ElectroCore files FDA 510(k) for Quell to treat chemotherapy‑induced peripheral neuropathy
ElectroCore, Inc. submitted a 510(k) pre‑market filing to the U.S. Food and Drug Administration seeking clearance of its Quell wearable neuromodulation platform for chronic chemotherapy‑induced peripheral neuropathy (CIPN). The filing is backed by two clinical studies covering 168 patients – a 142‑subject randomized trial and a 26‑subject open‑label study – that showed roughly a 40% drop in neuropathic pain and an 11.6% improvement in EORTC‑CIPN20 scores versus 8.7% for sham. The company noted that FDA approval is not guaranteed and the agency may request additional data.
Why it matters
If the FDA clears Quell, it would become one of the first devices with a labeled indication for CIPN, opening a new oncology‑supportive‑care market for electroCore. The filing already lifted the stock 7.17% to $8.32, reflecting investor optimism about the potential revenue opportunity.
Key facts
- 1ElectroCore submitted a 510(k) pre‑market filing to the FDA on Oct. 28, 2026. globenewswire.com
- 2The submission relies on two studies that together enrolled 168 subjects, including a 142‑subject randomized controlled trial and a 26‑subject open‑label feasibility study. globenewswire.com
- 3In the active treatment arm, neuropathic pain scores fell by about 40%, compared with a 24%–33% reduction in the sham group. globenewswire.com
- 4The 142‑subject trial showed an 11.6% improvement in EORTC‑CIPN20 scores versus an 8.7% gain for sham. globenewswire.com
- 5In the open‑label study, the 22 participants who completed six weeks exhibited a 13% improvement in EORTC‑CIPN20 scores. globenewswire.com
- 6ElectroCore’s shares rose 7.17% to $8.32 after the filing was announced. rttnews.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.