FDA Approves Nevro's Spinal Cord Stimulation For Diabetic Neuropathy Associated Chronic Pain

  • The FDA has approved Nevro Corp's NVRO Senza system for treating chronic pain associated with painful diabetic neuropathy (PDN).
  • The approval is specific to Nevro's 10 kHz stimulation. The company is touting that it now has the only spinal cord stimulation system approved by the FDA with a specific indication for treating PDN.
  • FDA approval follows the published results of the SENZA-PDN trial in JAMA Neurology, which demonstrated the safety and efficacy of the spinal cord stimulation system.
  • The company said it plans to immediately initiate the commercial launch activities for Senza in the U.S. under its recently launched HF branding as HFX for PDN.
  • Nevro anticipates mid-to-single-digit million revenue contributions from PDN in 2021, with the majority generated in Q4 of 2021.
  • A broader penetration and more significant revenue contribution from Senza for PDN should come in 2022 and beyond, Nevro said, with international phased launch plans in the U.K., Germany, and Australia planned for next year.
  • Piper Sandler analyst Adam Maeder tells investors in a research note that the approval adds a meaningful multiyear growth driver to the story and expects Nevro to have a multiyear first-mover advantage in this massive end-market.
  • SVB Leerink views the company as a 'Top-Tier TAM Expansion Story' With Omnia Platform.
  • Price Action: NVRO shares are up 5.40% at $151.96 during the market session on the last check Monday.
  • Related content: Benzinga's Full FDA Calendar.
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Posted In: NewsHealth CareFDAGeneralBriefsdiabetic neuropathy
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