New Study Finds the Fisher Wallace Stimulator® Effective in Treating Bipolar II Depression

FDA-Cleared Wearable Device Available to Treat Six Million Bipolar Depression Patients

A study conducted at Mount Sinai Beth Israel Hospital and published in the Journal of Nervous and Mental Disease concluded that Bipolar II Depression (BD II) patients who received daily treatment with the Fisher Wallace Stimulator® experienced significant reduction in self-reported depression symptoms compared to patients using a placebo device. No serious side effects or adverse events such as hypomania were experienced by patients in the study.

The double-blind, placebo-controlled study investigated the safety and effectiveness of the Fisher Wallace Stimulator®, the leading brand of neurostimulation device, for the treatment of Bipolar II Depression (BD II). After randomization, the active group received 2 mA of neurostimulation for 20 minutes on a daily basis, five days a week for two weeks, whereas the placebo group had the placebo device turned on and off. Symptom non-remitters from both groups received an additional 2 weeks of open-label active treatment. Active treatment but not placebo treatment was associated with a significant decrease in the Beck Depression Inventory (BDI) scores from baseline to the second week maintaining significance until week 4.

Kelly Roman, CEO of Fisher Wallace, remarked: "We are very grateful to the world-class team at Mount Sinai, led by Dr. Igor Galynker, that performed this research and statistical analysis with a level of integrity that is unimpeachable. The emergence of our device as a low-risk treatment option for bipolar depression will profoundly improve outcomes for millions of patients. Patients who suffer from bipolar depression can start using this device today, and psychiatrists can feel confident about it from a risk benefit perspective."

Designed to be used at home for 20 minutes on a daily basis, the device works by gently stimulating the brain to produce serotonin and other neurotransmitters that improve mood and sleep, and there is evidence that it improves the brain's ability to regulate the limbic system. The Fisher Wallace Stimulator® has been proven to be safe and effective in multiple published studies and causes no serious side effects.

Fisher Wallace Laboratories manufactures and markets the Fisher Wallace Stimulator®, a patented neurostimulation device that was cleared by the FDA for the treatment of depression, anxiety and insomnia.