Wave Neuroscience, a leader in personalized non-invasive neuromodulation technology, announced that its proprietary Magnetic EEG Resonance Therapy (MeRT) system has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for adjunctive treatment of Post-Traumatic Stress Disorder (PTSD).
The escalating prevalence of Post-Traumatic Stress Disorder (PTSD) in military and civilian populations, including first responders, has become a critical public health issue. Currently, there are no FDA-approved devices for treating this irreversibly debilitating condition. And there is an urgent need for innovative and non-pharmacologic, safe, and effective treatments for PTSD to address this underserved patient population.
This 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 address this critical healthcare need by accelerating the development, assessment, and review of Wave’s FDA submissions for the use of the MeRT system for more effective treatment of PTSD patients.
This MeRT system is unique in that it uses a personalized treatment frequency based on the individual’s brain wave data and a proprietary algorithm to optimize the treatment parameters of Transcranial Magnetic Stimulation (TMS).
KEY QUOTES:
“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. 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.”
- Dr. Leslie S. Prichep, Chief Science Officer of Wave Neuroscience
“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.”
- Dr. Erik Won, Wave’s Chief Medical Officer
“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.”
- Fred Walke, Wave’s CEO
