Updated: Mar 28, 2021
Gainesville, FL – March 22, 2021 –
Evren Technologies is pleased to announce the completion of our IRB-approved pilot study using the Phoenix® device to treat Post-traumatic Stress Disorder (PTSD).
The Phoenix® Pilot Study was designed as a take-home test, following COVID social distancing and sterilization guidelines, that allowed participants to use the device over two months. The study was designed to mimic the FDA pivotal trial that will be required for a PTSD indication. The FDA requires a six point reduction in the Clinician Administered PTSD Scale (CAPS-5) with a 50% response rate in order to prove efficacy for a PTSD indication and the Phoenix trial, designed to be approximately 20% the size of the FDA pivotal trial, had results that significantly surpassed these requirements.
“We are extremely satisfied with the results of our Phoenix pilot study.” Blythe Karow, President & CEO of Evren Technologies, “Not only did we see excellent improvements in patients CAPS-5 scores, we also saw significant improvements in Quality of Life.” The final results of the pilot study, excluding one non-compliant patient and one non-responder, were an average 21.1 point improvement in the CAPS-5.
To create the best PTSD treatment possible, Evren was also focused on Human Centered Design throughout the pilot study. The Phoenix pilot provided valuable feedback crucial to our design process for the earbud development and for the final pivotal study design.
About Evren Technologies
Evren Technologies is advancing the treatment of PTSD by delivering cutting-edge VNS technology through a user-friendly and intelligent hardware and software platform that is easy to use and personalized. Our initial medical device - the Phoenix® - delivers transcutaneous auricular vagal nerve stimulation (taVNS) in a discreet earbud design. Pairing the Phoenix with our PTSD symptom tracking app will allow for reimbursable remote clinician monitoring and the establishment of a leading PTSD database that collects biosignals, symptom tracking, triggering events, and therapy effectiveness.
Evren Technologies, Inc.