• Publications Show Reductions in Hospital Resource Utilization Associated with 10 kHz Therapy Spinal Cord Stimulation for the Treatment of Painful Diabetic Neuropathy and Nonsurgical Refractory Back Pain

REDWOOD CITY, Calif., Sept. 18, 2023 /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 publication of new data validating the health economic benefits of 10 kHz Therapy™, Nevro's proprietary high-frequency,10 kHz spinal cord stimulation (SCS) therapy. This data was derived from studies and analyses that evaluated health care utilization (HCU) – doctor visits, medical procedures, tests and emergency room visits, and medication costs – and related cost data, including inpatient and outpatient service, medication, and out-of-pocket costs.

Results from a study evaluating the effect of 10 kHz Therapy on resources needed to manage and care for patients with painful diabetic neuropathy (PDN) were published in the Journal of Managed Care & Specialty Pharmacy. Study participants were randomly assigned to 10 kHz Therapy or conventional medical management (CMM), with outcomes measured at six months. Results showed that the 10 kHz Therapy arm experienced about half the mean rate of hospitalizations per patient compared to the CMM group (0.08 vs. 0.15). Additionally, the CMM group's total healthcare costs per patient were approximately 51 percent higher compared to the 10 kHz Therapy group (equivalent to a mean annual cost per patient of $9,532 vs. $6,300).

"This new research underscores the financial and resource cost of treating patients with PDN – a patient population that has long gone without effective treatment options provided by today's standard of care," said David Caraway, MD, chief medical officer at Nevro. "I am grateful to the study researchers, who have provided managed care organizations with real-world data to help improve the treatment options available for patients with refractory PDN."

This latest publication comes on the heels of other recent studies, which add to the robust body of evidence to support 10 kHz Therapy for the treatment of both PDN and chronic nonsurgical back pain.

Cost-Effectiveness of 10 kHz Therapy for Nonsurgical Refractory Back Pain (NSRBP)

This analysis, published in the Journal of Neurosurgery: Spine, evaluated whether 10 kHz Therapy plus CMM is cost-effective compared to CMM alone for patients with chronic, refractory back pain who are not candidates for surgery. Nevro's NSRBP study is the first randomized controlled trial in the U.S. to prospectively gather HCU data to evaluate the cost-effectiveness of any type of SCS therapy to treat patients with nonsurgical back pain. This analysis showed that 10 kHz Therapy provides a higher quality of life (QOL) at a lower average cost per patient compared to CMM therapy and is predicted to be cost-effective for the treatment of nonsurgical back pain compared with CMM within 2.1 years. 

Healthcare Resource Utilization of 10 kHz Therapy for Chronic Refractory Low Back Pain

This analysis, published in Neuromodulation, evaluated the cost burden of 10 kHz Therapy in patients with Chronic Refractory Low Back Pain (CRLBP). Using IBM MarketScan databases, investigators retrospectively identified patients who received 10 kHz Therapy between 2016 and 2019. Those with low back pain who had no history of surgery were included in the cohort. Cost data were collected six months before implantation and one, three, and six months after implantation. In the six months before receiving 10 kHz Therapy, patients incurred median total costs of $15,766, whereas, in the six months post-implantation, the median total cost, excluding device acquisition, was $5,840. Median out-of-pocket costs for patients decreased by nearly $900 in the first six months post-implant. The average reduction in total cost was $6,914 (95% CI: $588, $12,458, p < 0.001). Investigators found that 10 kHz Therapy may be associated with a significant decrease in total healthcare costs, offsetting device acquisition costs within 27 months.

Healthcare Economics of High-Frequency SCS for PDN

Data published in the Journal of Diabetes Science and Technology evaluated HCU data of 10 kHz Therapy on a real-world PDN patient population. Using IBM MarketScan databases, investigators identified patients who received 10 kHz Therapy between 2016 and 2019 and who had received a diabetes or diabetic neuropathy diagnosis within two years before implantation. Cost data were collected for the six months before receiving the 10 kHz Therapy (baseline) and for the periods of one, three, and six months post-implantation. The median total cost before receiving 10 kHz Therapy was $19,220 and was $13,305 at six months post-implantation. The median out-of-pocket cost before receiving 10 kHz Therapy was $1,477 and was $710 at six months post-implantation. The average total cost reduction from before to six months post-implantation was $5,118 (P < .001), or $853 per month. Investigators concluded that 10 kHz Therapy significantly reduces HCU in patients with PDN.

"These publications demonstrate that our therapy is not only reshaping care for people with chronic pain but also reducing costs for both patients and health systems," said Kevin Thornal, CEO and president of Nevro. "This evidence underscores our commitment to producing highly effective, data-backed therapies that are accessible to those who need them most."

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.² 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.^3,4

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 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.

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

*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 in the cost effectiveness of our 10 kHz Therapy for PDN and NSBP patients; and our belief that this data demonstrates that our therapy is not only reshaping care for people with chronic pain but also reducing costs for both patients and health systems. 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.

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¹ World Health Organization. (‎2016)‎. Global report on diabetes. World Health Organization. https://apps.who.int/iris/handle/10665/204871
² 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.
³ CDC National Diabetes Statistics Report 2020.
⁴ Trinity Partners Market Research 2017.