Wave Neuroscience, in collaboration with the Texas A&M Health Institute of Biosciences and Technology, has received clearance from the U.S. Food and Drug Administration (FDA) for its MeRT System for the treatment of Post-Traumatic Stress Disorder (PTSD).

The clearance makes MeRT the first personalised, biomarker-guided neuromodulation technology approved by the FDA for PTSD. The milestone supports Wave Neuroscience’s plans for further clinical, commercial and strategic expansion.

MeRT, which stands for Magnetic EEG-guided Resonance Therapy, is the company’s proprietary platform that uses a patient’s brain activity data to guide personalised treatment. The technology applies biomarker-based analysis to deliver targeted therapy for individuals with PTSD.

The FDA clearance was supported by results from a double-blinded, randomised, controlled multi-site clinical trial conducted with investigators from the Texas A&M Health Institute of Biosciences and Technology. The study evaluated the safety and effectiveness of the MeRT System and reported significant and clinically meaningful reductions in PTSD symptom severity following treatment.

The approval is expected to support wider physician adoption of the technology, strengthen discussions with healthcare payers, expand institutional partnerships and create opportunities for future regulatory growth.

Wave Neuroscience said the clearance validates the scientific foundation of its platform and highlights the growing role of personalised, data-driven approaches in the treatment of complex neuropsychiatric disorders.

Researchers at Texas A&M noted that the availability of an FDA-cleared personalised treatment platform could help address the wide variation in symptoms and treatment needs among patients with PTSD, supporting more targeted and individualised care.

 

Source: prnewswire.com

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