NeuroMetrix surges on FDA Breakthrough Designation for neurostimulation technology

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

Headquarters of US Food and Drug Administration (FDA)

Grandbrothers/iStock Editorial via Getty Images

  • 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.

Recommended For You


To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.
Is this happening to you frequently? Please report it on our feedback forum.
If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh.