INVEST IN JELIKALITE TODAY!
Federal recognition achieved. FDA granted JelikaLite a Breakthrough Device Designation for its Cognilum system for reduction of symptoms of autism in pediatric patients aged 2 to 6
The autism market is growing. There are already over 1 million children living with ASD in the U.S. and 13 million children living with ASD in the world. The rates continue to increase. Costs of treatment in the US are projected to rise to over $450B by the year 2025. (Source)
There are very limited solutions. Current treatment is limited to therapy and medications. Unfortunately, therapy is expensive, does not work for all children, has to stop during quarantine, and is frequently unavailable due to lack of trained therapists. Medications have side effects and do not treat the underlying cause of the disease.
Our product is unique. Cognilum is an FDA-regulated medical device that provides safe noninvasive brain stimulation. It is designed to be easily administered in the child’s home, with time flexibility, privacy, and no need for the physical presence of a therapist. This product may become the “game-changer” for autism treatment, and may be the only practical solution for many families.
The treatment is personalized. The AI platform takes into account the child’s medical history, physical condition, symptoms and improvement. This data is used to continuously improve the treatment personalization.
Treatment improves the quality of life. We expect the overall benefit of Cognilum to be a 1/3 permanent improvement of each child's autism symptoms, resulting in over $1 million in lifetime savings.
Experienced team. Our multi-disciplinary team has experience in autism clinical therapy, medical device engineering and commercialization, tPBM research, artificial intelligence, software product development, and finance.
Effective Clinical Results. JelikaLite has completed the Phase I placebo-controlled clinical trial of its prototype and the results showed a statistically significant improvement in children who received the treatment.
Overview
*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.
THE PROBLEM
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)
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.
THE SOLUTION
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 TRACTION
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):
· Brain Foundation, Synchrony 2021Next steps:
THE MARKET
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.
WHY INVEST
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.
Autism is a serious developmental disorder that lasts a lifetime. JelikaLite believes that children on the spectrum can lead fulfilling and productive lives. That is why they are developing Cognilum, an innovative medical solution to permanently reduce a child's autism symptoms, enabling better integration into society and reducing lifetime costs. Cognilum will demystify autism - by opening a window into the child's brain waves, it will empower both parents and doctors to precisely deliver the needed treatments. JelikaLite is a development stage company whose product is not yet available to the general market.
Luis DeTaboada
Chief Technology Officer
Liza Logounova
Chief Operating Officer & Secretary
Maxim Kalachenkov
Director
Ali Mostashari, PhD
Advisor
Anne-Marie Maman
Advisor
Dr. Michael Hamblin, PhD
Advisor
Yuli Fradkin MD
Advisor
Dr. Robert K. Naviaux, MD
Advisor
Maximum Number of Shares Offered subject to adjustment for bonus shares
*Maximum Number of Shares Offered subject to adjustment for bonus shares. See Bonus info below.
Investment Incentives and Bonuses*
Time-Based:
Extremely Early Bird: First 7 days
15% Bonus Shares
Super Early Bird: Next 7 days
10% Bonus Shares
Early Bird: Next 3 days
5% Bonus Shares
Amount-Based
Tier 1: $5000+
5% bonus shares
Tier 2: $10,000+
10% bonus shares
Tier 3: $20,000+
20% bonus shares
*All perks occur when the offering is completed.
The 10% StartEngine Owners' Bonus
JelikaLite will offer 10% additional bonus shares for all investments that are committed by investors that are eligible for the StartEngine Crowdfunding Inc. OWNer's bonus.
This means eligible StartEngine shareholders will receive a 10% bonus for any shares they purchase in this offering. For example, if you buy 100 shares of Common Stock at $.59 / share, you will receive 110 shares of Common Stock, meaning you'll own 110 shares for $59. Fractional shares will not be distributed and share bonuses will be determined by rounding down to the nearest whole share.
This 10% Bonus is only valid during the investor's eligibility period. Investors eligible for this bonus will also have priority if they are on a waitlist to invest and the company surpasses its maximum funding goal. They will have the first opportunity to invest should room in the offering become available if prior investments are canceled or fail.
Investors will only receive a single bonus, which will be the highest bonus rate they are eligible for.
Voting Rights of Securities Sold in this Offering
Each Investor shall appoint the Chief Executive Officer of the Company (the “CEO”), or his or her successor, as the Investor’s true and lawful proxy and attorney, with the power to act alone and with full power of substitution, to, consistent with this instrument and on behalf of the Investor, (i) vote all Securities, (ii) give and receive notices and communications, (iii) execute any instrument or document that the CEO determines is necessary or appropriate in the exercise of its authority under this instrument, and (iv) take all actions necessary or appropriate in the judgment of the CEO for the accomplishment of the foregoing. The proxy and power granted by the Investor pursuant to this Section are coupled with an interest. Such proxy and power will be irrevocable. The proxy and power, so long as the Investor is an individual, will survive the death, incompetency and disability of the Investor and, so long as the Investor is an entity, will survive the merger or reorganization of the Investor or any other entity holding the Securities. However, the Proxy will terminate upon the closing of a firm commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933 covering the offer and sale of Common Stock or the effectiveness of a registration statement under the Securities Exchange Act of 1934 covering the Common Stock.
Irregular Use of Proceeds
The Company might incur Irregular Use of Proceeds that may include but are not limited to the following over $10,000: Vendor payments.
01.12.22
Dr. Eugenia Steingold presented in December 2021 at The BRAIN Foundation’s Synchrony 2021 Conference on translational autism.
Dr. Steingold discussed transcranial photobiomodulation (tPBM) and the results of JelikaLite’s recent double-blind, placebo-controlled clinical trial, with children aged 2 – 6.
To learn more, please watch the full Presentation
01.10.22
We will be closing this campaign on 11:59 pm PST January 18, 2022.
01.10.22
https://entrepreneurs.princeton.edu/events/2nd-annual-princeton-women-founders-startup-showcase
We are delighted to announce that JelikaLite has been chosen as one of 6 companies to present at the second annual Princeton Women Founders Startup Showcase on January 27, 2022.
01.06.22
Today we are proud to announce that JelikaLite has been granted Breakthrough Device Designation from the FDA for our Cognilum System - an individualized, non-invasive, technology for the reduction of autism symptoms in pediatric patients.
This is a great milestone for JelikaLite and a strong vote of confidence in our company that has a potential to change the landscape in the current approach to Autism. Congratulations to all JelikaLite team members, advisors, investors and supporters.
We look forward to helping millions of children and their families experience a better future.
You can read more in our Press Release
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