electroCore Files FDA 510(k) for Quell in Chemotherapy-Induced Neuropathy; ECOR Shares Rise 7%

electroCore, Inc. (ECOR) said it submitted a 510(k) premarket notification to the U.S. Food and Drug Administration seeking clearance of its Quell wearable neuromodulation platform for chronic chemotherapy-induced peripheral neuropathy (CIPN). Shares of ECOR rose 7.17% to $8.32 following the announcement. The submission is backed by data from two studies totaling 168 subjects, including a 142-subject randomized controlled trial and a 26-subject open-label study. In the active treatment group, neuropathic pain scores fell about 40%, versus 24% to 33% in the sham group. In a non-prespecified analysis of patients with moderate to severe baseline pain, scores declined roughly 50% in the active group versus 30% in the sham group. The randomized trial showed an 11.6% improvement in EORTC QLQ-CIPN20 scores for Quell-treated participants, compared with 8.7% for sham controls. Adverse events were generally infrequent, mild and self-limiting. No drugs or devices currently hold FDA approval or clearance specifically for CIPN. If cleared, Quell could become one of the first devices with a labeled indication for chronic CIPN.