Nevro Announces Publication Of Landmark SENZA-PDN Clinical Trial Results In JAMA Neurology

Rhea-AI Summary

Nevro Corp. (NYSE: NVRO) announced the publication of the SENZA-PDN clinical trial results in JAMA Neurology. This trial evaluated the use of the Senza® System for treating chronic pain associated with Painful Diabetic Neuropathy (PDN), potentially becoming the first FDA-approved spinal cord stimulation (SCS) system specifically for PDN. The trial showed significant pain relief for 85% of patients using high-frequency (10 kHz) SCS compared to 5% in the control group. The FDA review is expected to take six months, with a potential launch planned for the second half of 2021.

Positive

• 85% of PDN patients using 10 kHz SCS reported over 50% pain relief at six months compared to 5% in the control group.
• Study met primary endpoint and showed statistical significance in seven of eight secondary endpoints.
• Senza System could be the first FDA-approved SCS for PDN, expanding addressable market to $3.5-$5 billion.

Negative

• None.

REDWOOD CITY, Calif., April 5, 2021 /PRNewswire/ -- Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced that results of its SENZA-PDN randomized clinical trial (RCT) were published online in JAMA Neurology.  Data from the SENZA-PDN trial formed the basis of the company's recent PMA supplement submission to the U.S. Food and Drug Administration (FDA) for use of the Senza® System for the treatment of chronic pain associated with Painful Diabetic Neuropathy (PDN).  If approved, the Senza System would be the only spinal cord stimulation (SCS) system FDA approved with a specific on-label indication for treating PDN. 

The JAMA Neurology publication can be accessed at:
https://jamanetwork.com/journals/jamaneurology/fullarticle/10.1001/jamaneurol.2021.0538?guestAccessKey=aac5074b-819f-48cc-a293-5e17e3084b56&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=040521 

In addition, a JAMA Neurology podcast featuring Dr. Erika Petersen, Professor of Neurosurgery, Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences, and lead investigator of the study is also available at:
https://edhub.ama-assn.org/jn-learning/audio-player/10.1001/jamaneurol.2021.559

"It's been an honor to lead this clinical study showing the significant benefit of 10 kHz spinal cord stimulation for PDN patients who have suffered for years with refractory symptoms," stated Dr. Erika Petersen.  "The substantial pain relief and improved quality of life sustained over six months demonstrates that this therapy can safely and effectively treat this patient population.  I'm grateful to my co-investigators and the patients who participated in this study, as the results will have far-reaching impact on the lives of PDN patients."

"No conventional, low-frequency SCS treatments have been thoroughly evaluated or demonstrated such positive results in treating PDN patients, and we believe there is a significant opportunity to offer our innovative treatment option to patients who are unable to find relief with currently available pharmacologic options," said D. Keith Grossman, Chairman, Chief Executive Officer and President of Nevro.  "A six-month review cycle by the FDA could position the company to achieve approval and initiate U.S. launch activities to provide HF10® therapy for the treatment of chronic pain in PDN patients during the second half of 2021."

The randomized SENZA-PDN study met its prespecified primary endpoint demonstrating that PDN patients with symptoms refractory to best available treatments can be safely and effectively treated with high-frequency (10 kHz) SCS.  The study also demonstrated statistical significance in seven of eight prespecified secondary endpoints showing clear differences from the best available medical treatments.  This safety and efficacy data will be used to support physician referral decisions as well as our market access initiatives to ensure adequate payer coverage of this procedure.  The SENZA-PDN RCT results were previously presented during the plenary session at the 2021 North American Neuromodulation Society (NANS) Virtual Meeting in January. 

An investor presentation is available in the "Investor Relations" section of Nevro's website at www.nevro.com.

About the SENZA-PDN RCT

Nevro's SENZA-PDN study, the largest RCT of spinal cord stimulation treatment conducted for PDN, compares 10 kHz SCS plus Conventional Medical Management (CMM) to CMM alone in 216 patients at 18 centers in the United States.  The primary endpoint of the study is a composite endpoint that includes the difference in proportion of treatment responders without deterioration of neurological deficits at 3-month follow-up. Study participants continue to be followed out to 24 months. The SENZA-PDN RCT six-month data show sustained effectiveness of 10 kHz SCS versus CMM and demonstrated the following benefits:

Pain:

• At six months, 85% of participants in the 10 kHz SCS study arm reported pain relief >50% versus 5% in the CMM control arm (p < 0.001).
• At six months, average pain relief in the 10 kHz SCS treatment arm was 76% (% reduction of VAS from baseline) as compared to an average worsening of 2% in the control arm.

Safety:

• Safety was consistent with published reports of adverse event rates in traditional SCS trials, including for infections and explants in non-diabetic cohorts.^1,2,3
• Only 2 of 90 permanent SCS devices were explanted at six months for a 2.2% explant rate (both explants were due to infection). 

Neurological Improvement:

• At six months, 62% of the 10 kHz SCS treatment group had observed improvement upon an investigator-assessed neurological examination, compared to 3% in of CMM subjects (p < 0.001).

Quality of Life:

• At six months, 92% of patients were either "satisfied" or "very satisfied" with 10 kHz SCS therapy compared to 91% of CMM patients who were either "dissatisfied" or "very dissatisfied" with treatment.
• At six months, sleep disturbance due to pain in the 10 kHz SCS group was remarkably diminished.

Crossover:

• Subjects could opt to crossover to the other treatment arm at six months if they had insufficient pain relief (<50%), were dissatisfied with treatment, and were appropriate to proceed as determined by their physician. At six months, 82% of patients who met criteria in the CMM arm elected to crossover, vs none in the 10 kHz SCS + CMM treatment arm (p < 0.001).

SENZA-PDN RCT Abstract Awards

The SENZA-PDN RCT data has been presented at several physician meetings and recognized for scientific research excellence from the following professional societies:   

• American Academy of Neurology (AAN) – 2021 Merit of Distinction as top abstract in its category and featured on Neurology Minute Daily Briefing podcast
• Congress of Neurological Surgeons (CNS) – Best Pain Abstract 2020
• American Society of Regional Anesthesia and Pain Medicine (ASRA) – Best of Meeting award (top 3 abstracts) 2020

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.⁴ 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.⁵  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.^6,7

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 providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ≥65% of patients across six peer-reviewed clinical studies. The Senza® System, Senza II™ System, and the Senza® Omnia™ System are the only SCS systems that deliver Nevro's proprietary HF10® therapy. Senza, Senza II, Senza Omnia, HF10, Nevro and the Nevro logo are trademarks of Nevro Corp.

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

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1 Hoelzer et al 2017 Neuromodulation DOI: 10.1111/ner.12609

2 Mekhail et al 2011 Pain Practice 11,(2) 148–153

3 Hayek et al. Treatment-Limiting Complications of Percutaneous Spinal Cord Stimulator Implants: A Review of Eight Years of Experience From an Academic Center Database Neuromodulation 2015; 18:603–609.

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

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

6 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.

7 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 offer our innovative therapy to PDN patients who are unable to find relief with currently available pharmacologic options; our belief that our FDA submission, assuming a six-month review cycle and regulatory approval from the FDA, could position the company to achieve approval and initiate U.S. launch activities to provide HF10® therapy for treatment of chronic pain in PDN patients in the second half of 2021; and our belief that the safety and efficacy data from the SENZA-PDN RCT will be used to support physician referral decisions and market access initiatives to ensure adequate payer coverage of this procedure.  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 24, 2021, 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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SOURCE Nevro Corp.

FAQ

What are the results of the SENZA-PDN trial for NVRO?

The SENZA-PDN trial showed that 85% of patients using the high-frequency (10 kHz) SCS experienced over 50% pain relief after six months.

What is the significance of the SENZA-PDN trial publication in JAMA Neurology?

The publication confirms the study results and supports Nevro's FDA submission for the Senza® System as a treatment for Painful Diabetic Neuropathy.

When is the expected FDA approval for the Senza System?

Nevro anticipates a six-month FDA review cycle, potentially leading to approval and U.S. launch activities in the second half of 2021.

How does the Senza System compare to conventional treatments for PDN?

The Senza System demonstrated significantly better outcomes than conventional treatments, with 85% of patients reporting pain relief versus only 5% in the control group.

What is the market opportunity for the Senza System in treating PDN?

The total addressable market for treating Painful Diabetic Neuropathy with the Senza System is estimated between $3.5 billion to $5 billion annually.