Nevro, a global medical device company specializing in solutions for the treatment of chronic pain, announced today that the U.S. Food and Drug Administration (FDA) has approved its manufacturing operations in Costa Rica for the production of its proprietary spinal cord stimulation systems for 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 Nevro's first global manufacturing operation, ensuring greater controls and efficiency in the manufacture of products to patients around the world and augmenting its already strong 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, with a gradual ramp-up of production for the balance of the year and throughout 2023. Beginning in the second half of 2023 the company expects to see gross margin expansion, increasing over the subsequent three to five years from the high 60s% to the mid-70s%.
"This investment will allow us to continue to accomplish our mission to deliver comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment," commented Christofer Christoforou, Vice President of Technical Operations of Nevro. "The capabilities and operations are fully scalable and will allow us to accommodate additional growth and expansion of our product platform."
Nevro will have invested approximately $21 million in capital and operating expense by the end of 2022 to support future growth initiatives at this facility to ensure greater controls and efficiency in the manufacture of products to patients around the world. The company currently employs approximately 100 employees at the 41,000-square-foot space.