Sam Brusco, Associate Editor01.06.22
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to JelikaLite Corp for its Cognilium System, a wearable non-invasive therapeutic medical device that provides neurostimulation treatment, combined with an AI personalization platform. Cognilium reduces moderate to severe autism spectrum disorder symptoms in pediatric patients age two to six.
Data from a pilot study suggests the wearable Cognilum device can significantly improve symptoms of children living with autism. If approved it offers a home-based cost-effective treatment.
The designation was based on a clinical trial of 30 pediatric patients with moderate to severe autism. It showed both safety and efficacy, combining non-invasive brain stimulation with near-infrared light, EEG sensors, and the AI personalization platform. Autism symptoms showed improvement through gains in communication and daily living skills.
"We are thrilled that the FDA recognizes that we are developing a novel technology with a potential to change the landscape in the current approach to Autism," Dr. Eugenia Steingold, chief science officer of JelikaLite told the press. “For some of the participants in our active condition, the positive change was so dramatic that their parents expressed their desire to continue the treatment even after the study was over. We recognize that Autism is a spectrum, and no two children are alike; our ultimate goal is to develop a personalized approach to every child based on their unique needs and challenges.”
JelikaLite hopes to bring Cognilium into family homes raising children with autism worldwide. The treatment seeks to personalize treatment with an integrated feedback loop.
Data from a pilot study suggests the wearable Cognilum device can significantly improve symptoms of children living with autism. If approved it offers a home-based cost-effective treatment.
The designation was based on a clinical trial of 30 pediatric patients with moderate to severe autism. It showed both safety and efficacy, combining non-invasive brain stimulation with near-infrared light, EEG sensors, and the AI personalization platform. Autism symptoms showed improvement through gains in communication and daily living skills.
"We are thrilled that the FDA recognizes that we are developing a novel technology with a potential to change the landscape in the current approach to Autism," Dr. Eugenia Steingold, chief science officer of JelikaLite told the press. “For some of the participants in our active condition, the positive change was so dramatic that their parents expressed their desire to continue the treatment even after the study was over. We recognize that Autism is a spectrum, and no two children are alike; our ultimate goal is to develop a personalized approach to every child based on their unique needs and challenges.”
JelikaLite hopes to bring Cognilium into family homes raising children with autism worldwide. The treatment seeks to personalize treatment with an integrated feedback loop.