In a groundbreaking announcement, the FDA granted Breakthrough Device Designation to Wave Neuroscience for Magnetic EEG Resonance Therapy (MeRT) for the adjunctive treatment of PTSD. This recognition highlights MeRT’s potential to transform mental health care.
Dr. Erik Won, Chief Medical Officer of Wave Neuroscience, shared his excitement:
“The FDA’s recognition underscores the importance of personalized care. MeRT has the potential to change lives by offering a tailored approach to PTSD treatment.”
Understanding the Impact of PTSD
PTSD affects an estimated 13 million Americans, with symptoms including:
- Persistent flashbacks and intrusive thoughts.
- Severe anxiety and emotional numbness.
- Difficulty sleeping and concentrating.
First responders, military veterans, and civilians alike often face limited treatment options. MeRT could change that narrative.
How Does MeRT Work?
Unlike traditional approaches, MeRT uses EEG data to personalize treatment. By tailoring Transcranial Magnetic Stimulation (TMS) to each person’s brain activity, MeRT aims to restore disrupted brain networks.
Benefits of MeRT:
- Precision: We customize treatment to each patient’s unique brain wave activity.
- Non-pharmacologic: No medications are involved.
- Non-invasive: A gentle, safe approach to brain therapy.
Learn more about MeRT treatment for PTSD here.
Why the FDA Breakthrough Designation Matters
This designation speeds up the development and review process for MeRT, allowing patients faster access to this potentially life-changing therapy.
What patients can expect:
- Quicker availability of innovative treatments.
- A focus on safety and effectiveness during the expedited process.
- Hope for better outcomes in PTSD care.
Looking Ahead
Though not yet FDA-approved, MeRT is on the path to becoming a game-changing therapy for PTSD. As Dr. Leslie S. Prichep, Chief Science Officer of Wave Neuroscience, said:
“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.”