Gainesville, Fla. — September 16, 2024 – Evren Technologies Inc. (Evren) is proud to announce its acceptance into the United States Food and Drug Administration’s (FDA's) Total Product Life Cycle Advisory Program (TAP). This groundbreaking initiative was created by the FDA’s Center for Devices and Radiological Health (CDRH) to accelerate the development of high-quality, safe, and innovative medical devices, such as Evren’s, which are critical to public health. Evren’s participation in TAP will support its mission to advance the treatment and awareness of Post-Traumatic Stress Disorder (PTSD) through Transauricular Vagus Nerve Stimulation (taVNS).
The TAP program aims to streamline the pathway to market adoption and patient access by providing participants with access to strategic guidance from non-FDA parties. By fostering collaboration, the FDA is taking an active role in promoting patient access to innovative and effective devices like Evren’s.
TAP was developed by an experienced FDA team and offers expertise from a wide range of fields, including:
FDA leadership and staff with regulatory expertise throughout the product lifecycle
Clinicians with experience in payor coverage policies
Advisors from organizations like the American Brain Association and the American Medical Association CPT® Editorial Panel
Professionals from venture-backed and Fortune 500 MedTech companies specializing in research, development, marketing, and more
Physicians with leadership roles in healthcare provider groups
“We are excited to benefit from the vast expertise that TAP offers, as we continue our journey toward regulatory approval,” said Rick Giancola, President and CEO of Evren Technologies. “PTSD is widespread, yet often untreated. Current treatments may not work for everyone and sometimes come with side effects. Our goal is to bring the Phoenix® taVNS device to market as quickly and efficiently as possible, and TAP will help us achieve that.”
PTSD affects 7.5 million Americans annually, with rates tripling during the COVID-19 pandemic. PTSD impacts veterans, first responders, and trauma survivors, among others. The condition triggers the brain’s “fight or flight” mechanism, causing fear, panic, and anxiety long after the traumatic event has ended. Evren’s innovative bioelectric technology targets this mechanism, offering a non-invasive treatment option through taVNS.
About Evren TechnologiesEvren is a bioelectronic medical device company focused on transforming the treatment of PTSD, Acute Stress Reactions, Acute Stress Disorder, and Adjustment Disorders through non-invasive Vagus Nerve Stimulation (VNS). Evren’s initial product, the Phoenix® CR, delivers taVNS therapy safely and effectively in clinical and home settings. Launched in 2023 for research use, the Phoenix CR is now the foundation for Evren’s clinical trials as the company seeks De Novo classification from the FDA.
For more information, visit www.evrenvns.com.
Contact:
Rick Giancola
President and CEO
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