According to the CDC, one child of every 69 born in the U.S. has autism spectrum disorder (ASD). In 2017 the Hindustan Times in Delhi, India, stated the ratio in that country is one in 89 children. We have written about other health tech developed for people with ASD. Researchers at the Lancaster University’s School of Computing and Communications developed a personalized wearable to help autistic people with anxiety. Awake Labs’ Reveal wristband also reduces anxiety in people with ASD. Researchers at the University of Toronto‘s Institute of Biomaterials and Biomedical Engineering (IBBE) are developing social-skills coaching software for Google Glass to help people with ASD handle social interaction.
In direct response to the prevalence of ASD in India and to gather data to support an FDA application, San Diego-based Avacen Medical has commenced sales in India of the company’s Avacen 100 dry-heat therapy medical device for help people who suffer from ASD. The device’s purpose is to safely and non-invasively warm the body by infusing heat into the circulatory system. The company cites studies that show a moderate fever can relieve behaviors related to ASD for days or weeks. According to Avacen, its device mimics the effects of a moderate fever and thus can be used to treat ASD behavioral symptoms. To collect data that supports Avacen 100’s efficacy in relieving ASD symptoms, the company is offering the device at significant discounts to Indian families with autistic children. In exchange for the reduced price, parents agree to keep a daily diary of their child’s progress for 60 days. The plan is to include feedback from the diaries with the FDA application for approval to use the Avacen 100 to treat autism behavior in the U.S.
The Avacen 100 is currently cleared for sale in the E.U., Canada, and the U.S., but not for autism. The heat therapy device approval covers temporary relief for minor muscle and joint pain and stiffness associated with various causes and conditions. Avacen holds four U.S. patents for the relief of circulatory, neurological, lymphatic, and endocrinal dysfunctions with dry-heat therapy but has not yet received FDA clearance for the Avacen 100 for those conditions.