Nevro Announces FDA Approval of Costa Rica Manufacturing Operations
REDWOOD CITY, Calif., Oct. 4, 2022 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing 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.
Internet Posting of Information
Nevro routinely posts information that may be important to investors in the "Investor Relations" section of its website at www.nevro.com. The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro.
About Nevro
Headquartered in Redwood City, California, Nevro is a global medical device company focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 80,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy.
Senza®, Senza II®, and Senza Omnia™ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's unique support services provide every patient with an HFX Coach™ throughout their pain relief journey and every physician with HFX Cloud™ insights for enhanced patient and practice management.
Senza, Senza II, Senza Omnia, HFX, HFX Coach, HFX Cloud, HFX Connect, Nevro and the Nevro logo are trademarks of Nevro Corp.
To learn more about Nevro, connect with us on LinkedIn, Twitter, Facebook and Instagram.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements reflecting the company's current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: the Company's belief that the Costa Rica 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; the Company's expectation that 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; the Company's expectation that, beginning in the second half of 2023, it will see gross margin expansion increasing from the high 60s% to the mid-70s% over the subsequent three to five years; and that the Costa Rica 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. These forward-looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to successfully commercialize our products; our ability to manufacture our products to meet demand; the level and availability of third-party payor reimbursement for our products; our ability to effectively manage our anticipated growth and the costs and expenses of operating our business; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These factors, together with those that are described in greater detail in our Annual Report on Form 10-K filed on February 23, 2022, as well as any reports that we may file with the Securities and Exchange Commission in the future, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
Investors and Media:
Julie Dewey, IRC
Nevro Corp.
Chief Corp Communications and Investor Relations Officer
650-433-3247 | julie.dewey@nevro.com
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SOURCE Nevro Corp.
