Nevro Corp. NVRO recently received CE Mark Certification in Europe for its HFX iQ spinal cord stimulation (SCS) system. The company can now market HFX iQ in all countries that recognize this certification. Nevro plans to launch the HFX iQ system in select European countries starting first-quarter 2025.
With the latest CE Mark Certification for HFX iQ, Nevro marks a milestone in its strategic journey to drive market penetration through data-backed, AI-powered SCS therapy.
Following the announcement, shares of the company moved south 12.1% to $4.45 on Wednesday.
Nevro has been experiencing high synergies with its HFX SCS platforms. It continues to cater to a lucrative SCS therapies market. The company has developed and commercialized its HFX SCS platform, which includes the Senza SCS system. Henceforth, we expect the company’s CE Mark Certification for HFX iQ to positively impact NVRO stock in the coming days.
Meanwhile, NVRO currently has a market capitalization of $152.5 million. In the last reported quarter, it delivered an earnings surprise of 31.75%.
HFX iQ is the first and only SCS system with artificial intelligence (AI) technology. It combines high-frequency (10 kHz) therapy built on landmark evidence, using ongoing cloud data insights to provide personalized pain relief. HFX iQ has several key advantages, including an indication-specific HFX Algorithm for back and leg pain, non-surgical refractory back pain, painful diabetic neuropathy, and chronic upper limb and neck pain.
Also, HFX iQ combines clinical inputs, such as pain relief and pain score, with Quality of Life (QoL) inputs, such as pain medication and activity level changes, to provide an individualized program setting for each patient on its HFX App. HFX iQ can program both low-frequency and 10 kHz therapy. Nevro’s 10 kHz therapy has CE-marked labeling for all major SCS indications and outcomes beyond pain relief.
Additionally, HFX iQ received Food and Drug Administration (“FDA”) approval in 2022.
Per a Grand View Research report, the global SCS devices market was valued at $2.74 billion in 2023 and is projected to witness a compound annual growth rate of 7.9% from 2024 to 2030.
The major factors driving the spinal cord stimulation devices market growth are an increase in the prevalence of chronic pain, the surge in aging population, technological advancements, and a rise in awareness about spinal cord stimulation devices. Technological advancements in spinal cord stimulation devices are driving the market’s growth. New devices are being developed with advanced features like wireless connectivity, longer battery life and improved programming.
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In September, Nevro received FDA clearance and announced the limited market release of HFX iQ with HFX AdaptivAI — a responsive, personalized pain management platform powering the HFX iQ SCS system.
In the past year, NVRO’s shares have lost 75.9% against the industry’s 20 % growth.
NVRO currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Penumbra PEN, Globus Medical GMED and ResMed RMD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Penumbra shares have risen 4.4% compared to the industry’s 20% growth over the past year. Estimates for the company’s earnings per share (EPS) have jumped 7.7% to $2.79 for 2024 in the past 30 days. PEN’s earnings outpaced estimates in three of the trailing four quarters and missed in one, delivering an average beat of 10.54%.
Estimates for Globus Medical’s 2024 EPS have remained constant at $2.84 in the past 30 days. Shares of the company have surged 60.6% in the past year compared with the industry’s growth of 32.7%. GMED’s earnings surpassed estimates in each of the trailing four quarters, the average beat being 12.1%. In the last reported quarter, it delivered an earnings surprise of 10.3%.
Estimates for ResMed’s fiscal 2025 EPS have risen 2.7% in the past 30 days. Shares of the company have surged 86.3% in the past year compared with the industry’s 32.1% growth. RMD’s earnings surpassed estimates in each of the trailing four quarters, the average beat being 6.4%. In the last reported quarter, it delivered an earnings surprise of 8.4%.
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