Pilot study data suggests that JelikaLite’s Cognilum medical device reduces symptoms of autism in young children and improves the quality of life of their families.
NEW YORK–(BUSINESS WIRE)–JelikaLite Corp announced today positive results from a study funded by the NSF SBIR Phase I grant. This study demonstrated that tPBM is a potentially effective treatment modality for improving symptoms of autism in children. Open Label Study had 25 participants. As a result of the treatment, children’s behavior and communication skills improved – as measured by CARS (Childhood Autism Rating Scale) and observations by an independent SLP. The EEG data revealed redistribution of brainwaves from slowest (delta) to fastest (gamma), suggesting that Near InfraRed light may modulate brain tissue. Additional studies are being planned to further elucidate this mechanism and other efficacious effects of the technology platform.
In addition, the company has announced a successful raise if $760k. Investors included NY Ventures and Brain Foundation / BioVerge SPV, through which many angel investors participated.
Furthermore, JelikaLite has been accepted to Elementa Labs, the virtual incubator program of the Mount Sinai Health System in New York, NY, as a member of its 2023 cohort.
“The JelikaLite team is excited to start Elementa Labs, as it is a significant milestone for the company. The program will provide guidance for potential commercialization of our technology in the US. The news is especially encouraging as the company has just completed its 2 clinical studies with positive results,” noted Katya Sverdlov, CEO at JelikaLite.
Based in New York, JelikaLite was launched in 2019 to develop Cognilum™, a non-invasive brain stimulation platform for autistic children, designed to improve communication skills and reduce social anxiety. Cognilum™ is an intelligent medical device, combining a wearable non-invasive brain stimulation with near infrared light, sensors and a personalization platform. Within a few weeks of treatment, children’s teachers, therapists and parents are able to see significant improvement in responsiveness, language and social skills, seeing progress of over 5x the rate of typical therapies.
To date, JelikaLite conducted two clinical studies using our proprietary prototype, received FDA Breakthrough Device Designation, received National Science Foundation grant, conducted extensive customer discovery research and raised over $2MM. We are currently raising funds for pilot implementation in clinics in early 2023 and a Pivotal clinical trial (needed for FDA de-novo marketing approval).
The Company 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.
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