Helping Children with Autism

Steve Melito: Hey. Welcome to New York State Manufacturing Now, the podcast that’s powered by FuzeHub. My name is Steve Melito and I’ll be your host. And today, we are with Katya Sverdlov, co- founder and CEO of JelikaLite. Katya, welcome to New York State Manufacturing Now.

Katya Sverdlov: Thank you so much for having me.

Steve Melito: It’s great to have you here. Let’s begin at the start, as they say. What is the JelikaLite story? How did you get started, and how long have you been around?

Katya Sverdlov: The company was started two years ago, by myself and Dr. Steingold, the co- founder. We have both known each other for many years, and we have both worked professionally with families affected by autism. I am an attorney and she is a clinical child psychologist. Both of us saw that nothing was helping and there are really no solutions right now to children with moderate to severe forms of autism. And then, Dr. Steingold learned about the technology of transcranial photobiomodulation that has been used for several neurological and psychiatric conditions, including traumatic brain injury, dementia, stroke, and depression. She also learned of two pioneering studies by scientists from Harvard Medical School and from Haifa University that tested this technology for autism. There preliminary studies gave really hopeful results, but then we did additional research to see if there is anything commercially available and we saw that there was nothing, yet families are desperate for solutions right now, because the critical period for children to learn language is approximately five years of age. If children do not learn to speak by that time, they are most likely never going to learn. So as we realize that there is nothing available to help these children out, we decided to work on bringing this technology to parents ourselves. We personally, both of us, know lots of families who are affected by this devastating disorder and that is why we’re committed to developing this product and bringing it to families who are fighting this disease.

Steve Melito: Certainly a very important cause and can remember meeting you back at the commercialization competition talking about the work that you’re doing, in terms of looking for treatments for autism. So tell me more about how you do it and why the technology is better? You’ve used some terms that I’m not sure I could even repeat them back to you. Transcranial, I believe, was one of the words.

Katya Sverdlov: Yes, and that means through the brain, through the head. We believe that individuals on the autism spectrum can lead an independent and productive life. JelikaLite is developing Cognilum, it is a solution to permanently reduce children’s autism symptoms. Our product is a combination system of a home- based therapeutic, wearable device and an intelligent personalization platform. The physical device provides therapy through transcranial photobiomodulation. This treatment is noninvasive, it is safe, and it has no side effects. The way the photobiomodulation works is by safely stimulating the brain with near infrared light. It has an effect of increasing cerebral blood flow and reducing inflammation. As a result, the brain receives more oxygen and nutrition and has more power to heal. With the continued usage of this technology, cellular mitochondria is activated and the production of energy molecules, ATP, is increased. This leads to more connections between the neurons. When we talk about it, it may even sound like voodoo sometimes. However, in prior studies, when this technology, photobiomodulation was used with patients with depression, dementia, and stroke, the clinically documented results were improved language skills, reduced anxiety, and improved sleep. And so, the more relevant question to us is, does this technology also work for autism? As I mentioned earlier, into previous clinical studies, not done by us, after only eight weeks of treatment, transcranial photobiomodulation was shown to improve both children’s and adults’ severe autism symptoms by almost a third and the improved symptoms were increased language skills and reduced anxiety. And why would parents care about one- third improvement? The difference between severe and moderate levels of autism is having to be confined to an institutionalized setting for life versus being able to live independently in a community. I want to talk about just one additional thing, as therapy is incredibly important, collecting and analyzing the data is just as important, so our physical wearable device is paired up with the software program. This intelligent personalization platform conducts an initial comprehensive assessment, captures data from the wearable device sensors, and from a port, and it provides them personalized recommendations to parents and to therapists. So why is our product better than what is out there? There are existing photobiomodulation products on the market, but none of them are currently designed for children or for autism treatment. There are some medications on the market, but drugs always have side effects. And therapy, the number one used treatment for autism right now, really relies on the luck of finding a talented and continuously available therapist. A lot of parents don’t have the money, a lot of parents don’t have the skills, and a lot of parents simply live in geographical areas where there are no therapists available. So our product is positioned to be unique. It is home- based, not relying on the presence of a therapist, it is autism- focused, specifically designed to alleviate symptoms of autism, and yet it is potentially expandable to other pediatric, neurological disorders.

Steve Melito: Fascinating. So you have a very tailored product, you’ve got some demonstrated results, a third, as you said, of the improvement can really make a difference. So tell us some more about some of the successes that you’ve had so far. As I had mentioned earlier, you and I first met back at the FuzeHub commercialization competition. Since then, I know we’ve talked a few times. We’ve had you talk to Tavis at the Sensor CAT, for example, so I just hope you could tell us a little bit about what’s going on.

Katya Sverdlov: To date, and in the last two years since we started the company, we have developed a prototype of the physical device and the initial assessments for the platform. We have raised money to continue the development. We have conducted comprehensive market research both with parents and with therapists. We filed patents. We have received feedback from the FDA and permission from the IRB for the study. And one of the greatest things that happened to us is that we won the Fuze commercialization award. But honestly, the most important thing that we’re seeing so far, is that we started our own clinical trial using our technology in March of 2021. And after only seven weeks of treatment, we are seeing some really encouraging results. We have one two- year- old boy who used to be completely non- responsive. He would just sit on the floor, stare in front of himself, and he wouldn’t look at us or his mother, even if we danced and sang in front of him. Nothing worked to get his attention. Now, after eight weeks of treatment, he’s looking at people, he’s looking at faces, he’s playing with toys, he gives high- five, and he consistently responds to his name. He’s also able to laugh and smile at people. His therapists, who do not work with us and were not even aware of the study, have reclassified him from non- responsive to alert. It is so exciting for his parents that his mother has now put him in daycare, just last week, because now that he’s responsive to people and to other children, she feels that he’s ready. His mother started working for the first time, because she’s so excited that after having this therapy with us, he can start daycare and she can return to work. It is a completely new life for her and it’s the most amazing change. We have another four- year- old boy who was quite different. He was actually a hyperactive child who would throw himself on the wall, literally, and bang his head and he would hit himself and hit others. He was not able to establish any eye- contact and he was not able to follow any commands. His speech was at a minimum. When he came in, he had about 10 words or so. Now, he is, again, after eight weeks of treatment, he’s saying individual words. Last week we observed him touching bright blue boots and saying, ” boots.” He is not just saying words, he is saying them on purpose. Furthermore, we talked to his daycare teacher, who is completely not aware of our study at all, the daycare teacher told us the parent must’ve put him on medication, because he has been so calm recently. He doesn’t have any tantrums. He’s able to concentrate, to sit down, and to work with a therapist. Moreover, he has eye- contact. He is looking at people and trying to follow directions. These are extremely noticeable changes. Just one other success that we have. We have another almost five- year- old boy who was severely echolalic. That means that he would repeat. He had many words that he could say, but he would repeat them and not create new sentences. You could say to him, ” Give me a bottle.” And he would repeat, ” Give me a bottle.” He would use language to parrot what was said. He could also use the words to label objects. A couple of weeks after he started the treatment, he started producing new sentences. His ABA therapist was shocked. Instead of saying, ” Not bread,” he now says, ” Michael does not want bread.” He is saying full, grammatical sentences. Not all the time, but it’s a huge progress. So overall, this is really the greatest success that we can ultimately have, to see the children continuously improving and interacting with their surroundings and their family.

Steve Melito: Those are some wonderful stories. Thank you for sharing them with us. It’s really good to hear about the successes that you’ve had, especially for the young kids involved.

Katya Sverdlov: Thank you, thank you. We cannot wait to see, as more children are coming through. We are really excited to see their results and what will happen.

Steve Melito: So Katya, in the course of any company, any enterprise, there are always challenges to overcome, as well. What are some of the challenges that you’ve overcome so far?

Katya Sverdlov: Our biggest challenge to date has been receiving permission from an IRB to conduct this clinical study. We are working with young, sick children using an experimental, interventional treatment technology that has not been used with young children in the past. It took us almost a year to get this permission. The IRB required us to go to the FDA first and to get classification for our study. We did that and we received a non- significant risk device designation from the FDA. Then, we went back to the IRB and received permission for this work. Really, this current study is groundbreaking as JelikaLite is the only company in the United States to receive permission from an IRB for using this technology with such young kids. Our second biggest challenge, and it’s ongoing, is time. Both myself and the co- founder, Eugenia Steingold, have been building this company part- time, as we each still have our individual practices. She’s a practicing child psychologist. As I said, I have my own law practice, and that has been incredibly difficult, to build a company and recruit and figure out the technology and the patents and the regulatory pathway all on a part- time basis. Unfortunately, until we raise additional money, we will have to continue doing that and speaking of funding, this is our third and ongoing challenge, to date we have raised money from several angel investors, which was really based on an idea that we had and based on other people’s science. That was difficult, but it enabled us to build the prototype, to file patents, to get the regulatory approval, and to move forward with the study, raising further money for the commercialization of the product is an ongoing challenge, and we’re incredibly grateful to Fuze for supporting us and for helping us on our journey.

Steve Melito: There’s always successes, always some challenges. In the industry that you’re in, things don’t necessarily happen quickly. Anytime you’re talking about medical devices, there’s long timelines. Where do you see- JelikaLite in five years?

Katya Sverdlov: If I can, actually, on the timing, though, just to go back, that was really- I don’t even want to say a challenge, but it was just a surprise. Neither of us have worked with medical devices in the past, and we did not expect such multiple complexities of bringing a medical device to market and the timeline. We even considered building this, at first, not as a medical device, but as a wellness device, because that considerably reduces the timeline to market. But, in the end, we decided that we want to go the proper way through the regulatory approvals, so that we can work with the doctors and the therapists and have the credibility that the FDA certification gives us. I want to just mention one additional thing of what has not been difficult, surprisingly enough, is actually recruiting children into the study. We started less than two months ago, we already have 12 people enrolled and more are coming, and we haven’t even started advertising yet. So this gives us great encouragement for going forward in commercialization, because the reason why we’re now having people come is because the initial parents who have been coming through and seeing results, they are now telling everybody about this, and so more people are calling and asking if they can enroll their kids into the study and we cannot take all of them, for various reasons, there are screening conditions, but it gives us great encouragement that if we get sufficient patient testimony, the product will tell and sell well. I went back a little. But where do we see ourselves?

Steve Melito: Yeah, where do you see yourself in five years? For example, do you think you’ll be doing this full- time? Do you think you’ll be able to just focus on JelikaLite to the exclusion of other things?

Katya Sverdlov: Oh, absolutely. Yes. There are a dime a dozen lawyers and there are a dime a dozen of child psychologists, although Dr. Steingold is an excellent child psychologist with a waiting list of patients who want to see her. Nonetheless, helping children where there are no other solutions available is the ultimate mitzvah, the ultimate good deed that we could find. So we want to reach as many children as possible across the world and help them reach their full potential, which, through this company, we will be able to do much more than working with individual clients or patients in our individual practices. Unfortunately, autism rates continue to rise and there is no cure right now. Furthermore, current treatment is really limited to people who can organize, find, and afford private individualized therapy. We want to bring this effective treatment solution to children across the world. We constantly hear heartbreaking stories from parents from other countries, where treatment for autism is either completely non- existent or there are waiting lists of almost two years. In fact, just yesterday, we got an email from a mother in Ireland asking if we can send her the design for our product or the product itself, as there is nothing available for her seven- year- old son there. Specifically in the US, we want to ensure that racial and ethnic minority children also receive timely and affordable treatment, as they are the ones who are disproportionately affected by the lack of quality healthcare and lack of early intervention agencies in their neighborhood. As a result of this lack, they receive both late diagnosis and inadequate therapy. Moreover, this lack of proper healthcare access is exacerbated by the increased rates of disabilities amongst lower- income children. And I do want to say that the product that we’re developing is an affordable home- based solution that can be used with children starting at age two, accessible to English speakers and non- English speakers, and that is why we think that it will be extremely useful to parents across the world. Looking even further, unfortunately, both mental and developmental disorders among children are on the rise. Cognilum’s integrated system of home- based, non- invasive light therapy sensors and personalization may be used for multiple pediatric, neurological conditions such as anxiety, depression, general developmental delays and even sleep disorders.

Steve Melito: Lot of potential applications there.

Katya Sverdlov: Yes.

Steve Melito: So let’s change gears a little bit. We had talked about how you were a winner of the FuzeHub commercialization competition. Have you ever worked with other New York State funded assets or received help for your company from New York State?

Katya Sverdlov: We went through the Westchester County biomedical accelerator. And so, that is New York State funded, and that was incredibly helpful to us, both in the education and in the connections that we made, so that was very helpful. We are currently part of the Long Island BioMentor Institute, as well, as they’re providing mentorship to us.

Steve Melito: Fantastic. And I have to mention my friend Tavis Ezell from CUNY, from the Sensor CAT. I remember making a referral to him for you and he connected you to a company.

Katya Sverdlov: Yes, and he connected us to a company which we are now working with together and they have been so helpful to us in conducting proper measurements of our prototype, because it takes special type of machinery that we do not have, and we have been working extremely closely with James Schultz on making sure that the treatment power that we deliver is within the permissible range, but also not too little. And so, we have developed several prototypes, he has been incredibly helpful in working with us, ensuring that we’re delivering proper dosage of the therapy.

Steve Melito: I think we’ve talked about this before, but at FuzeHub we will help you along the way from commercialization competition to making connections to the manufacturer or solutions programs. Eventually, when you get to the point that you’re looking for a contract manufacturer, we can help you that way, too. But enough about us, before we close here, is there anything else you’d like our listeners to know about JelikaLite?

Katya Sverdlov: I want the listeners to know about the therapy and how they can help. Near infrared light therapy is now increasingly being studied for the treatment of multiple neurological disorders. This is a groundbreaking and increasingly used science. So if you would like to be a part of this groundbreaking scientific research, we are providing an opportunity to invest. In terms of actual real life impact, the benefit of our product is expected to be a one- third permanent improvement of children’s autism symptoms, which results in over one million dollars in lifetime savings. But more important than the dollars, it results in a child, an individual, being able to live a productive and independent life. We are raising money for additional product development, clinical trials, phase two clinical trials, and commercialization. And so, if you’re looking to reach this untapped but growing market and, in the process, help millions of children achieve independent lives, please join us.

Steve Melito: Katya Sverdlov, thank you for spending some time with us here at New York State Manufacturing Now. We’ve been talking to the co- founder and CEO of JelikaLite, a FuzeHub commercialization competition winner from last year. And on behalf of New York State Manufacturing Now, I just want to remind companies out there that if you’re looking for business or technical assistance, come to FuzeHub, you can do so anytime day or night, although I can’t promise you anyone’s going to answer at 2: 00 am, but on your computer browser, you can go to www. fuzehub. com, go to the solutions program menu, look for the request an expert consultation link, and then complete the form. Tell us what you’re looking for, tell us what you need and then, within the next business day, a member of our team will get back in touch with you. And, of course, FuzeHub also has some events coming up this year. There’s going to be another commercialization competition in the fall, so make sure that you sign up for the FuzeHub newsletter when you’re at the website. On behalf of New York State Manufacturing Now, my name is Steve Melito, I am your host, and I’ll be signing off.