Woburn, Massachusetts-based NeuroMetrix’s Quell garnered the breakthrough nod for reducing moderate-to-severe symptoms of chemotherapy-induced peripheral neuropathy (CIPN) that have persisted for at least six months following the end of chemotherapy.
Shares of NURO were up 36.6% at $6.72 per share in late-afternoon trading on the back of the breakthrough device designation news. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down 1.8%.
NeuroMetrix designed Quell as a wearable, non-invasive neuromodulation technology enabled by a proprietary microchip. The device automatically adjusts stimulation through position and motion sensing while supporting Bluetooth low energy (BLE) to communicate with smartphone and smartwatch apps to control and personalize the treatment.
The company earned the breakthrough designation by submitting results from a six-week open-label study that evaluated Quell’s safety and effectiveness in 29 patients. The primary outcome measure was EORTC-CIPN20 — a composite measure of CIPN symptoms and functional impairments. There were statistically significant group improvements in the EORTC-CIPN20 and other outcome measures, with the relative improvements ranging from 13 to 52%. All adverse effects were mild and self-limited.
NeuroMetrix is currently conducting a National Cancer Institute-funded trial of Quell for 150 patients over six weeks. The company expects the study to complete by the end of 2022.
“This breakthrough device designation is an important step in our effort to make Quell technology available to patients suffering from the debilitating effects of CIPN,” NeuroMetrix CEO Dr. Shai N. Gozani said in the release. “We are looking forward to completion and subsequent reporting of the results from the ongoing multi-center RCT of Quell in CIPN. Depending on the outcome of the trial, we hope to be positioned for an FDA filing in 2023.
Following on our first breakthrough designation for fibromyalgia, this new designation for CIPN advances our effort to build a portfolio of Quell-based prescription wearable neurotherapeutics.”