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。
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。”
Statement:
It has been discovered that some entities or individuals maliciously impersonate our company and our employees, and conduct illegal financing through live broadcasts on the internet to profit illegally. Such illegal behavior has seriously damaged our image. We kindly remind you not to believe in information released other than our official channels, official channels of Hengxu Capital include - website: www.hengxucapital.com; WeChat account: Hengxu Capital (ID: Hengxucapital). Our solemn statement:
1.Illegal behavior carried out by anyone who impersonates our company or our employees will be subject to legal action and take legal responsibility for rights infringement, we pursue protecting the legitimate rights and interests of our company and our personnel. Hengxu Capital will not tolerate such illegal activities, we have taken and will continue to take legal action to pursue the legal responsibility of individuals or entities engaged in such illegal activities.
2.Hengxu Capital is a private equity and venture capital fund manager registered with Asset Management Association of China, and conducts business strictly in accordance with relevant regulatory requirements. To avoid losses, we would like to remind investors to be vigilant and invest through legal and legitimate channels, and not believe in false information obtained from non-official channels of Hengxu Capital.
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