Nevro Announces FDA Approval of HFX iQ™ Spinal Cord Stimulation System to Personalize Chronic Pain Treatment

New Generation Senza® HFX iQ™ is the first and only SCS system that uses artificial intelligence to optimize and maintain pain relief using each patient’s response

REDWOOD CITY, CA., October 12, 2022 /PRNewswire/ — Nevro Corp. (NYSE: NVRO), a global medical device company that provides breakthrough, comprehensive solutions for the treatment of chronic pain, today announced that it has received U.S. Food and Drug Administration (FDA) clearance. for the Senza HFX iQ Spinal Cord Stimulation (SCS) System.

Senza HFX iQ is the first and only AI-based SCS system that learns from patients. It was developed to address patient-to-patient variability in pain and to help patients optimize and maintain long-term pain relief and improved quality of life. The Senza HFX iQ System is comprised of the HFX iQ Implantable Pulse Generator (IPG), HFX Trial Stimulator, Charger and HFX App and will be launched with algorithms specifically for the treatment of chronic back pain and to the legs, including non-surgical back pain and painful diabetic neuropathy. .

Senza HFX iQ is digital and designed to optimize care by collecting patient data and guiding the patient through a personalized treatment journey. It offers several key advantages over other SCS systems:

  • Patients begin the program most likely to relieve pain, based on the HFX™ algorithm, which was built from over 20 million data points and 80,000 implanted patients;
  • Recommends personalized therapy adjustments informed by patient inputs on the HFX app, including percent pain relief, pain score, change in activity levels, and change in pain medications;
  • Directly adjusts the pain relief schedule on the patient’s IPG from the HFX app on their smartphone, without the need for a separate handheld remote;
  • Captures patient and device data to enable sharing of patient-level results with referring and referring physicians; and
  • Provides a connected digital environment around a patient’s therapy that will enable future updates to the HFX algorithm, as well as new features and capabilities for patients and providers.

“HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalizes care,” said D. Keith Grossman, Chairman and CEO of Nevro. “Pain is variable from patient to patient and over time. Using big data from our HFX Cloud patient database, our unique HFX algorithm was developed to identify programs where patients were most likely to achieve real-world relief.HFX iQ takes direct input from each patient on their pain and quality of life metrics to become smarter over time and recommend program changes.HFX iQ uses our platform superior 10kHz high frequency therapy, which is proven in clinical trials and further supported by real worldwide evidence from over 90,000 implanted patients.With HFX iQ, our goal is to provide physicians and patients the personalization needed to achieve and maintain the best possible long-term results.We believe that HFX iQ represents the future of SCS therapy.

Nevro will launch a limited version of Senza HFX iQ in the US this quarter, with a broad US market launch planned for early 2023. In addition to US approval for HFX iQ, Nevro has submitted an application for approval in Europe.

Publication of information on the Internet

Nevro periodically 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 periodically check Nevro’s website for important information about Nevro.

About Neuro

Based at Redwood City, California, Nevro is a global medical device company focused on providing comprehensive, life-changing solutions that continue to set the standard for lasting patient outcomes in the treatment of chronic pain. The company started with a simple mission to help more patients with debilitating pain and developed its proprietary 10 kHz therapy, an evidence-based, non-pharmacological innovation that has impacted the lives of more than 90,000 patients worldwide. the world. 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®, Senza Omnia™ and HFX iQ™ are the only SCS systems that deliver Nevro’s exclusive 10 kHz therapy. Nevro’s unique support services provide every patient with an HFX Coach™ along their pain relief journey and every physician with HFX Cloud™ insights for better patient and practice management.

SENZA, SENZA II, SENZA OMNIA, OMNIA, HF10, the HF10 logo, 10 kHz Therapy, HFX, the HFX logo, HFX iQ, the HFX iQ logo, HFX Algorithm, HFX CONNECT, the HFX Connect logo, HFX ACCESS, the HFX The Access logo, HFX COACH, the HFX Coach logo, HFX CLOUD, the HFX Cloud logo, RELIEF MULTIPLIED, the X logo, NEVRO and the NEVRO logo are trademarks or registered trademarks of Nevro Corp. Patents covering Senza HFX iQ and other Nevro products are listed at Nevro.com/patents.

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Forward-looking statements

In addition to historical information, this press release contains forward-looking statements reflecting the company’s current beliefs and management’s expectations under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: our belief that HFX iQ represents the future of SCS therapy; and our expectation that we will launch a limited launch of Senza HFX iQ in the United States this quarter, with a broad U.S. market launch expected in early 2023. These forward-looking statements are based on information 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 market our products; our ability to manufacture our products to meet demand; the level and availability of third-party payment 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 availability of capital and credit; our ability to attract and retain qualified personnel; and product liability claims. These factors, together with those more fully described in our Annual Report on Form 10-K filed on February 23, 2022, and any reports we may file with the Securities and Exchange Commission in the future, could 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 these forward-looking statements.

Investors and media:
Julie DeweySHOUT
Nevro Corp.
Director of Communications and Investor Relations
650-433-3247 | [email protected]

SOURCENevro Corp.

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