Wave Neuroscience Announces FDA Clearance of MeRT® for PTSD

FIRST-EVER FDA-CLEARED PERSONALIZED CLINICAL TREATMENT SYSTEM FOR POST-TRAUMATIC STRESS DISORDER (PTSD) ESTABLISHES A NEW CATEGORY IN PRECISION MENTAL HEALTHCARE

NEWPORT BEACH, Calif., June 11, 2026 /PRNewswire/ -- Wave Neuroscience, in partnership with the Texas A&M Health Institute of Biosciences and Technology, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the company's MeRT® System, representing the first personalized, biomarker-guided neuromodulation technology to receive FDA clearance for Post-Traumatic Stress Disorder (PTSD).

The clearance marks a major regulatory milestone for Wave Neuroscience and establishes a foundational platform for the company's long-term clinical, commercial, and strategic expansion initiatives. MeRT®, or Magnetic EEG-guided Resonance Therapy, is Wave's proprietary platform that utilizes a patient's own brain data to inform highly personalized, biomarker-guided treatments utilizing legally marketed devices for the treatment of PTSD.

The clinical study submitted in support of the FDA clearance leveraged Wave's technological advances along with the expertise of investigators at the Texas A&M Health Institute of Biosciences and Technology to complete a double-blinded randomized controlled multisite trial to evaluate the safety and effectiveness of MeRT for PTSD. The results of the study demonstrated significant and clinically meaningful reductions in PTSD symptom severity after treatment using the MeRT System.

FDA clearance positions MeRT at the forefront of precision mental healthcare and next-generation neurotechnology, and accelerates opportunities for physician adoption, payer engagement, institutional partnerships, and future regulatory growth.

"This FDA clearance represents an inflection point not only for Wave Neuroscience, but for the broader evolution of mental healthcare," said Fred Walke, Chief Executive Officer of Wave Neuroscience. "Healthcare for mental conditions has historically evolved through distinct eras — first psychotherapy followed by pharmacologic innovation. We believe the next era will be defined by precision-based biomarker-guided technologies capable of personalizing treatment to the unique neurophysiology of each patient. MeRT was specifically built to lead that transition. FDA clearance for PTSD validates the scientific foundation of our platform and reinforces the growing importance of data-driven, individualized approaches to treating complex neuropsychiatric conditions."

"Our partnership with Wave Neuroscience has opened the door for translational and clinical investigators at Texas A&M to transform the personalized brain healthcare ecosystem," said Dr. Ken Ramos, MD, PhD, Distinguished Professor and Executive Director of the Texas A&M Health Institute of Biosciences and Technology. "The availability of an FDA-cleared, personalized platform for targeted PTSD treatment represents a significant advancement in our ability to overcome the extensive heterogeneity in clinical presentation of patients with PTSD."

 Addressing a Significant Unmet Need

PTSD remains one of the largest unmet needs in mental healthcare, affecting millions of individuals globally, including veterans, active-duty military personnel, first responders, trauma survivors, and civilians.

The MeRT system was granted FDA Breakthrough Device designation in 2024, recognizing the potential to address this urgent unmet need. Wave Neuroscience believes the FDA clearance of the MeRT System creates a significant opportunity to expand access to personalized, non-invasive treatment options for patients who continue to experience persistent symptoms despite existing interventions.

Scientific Foundation of Personalized Neuromodulation

MeRT, built on top of Wave's extensive intellectual property portfolio, combines AI-augmented EEG-based brain activity biomarker analysis with highly precise and personalized neuromodulation protocols designed to optimize treatment delivery based on each patient's unique neural activity patterns.

This personalized approach differentiates MeRT from the historical, one-size-fits-all neuromodulation systems and represents an important advancement in precision psychiatry.

"PTSD is fundamentally a disorder of dysregulated brain network activity, and effective treatment requires understanding the unique neural dynamics of each individual patient," said Dr. Leslie Prichep, PhD, Chief Scientific Officer of Wave Neuroscience. "The FDA clearance of the MeRT System reflects decades of scientific research supporting the role of electrophysiological biomarkers in identifying abnormal brain activity patterns and guiding personalized intervention strategies. We believe this represents an important advancement toward a more objective, data-informed model of mental healthcare."

"Many PTSD patients continue to struggle despite conventional therapies and pharmacologic interventions," said Dr. Erik Won, MD, Chief Medical Officer of Wave Neuroscience. "This clearance supports the advancement of a non-invasive treatment approach designed to align therapy with each patient's individual brain physiology. The idea that neuromodulation therapies can be personalized using measurable neurophysiologic data was once viewed as aspirational. Today, it has become part of FDA-cleared clinical care for PTSD."  

Strategic Impact of the FDA Clearance

Wave Neuroscience believes the FDA clearance materially strengthens the company's standing within the expanding neurotechnology and behavioral health sectors.

Key strategic implications of the clearance include:

• Establishing the first FDA-cleared indication for the MeRT platform.
• Creating a regulatory framework for future clinical programs and additional indications.
• Increasing institutional confidence among healthcare systems, referral networks, and strategic partners.
• Advancing reimbursement and payer engagement initiatives.
• Enhancing physician adoption and patient trust.
• Strengthening the company's long-term scalability and enterprise value.
• Expanding partnership opportunities involving veterans' health, trauma care, and integrated behavioral health systems.

FDA clearance also reflects growing demand for non-invasive, personalized, and technology-enabled approaches to brain healthcare.

Building a Multi-Indication Regulatory Platform

The PTSD clearance will support a broader regulatory and clinical strategy focused on additional neurological and psychiatric conditions involving dysregulated neural network activity.

"FDA clearance is a pivotal step toward transforming how mental health is understood, managed, and treated," said Fred Walke, CEO of Wave. "Mental health is ultimately brain health, yet clinicians have historically had few objective tools to measure the brain systems that drive mental well-being. Wave was founded on the belief that better measurement leads to better understanding, better assessment, better treatments, and ultimately better outcomes. By bringing objective brain health metrics into clinical practice, we hope to shift mental healthcare from approaches guided primarily by symptoms to those informed by direct insights into a person's unique brain function. We believe this clearance represents an important step toward a future where mental healthcare is grounded in objective, biological measurements, as now realized in other areas of medicine."

About Wave Neuroscience

Wave Neuroscience is a leader in personalized non-invasive neuromodulation technology focused on advancing precision brain health for neurological and mental health conditions. The company's proprietary MeRT® platform combines EEG-based brain analysis with individualized neuromodulation protocols designed to optimize treatment delivery based on each patient's unique brain activity patterns.

Wave Neuroscience partners with physicians, clinics, researchers, and healthcare organizations committed to advancing personalized mental healthcare and precision neuromodulation. Its partnership with Texas A&M Health and others will magnify the scope of its clinical and research portfolios.

Wave Neuroscience is improving brain function for the benefit of mental health.

For more information, visit www.waveneuro.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding future regulatory submissions, anticipated commercial expansion, reimbursement opportunities, strategic partnerships, future FDA clearances, market growth, research initiatives, and long-term business performance. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. FDA clearance for one indication does not guarantee future clearances or commercial outcomes. Wave Neuroscience undertakes no obligation to update forward-looking statements except as required by law.

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SOURCE Wave Neuroscience