Sana Health ( http:///www.sana.io ) , a Colorado-based medical technology startup backed by global hard tech investor firm SOSV and Founders Fund, announces designation of its non-invasive at-home therapy as a “Breakthrough Device” by the U.S. Food and Drug Administration, for fibromyalgia. 10 million Americans suffer from fibromyalgia, a condition with symptoms including musculoskeletal pain, fatigue, sleep disturbance, and memory and mood changes. Current treatments offer limited long-term benefit, and often fail to significantly improve quality of life for a large portion of the fibromyalgia community.
Sana Health believes patients have new, non-drug hope on the horizon, with the invention of the Sana Device, a portable headset providing computerized audio-visual stimulation, to patients, in their own homes. The Sana Device is a patented system that guides the user into a state of relaxation during a 16 minutes therapy session, with a combination of effects observed in pilot studies showing improvements in pain, sleep and mood.
Breakthrough Device Designation is a recognition based on that pilot data that the technology warrants expedited attention by the FDA and CMS. The Breakthrough program is part of a federal effort to bring novel and efficacious technologies into the hands of those that need it, especially where other treatment options are lacking.
A major clinical trial at the Duke University Clinical Research Institute will support further FDA requirements, and is measuring safety, efficacy, and quality of life endpoints in fibromyalgia, with the Sana Device.
With this designation by the FDA, Sana Health also announces a new 1000-person community-based clinical study, for fibromyalgia, in partnership with TheMighty.com – a 2 million person strong digital health community created to empower and connect people facing health challenges and disabilities. This will be the largest non-drug study of patients with fibromyalgia ever undertaken.
Richard Hanbury, Founder and CEO of Sana, originally developed the earliest prototype after a jeep crash in Yemen in 1992 left him in severe, chronic pain and with a 5-year life expectancy. His earliest prototype treated his own nerve-damage pain, and in doing so, he believes it saved his life.
Since then, Hanbury and Sana have been on a mission to bring this technology to the world and to help the millions of people in need of non-drug solutions to reduce pain, facilitate sleep, and diminish anxiety. Clinical trials have begun for the use of the Sana Device in treatment of europathic pain, and the company is exploring additional application in a range of disorders.