NeuroMetrix Inc. (NASDAQ: NURO) shot up 35% after announcing that the FDA awarded it Breakthrough Device Designation for its Quell technology. This innovative technology is designed to help reduce severe to moderate chemo symptoms that persist for at least six months after one is done with chemo.
Almost 650,000 people battling cancer receive chemotherapy every year in the United States alone. Chemotherapy-induced peripheral neuropathy, or CIPN in short, is an incredibly disabling medical condition that’s there in most patients who are using chemotherapeutic medications, like cisplatin, paclitaxel, and vincristine.
What is CIPN?
For starters, symptoms of CIPN include numbness, cramping, tingling, and a shooting/burning pain in your hands and feet. This medical condition is also linked to decreased quality of life and impaired balance. Roughly 30% of cancer patients have to deal with chronic or severe CIPN.
This means they endure symptoms for as long as three to six months after they’re done with their treatment.
Chemotherapy-induced peripheral neuropathy doesn’t have any FDA-approved treatments, and those on the market have side effects and limited effectiveness.
Details about Quell
Neurometrix’ Quell product is an advanced, neuromodulation, non-invasive tech that’s covered by about nineteen United States utility patents. It’s a wearable neuromodulator that’s powered by a microchip device that offers high-power, precise nerve stimulation.
The Quell tech uses motion and position sensing to adjust stimulation for the best possible experience throughout the day and night. In addition, you can use its Bluetooth low energy feature to communicate with smartwatch and smartphone applications that help cancer patients control and personalize their treatments.
The Breakthrough Device Designation program by the FDA is meant to help cancer patients get more straightforward and quicker access to breakthrough tech that can offer more effective diagnosis or treatment for irreversibly debilitating or life-threatening conditions and diseases.
Under this FDA-designed program, the Food and Drug Administration will offer Neurometrix Inc an interactive communication and priority review associated with device development.
The information submitted by the company in support of this FDA-designed program included findings from an open-label, six-week study that analyzed the effectiveness and safety of the Quell technology when used at home to treat cancer patients battling CIPN.
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