HFX iQ utilizes AI, high-frequency (10 kHz) therapy and ongoing cloud insights to deliver personalized pain relief. It features an implantable pulse generator (IPG), trial stimulator and application. It includes a new, Bluetooth-enabled IPG, that offers upgrades and direct connection to the HFX app. Each patient can input assessments into their smartphone and receive adjustments in real-time.
The system utilizes the HFX algorithm to select programs most likely to provide pain relief for patients. Nevro built this on more than 20 million data points and 80,000 implanted patients. The system combines clinical inputs like pain relief and pain score to provide an individualized program setting.
Redwood City, California–based Nevro won FDA approval for HFX iQ in October 2022 and commenced a full launch in March 2023. It plans to kick off a launch in select European countries in the first quarter of 2025.
“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 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.”
Nevro also reports third-quarter earnings
The company’s third-quarter earnings, announced after hours on Nov. 11, came in ahead of the consensus forecast on Wall Street.
Nevro reported losses of $15.3 million. That equals 41¢ per share on sales of $96.9 million for the three months ended Sept. 30, 2024. It recorded a 34.6% bottom-line gain on a sales decrease of 6.7%.
Adjusted to exclude one-time items, earnings per share came in at 51¢. That landed 31¢ ahead of expectations on Wall Street. Sales also topped the forecast as experts projected $92.9 million in revenue.
Nevro reaffirmed its full-year revenue guidance range for between $400 million and $405 million.
A key highlight of the quarter came right at the end when Nevro won FDA approval for HFX AdaptiveAI, an AI-powered, personalized pain management platform for spinal cord stimulation. The company expects to fully launch HFX AdaptiveAI by the end of this month.
“We continue to make improvements in our commercial execution and allocation of marketing resources to address ongoing market challenges and return to top-line growth,” Thornal said. “We are excited about our recent limited market launch of HFX AdaptivAI, the only artificial intelligence (AI)-driven technology in spinal cord stimulation, which delivers responsive and personalized pain relief in real-time.”
Thornal also touched on the company’s effort to seek out broader options alongside its current standalone path, which he first revealed in August.
“In addition, we continue to explore strategic options to accelerate our growth, diversify our product portfolio and deliver shareholder value. While this process is ongoing and we are in discussions, we remain focused on our strategy to become the leading provider of treatment options with the most diversified, differentiated and innovative product portfolio in the pain management space,” Thornal said.
NVRO shares were down more than 1% to $5.24 apiece near the close of trading today.
