Nevro's HFX iQ™ Spinal Cord Stimulation with AI Technology Receives CE Mark Certification in Europe, Increasing Product Expansion Globally
Nevro Corp. (NYSE: NVRO) has received CE Mark Certification in Europe for its HFX iQ™ spinal cord stimulation (SCS) system, enabling marketing in all CE-recognizing countries. HFX iQ is the first SCS system with AI technology combining high-frequency therapy with cloud data insights for personalized pain relief. The system features indication-specific algorithms, customized therapy adjustments through the HFX App, and the only 10 kHz Therapy with CE-marked labeling for all major SCS indications. Market launch in select European countries is planned for Q1 2025. The system previously received FDA approval in 2022.
Nevro Corp. (NYSE: NVRO) ha ricevuto la certificazione CE in Europa per il suo sistema di stimolazione del midollo spinale HFX iQ™ (SCS), che consente la commercializzazione in tutti i paesi che riconoscono il marchio CE. HFX iQ è il primo sistema SCS con tecnologia IA che combina la terapia ad alta frequenza con analisi dei dati nel cloud per un sollievo dal dolore personalizzato. Il sistema presenta algoritmi specifici per le indicazioni, regolazioni della terapia personalizzate tramite l'app HFX, e l'unica Terapia a 10 kHz con etichetta certificata CE per tutte le principali indicazioni SCS. Il lancio sul mercato in alcuni paesi europei è previsto per il primo trimestre del 2025. Il sistema aveva già ricevuto l'approvazione della FDA nel 2022.
Nevro Corp. (NYSE: NVRO) ha recibido la certificación CE en Europa para su sistema de estimulación de la médula espinal HFX iQ™ (SCS), lo que permite su comercialización en todos los países que reconocen el marcado CE. HFX iQ es el primer sistema SCS con tecnología de IA que combina terapia de alta frecuencia con información de datos en la nube para un alivio del dolor personalizado. El sistema cuenta con algoritmos específicos para indicaciones, ajustes de terapia personalizados a través de la aplicación HFX, y la única terapia de 10 kHz con etiquetado CE para todas las principales indicaciones de SCS. El lanzamiento al mercado en ciertos países europeos está planeado para el primer trimestre de 2025. El sistema recibió anteriormente la aprobación de la FDA en 2022.
네브로(Nevro Corp. (NYSE: NVRO))가 유럽에서 HFX iQ™ 척수 자극기(SCS) 시스템에 대한 CE 마크 인증을 받았으며, 이는 CE 인증을 인정하는 모든 국가에서 마케팅을 가능하게 합니다. HFX iQ는 인공지능 기술을 결합한 최초의 SCS 시스템으로, 클라우드 데이터 인사이트와 고주파 요법을 결합하여 개인화된 통증 완화를 제공합니다. 이 시스템은 특정 적응증에 대한 알고리즘, HFX 앱을 통한 맞춤형 요법 조정 기능, 모든 주요 SCS 적응증을 위한 CE 마크가 부착된 유일한 10 kHz 요법을 특징으로 합니다. 선택된 유럽 국가에서의 시장 출시는 2025년 1분기로 예정되어 있습니다. 이 시스템은 2022년에 FDA 승인을 받았습니다.
Nevro Corp. (NYSE: NVRO) a reçu la certification CE en Europe pour son système de stimulation de la moelle épinière HFX iQ™ (SCS), permettant la commercialisation dans tous les pays qui reconnaissent la marque CE. HFX iQ est le premier système SCS avec une technologie IA combinant une thérapie à haute fréquence avec des analyses de données dans le cloud pour un soulagement de la douleur personnalisé. Le système dispose d'algorithmes spécifiques aux indications, des ajustements de thérapie personnalisés via l'application HFX, et de la seule thérapie à 10 kHz avec une étiquette marquée CE pour toutes les principales indications SCS. Le lancement sur le marché dans certains pays européens est prévu pour le premier trimestre 2025. Le système avait précédemment reçu l'approbation de la FDA en 2022.
Nevro Corp. (NYSE: NVRO) hat die CE-Zertifizierung in Europa für ihr HFX iQ™ Rückenmarksstimulationssystem (SCS) erhalten, was die Vermarktung in allen CE-anerkennenden Ländern ermöglicht. HFX iQ ist das erste SCS-System mit KI-Technologie, das hochfrequente Therapie mit Cloud-Datenanalysen zur personalisierten Schmerzbehandlung kombiniert. Das System verfügt über indikationsspezifische Algorithmen, maßgeschneiderte Therapieanpassungen über die HFX-App und die einzige 10 kHz-Therapie mit CE-zertifizierter Kennzeichnung für alle wichtigen SCS-Indikationen. Der Marktstart in ausgewählten europäischen Ländern ist für das erste Quartal 2025 geplant. Das System erhielt zuvor 2022 die FDA-Zulassung.
- First-to-market AI-powered SCS system in Europe through CE Mark approval
- Expansion into European markets starting Q1 2025
- Broadest range of frequencies among SCS systems in the market
- System built on data from 20 million data points and 80,000 implanted patients
- Market launch delayed until Q1 2025
- initial rollout to select European countries only
Insights
The CE Mark certification for HFX iQ represents a significant technological advancement in the
The system's ability to provide real-time programming adjustments through a smartphone app and its comprehensive coverage of all major SCS indications positions Nevro competitively against market leaders Medtronic and Boston Scientific. The timing of the European launch in Q1 2025 allows for proper market preparation and training infrastructure development.
However, with Nevro's current market cap of just
This regulatory milestone opens up significant market opportunities in Europe, where chronic pain affects approximately
The system's ability to reduce in-person programming visits aligns with European healthcare systems' focus on cost efficiency and resource optimization. This could accelerate adoption among both public and private healthcare providers. However, success will require substantial investment in physician education and patient awareness programs.
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*
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
"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
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
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.
- Patients used a Senza, Senza II, or Omnia device offering 10 kHz Therapy.
Internet Posting of Information
Nevro routinely posts information that may be important to investors in the "Investors" 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
Nevro recently added a minimally invasive treatment option for patients in the
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.
To learn more about Nevro, connect with us on LinkedIn, X, Facebook, and Instagram.
Investors and Media:
Angie McCabe
Vice President, Investor Relations & Corporate Communications
angeline.mccabe@nevro.com
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SOURCE Nevro Corp.
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