Precision Autism: Get more from life with light!

*Above graphic is a computer generated version.

Cognilum is a therapeutic wearable medical device which combines non-invasive brain stimulation using near-infrared light, EEG sensors and an AI personalization platform.

The non-invasive wearable device provides neurostimulation through transcranial photobiomodulation (tPBM). The device also measures brains’ electrophysiological activity through EEG.

The software platform monitors each child’s developmental trajectory, warns parents and doctors about any set-backs, and personalizes treatments.    

Cognilum will enable children to integrate into society; parents to receive a home-based easy-to use personalized cost-effective treatment — therapists to track progress and efficacy of existing interventions, and both payers and government to spend less money on special education and lifelong residential care - It will allow parents and children to have less stressful, more predictable and more fulfilling lives.

The benefit is expected to be a 1/3 permanent improvement of a child's autism symptoms, as demonstrated by gains in communication and daily living skills, resulting in over $1MM in savings over an individual's lifetime cost of autism.

There is no cure for Autism

1 out of 44 children in the US are now diagnosed with Autism (Source). The rates continue to rise, the cause of the disease remains unknown and there is no cure. 

The vast majority of affected individuals have difficulties with language learning and 40% remain non-verbal. (Source)

Source

Costs of treatment in the US are projected to rise to over $450B by the year 2025. (Source) Individual’s lifetime costs range from $1.5MM to $3.5MM, depending on the severity of symptoms. (Source)

There are several unmet needs that all parents of children with autism  are grappling with: the pervasive symptoms, lack of consistently effective treatment, lack of treatment continuity, the effectiveness of various interventions is hard to measure quantitatively, busy parents have difficulty scheduling the needed therapy and following through with lessons at home.

Furthermore, autism rates among racial minorities in the US have increased by double digits in recent years. (Source) Exacerbating this rise are major racial and socio-economic disparities in access to Early Intervention services. Therefore, there is a significant unmet need for a convenient home-based personalized effective treatment that does not rely on the continued physical presence of a trained therapist and that provides data to the parent and therapist so they can quantitatively and consistently measure the effect of various interventions.

We use infrared light technology to treat autism symptoms

JelikaLite developed Cognilum, a wearable headset that harnesses the power of Photobiomodulation (PBM therapy) to reduce symptoms of autism in children, by improving language skills, and responsiveness. It is a data-integrated system that collects data from both the infrared headset as well as parental reports of a child’s observable behavior and symptoms which are analyzed on the platform. This platform provides personalized treatment for each child, including calculating expected developmental trajectory, tracking autism symptoms progressions, and optimizing various treatment interventions. 

*Above graphic is a computer generated version of the app.

PBM therapy is an innovative red / near infrared light treatment that is used to stimulate cellular functions. Simply, it increases cerebral blood flow and reduces inflammation, which helps the brain receive more oxygen and nutrition to heal. Cognilum can enable children to integrate into society and empower parents to receive a home-based cost-effective treatment while having a better quality of life.

JelikaLite will use a subscription-based model by collecting the revenue sources from the price of the therapeutic device and monthly access costs to the software platform. Initially, we expect the device to be paid for privately by parents, but with sufficient data, payers will be approached for reimbursement. The availability of insurance coverage is likely to increase the sales of the product significantly. 

Our innovative approach yields successful results

Regulatory: Received ‘non-significant risk device designation” from the FDA. 

Product:  developed a beta version of the physical prototype which was used in the Phase I clinical trial and developed initial assessments for the AI platform.

Awards: Won a FuzeHub Commercialization Competition.

Patents: Performed Freedom to Operate Search and filed 3 patents.  

Clinical:  In October 2021, JelikaLite finished a pivotal double-blind, placebo controlled clinical trial, using JelikaLite's proprietary prototype. The difference between the ‘active group’ and the ‘placebo group’ was statistically significant on each of the 3 separate measurements – Childhood Autism Rating Scale tests, parental reports of child’s progress and EEG data.

• Children who received the treatment developed new verbal skills, improved socialization skills and responsiveness. 

The results of the clinical trial have been published and / or already accepted for publication and presentation in the following:  

·         Journal of the American Academy of Child & Adolescent Psychiatry, Volume 60 / Number 10S / October 2021

·         1st Annual Autism Conference  at Rutgers University Center for Autism Research, Education, and Services (10/28/2021):  

Next steps:

• Submitting a request for Break-through device designation to the FDA 
• Working on Phase II clinical study protocol
• Enhancing the prototype -  to be ready for Phase II trial and manufacturing

Parents are Seeking a Solution 

Mental and developmental disorders among children are on the rise. The causes of these diseases remains unknown and there are no known cures. There are existing tPBM products on the market, but none of them are designed for children or for autism treatment. There are existing software platforms, but none of them have the integrated feedback loop with the physical device nor AI personalization.

Cognilum is positioned to be unique: it is home based, easy to use for busy parents, provides a personalized feedback loop, and it is potentially expandable to other pediatric conditions. JelikaLite has several competitive advantages. First, we filed patents on the combination of tPBM, EEG sensors and personalization. Second, we already have access to a large number of organizations that work with children with autism and a community of parents. 

Most importantly, the data-device personalization feedback loop is unique for autism.  The platform will collect both physical measurements from the devices' sensors and behavioral data of children from parents and therapists, thus measuring the effectiveness of treatments and treatment interactions. This data can eventually establish correlations of condition severity and child’s progress with child’s demographic, medical and developmental history. Our AI protocol will analyze the disparate inputs, model the child’s developmental trajectory, and personalize treatment. 

As the platform collects more data from more parents, it will give us a constantly growing competitive advantage.

Real change for real children

We believe that all children on the autism spectrum can lead fulfilling and productive lives. Investing in our company gives investors both the opportunity to position themselves in a massive and growing market and an opportunity to improve the quality of life for millions of families across the world. 

JelikaLite will enable children to integrate into society, parents to receive a home-based cost-effective treatment while having a better quality of life, therapists to track progress and efficacy of existing interventions, and both insurance companies and government to spend less money on special education and lifelong residential care. 

Help us on our journey to become the face of hope in autism treatment and become a shareholder in JelikaLite.