人以及核心研发团队,以及全球化的研发、技术引进与注册/销售布局;更在于企业发展的核心指导思想:即专注于底层技术的开发积累,并以此实现产品管线迅速、持续的迭代能力。


励楷科技创始人兼CEO 刘安表示:“Skathi™远端通路导管获得了美国 FDA 510(k) 的批准,这是公司的第一个海外批准,公司的国际化布局实现了又一个重要的里程碑。”

 

    

恒旭认为:
神经介入行业是快速发展的刚需市场,空间广阔但企业竞争激烈。本次励楷科技Skathi™远端通路导管获美国食品药品监督管理局FDA的批准让我们看到了企业完善的注册报证体系以及中美双报的能力。我们坚定看好励楷在未来推出的一系列新产品,以及未来的医疗器械创新平台愿景。

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3.Thank you for your kind support and attention. If you find any abnormal identity or information, please contact us for verification in a timely manner. At the same time, we encourage you to actively provide information and report aforementioned illegal activities at +86-21-22016849. Victim is requested to report to local police promptly to protect your own interests, and  ensure offenders are held accountable as soon as possible.

 

Shanghai SAIC Hengxu Capital Co., Ltd.

Aug. 22, 2022