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Nevro's HFX iQ Spinal Cord Stimulation System Receives CE Mark for Personalized Pain Relief

• Nevro's HFX iQ spinal cord stimulation (SCS) system, leveraging AI and high-frequency therapy, has secured CE mark in Europe for personalized pain relief. • The HFX iQ system incorporates an implantable pulse generator (IPG), trial stimulator, and app, enabling real-time adjustments based on patient input. • Built upon 20 million data points and 80,000 implanted patients, the HFX algorithm selects programs tailored to individual pain relief needs. • Nevro plans a phased launch in select European countries starting in Q1 2025, expanding access to this AI-powered SCS therapy.

Nevro (NYSE:NVRO) has announced the CE mark approval in Europe for its HFX iQ spinal cord stimulation (SCS) system, offering a new avenue for personalized pain relief. The HFX iQ system integrates artificial intelligence (AI), high-frequency (10 kHz) therapy, and cloud-based insights to optimize pain management for patients with chronic pain.

HFX iQ System Details

The HFX iQ system comprises an implantable pulse generator (IPG), a trial stimulator, and a dedicated application. The Bluetooth-enabled IPG facilitates upgrades and direct connectivity to the HFX app, allowing patients to input assessments and receive real-time adjustments. This closed-loop system aims to provide tailored pain relief based on individual patient needs.

AI-Driven Personalization

At the core of the HFX iQ system is the HFX algorithm, which selects programs most likely to alleviate pain. This algorithm is built on a foundation of over 20 million data points from 80,000 implanted patients. By combining clinical inputs, such as pain relief scores, the system delivers individualized program settings, enhancing the precision and effectiveness of the therapy.

Strategic European Launch

Following FDA approval in October 2022 and a full launch in the United States in March 2023, Nevro is now set to introduce HFX iQ to the European market. The company plans to initiate a phased launch in select European countries in the first quarter of 2025. According to Kevin Thornal, Nevro CEO and president, the CE mark is a significant milestone in the company's strategy to drive market penetration through data-backed, AI-powered SCS therapy, offering patients in Europe access to personalized pain relief solutions.

Third-Quarter Earnings

Nevro's third-quarter earnings, reported on November 11, 2024, exceeded Wall Street's consensus forecast. The company reported losses of $15.3 million, or 41 cents per share, on sales of $96.9 million for the three months ended September 30, 2024. Adjusted earnings per share were 51 cents, surpassing expectations by 31 cents. Sales also exceeded forecasts, with experts projecting $92.9 million in revenue. Nevro reaffirmed its full-year revenue guidance range of $400 million to $405 million.

HFX AdaptivAI

Nevro also recently secured FDA approval for HFX AdaptiveAI, an AI-powered, personalized pain management platform for spinal cord stimulation. The company anticipates a full launch of HFX AdaptiveAI by the end of November, further solidifying its position in the pain management space.
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Reference News

[1]
Nevro wins CE mark for HFX iQ spinal cord stim for pain relief - MassDevice
massdevice.com · Nov 12, 2024

Nevro received CE mark for its HFX iQ SCS system in Europe, featuring AI, 10 kHz therapy, and cloud insights for persona...

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