FDA Breakthrough Device for PTSD
15 million Americans suffer from Post-Traumatic Stress Disorder (PTSD).
But current treatment practices like therapy and prescription drugs don’t work. These people are suffering, and searching for a better option. That’s why Evren Technologies was created.
This company is advancing PTSD treatment with an innovative medical device called the Phoenix. This is an earbud that stimulates a wearer’s central nervous system, targeting the part of the brain that controls things like stress levels and memory. The result is a device that improves patient health and well-being, with fewer side effects and higher patient engagement rates.
After receiving Breakthrough Device Designation from the FDA, and a $250,000 grant from the National Institutes of Health, Evren has developed and tested its device. Now it’s gearing up to commercialize its technology, and target a U.S. market worth more than $22 billion.
As mentioned, according to the National Center for PTSD, 15 million U.S. adults suffer from this disorder. While traditionally associated with military veterans, it can also affect healthcare workers, first responders, or anyone who has experienced trauma.
46% of those suffering from PTSD have substance issues. And they’re 13x more likely to commit suicide.
Treatment options are primarily antidepressants and therapy. But 75% of people who take antidepressants experience side effects. 70% discontinue their medication. Therapy, meanwhile, has 50% dropout rates.
As a result, 66% of those suffering from PTSD are looking for a new solution. This is where Evren’s device could help.
The company’s earbud provides a light electrical tingle to the vagus nerve. This is part of the body’s central nervous system, and is directly related to the balance of calm/stress, as well as how we store and retrieve fearful memories. Its patented stimulation process alleviates symptoms associated with PTSD, including depression, anxiety, insomnia, social avoidance, and thoughts of suicide. Just as important, it does so without significant side effects.
Notably, the earbud pairs with a free mobile app, which enables users to track symptoms, record sleep activity, and identify triggers.
Evren completed a pilot with its device, and 100% of users wanted to continue using it following the trial. Results included reduction in PTSD symptom severity, improved quality of life, and no significant side effects.
In addition to its designation from the FDA and grant from the NIH, Evren’s device received a SBIR Phase I awarded for a “programmable tVNS research device for PTSD and related conditions.” Meanwhile, the company completed the Medtech Innovator Accelerator, GuideWell Scale Up Accelerator, and the 2021 Rosenman Innovator program.
Evern plans to sell its device through three channels:
• Directly to consumers.
• Sales to the Department of Veterans Affairs.
• And reimbursed sales through healthcare providers.
Its DTC model will begin at $99 per month for the first year (until the device is paid off) and then $49 per month to cover additional supplies and support.
In addition to product sales, Evren plans to leverage its growing HIPAA-compliant database of de-identified data, which can be used to support advancements in the understanding and treatment of PTSD. This could potentially make the company a sought-after acquisition target for health management companies.
Neil has spent the past 20 years leading teams developing medical devices and technology. Notably, he was the chief designer and manager of an FDA-cleared Philips Healthcare team that developed support software for ventilated patients.
Throughout his career, he’s earned more than 40 patents for his work. Furthermore, he has 19 years of experience managing R&D grants. He has been involved in the successful FDA clearance of more than half a dozen medical devices.
Neil earned a Bachelor’s degree in Computer Science, a Master’s degree in Electrical Engineering, and a Ph.D. in Signal Processing from the University of Florida.
Weaver has more than 25 years of experience in the biotech and life-sciences industries.
Most recently, he was co-founder and CEO of OBMedical Company, a medical device company that developed an electronic maternal fetal monitor. This device received FDA clearance and the company was acquired by Philips Healthcare in 2018.
Before that, he was an adjunct professor at the University of Virginia School of Law, teaching a course on starting a medical device company. Prior to that, he was Chairman of the Board of Directors with Nanotherapeutics, a specialty pharmaceutical company.
Earlier in his career, Weaver was Chairman and President of Ixion Biotechnology, a biotech startup focused on treatment options for Type 1 diabetes. Prior to that, he was an executive Vice President with Mutual of New York, an insurance company.
He holds a Bachelor’s degree in Philosophy from Dartmouth and a Law degree from the University of Virginia.
Kimberly has three decades of corporate finance and operations experience.
Most recently, she was Founder and President of Bio/Med CXO, a company providing consulting services to medical device startups. Before that, she was co-founder and Chief Financial Officer with OBMedical Company, the medical device startup acquired by Philips Healthcare.
She holds a Bachelor’s degree in Accounting from the University of Florida.
An agency of the U.S. Department of Health and Human Services, the NIH is the primary agency of the United States government responsible for biomedical and health-related research. The NIH both conducts its own scientific research through its Intramural Research Program (IRP) and provides major biomedical research funding to non-NIH research facilities through its Extramural Research Program.