NeuroMetrix Stock Surges As Its Nerve Stimulator Scores FDA Breakthrough Designation For Fibromyalgia

  • NeuroMetrix Inc's NURO Quell device has received Breakthrough Designation from the FDA to treat fibromyalgia symptoms in adults.
  • Fibromyalgia is a common form of chronic pain accompanied by fatigue, sleep, cognitive and mood disturbances. 
  • Quell is a wearable electrical nerve stimulator. It utilizes position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night.
  • The data submitted by NeuroMetrix in support of the Breakthrough Designation included results of 119 subjects
  • In an intention-to-treat (ITT) analysis of all subjects, 56% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life compared to 35% that received sham therapy.
  • The Company expects to launch Quell for fibromyalgia in the second half of 2022.
  • Price Action: NURO shares jump 43.9% at $4.69 during the market session on the last check Tuesday.
  • Related content: Benzinga's Full FDA Calendar.
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