Nevro Corporation announced recently that the US Food and Drug Administration (FDA) has approved its manufacturing operations in Costa Rica for the production of its proprietary spinal cord stimulation (SCS) systems in the treatment of chronic pain—including its HFX product platform.
This new facility, located in the Coyol Free Trade Zone in Alajuela, Costa Rica, is the company’s first global manufacturing operation. According to a Nevro press release, it will ensure greater controls and efficiency in the manufacture of products for patients around the world, augmenting existing manufacturing and supply chain partners.
“We are pleased that the FDA has approved our new global manufacturing operations in Costa Rica,” stated D Keith Grossman, chairman, CEO and president of Nevro. “As part of our growth plans moving forward, this manufacturing facility will support our pipeline of future products to ensure that we have the most efficient cost structure and flexible capacity, while maintaining the highest level of quality control as we scale. Thank you to our excellent Costa Rica team for delivering this very meaningful milestone for Nevro.”
The company anticipates it will begin shipping product by the end of October this year, with a gradual ramp-up of production for the balance of the year and throughout 2023. By the end of 2022, Nevro will have invested approximately US$21 million in capital and operating expense to support future growth initiatives at this new facility, the release adds.