The FDA has granted Breakthrough Device designations to two novel neuromodulation therapies, signaling a potential shift in the treatment landscape for Post-Traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD). Wave Neuroscience and Pulvinar Neuro, a subsidiary of Electromedical Products International, Inc. (EPI), each received the designation for their respective innovative approaches to mental health treatment.
Wave Neuroscience's MeRT System for PTSD
Wave Neuroscience's Magnetic EEG Resonance Therapy (MeRT) system has been granted Breakthrough Device Designation by the FDA for adjunctive treatment of PTSD. This designation recognizes the potential of MeRT to provide a more effective treatment for this debilitating condition, which affects millions of Americans. According to Wave Neuroscience, approximately 13 million Americans suffer from PTSD.
The MeRT system employs a personalized approach, utilizing an individual's brain wave data and a proprietary algorithm to optimize Transcranial Magnetic Stimulation (TMS) parameters. This individualized treatment frequency aims to address the specific neurological imbalances associated with PTSD.
"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. "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."
Pulvinar Neuro's Closed-Loop tACS for MDD
Pulvinar Neuro received Breakthrough Device Designation for its Closed-Loop Transcranial Alternating Current Stimulation (tACS) device, intended for the acute reduction and treatment of MDD symptoms. The device is designed to be used as an adjunct to standard care in adult patients who are not considered refractory to medication.
An initial clinical trial, published in the American Journal of Psychiatry, demonstrated a significant reduction in symptom severity among participants with MDD. Notably, 80% of patients were assessed to be free of clinical depression symptoms two weeks post-treatment by a psychiatrist. The technology personalizes brain stimulation based on real-time measurements of brain activity, targeting specific rhythmic electric activity patterns disrupted in MDD.
Dr. Flavio Frohlich, Professor of Psychiatry at the University of North Carolina at Chapel Hill, described the FDA’s Breakthrough Device designation for Closed-Loop tACS technology as a “recognition of its transformative potential and a step forward in advancing innovative treatments for Major Depressive Disorder that bring rapid relief.”
Implications of Breakthrough Device Designation
The FDA's Breakthrough Device program is designed to accelerate the development, assessment, and review of medical devices that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating conditions. While the designation does not guarantee FDA clearance or approval, it provides manufacturers with increased access to the FDA's expertise and resources, potentially expediting the regulatory process.
These designations highlight the growing interest in neuromodulation therapies for mental health conditions and the potential for personalized approaches to improve treatment outcomes. As both Wave Neuroscience and Pulvinar Neuro advance their respective technologies, the field will be watching closely for further clinical data and regulatory milestones.
