Newly Released Clinical Data Demonstrates Substantial Improvement in Overall Health-Related Quality of Life in Patients with Painful Diabetic Neuropathy Treated with Nevro HFX Spinal Cord Stimulation Therapy

Rhea-AI Summary

Nevro Corp. (NYSE: NVRO) reported 12-month results from the SENZA-PDN trial, showing extensive pain relief and significant improvements in health-related quality of life (HRQoL) for patients with painful diabetic neuropathy (PDN) treated with 10 kHz spinal cord stimulation. Key findings include a 2.5- to 4.5-fold improvement in HRQoL metrics compared to minimal clinical importance, with over 70% of patients indicating better overall health. The data supports the product's potential for expanding market access and payer coverage, with a total addressable market of approximately $3.5 billion to $5.0 billion.

Positive

• Significant pain relief and HRQoL improvements in PDN patients over 12 months.
• Over 70% of participants reported better overall health post-treatment.
• High patient satisfaction with 10 kHz Therapy at 92%.
• Potential annual market opportunity estimated at $3.5 billion to $5.0 billion.

Negative

• None.

High-Frequency 10 kHz Therapy Provided Substantial and Durable Pain Relief, Improved Health-Related Quality of Life, Better Sleep Quality and Neurologic Improvements Over 12 Months 

REDWOOD CITY, Calif., July 5, 2022 /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 that the complete 12-month results from the SENZA-PDN Randomized Controlled Trial (RCT), including health-related quality of life (HRQoL) outcomes in patients with Painful Diabetic Neuropathy (PDN) treated with high-frequency 10 kHz spinal cord stimulation (SCS), were published in Mayo Clinic Proceedings: Innovations, Quality & Outcomes.

"In addition to the strong clinical efficacy for HFX Therapy that has already been shown in our landmark SENZA-PDN trial, these results demonstrate improvement in several important health-related quality of life metrics in patients with PDN," said D. Keith Grossman, Chairman, CEO and President of Nevro.  "Coupled with previously reported data that showed substantial pain relief and neurological improvements at 12 and 24 months, these data will be used to support physician referral decisions as well as our ongoing market access initiatives to expand payer coverage for this patient population."     

High-Frequency 10 kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients with Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial

The published data in the Mayo Clinic Proceedings showed treatment with 10 kHz Therapy resulted in significant pain relief and multiple significantly improved metrics of HRQoL.  Results included significantly less pain interference with sleep, mood, and daily activities.  Importantly, at 12 months, 10 kHz SCS treatment resulted in improvement in overall HRQoL that was 2.5- to 4.5-fold higher than the minimally clinically important difference.  Furthermore, over 70% of clinicians and patients reported overall improvement as better or a great deal better than the pre-SCS baseline.  These outcomes were durable over 12 months and support 10 kHz SCS treatment in patients with refractory painful diabetic neuropathy.  In addition, approximately 92% of participants were satisfied or very satisfied with 10 kHz Therapy.  

This paper can be accessed at: https://www.sciencedirect.com/science/article/pii/S2542454822000297.

Current treatment options remain inadequate for many patients suffering from PDN, a condition that is associated with pain in the extremities and diminished sleep quality and quality of life, resulting in large unmet needs.  The SENZA-PDN study is the largest RCT conducted to date for SCS treatment of PDN.  Compared with pharmacotherapy, high-frequency 10 kHz SCS resulted in more profound pain relief and pronounced HRQoL improvements, including well-being, sleep quality and function. 

Previously published 12-month results in Diabetes Care demonstrated significantly improved and sustained outcomes with high-frequency 10 kHz Therapy, including substantial, sustained pain relief and improved health-related quality of life in patients suffering from PDN.¹  The company expects the complete 24-month data from the SENZA-PDN RCT to be available in the fourth quarter of 2022 and plans to submit this data set for presentation at NANS in January 2023 and publish as soon possible thereafter.

About Painful Diabetic Neuropathy (PDN)

The World Health Organization estimates 422 million adults with diabetes worldwide and prevalence (8.5%) that has nearly doubled over four decades.² Diabetes may cause systemic damage with profound impact on health-related quality of life and is potentially life-threatening.  Diabetic peripheral neuropathy is a common complication presenting as pain and other dysesthesias, including numbness, burning, or tingling.  Approximately 20% of patients with diabetes will develop PDN, a progressive, potentially debilitating chronic neuropathic pain condition.³  In the U.S., it is estimated that there are approximately 140,000 to 200,000 PDN patients each year that become refractory to conventional medical management, representing an annual total addressable market opportunity of approximately $3.5 billion to $5.0 billion.^4,5

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 80,000 patients globally. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy. 

Senza®, Senza II®, and Senza Omnia™ 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 HFX Cloud™ insights for enhanced patient and practice management.

Senza, Senza II, Senza Omnia, HFX, HXF Coach, HFX Cloud, HFX Connect, Nevro and the Nevro logo are trademarks of Nevro Corp.

To learn more about Nevro, connect with us on LinkedIn, Twitter, Facebook and Instagram.

1 Petersen et al.  Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a Randomized Controlled Trial. Diabetes Care. 2022;45:e1–e4; https://doi.org/10.2337/dc21-1813.

2 World Health Organization. (‎2016)‎. Global report on diabetes. World Health Organization. https://apps.who.int/iris/handle/10665/204871

3 Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18(6):350-354.

4 CDC National Diabetes Statistics Report 2020; Schmader KE. Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. Clin J Pain. 2002;18(6):350-354.

5 Trinity Partners Market Research 2017.

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: the belief that these data will support physician referral decisions as well as our ongoing market access initiatives to expand payer coverage for this patient population; and our expectation that the complete 24-month SENZA-PDN clinical trial results will be available later in the fourth quarter of 2022.  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, 2022, 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.

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Investors and Media:
Julie Dewey, IRC
Nevro Corp.
Chief Corp Communications and Investor Relations Officer
650-433-3247  |  julie.dewey@nevro.com

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SOURCE Nevro Corp.

FAQ

What were the main results of the NVRO SENZA-PDN trial published?

The NVRO SENZA-PDN trial results showed substantial pain relief and health-related quality of life improvements after 12 months of 10 kHz spinal cord stimulation treatment.

How does the 10 kHz therapy impact patients with painful diabetic neuropathy?

10 kHz therapy significantly improves pain interference with sleep, mood, and daily activities for patients suffering from painful diabetic neuropathy.

What is the estimated market opportunity for Nevro's 10 kHz therapy?

The total addressable market for Nevro's 10 kHz therapy in painful diabetic neuropathy is estimated to be between $3.5 billion and $5.0 billion annually.

When will the complete 24-month data from the SENZA-PDN trial be available?

Nevro expects the complete 24-month data from the SENZA-PDN trial to be available in the fourth quarter of 2022.