Evren Technologies has developed the Phoenix, a discrete earbud that utilizes our groundbreaking treatment for PTSD. Backed by clinical evidence, the Phoenix® improves patient health and well-being with fewer side effects and higher patient engagement than seen with current prescription drugs and therapies.
In case you missed it, here are some of the important topics that were talked about in our recent Q&A webinar.
Four categories of PTSD symptoms
There are as many as twenty symptoms we're looking for when looking for PTSD, but they fall into four categories. First, there are intrusive thoughts - things like frightening memories, nightmares and flashbacks. The second is avoidance, such as avoiding certain situations. There are people who don't leave the house, they don't go into public places because they can't control the environment. With veterans, we see that if they can't control their immediate environment, or if they don’t feel safe, they won’t go. Third is altered arousal or reactivity, which is classified as a number of changes in mood and attendant reactive irritability or vigilance - things that inspire the startle response. We hear stories all the time about veterans who return and assault their family members - they'll start having nightmares in their sleep and they'll attack a family member, usually a spouse or a significant other. Lastly, negative thoughts: feelings of worthlessness, shame, or guilt. We often see this in soldiers who feel responsible for the death of comrades - commanding officers or sergeants, the lower level or non-commissioned officers who are responsible for a group of men. If something happens to one of them, they feel responsible; not only to the individual, but to the family of the person who was killed.
The Phoenix PTSD Pilot Trial
Clinical trial participants were given the device and were instructed to use it twice daily. They put the earpiece in their ear,turned on the device, and then used it for 30 minutes. The low amperage electricity activates the vagus nerve, which provides a calming effect to the nervous system.
After a month and at the end of the trial, we re-administered the CAPS-5, a validated quality of life measurement tool, to see what was happening to patient symptoms, because the CAPS-5 tells us about the intensity of PTSD symptoms. We saw a remarkable decline in symptom intensity: almost everybody who used the device seems to derive some benefit from it. Several even achieved complete remission!! Amazingly, every patient wanted to keep their device after the 2 month trial was over and they all said they would pay out of pocket (>$1000) for it!
Even better, the FDA awarded Evren a Breakthrough Device Designation, showing that after they reviewed this data, they believed the Phoenix might provide better outcomes compared to current standard therapies.
Quality of Life
Our clinical trial evaluated sleep disturbance, anxiety, depression, and social engagement. In our trial, we focused on measuring quality of life, because a lot of PTSD treatments can help people's symptoms, but they don't always make their lives better. We don't just want PTSD symptoms to go down, we want these people to actually function better, to be able to live their lives and connect with their families.