Business
gammaCore™ Non-Invasive Vagus Nerve Stimulation(nVNS) Receives Breakthrough Device Designation for Treatment of Posttraumatic Stress Disorder (PTSD)
nVNS reduces symptoms of PTSD by 31% in sham-controlled study ROCKAWAY, N.J., Jan. 12, 2022 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a
About this update from Electrocore, Inc.
[{"type":"text","content":"nVNS reduces symptoms of PTSD by 31% in sham-controlled study\nROCKAWAY, N.J., Jan. 12, 2022 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that its gammaCore™ nVNS device has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for the treatment of posttraumatic stress disorder (PTSD) after showing a reduction of symptoms of PTSD by 31% when compared to sham. PTSD is a highly prevalent and disabling disorder with limited approved treatment options. According to the U.S. Department of Veterans Affairs National Center for PTSD, approximately 15 million adults in the U.S. experience PTSD each year. In the Military and Veterans Administration alone, PTSD is reported to affect between 10-20% of veterans who served in each Operations Iraqi Freedom (OIF) and Enduring Freedom (OEF), the Gulf War (Desert Storm), and the Vietnam War. More than half of all patients with PTSD report severely impaired quality of life in areas including mood, social and family relationships, leisure activities, sense of well-being and life satisfaction. The Breakthrough Device Designation was supported, in part, by research from an Emory-Georgia Tech team led by J. Douglas Bremner, M.D., in the Departments of Psychiatry and Radiology at the Emory University School of Medicine, and Omer T. Inan, Ph.D., from the School of Electrical and Computer Engineering and the Coulter Department of Biomedical Engineering at the Georgia Institute of Technology in Atlanta, Georgia. Their research, built upon a strong mechanistic rationale and animal studies, shows nVNS blocks sympathetic and inflammatory responses to memories of traumatic events in patients with PTSD, modulates brain responses to traumatic memory, and reduces symptoms of PTSD by 31% when compared to a sham stimulation. Dr. Douglas Bremner commented, “Current treatments for PTSD involving medication and psychotherapy have limitations due to limited efficacy, possible side effects, and the unwillingness of many PTSD patients to engage in therapies that involve reliving traumatic memories. gammaCore represents a new class of treatment separate from medication or psychotherapy that is safe, relatively free of side effects, and does not involve costly and invasive procedures for implantation, like previous VNS...