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.
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.