The FDA has granted Breakthrough Designation to NeuroMetrix Inc's (NASDAQ: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.
