NeuroMetrix Shares Rally On FDA Breakthrough Tag For Neurostimulation Device

The FDA has granted Breakthrough Designation to NeuroMetrix Inc's NURO Quell technology for reducing moderate to severe symptoms of chemotherapy-induced peripheral neuropathy (CIPN) that have persisted for at least 6-months following the end of chemotherapy.

• There are no FDA-approved treatments for CIPN, and those that are used have limited effectiveness and have side effects.
• Quell is a non-invasive neuromodulation technology covered by 19 U.S. utility patents. 
• Related content: Benzinga's Full FDA Calendar.
• It is the only wearable neuromodulator enabled by a proprietary microchip that provides precise, high-power nerve stimulation in a form factor the size of a credit card. 
• The Quell device utilizes position and motion sensing to adjust stimulation automatically.
• A National Cancer Institute-funded sham-controlled trial of Quell in CIPN is currently ongoing. 150 patients will be enrolled for six weeks. 
• The primary outcome measure is the baseline to 6-week change in the EORTC-CIPN20. 
• Other outcomes include individual CIPN symptoms and objective central descending pain inhibition measures, lower limb sensation threshold, and balance. 
• The study is expected to complete by the end of 2022.
• Depending on the trial's outcome, we hope to be positioned for an FDA filing in 2023. 
• Price Action: NURO shares are up 36.6% at $6.72 during the market session on the last check Tuesday.