GAINESVILLE, Fla., July 26, 2021 / PRNewswire / – Evren Technologies, Inc. announced today that its Phoenix® non-invasive earbuds have received Breakthrough Device Designation from the U.S. Food and Drug Administration for the treatment of post-traumatic stress disorder has (PTSD). 7.5 million Americans receive treatment for PTSD each year, and rates tripled during the COVID shutdown. Current standard of care also leaves 66% unmet medical need in this $ 8 billion market. The Phoenix is an earphone that offers personalized medicine that addresses the underlying autonomic imbalance of PTSD through transcutaneous auricular vagus nerve stimulation (taVNS) in a proprietary closed system. “Evren is committed to the human-centered design of our Phoenix earbuds and has conducted in-depth clinical research to demonstrate the benefits, ease of use, safety and effectiveness of our technology,” said Blythe Karow, Co-Founder and CEO of Evren. “We look forward to our pivotal study next year and to applying for market approval under the De Novo classification program.” “We are grateful for the FDA’s recognition of the potential of this novel Phoenix device,” said Donna DiGangi of DiGangi Consulting, LLC and regulatory advisor to Evren. “We appreciated the FDA’s responsiveness in answering their key questions that enabled us to receive this award.” The goal of the Breakthrough Designation Program is to accelerate the development of medical devices and reduce review time that have the potential to more effectively treat life-threatening or irreversibly debilitating diseases. Preliminary clinical evidence demonstrating a significant improvement in a clinically significant endpoint compared to other available therapies is an essential requirement for designation. In addition, government guidelines are being considered that, if finally passed, could facilitate Medicare reimbursements for post-marketing approval for breakthrough FDA products. About Evren Technologies Evren Technologies is advancing the treatment of PTSD through an easy-to-use platform. The Phoenix® medical device offers personalized medicine in a discreet earplug design that delivers transcutaneous auricular vagus nerve stimulation (taVNS). The combination of the Phoenix with our PTSD Symptom Tracking App enables reimbursable remote monitoring by the doctor and the establishment of a leading PTSD database that collects biosignals, symptom tracking, triggering events and therapy effectiveness. Media and investors: interviews, pictures, video clips available on request. M. Blythe KarowCo-Founder and CEO352.533.3381 x702[email protected]
SOURCE Evren Technologies Related Links evrenvns.com
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