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 (PTSD). 7.5 million Americans seek treatment for PTSD each year, and rates have tripled during the COVID shutdown. Current standard of care also leaves 66% unmet medical need in this $ 8 billion market. The Phoenix is an earbud that delivers personalized medicine that addresses the underlying autonomic imbalance of PTSD by delivering transcutaneous auricular vagus nerve stimulation (taVNS) in a proprietary closed-loop system rather than the pursuit of solid clinical research to see its benefits To prove the usability, 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 marketing authorization 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 Evren’s regulatory advisor.” We appreciated the FDA’s responsiveness to its key questions that it enabled us to use to receive this award. “The goal of the Breakthrough Designation Progr am is to accelerate the development of medical devices and reduce review time, which 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 adopted, could facilitate post-market reimbursement of Medicare reimbursements for breakthrough products by the FDA. About Evren TechnologiesEvren 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 x702blythe.karow@evrenvns.com View original content to download multimedia: https://www.prnewswire.com/news-releases/evren-technologies-receives-fda-breakthrough-device- designation- for-the-phoenix — revolutionary-transcutaneous-auricular-vagus-nerve-therapy-to-treat-ptsd-301341288.html SOURCE Evren Technologies
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