Evren Technologies, Inc. announced today that its non-invasive Phoenix® earbud device received Breakthrough Device Designation from the U.S. Food and Drug Administration for the treatment of Post-traumatic Stress Disorder (PTSD).
7.5 million Americans seek treatment for PTSD every year and the rates tripled during the COVID shutdown. The current standard of care in this $8 billion market also leaves a 66% unmet medical need. Evren’s Phoenix device provides personalized medicine that addresses the underlying autonomic imbalance of PTSD by delivering therapeutic levels of transcutaneous auricular vagal nerve stimulation (taVNS) in a proprietary, closed-loop, discreet, and wireless earbud design.
“Evren is committed to human centered design for our Phoenix earbud, as well as pursuing good science and sound clinical research to prove the benefits, useability, safety, and effectiveness of our technology,” said Blythe Karow, Co-founder & CEO of Evren. “We look forward to our pivotal trial next year and to applying for marketing approval under the De Novo Classification program.”