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 also leaves a 66% unmet medical need in this $8 billion market. The Phoenix is an earbud that provides personalized medicine that addresses the underlying autonomic imbalance of PTSD by delivering transcutaneous auricular vagal nerve stimulation (taVNS) in a proprietary closed-loop system.

“Evren is committed to human centered design for our Phoenix earbud, as well as pursuing 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.”

“We are grateful for the recognition by the FDA of the potential for this novel Phoenix device,” said Donna DiGangi of DiGangi Consulting, LLC and Evren’s regulatory advisor. “We appreciated the FDA’s responsiveness as we replied to their key questions, allowing us to secure this designation.”

The goal of the Breakthrough Designation Program is to help speed the development and shorten review time of medical devices with the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases. A key requirement for the Designation is preliminary clinical evidence demonstrating substantial improvement on a clinically significant endpoint compared with other available therapies. In addition, there are government policies under consideration that, if eventually adopted, may facilitate Medicare reimbursement for FDA Breakthrough Devices following marketing authorization.

Source: Company Press Release