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.”
“We are grateful for the recognition by the FDA of the potential for this novel, closed-loop taVNS Phoenix device,” said Donna DiGangi, Principal Consultant at 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 while preserving statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization. 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.