R&D and Production
  • R&D Center
  • Production

    We have an established manufacturing facility, which occupies approximately 6,206.6 sq.m. in Ningbo, Zhejiang. It is designed and built for manufacturing medical devices in compliance with GMP requirements with full manufacturing capabilities, covering production, packaging and quality assurance, and is capable of producing various products in relation to structural heart diseases. Our manufacturing facility has several production lines, including independent production lines for stents, valves, and delivery systems, respectively. There exist high entry barriers for the manufacturing of interventional structural heart devices given the stringent manufacturing standards and high quality requirements. To ensure adherence to the GMP requirements of China, the United States and the EU, we procured equipment and machinery from reputable suppliers and completed complex qualification steps to validate that the equipment and programs are installed and operated with the requisite specification. We believe our in-house manufacturing capability will help us take better control of our clinical trial progress and future commercialization.