The study was a phase 2, multi-site, double blinded, randomized, sham-controlled trial. A total of 142 subjects with CIPN were randomized to an active or sham Quell device for 6-weeks. Subjects in both arms wore their device for 5 hours each day. Only a small number of minor adverse events were reported, primarily mild skin irritation that self-resolved. The trial met its pre-specified primary endpoint of a significant least-squares between-group difference of the EORTC-CIPN20 total score. The EORTC-CIPN20 is a validated patient questionnaire measuring CIPN related quality of life. Of greater clinical relevance, patients with moderate to severe CIPN symptoms of hot/burning pain, sharp/shooting pain or muscle cramping experienced about a 50% reduction in these symptoms for active treatment compared to about 30% for sham treatment. The study authors concluded "The study supports the preliminary efficacy of the TENS device for painful CIPN symptoms."
"CIPN is very difficult to manage, with no FDA approved treatments. Painful CIPN affects about half of patients with CIPN and is associated with particularly low quality-of-life. Duloxetine is the only treatment recommended for painful chronic CIPN in the current
The use of Quell for chemotherapy induced peripheral neuropathy is investigational and has not been cleared or approved by the FDA. The safety and effectiveness for this purpose have not been reviewed by the FDA.
About Chemotherapy Induced Peripheral Neuropathy
About 700,000 cancer patients receive chemotherapy annually in
About Quell Technology
Quell is an advanced, non-invasive, neuromodulation platform that is covered by 26 issued U.S. utility patents. It is the only wearable neuromodulator that is enabled by a proprietary microchip to provide precise, high-power nerve stimulation in a form factor the size of a credit card. Quell utilizes position and motion sensing to automatically adjust stimulation for an optimal user experience both day and night. The device supports Bluetooth® low energy (BLE) to communicate with mobile apps and the Quell Health Cloud. Quell is indicated to help reduce fibromyalgia symptoms in patients with high pain sensitivity and to reduce lower extremity chronic pain.
NeuroMetrix is a commercial stage healthcare company that develops and commercializes neurotechnology devices to address unmet needs in the chronic pain and diabetes markets. The Company's products are wearable or hand-held medical devices enabled by proprietary consumables and software solutions that include mobile apps, enterprise software and cloud-based systems. The Company has two commercial brands. Quell® is a wearable neuromodulation platform. DPNCheck® is a point-of-care screening test for peripheral neuropathy. For more information, visit www.neurometrix.com.
SVP and Chief Financial Officer
Source: NeuroMetrix, Inc.