Hoolest Performance Technologies, a startup focused on neurotechnologies designed to enhance mental health and human performance, announced that its newest technology has reached a new milestone with the launch of a clinical trial seeking FDA approval. Hoolest, with support from the Arizona WearTech Applied Research Center has developed the P57 ONE, a non-invasive electrical nerve stimulation device to treat anxiety and other medical conditions. The device was specifically designed to provide fast-acting anxiety relief for anyone looking for an effective drug-free solution.

“284 million people in the world have an anxiety disorder. Medication continues to be the first line of defense because available drug-free solutions to manage anxiety are simply ineffective for many people. The problem with medication is that it impairs your mind, and you are unable to perform tasks at a high level, whether you are an athlete, a business leader, a student, or a working mother. People with anxiety need an effective drug-free, fast-acting solution that can be used whenever they need it,” said Nick Hool, CEO and Co-Founder of Hoolest Performance Technologies.

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The P57 ONE works by applying mild electrical impulses to a region on the side of the neck that contains the Auricular Branch of the Vagus Nerve (ABVN) and Great Auricular Nerve (GAN). These nerves directly communicate with regions in the brain that control parasympathetic activity and production of neurotransmitters involved in reducing anxiety. The P57 ONE is intended to provide relief in 10 minutes or less and uses Hoolest’s proprietary electrode technology to provide a superior user experience during treatment.

Hoolest was founded by Nick Hool, Ph.D., and John Patterson, M.S., who both studied engineering at Arizona State University. They won their first check for their idea through the Venture Devils program at ASU, and worked to develop the P57 ONE with additional support from the Arizona WearTech Applied Research Center, an initiative of the Partnership for Economic Innovation to support the development and launch of future-of-health technology products. One of the ways the WearTech Center does this by providing assistance during the research, prototyping, and validation stages of product development.

“The great thing about the WearTech Center is being able to witness an abstract idea come to life and have an immediate impact on people’s lives,” said Greg Raupp. “It’s been an inspirational experience to follow Nick and John’s path taking their research that started at ASU to developing a product that will truly help people at the WearTech Center.”

“Being selected to participate at the WearTech Center has been vital for the process of catapulting our innovative product to market. We now look forward to the completion of our FDA clinical trial and bringing the P57 ONE a step closer to market,” added Hool.

Hoolest has entered the initial stages of FDA approval for the P57 ONE with the launch of a national clinical trial that will include participants in three different locations. The goal of the clinical trial is to demonstrate product safety and verify anxiety reduction in patients after 10 minutes of use. Following the results of the trial, Hoolest will apply for FDA clearance as a medical device for acute anxiety relief.

“It’s thrilling to see a project from the WearTech Center reach the FDA trial period of development, a significant validation step for any health product to reach consumers,” said Michael Lawton, MD, WearTech Center Advisory Board Member and President and CEO of Barrow Neurological Institute, where he is also Chair of the Department of Neurosurgery. “Congratulations to Nick and his team for pursuing their vision to provide a new solution for those living with anxiety.”

WearTech Center is currently supporting the development of other life-changing technology including exoskeleton development and testing, fall-prevention and risk assessment, and others. Information on these projects and more is available at azweartech.org.