electroCore, Inc. Submits 510(k) Premarket Notification to FDA Seeking Clearance of Quell® for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)
electroCore has submitted a 510(k) premarket notification to the FDA seeking clearance of its Quell wearable neuromodulation platform for chronic chemotherapy-induced peripheral neuropathy, an indication with no FDA-approved or cleared therapies. The submission is backed by two studies totaling 168 subjects, including a 142-subject randomized controlled trial in which neuropathic pain scores fell roughly 40% in the active group versus 24-33% for sham; EORTC-CIPN20 quality-of-life scores improved 11.6% vs 8.7% for sham, meeting the pre-specified significance threshold.
Key figures
- Drug Name
- Quell (wearable neuromodulation platform)
- Phase Of Trial
- 510(k) premarket notification submitted
- Rct subjects
- 142
- Total subjects
- 168
- Open label subjects
- 26
- Pain reduction sham
- ~24-33%
- Pain reduction active
- ~40%
- Eortc cipn20 improvement sham
- 8.7%
- Eortc cipn20 improvement active
- 11.6%
AI analysis
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