Monday, November 28, 2022

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

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) 82nd 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 82nd 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 StimulationNevro 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
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