NON-INVASIVE TREATMENT FOR

AUTISM SPECTRUM DISORDER

BREAKTHROUGH TECHNOLOGY FOR YOUR CHILD

Non-invasive Wearable Brain Neurostimulation with Near Infrared Light

What: 

• Safe - received FDA Non-Significant Risk Device Study designation
• No known negative long term side effects
• Comfortable to wear for children with sensory issues
• Requires only 2x per week treatment, of up to 20 minutes at a time

• Received FDA Breakthrough Device Designation 
• Accelerates language development *
• Promotes social interaction *
• Increases responsiveness *

Cognilum is a medical device that will be regulated by the FDA prior to launch.

*These statements are based on the results of the double blind placebo controlled Phase I clinical trial and have not yet been evaluated by the FDA. 

See COGNILUM in Action

Meet Julia Krutoy, Speech Therapist who evaluated children in the clinical trial.

Meet a family, whose child received Cognilum treatment.

* * * * *

“He is having more frequent and more prolonged eye contact. He said 5 new words this week! He is smiling! He can now concentrate with therapists. Teacher thought he started medications!”  *** Mother of a 4-year-old mostly non-verbal autistic son

“He told me “I love you, Mommy”. First time in his life. I cried”.  *** Mother of a 4-year-old son diagnosed with ASD

“She is now interested in playing with other children. Incredibly - her teacher decided to transfer her to a more advanced class in school, because she can now speak sentences!”  *** Mother of a 5-year-old girl diagnosed with ASD, after 12 treatment sessions

“The Teachers called us and said ‘we don’t know what you’re doing with J, but the shift in his behavior is massive! He’s interacting with us and for the first time asked to use the bathroom - whatever you’re doing, keep it up!” *** Mother of twins both diagnosed with profound ASD

"He now walks on the street holding my hand, without running into oncoming traffic. His teachers said that he is doing work in school - which he has NEVER done before. " *** Mother of a 5 year old boy diagnosed with ASD

“Every day he is getting better and better. He started using hand gestures. He started saying “no” and “hi”. He is interested in other children now.” *** Mother of a 2 year old boy diagnosed with ASD

How Does it Work?

The device provides treatment through transcranial photobiomodulation (tPBM). tPBM is a treatment that uses gentle LED light to help improve brain function in autistic children. 

• A special device (Cognilum) shines a safe light onto your child's head, targeting specific brain areas.
  • The light passes through the skin and skull, reaching the brain.
• Inside the brain, the light helps brain cells create more energy.
  • Over 80% of autistic children have mitochondrial disfunction and tPBM, with its beneficial effect on mitochondria, may improve the brain functioning. 
• This extra energy supports brain cells in working better and can promote healing.
  • Systemic effects: The improved cellular function can lead to various beneficial effects, such as reduced inflammation, increased blood flow, and enhanced neuroplasticity (the brain's ability to form new connections).
• As a result, your child may experience improvements in communication, social skills, and other areas affected by Autism Spectrum Disorder.

In summary, tPBM is a non-invasive and painless treatment that uses light to help enhance brain function in autistic children, potentially leading to better overall well-being

Frequently Asked Questions

1. Cognilum is currently going through certification. What does this mean? 
   
   • In broad terms, this means we are currently demonstrating to the FDA that there is appropriate clinical and safety evidence for Cognilum to be used as a medical device for the amelioration of certain symptoms associated with ASD. This demonstration requires extensive clinical trials and safety testing. Until this process is completed, we are unable to provide you with the Cognilum, and Cognilum remains unavailable to purchase. We expect this process to be completed in 2024. At launch, we will provide our exclusive waitlist members the opportunity to confirm that Cognilum, as approved, is an appropriate medical treatment for their child. 
2. Will Cognilum cure conditions or alleviate symptoms? 
   • Cognilum is not designed to cure ASD. However, Cognilum is designed and intended to alleviate a range of psychological symptoms that are commonly experienced by children diagnosed with such conditions including inability to communicate, repetitive behaviors, social anxiety and problematic behaviors (such as bolting and self-harm). In some cases, Cognilum may also enhance the child's physical stamina and dexterity. Once Cognilum is approved, waitlist members will have early access to assess whether their children's symptoms are a match for those approved for treatment with Cognilum- and will be able to apply an exclusive discount to receive treatment. 
3. Does the Waitlist form a commitment to buy?
   • No. In fact, Cognilum is currently unavailable to purchase. We are unable to offer the Cognilum for purchase or otherwise place it on the market, until it has been approved for sale by the FDA. However, joining the waitlist does guarantee you a first assessment of whether Cognilum, once approved, is an appropriate solution for your child's needs, and lock in an exclusive discount off retail pricing.
4. My child does not have any formal clinical diagnoses. Can they still benefit from Cognilum?
   • Cognilum is intended as a medical device, specifically designed to reduce symptoms of ASD. If your child exhibits such symptoms but is not diagnosed yet, our team of pediatric psychiatrists and psychologists can evaluate your child and assess if they satisfy the diagnostic criteria for ASD. Alternatively, you may go to your local medical provider and ask for your child to be evaluated for ASD. If your child is diagnosed and can benefit from Cognilum, you should be able to get a prescription.
5. Do I need to pay anything to join the Waitlist?
   • No. Joining the waitlist is not the same as purchasing Cognilum. As Cognilum will be a medical device, it can only be purchased and used by those for whom it is appropriate, after it has been approved by the FDA. Waitlist members will have the first opportunity to assess whether Cognilum is suitable for their children.
6. Is Cognilum safe?
   • Yes. While conducting clinical studies, we have received from the FDA a designation of Non-Significant Risk Device. As with all medical technologies, however, there will be certain people for whom Cognilum is an inappropriate choice. At launch, Cognilum will be a regulated medical device, meaning the competent authorities have assessed Cognilum as having appropriate clinical and safety evidence for Cognilum to be used as a medical device for reduction of symptoms of ASD. As part of this process, Cognilum is subjected to extensive safety testing, including ensuring the device's electrical and wireless emissions are well below the required limits for safety. At launch, we'll provide our exclusive waitlist members the opportunity to confirm that Cognilum, as approved, is an appropriate medical treatment for their children.
7. Have you conducted efficacy research with Cognilum?
   • Yes, extensively. We have run more than 2 years of tests on Cognilum itself, and this builds on decades of research into the underlying neuro technology, photobiomodulation and its mechanism of action. These tests range across safety, efficacy, ergonomics and more. We are actively updating our website to provide further details on these trials, the results are awaiting publications in journals. We also have ongoing clinical trials right now. If you want to learn more, or to participate in these clinical trials - please reach out at info@jelikalite.com. 
8. How much does treatment with Cognilum cost? 
   • Cognilum treatment might require a minimum of 24 sessions. We anticipate intial price to be $4,500 for 24 sessions. Initial treatment will be provided through clinician's offices, where the participating doctor will be setting their own price. Signing up to the waitlist does not commit you to receive the Cognilum treatment, but does secure you a discount at launch if you decide that Cognilum is right for your child. If you sign up through this Early Access Campaign, you will receive a discount of $750. 
9. What ages is Cognilum appropriate for? 
   • The final age range will be determined by FDA clearance. To date, JelikaLite has run clinical studies with children up to 9 years of age. There were other studies that showed tPBM being effective in improving communication skills and responsiveness in older autistic individuals. We plan to conduct additional clinical studies and get FDA approval for older children, teenagers and young adults. Please join our waitlist and we will know once either clinical trials open up or the product for older children becomes available. 
10. Will Cognilum be covered by insurance?
    • Initially, we do not anticipate any insurance coverage. We will be working with Veterans Affairs, Medicaid and private insurers to expedite coverage after FDA clearance. You may receive some out of network payments from your private insurer and we can assist with filling out these forms. 
11. If you have questions, please reach out to info@jelikalite.com or go to www.jelikalite.com