New 24-Month Data Shows Nevro's SCS Therapy Provides Highly Effective, Long-Term Relief from Painful Diabetic Neuropathy
Evidence Published in Diabetes Research and Clinical Practice Shows 10 kHz Therapy Yields Lasting Pain Relief and Enhances Health-Related Quality of Life and Sleep
REDWOOD CITY, Calif., Aug. 16, 2023 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced the publication of 24-month data from the SENZA Painful Diabetic Neuropathy (PDN) Randomized Controlled Trial (RCT), the largest RCT to evaluate spinal cord stimulation (SCS) to treat PDN, in Diabetes Research and Clinical Practice.
Globally, the number of people with diabetes has quadrupled in the last two decades1, and PDN is one of its most common complications, affecting up to 25 percent of all people with diabetes. PDN symptoms can have a significant impact on quality of life. These symptoms include numbness, tingling/paresthesia, loss of protective sensation, impaired balance, and reduced response to sensory stimuli.2 Patients typically manage this complication with oral pain medications, but the efficacy of these medications is relatively low and can result in intolerable side effects for patients.3 As a result, people with PDN suffer significantly-reduced health-related quality of life (HRQoL), impaired functionality, and other comorbidities like sleep disorders, depression, and anxiety.4
Published 24-month data from the SENZA-PDN RCT evaluated the long-term efficacy of high-frequency 10 kHz SCS to treat refractory PDN. The data show that patients who received a high-frequency 10 kHz SCS implant and conventional medical management (CMM), compared to CMM alone, experienced durable pain relief and significant improvements in both HRQoL and sleep at 24 months post-implantation.
Furthermore, most participants experienced neurological symptom improvements, including those in motor, sensory, and reflex function. The long-term data further supports that 10 kHz SCS is a safe and highly effective therapy for PDN, as well as a therapy that demonstrates durable quality of life improvements.
"The 24-month data from the SENZA-PDN RCT show us high-frequency SCS is a viable, long-term relief solution for people with PDN, which is particularly encouraging for a condition that naturally worsens over time," said lead Principal Investigator Dr. Erika Petersen, Professor of Neurosurgery and Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences. "These results further validate not only the efficacy of high-frequency 10 kHz SCS for pain relief, but also show profound improvements in quality of life, sleep, and neurological function."
The SENZA-PDN RCT 24-month data demonstrated the following benefits of 10 kHz SCS Therapy:
Durable Pain Relief
At 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief.
A DN4 score ≥4 is consistent with clinically confirmed PDN. In the 10 kHz SCS recipients, the proportion with a DN4 score <4 increased significantly from 3.9% at preimplantation to 48.9% at 24 months. (P < .001).
Neurological Improvements:
Investigators assessed neurological function versus study baseline in all implanted patients. At 24 months, 65.7% of implanted patients exhibited clinically meaningful improvements over study baseline in sensory, motor, or reflex function without worsening in any category. A majority of these neurological improvements were in sensory function, which may have implications in restoring protective sensation.
No other SCS treatment for PDN has exhibited the potentially disease-modifying effects demonstrated by Nevro HFX™ in improving neurological function.
HRQoL:
HRQoL significantly improved with 10 kHz SCS, based on the EuroQol 5-Dimensional 5-Level (EQ-5D-5L) questionnaire.
Among all implanted patients, the mean EQ-5D-5L index value increased by 0.146 from preimplantation to 24 months, which is 2.9 to 4.9 times the minimally important difference for people with type 2 diabetes.
Pain Interference with Sleep:
Baseline sleep quality was poor among all study participants, as shown by a mean score on the Pain and Sleep Questionnaire 3-Item Index (PSQ-3; 0-10 cm scale) of 6.5 cm at preimplantation.
Treatment with 10 kHz SCS significantly reduced pain interference with sleep in the group of all implanted patients over 24 months, as demonstrated by a 65.5% decrease in the mean PSQ-3 score, from 6.5 at preimplantation to 1.9 at 24 months.
Safety:
The incidence and type of procedure-related complications were comparable to those reported in the SCS literature for all patient populations. Five (3.2%) SCS systems were explanted due to infection, and no devices were explanted due to lack of efficacy.
Consistent Outcomes:
Comparable to the 6- and 12-month SENZA-PDN study outcomes, the 24-month results confirm robust and long-lasting beneficial effects of 10 kHz SCS in PDN patients. These are important findings, given the severe, chronic, and debilitating nature of PDN and the lack of effective treatment options for this patient population.
"We're encouraged by the latest data demonstrating the long-term efficacy of Nevro HFX to treat the millions of people suffering from PDN worldwide," said Dr. David Caraway, Nevro's Chief Medical Officer. "Compared to previous studies evaluating traditional low-frequency systems for these patients, high-frequency 10 kHz SCS demonstrated greater pain reduction and higher responder rates over time.5 As we continue gathering data, we expect these results to be used in physician referral decisions and continue to support market access for high-frequency SCS for PDN patients."
Nevro's SENZA-PDN trial is the largest RCT conducted to date studying SCS therapy for PDN patients, enrolling 216 patients with refractory PDN. In total, 142 patients implanted with Nevro's high-frequency (10 kHz) SCS system, Nevro HFX, were followed for 24 months, including 84 initial 10 kHz SCS+CMM recipients and 58 crossovers from CMM alone.
This study aimed to provide high-level evidence to aid clinical decision-making, albeit with some limitations, including risks of biased outcomes and potential placebo effects, the potential impact of missed follow-up visits on study results, and limitations related to interpreting the observed neurological improvements.
About Painful Diabetic Neuropathy (PDN)
The World Health Organization estimates 422 million adults live with diabetes worldwide and its prevalence (8.5%) has nearly doubled over four decades.1 Diabetes may cause systemic damage with a 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.6 In the U.S., it is estimated that there are approximately 140,000 to 200,000 PDN patients each year that are refractory to conventional medical management, representing an annual total addressable market opportunity of approximately $3.5 billion to $5.0 billion.7,8
Internet Posting of Information
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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, with and without surgery, 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 HFX Cloud™ 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, HFX CLOUD, the HFX Cloud logo, RELIEF MULTIPLIED, 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.
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*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.
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 that this study will provide additional confirmatory evidence of the benefits of Nevro's proprietary 10 kHz Therapy in these PDN patients; our belief that, by restoring sensation in the feet, 10 kHz Therapy may alleviate this tremendous disease burden, prevent amputations, and enable patients to be more active, all of which would improve overall health and quality of life and of course reduce healthcare costs; and our belief that this study will provide additional confirmatory evidence of the benefits of Nevro's proprietary 10 kHz Therapy in PDN patients, and the additional Level 1 data generated will be very helpful as we work to expand PDN coverage generally and update PDN clinical treatment guidelines. 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 21, 2023, 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.
1 World Health Organization. (2016). Global report on diabetes. World Health Organization. https://apps.who.int/iris/handle/10665/204871
2 Pop-Busui R, Ang L, Boulton AJM, Feldman EL, Marcus RL, Mizokami-Stout K, et al. Diagnosis and Treatment of Painful Diabetic Peripheral Neuropathy. Arlington (VA): American Diabetes Association; 2022.
3 Yang, M., Qian, C., & Liu, Y. (2015). Suboptimal Treatment of Diabetic Peripheral Neuropathic Pain in the United States. Pain medicine (Malden, Mass.), 16(11), 2075–2083.
4 Alleman, C. J., Westerhout, K. Y., Hensen, M., Chambers, C., Stoker, M., Long, S., & van Nooten, F. E. (2015). Humanistic and economic burden of painful diabetic peripheral neuropathy in Europe: A review of the literature. Diabetes research and clinical practice, 109(2), 215–225.
5 van Beek, M., Geurts, J. W., Slangen, R., Schaper, N. C., Faber, C. G., Joosten, E. A., Dirksen, C. D., van Dongen, R. T., van Kuijk, S. M. J., & van Kleef, M. (2018). Severity of Neuropathy Is Associated With Long-term Spinal Cord Stimulation Outcome in Painful Diabetic Peripheral Neuropathy: Five-Year Follow-up of a Prospective Two-Center Clinical Trial. Diabetes care, 41(1), 32–38.
6 Schmader K. E. (2002). Epidemiology and impact on quality of life of postherpetic neuralgia and painful diabetic neuropathy. The Clinical journal of pain, 18(6), 350–354.
7 CDC National Diabetes Statistics Report 2020.
8 Trinity Partners Market Research 2017.
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