NeuroMetrix surges on FDA Breakthrough Designation for neurostimulation technology

Jan. 18, 2022 11:06 AM ETNeuroMetrix, Inc. (NURO)By: Dulan Lokuwithana, SA News Editor

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  • Nano-cap, NeuroMetrix (NURO +30.7%) is trading sharply higher in morning hours after announcing that the FDA granted the Breakthrough Designation for its Quell technology designed to address symptoms in chemotherapy-induced peripheral neuropathy (CIPN).
  • Under the designation, NeuroMetrix is entitled to priority review and more interactive communications with the regulator during the development of the device.
  • While an estimated ~650K cancer patients undergo chemotherapy annually, many experience CIPN in response to common chemotherapeutic agents such as vincristine, paclitaxel, and cisplatin.
  • Quell is a wearable device for neuromodulation covered by 19 U.S. utility patents, the company said. The FDA’s Breakthrough Designation was backed by the data from a 6-week open-label study.
  • Breakthrough Designation is a program designed by the regulator to expedite access to technologies with the potential to provide more effective treatments or diagnoses of major medical conditions.
  • NeuroMetrix’s (NASDAQ:NURO) De Novo request for Quell as a treatment for adults with fibromyalgia is currently under FDA review.

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