“The trial results demonstrated rapid, clinically significant improvement of depression in adults, most notably among the 185 female participants. In addition to the rapid treatment effect, approximately three quarters of women in the active treatment group responded by week four, and there were no reports of serious side effects,” noted Kyle Lapidus, MD, PhD, a board certified psychiatrist and the study’s principal investigator. “A follow up study will assess long-term treatment durability and whether men respond as impressively as women.”
Trial Results and Next Steps
The peer-reviewed findings validate Fisher Wallace’s patent-pending Version 2.0 technology as one of the most rapid treatments for depression. The wearable proved to be significantly effective in relieving Major Depressive Disorder (MDD) in the first week when used twice-a-day for 20 minutes. The triple-blind, randomized, sham-controlled trial studied four weeks of treatment, demonstrating that active treatment was significantly superior to sham (placebo) treatment at week one in the intent-to-treat population, and at all time points (week one, two and four) in the per protocol (usage adherent) population and the 185 female participants. The study also achieved its secondary endpoint at week four that analyzed the responder rate (≥50% improvement) in the intent-to-treat population, with approximately 65 percent of active arm participants responding to treatment. No serious side effects were reported in the study.
A new 12-week study using Fisher Wallace’s Version 2.0 technology has been designed by Dr. Maurizio Fava, Psychiatrist-in-Chief of Massachusetts General Hospital and the Associate Dean for Clinical and Translational Research at Harvard Medical School, to assess the durability and effectiveness of treatment in men and women. The company intends to use the results of this 12-week study to obtain FDA approval of its Version 2.0 wearable, OAK, which has been designed and engineered by the teams behind Beats, Nest and the HoloLens.
Additionally, the successful results of a recent eight-week Generalized Anxiety Disorder study that used the same Version 2.0 wearable, and was conducted by the Seattle Police Department and Washington State University, are being prepared for peer-reviewed journal submission and will be used to apply for a new FDA indication. Approximately half of patients suffering from depression also suffer from anxiety.
Technology Basics
Fisher Wallace’s Version 2.0 technology deploys a unique form of transcranial alternating current stimulation (tACS) that utilizes a square waveform, high-carrier frequency, and ultra-rapid pulse rate, to trigger action potentials and induce neuroplasticity. Patients may comfortably and safely self-administer treatment while engaging in quiet activities.
“When wearable brain stimulation rapidly and durably improves neuroplasticity, many aspects of brain function often improve simultaneously. Depression is the primary and, for hundreds of millions of people, the most important problem we are solving. However, I believe that we’ve developed a superdevice for brain health that will be proven to be rapidly effective for a universe of conditions and also optimize brain performance,” noted Fisher Wallace Labs Co-Founder and CEO Kelly Roman. “Ten years from now, I believe wearable brain stimulation devices will be as ubiquitous as smartphones and used by patients throughout their lives.”
About Fisher Wallace Laboratories, Inc.
Fisher Wallace Laboratories (Fisher Wallace Labs) is family office funded developer of wearable brain stimulation technology for the treatment of neuropsychiatric and cognitive disorders. The company is currently pursuing regulatory approval for its Version 2.0 wearable, OAK, and is led by Co-Founder and CEO Kelly Roman, who has helped pioneer the category since 2009. For more information, visit https://www.fisherwallace.com/.
Media Contact:
Erica Camilo
Connexa Communications
+1 610-639-5644
erica@connexacommunications.com
