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."
The MeRT system is unique in that it uses a personalized/individualized treatment frequency based on the individual's brain wave data using a proprietary algorithm to optimize treatment parameters of Transcranial Magnetic Stimulation (TMS).
Dr. Erik Won, Wave's Chief Medical Officer, added,
"The FDA recognition in granting Breakthrough Device Designation underscores the impact of our work and the potential for MeRT to transform PTSD treatment by delivering individualized care. We are encouraged by the clinical data and excited to continue collaborating with the FDA to bring this therapy to those most in need."
"Wave Neuroscience welcomes this announcement with humility and excitement. We are focused on bringing our imminently scalable platform to help the 13 million Americans suffering from the effects of PTSD."
Said Fred Walke, Wave's CEO.
