Electromedical Products International, Inc.

FDA Grants Breakthrough Device Designations for Novel Neuromodulation Therapies Targeting PTSD and MDD

• Wave Neuroscience's MeRT system received FDA Breakthrough Device Designation for adjunctive treatment of PTSD, addressing the critical need for effective, non-pharmacologic options. • Pulvinar Neuro, a subsidiary of EPI, obtained FDA Breakthrough Device Designation for its Closed-Loop tACS device, aiming to provide rapid relief from Major Depressive Disorder (MDD) symptoms. • Both devices leverage personalized neuromodulation techniques, tailoring treatment to individual brain activity patterns, potentially transforming mental health care. • The FDA's designation is expected to accelerate the development and review processes for these innovative therapies, offering hope for improved outcomes in underserved patient populations.