Nevro Announces the Launch of HFX AdaptivAI™, the Only AI-Driven Technology in Spinal Cord Stimulation

Rhea-AI Summary

Nevro Corp. (NYSE: NVRO) has announced the FDA approval and market release of HFX iQ™ with HFX AdaptivAI™, an AI-driven spinal cord stimulation (SCS) system for chronic pain management. This technology leverages insights from over 100,000 patients and more than 100 million data points to provide personalized, responsive pain relief in real time.

Key features of HFX AdaptivAI include:

• Continuous therapy optimization
• Bipole Interlacing™ for customized programs
• Smart Power technology for reduced charging frequency
• Real-time quality of life metrics and device data collection
• Advanced proactive remote monitoring for physicians

Nevro expects a full market release in the U.S. in Q4 2024, positioning itself as a leader in data-driven pain management solutions.

Positive

• FDA approval for HFX iQ™ with HFX AdaptivAI™, an innovative AI-driven spinal cord stimulation system
• Utilizes data from over 100,000 patients and 100 million data points for personalized pain relief
• Smart Power technology allows patients to charge their device as little as six times per year
• Enhanced real-time insights and remote monitoring capabilities for improved patient-clinician interactions
• Full market release expected in Q4 2024, potentially driving future revenue growth

Negative

• market release initially, which may restrict immediate revenue impact
• Full market release not until Q4 2024, potentially delaying significant financial benefits

Insights

Medical Technology Analyst

The launch of HFX AdaptivAI represents a significant advancement in spinal cord stimulation (SCS) technology for chronic pain management. This AI-driven system leverages data from over 100,000 patients to provide personalized, responsive pain relief in real-time. Key features include:

• Bipole Interlacing™ for customized therapy programs
• Smart Power technology for reduced charging frequency
• Enhanced real-time insights for better patient-clinician interactions
• Advanced proactive remote monitoring capabilities

The technology's ability to optimize therapy continuously, even after achieving 50% pain relief, sets it apart in the market. This innovation could potentially improve patient outcomes and satisfaction, which may translate to increased market share for Nevro in the competitive SCS space.

However, the market release in Q4 2024 suggests a cautious approach, likely to gather more real-world data before a full launch. This gradual rollout may impact near-term revenue growth but could lead to stronger long-term adoption if the technology proves successful in clinical practice.

Financial Analyst

The launch of HFX AdaptivAI positions Nevro at the forefront of AI-driven pain management solutions, potentially strengthening its market position. Key financial implications include:

• Potential for increased market share in the SCS segment
• Possible premium pricing for advanced AI technology
• Reduced long-term costs for patients due to less frequent charging
• Enhanced patient data collection, valuable for future R&D and market insights

However, the Q4 2024 release suggests a conservative approach, which may limit immediate revenue impact. The full market release timeline will be important for projecting fiscal year 2025 performance. Investors should monitor adoption rates, reimbursement decisions and any clinical data supporting improved outcomes.

With a current market cap of $216,242,351, Nevro is a relatively small player. This innovative product could be a significant growth driver if it gains traction, but it's important to consider the company's ability to fund a full-scale launch and compete with larger medical device firms in the pain management space.

HFX AdaptivAI combines insights from over 100,000 patients and more than 100 million data points¹ and leverages artificial intelligence (AI) to deliver responsive and personalized pain relief in real time*

REDWOOD CITY, Calif., Sept. 24, 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 the U.S. Food and Drug Administration (FDA) approval and limited market release of HFX iQ™ with HFX AdaptivAI™ – a responsive, personalized pain management platform powering the HFX iQ spinal cord stimulation (SCS) system.

Building on a foundation of landmark evidence², clinical research and big data, HFX AdaptivAI is the only technology with artificial intelligence (AI) to provide patients suffering from chronic pain with an unprecedented level of personalized, responsive pain relief.

"Nevro is further establishing its position as the leading developer of data-driven solutions for pain management through the launch of HFX iQ with HFX AdaptivAI," said Kevin Thornal, Nevro's CEO and president. "HFX AdaptivAI delivers personalized pain relief, utilizing AI and leveraging millions of data points and ten years of innovation and patient care. We believe this new solution is a major milestone, and it demonstrates our dedication to freeing patients from the burden of chronic pain through evidence-based therapies that transform patients' lives. Importantly, HFX AdaptivAI puts patients in control of their pain relief while, at the same time, providing physicians the ability to monitor their patient's pain journey – closing the loop that matters."

"HFX AdaptivAI is a significant leap forward in pain management," said Dr. Usman Latif, MD, MBA, a Harvard-trained interventional pain specialist at The University of Kansas Health System. "Drawing from landmark evidence and big data, this technology has the potential to offer patients a faster and more sustainable approach to pain relief. HFX AdaptivAI is on the right path to make a lasting impact on how we manage chronic pain and improve patient outcomes."

HFX AdaptivAI Offers:

• Relief and Beyond: HFX AdaptivAI is engineered to maximize pain relief over time by continuing to optimize therapy even when pain relief over 50% has been achieved¹.
• Bipole Interlacing™: Proprietary technology creates customized therapy programs in real-time using direct patient input¹**.
• Smart Power: Through therapy optimization, advanced Smart Power technology allows patients to charge their device as little as six times per year³.
• Enhanced Real-Time Insights: HFX AdaptivAI technology gathers real-time quality of life (QoL) metrics and device data, enabling more impactful patient-clinician interactions. This real-time information helps patients report pain relief in significantly less time than with traditional programming¹.
• Advanced Proactive Remote Monitoring: With the launch of HFX AdaptivAI, physicians will have the ability to remotely monitor each of their patient's pain journey in real time through Nevro's healthcare provider portal.

"Chronic pain is a dynamic, biopsychosocial human condition unique to each individual⁴," said Dr. David Caraway, MD, PhD, Nevro's chief medical officer. "To effectively treat suffering – as perceived by each patient – therapies must be personalized based on the changing experience of pain. Only HFX AdaptivAI seeks to engage with the patient and personalize the SCS therapy in real time using evidence based on algorithms and multi-dimensional metrics of pain relief, function and satisfaction."

Nevro noted that it expects to launch its full market release of HFX iQ with HFX AdaptivAI in the U.S. in the fourth quarter of 2024.

For more information on HFX AdaptivAI, please visit https://nevro.com/English/us/providers/Product-HFX-AdaptivAI.

Internet Posting of Information

Nevro routinely posts information that may be important to investors in the "Investor Relations" 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 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 100,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic neuropathy.

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.

*HFX AdaptivAI™ technology includes an advanced algorithm with an ability to interlace bipoles. Senza HFX iQ uses a fixed set of instructions to provide optimized treatment recommendations that utilize direct patient input from assessments on pain and quality of life measures. Big data refers to Nevro's internal cloud database.

**HFX AdaptivAI™ customized programs are pre-defined parameters programmed by the physician.

To learn more about Nevro, please visit our website at www.nevro.com and connect with us on LinkedIn, Twitter, Facebook and Instagram.

¹ Data on file.

² Kapural, L., et al. (2016). Comparison of 10-kHz high-frequency and traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: 24-month results from a multicenter, randomized, controlled pivotal trial. Neurosurgery, 79(5), 667–677. Patel, N.P., et al. (2023). Durable responses at 24 months with high-frequency spinal cord stimulation for nonsurgical refractory back pain. J Neurosurg Spine:1-11. Petersen, E., et al. (2023). Long-Term Efficacy of High-Frequency (10 kHz) Spinal Cord Stimulation for the Treatment of Painful Diabetic Neuropathy: 24-Month Results of a Randomized Controlled Trial. Diabetes Research and Clinical Practice, 110865.

To learn more about Nevro's landmark publications, please visit the company's Publications page on its website.

³ Data on file, 3% PD 10 KHz 30 μs 2.0 mA 20 secs 10mins 800 Ohms.

⁴ Deer T.R., Caraway D.L., Wallace M.S. 2014. A Definition of Refractory Pain to Help Determine Suitability for Device Implantation. Neuromodulation 2014; 17: 711–715

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements reflecting the company's current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including: our belief that HFX AdaptivAI™ is the future of SCS therapy and keeps Nevro firmly at the forefront of innovation. These forward-looking statements are based upon information that is currently available to us or our current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including our ability to successfully commercialize our products; our ability to manufacture our products to meet demand; the level and availability of third-party payor reimbursement for our products; our ability to effectively manage our anticipated growth and the costs and expenses of operating our business; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of third parties; competition in our industry; additional capital and credit availability; our ability to attract and retain qualified personnel; and product liability claims. These factors, together with those that are described in greater detail in our Annual Report on Form 10-K filed on February 23, 2024, as well as any reports that we may file with the Securities and Exchange Commission in the future, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. We expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

Investors and Media:

Angie McCabe
Vice President, Investor Relations & Corporate Communications
angeline.mccabe@nevro.com

 

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SOURCE Nevro Corp.

FAQ

What is HFX AdaptivAI and when was it approved by the FDA?

HFX AdaptivAI is an AI-driven technology for spinal cord stimulation that provides personalized pain relief. It was approved by the FDA and announced for market release on September 24, 2024, by Nevro Corp. (NYSE: NVRO).

How does HFX AdaptivAI improve pain management for patients?

HFX AdaptivAI improves pain management by using AI to deliver responsive and personalized pain relief in real time. It optimizes therapy even after achieving over 50% pain relief, uses Bipole Interlacing for customized programs, and provides real-time quality of life metrics for better patient-clinician interactions.

When is the full market release of HFX iQ with HFX AdaptivAI expected for Nevro (NVRO)?

Nevro Corp. (NYSE: NVRO) expects to launch the full market release of HFX iQ with HFX AdaptivAI in the United States during the fourth quarter of 2024.

What are the key features of Nevro's (NVRO) HFX AdaptivAI technology?

Key features of Nevro's HFX AdaptivAI include continuous therapy optimization, Bipole Interlacing for customized programs, Smart Power technology for reduced charging frequency, real-time quality of life metrics collection, and advanced proactive remote monitoring for physicians.