JelikaLite Corp., a medical technology company, announced that the U.S. Food and Drug Administration (FDA) has granted the Breakthrough Device Designation to its Cognilum™ System for the reduction of symptoms of moderate to severe autism spectrum disorder in children ages two to six. The Cognilum System is a data-device integrated system with wearable medical device that combines non-invasive brain stimulation with near-infrared light, EEG sensors, and an artificial intelligence personalization platform. The system provides feedback for parents, caregivers, and primary care professionals.
The FDA designation is based on the outcomes of a double-blind, placebo controlled clinical trial of 30 young children diagnosed with moderate to severe autism. Compared to children assigned to a sham device, children assigned to the Cognilum System demonstrated improvement in autism symptoms through gains in communication and daily living skills.
The FDA’s Breakthrough Device Program recognizes medical devices that meet the criteria and hold the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or condition. The designation fast-tracks FDA marketing approval. If approved, the Cognilum System will offer families access to a home-based, easy-to-use, and cost-effective treatment for children with autism.
Based in New York, JelikaLite was launched in 2019 to develop Cognilum™, an innovative solution to permanently reduce children’s autism symptoms, enabling better integration into society and reducing lifelong costs. JelikaLite was founded and is currently run by a multidisciplinary team that includes experts in autism clinical therapy, transcranial photobiomodulation, commercialization of medical devices, artificial intelligence, product management, and finance.
This was reported by JelikaLite Corporation on January 6, 2022.