By Michael Dabaie

ElectroCore Inc. shares were up 8.4% to 58 cents premarket Wednesday after the company said its gammaCore non-invasive vagus nerve stimulation received U.S. Food and Drug Administration breakthrough device designation for the treatment of posttraumatic stress disorder.

The commercial-stage bioelectronic medicine company said the designation came after the device showed a reduction of symptoms of PTSD by 31% when compared to sham.

The goal of the breakthrough devices program is to provide patients and health care providers with timely access to critical medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

January 12, 2022 09:02 ET (14:02 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
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