Clinical Data Presented at American Diabetes Association 82nd Scientific Sessions Reinforce Significant and Durable Benefits of Nevro's HFX 10 kHz Therapy

Rhea-AI Summary

Nevro Corp. (NYSE: NVRO) announced positive results from the SENZA-PDN trial at the ADA 82nd Scientific Sessions. The 24-month follow-up demonstrated that 10 kHz spinal cord stimulation (SCS) therapy provides significant pain relief for patients with painful diabetic neuropathy (PDN). Key findings include an 84% responder rate, a 77% average reduction in pain, and 89% patient satisfaction. The study involved 216 patients across 18 U.S. centers, marking it as the largest RCT of its kind. Nevro plans to release additional data in Q4 2022 and anticipates expanding treatment options for PDN patients.

Positive

• 84% responder rate in pain management.
• 77% average reduction in pain over 24 months.
• 69% reduction in sleep disturbances.
• Average quality of life improvement is 3x the minimal clinically important difference (MCID).
• 71% sensory improvement rate.
• 89% of patients reported being satisfied with the treatment.
• No explants required for loss of efficacy.

Negative

• None.

SENZA-PDN Randomized Controlled Trial Results From Original 10 kHz Arm Demonstrate Significant and Sustained Outcomes with 10 kHz Therapy at 24-Months Follow-Up

REDWOOD CITY, Calif., June 7, 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  the results from data presentations at the American Diabetes Association (ADA) 82^nd Scientific Sessions supporting the use of 10 kHz spinal cord stimulation (SCS) therapy for patients with chronic pain, including results from the SENZA Painful Diabetic Neuropathy (PDN) randomized controlled trial (RCT).  Results were presented on Sunday, June 5, 2022.

"At this year's ADA Scientific Sessions, we were excited to share for the first time the 24-month results from the 10 kHz arm of our landmark SENZA-PDN trial, which continue to clearly demonstrate the safety, durability and consistency of pain relief and other outcomes that can be achieved with HFX for PDN," stated D. Keith Grossman, Chairman, CEO and President of Nevro.  "While prior research has looked at the benefit of SCS for treating pain related to diabetic neuropathy, this is the first time that neurological improvement after SCS was studied. No traditional, low-frequency SCS treatments have demonstrated such positive results in treating PDN patients, and we believe there is a significant opportunity to expand this innovative treatment option to PDN patients who are unable to find relief with currently available pharmacologic options."

24-Month Results for 10 kHz Spinal Cord Stimulation (SCS) in Treating Painful Diabetic Neuropathy (PDN)  

The data presented at the ADA 82^nd Scientific Sessions highlighted 24-month results for the original 10 kHz arm of the SENZA-PDN trial, the largest PDN RCT of SCS treatment conducted to date with 216 randomized subjects at 18 U.S. centers.  Key findings at 24 months, presented by lead Principal Investigator Dr. Erika Petersen, Professor of Neurosurgery and Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences, included significant and sustained outcomes with 10 kHz SCS:

• Responder rate: 84% 
• Substantial pain relief: 77% average reduction in pain, consistent over 24 months
• Improved sleep: 69% average reduction in sleep disturbance
• Improved quality of life: Average improvement = 3x minimal clinically important difference (MCID)
• Improved sensory function: 71% sensory improvement rate
• High patient satisfaction: 89% very satisfied or satisfied
• No explants were required for loss of efficacy

Previously published complete 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.

ADA Product Theater Presentation - Revolutionizing the Treatment of Painful Diabetic Neuropathy (PDN) with High Frequency (10 kHz) Spinal Cord Stimulation

Nevro also participated in the ADA's Product Theater with a presentation by Dr. Erika Petersen and Dr. George Grunberger, Chairman, Grunberger Diabetes Institute, Bloomfield Hills, MI.  A copy of this product theater presentation is available in the "Investors" section of Nevro's website at www.nevro.com.

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: our belief that there is a significant opportunity to expand our innovative SCS therapy as an option to PDN patients who are unable to find relief with currently available pharmacologic options; 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.  

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 results of the SENZA-PDN trial for NVRO on June 5, 2022?

The SENZA-PDN trial results demonstrated a significant 84% responder rate and a 77% average reduction in pain with 10 kHz SCS therapy at the 24-month follow-up.

How many patients were involved in the SENZA-PDN trial for NVRO?

216 patients were randomized in the SENZA-PDN trial across 18 U.S. centers.

What is the significance of the 10 kHz therapy for diabetic neuropathy patients?

10 kHz therapy showed significant, sustained outcomes, providing an innovative treatment option for PDN patients who do not find relief with traditional medications.

When will NVRO release the complete data from the SENZA-PDN trial?

Nevro plans to release the complete 24-month data from the SENZA-PDN trial in Q4 2022.

What is the potential market size for NVRO's PDN treatment?

The total addressable market opportunity for treating PDN patients is estimated to be approximately $3.5 billion to $5.0 billion annually.