“We think the device’s wearability—ability to deliver treatment whenever and wherever—will change the care paradigm for depression.”


Irvine, Calif. — Niraxx Light Therapeutics, a leader in wearable neurotechnology, today announced the initiation of a Phase 2 multicenter study of Niraxx Brain Pacer™ in patients with Major Depressive Disorder (MDD). The one-year, 80-subject, multisite randomized, sham-controlled study is led by China Medical University (CMU) in Taiwan.

 “While medications are the first-line treatment, not every patient responds to or prefers them. There is a huge unmet need and as a [healthcare] community, we need to start offering depression treatments that go beyond the one-size-fits-all approach,” said Niraxx co-founder and Chair of Scientific Advisory Board Dr. Paolo Cassano, MD, PhD. He is an Assistant Professor of Psychiatry at Harvard Medical School, Director of Photobiomodulation (PBM) at Massachusetts General Hospital (MGH), and a practicing physician. He has over 10 years of experience in using light therapy to treat patients with depression.

The Brain Pacer is Niraxx’s first e-textile wearable solution. The Bluetooth-controlled wearable solution delivers effective, non-medication light therapy in six tailored programs via the Niraxx Life™ app. The application of unique wavelengths of near-infrared light activates the brain’s natural restorative and regenerative processes and drives increased brain energy and oxygen metabolism. Dynamic metabolic changes in neurons enhance brainpower, resulting in better cognition, emotional balance and energy.

“We are really excited to start the project. We think the device’s wearability—ability to deliver treatment whenever and wherever—will change the care paradigm for depression,” said study Principal Investigator Ta-Wei Guu, MD, PhD. He is the Chief of Education Division at CMU Beigang Hospital and a certified psychiatrist and sleep medicine specialist. “We are not only evaluating the clinical outcomes of depression and sleep-wake rhythms, but also exploring oxidative stresses, inflammatory markers and neurotrophic effects under the intervention,” he added.

Niraxx licenses its PBM technology from MGH, a teaching hospital for Harvard University. The hospital’s psychiatry department has been ranked No. 1 in the U.S. for 16 consecutive years by U.S. News & World Report. MGH is also home to the Wellman Center for Photomedicine, the largest academic research center in the world dedicated to studying the clinical application of light.

About China Medical University, Taiwan

Founded in 1958, CMU is the first academic institution in Taiwan where Chinese medicine and pharmacy programs are provided. The university is one of the foremost medical universities in Taiwan, focusing on the interdisciplinary teaching of western medicine and Chinese medicine. Its two major campuses are located in Taichung and Beigang. For more information, visit https://english.cmu.edu.tw.

About Niraxx Light Therapeutics

Niraxx is a NeuroTech company that aims to democratize access to safe, effective brain health care by delivering truly wearable digital health experience integrating PBM in clothing. Our mission is to empower individuals to take charge of their brain health for life. For more information, visit https://niraxx.com.

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