The escalating prevalence of Post-Traumatic Stress Disorder (PTSD) in both military and civilian populations, including first responders, has become a critical public health issue. Currently, there are no FDA approved devices that treat this irreversibly debilitating condition. There is an urgent need for innovative, non-pharmacologic, safe and effective treatments for PTSD to address this underserved patient population.The Breakthrough Device Designation is awarded to treatments that have demonstrated the potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions. While Breakthrough Designation does not indicate FDA clearance,this designation will help Wave Neuroscience to address this critical healthcare need by accelerating the development, assessment, and ultimately the review of Wave’s FDA submissions for the use of the MeRT system for more effective treatment of PTSD patients.

“Our team at Wave Neuroscience is honored to receive this designation, which validates our commitment to transforming mental health treatment for those who suffer from PTSD,” said Dr. Leslie S. Prichep, Chief Science Officer of Wave Neuroscience. “Our unique personalized approach to brain health using the MeRT System, offering a non-pharmacological and a non-invasive PTSD treatment option to a broad population suffering from this debilitating, life altering condition. With the FDA’s support, we are accelerating our mission to fill a gap in health care by providing safe and effective treatment of PTSD, as we move forward with our multisite randomized control pivotal study.”