Sam Brusco, Associate Editor01.18.22
NeuroMetrix’s Quell technology received breakthrough designation from the U.S. Food an Drug Administration (FDA) to reduce moderate to severe chemotherapy induced peripheral neuropathy (CIPN) symptoms that have persisted for at least six months after the end of chemo.
CIPN occurs in some patients treated with chemotherapeutic drugs such as vincristine, paclitaxel, and cisplatin. Symptoms include burning/shooting pain, tingling, cramping, and numbness in the hands and feet. It’s also linked to with impaired balance, walking, and sleep, decreased quality of life, and increased risk of falls. About 30 percent of chemo patients experience chronic CIPN, and there are no FDA approved treatments for it.
Quell is a non-invasive wearable neuromodulation technology that offers high-power nerve stimulation in the device of a credit card. It utilizes position and motion sensing to adjust stimulation and supports Bluetooth low energy to communicate with mobile apps to personalize treatment.
NeuroMetrix’s supporting study enrolled 29 patients with a CIPN diagnosis and reported lower extremity symptoms of pain, tingling, numbness, or cramping. Relative improvements in EORTC-CIPN 20 (a composite measure of CIPN symptoms and functional impairments) ranged from 13-52 percent. A National Cancer Institute trial of Quell for CIPN is currently ongoing. 150 patients will be enrolled, with subjects randomized to an active or sham Quell device for six weeks. The study is expected to be completed by the end of this year.
"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,” Shai N. Gozani, M.D., Ph.D., CEO of NeuroMetrix told the press. “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."
CIPN occurs in some patients treated with chemotherapeutic drugs such as vincristine, paclitaxel, and cisplatin. Symptoms include burning/shooting pain, tingling, cramping, and numbness in the hands and feet. It’s also linked to with impaired balance, walking, and sleep, decreased quality of life, and increased risk of falls. About 30 percent of chemo patients experience chronic CIPN, and there are no FDA approved treatments for it.
Quell is a non-invasive wearable neuromodulation technology that offers high-power nerve stimulation in the device of a credit card. It utilizes position and motion sensing to adjust stimulation and supports Bluetooth low energy to communicate with mobile apps to personalize treatment.
NeuroMetrix’s supporting study enrolled 29 patients with a CIPN diagnosis and reported lower extremity symptoms of pain, tingling, numbness, or cramping. Relative improvements in EORTC-CIPN 20 (a composite measure of CIPN symptoms and functional impairments) ranged from 13-52 percent. A National Cancer Institute trial of Quell for CIPN is currently ongoing. 150 patients will be enrolled, with subjects randomized to an active or sham Quell device for six weeks. The study is expected to be completed by the end of this year.
"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,” Shai N. Gozani, M.D., Ph.D., CEO of NeuroMetrix told the press. “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."