JelikaLite, a CNYBAC MDIC 2021 Team, Granted FDA Breakthrough Device Designation:
Provided by Business Wire- 1/6/21
NEW YORK--(BUSINESS WIRE)--JelikaLite Corp, a medical technology company, announced today 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 pediatric patients who are 2 to 6 years of age.
“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”Tweet this
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. Data from a pilot study suggests that Cognilum, a wearable medical device, can significantly improve the symptoms of children living with autism. If approved, it will offer families access to a home-based, easy-to-use, and cost-effective treatment for children with autism not available anywhere else.
Autism is a serious developmental disorder that impacts families around the globe. JelikaLite Corp. believes that it can provide relief to patients and families by reducing children's autism symptoms. Children will be able to better integrate into the society and have more fulfilling lives. Their caregivers can lead less stressful lives and both insurance companies and the government will be able to spend less money on effective intervention, special education and lifelong residential care.
The Breakthrough Device Designation for Cognilum was based on the results of a double-blind, placebo controlled clinical trial of 30 pediatric patients with moderate to severe autism. The trial showed both safety and efficacy of this technology. By combining non-invasive brain stimulation with near-infrared light, EEG sensors, and AI personalization platform, Cognilum demonstrated improvements in autism symptoms 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," said Dr. Eugenia Steingold, Chief Science Officer of JelikaLite. “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’s vision is to bring Cognilum into the homes of families raising children with autism around the globe. This device is truly unique as it seeks to offer a personalized treatment for each child with an integrated feedback loop for both caregivers and doctors.
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. Cognilum™ is a data-device integrated system, where a wearable non-invasive therapeutic medical device that provides neurostimulation treatment is combined with an AI personalization platform.
JelikaLite has been founded and run by a multidisciplinary team, with experts in autism clinical therapy, transcranial photobiomodulation, commercialization of medical devices, artificial intelligence, product management, and finance.
The Cognilum system is not yet commercially available.
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are indicated by words or phrases such as “believes,” “expects,” “should,” “plans,” “may,” “might,” “could,” “seeks,” “intends” and similar words or phrases. These forward-looking statements involve risks, uncertainties, and assumptions. If any of these risks or uncertainties materialize or if any of these assumptions prove incorrect, the results of JelikaLite Corp could differ materially from the results expressed or implied by the forward-looking statements contained in this press release. Except for historical information, all other statements are forward-looking statements, including but not limited to: statements concerning our product candidates, our pre-clinical and clinical studies and trials, and our research and development activities; statements regarding our business or management plans; projections of operations or other financial items; and statements about current or future economic and industry conditions. All such forward-looking statements should be considered in light of these factors, and there can be no assurance that these factors or other factors will not affect the accuracy of such forward-looking statements.