Nevro's HFX iQ™ Spinal Cord Stimulation with AI Technology Receives CE Mark Certification in Europe, Increasing Product Expansion Globally

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HFX iQ is the first and only spinal cord stimulation (SCS) system integrating high-frequency SCS landmark evidence with cloud data insights, leading the way for personalized, data-driven patient care*

REDWOOD CITY, Calif., Nov. 12, 2024 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that it has received CE Mark Certification in Europe for its HFX iQ™ spinal cord stimulation (SCS) system. The CE marking allows Nevro to market HFX iQ in all countries that recognize this certification.

HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief.*

"We are thrilled to receive the CE Mark Certification for HFX iQ as it marks an important milestone in our strategic path to drive market penetration through our data-backed, AI-powered SCS therapy," said Kevin Thornal, Nevro's CEO and president. "Patients in Europe suffering from chronic pain will now have access to personalized pain relief – and will be able to maintain that pain relief over time."

"HFX iQ represents a transformative advancement in how we approach chronic pain management," said Dr. Ganesan Baranidharan, anesthesia and pain management consultant at Leeds Teaching Hospital NHS Trust. "By leveraging AI technology and data-driven programming – developed using over 10 years of outcomes and real-world patient data – HFX iQ has the potential to not only help optimize healthcare resources through reduced in-person programming and unnecessary hospital visits, but it also sets new standards for earlier and effective pain management along with patient engagement in spinal cord stimulation."

HFX iQ is digitally enabled and designed to optimize care by collecting patient data and guiding the patient through a personalized treatment pathway. It provides several key advantages over other SCS systems, including:

• Indication-specific HFX Algorithms™ for back and leg pain, non-surgical refractory back pain, painful diabetic neuropathy, chronic upper limb and neck pain.
• Customized therapy adjustment recommendations informed by patient inputs on the HFX App.
• The only 10 kHz Therapy™ that has CE-marked labeling for all major SCS indications and outcomes beyond pain relief.

"With HFX iQ, we are entering a new era of patient-centered pain management," said Prof. Faycal El Majdoub, head of Stereotaxy and Functional Neurosurgery at Cologne-Merheim Medical Center. "The technology's responsiveness to individual pain levels and real-time adaptation to patient needs means empowering patients in their pain relief journey. Patients experience an enhanced quality of life with few interruptions, allowing them to reclaim their lives with confidence and with less dependence on clinical interventions. HFX iQ is truly redefining what is possible for long-term pain relief."

HFX iQ starts patients on the program most likely to provide pain relief, based on the HFX Algorithm™, which was built from more than 20 million data points and 80,000 implanted patients.¹ HFX iQ combines clinical inputs, such as pain relief and pain score, along with Quality of Life (QoL) inputs, such as pain medication and activity level changes, to provide an individualized program setting for each patient.² HFX iQ has the ability to program both low frequency and Nevro's proprietary 10 kHz Therapy, which represents the widest range of frequencies of any SCS system on the market.

The Senza HFX iQ system is comprised of the HFX iQ Implantable Pulse Generator (IPG), HFX Trial Stimulator and HFX App. With a new Bluetooth®-enabled IPG that is upgradeable and connects directly to the HFX App, each patient can input assessments into their smartphone and then receive programming adjustments in real-time.

In addition to receiving CE marking, HFX iQ received U.S. Food and Drug Administration (FDA) approval in 2022.

Nevro will offer the HFX iQ system in select European countries starting in the first quarter of 2025.

To learn more about HFX iQ in the U.K., visit http://nevro.com/English/en/providers/Product-HFX-iQ.

References

* The HFX iQ algorithm is an expert programming system designed to provide therapy recommendations with the intention to complement the role of a physician.

1. Patients used a Senza, Senza II, or Omnia device offering 10 kHz Therapy.

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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 115,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes the Senza^® SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy.

Nevro recently added a minimally invasive treatment option for patients in the U.S. suffering from chronic sacroiliac joint ("SI joint") pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients.

Senza^®, Senza II^®, Senza Omnia™, and HFX iQ 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 Nevrocloud™ insights for enhanced 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 Access logo, HFX COACH, the HFX Coach logo, Nevrocloud, RELIEF MULTIPLIED, HFX AdaptivAI, 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. Bluetooth^® and the Bluetooth symbol are registered trademarks of their respective owners.

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Angie McCabe
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SOURCE Nevro Corp.