NY Launch Pod: Welcome to the New York Launch Pod, the New York Press Club, award-winning podcast highlighting the most interesting new startups, businesses and openings in the New York City area. I’m your host and New York attorney Hal Coopersmith, and in this episode, we are speaking about autism. It is a growing problem for families and no one is quite sure why autism rates are increasing. Our Guest Katya Sverdlov saw the growing problem and could not stay on the side lines. Katya is the co-founder of JelikaLite, a device designed for people with autism that has shown promising results. Here is Katya:
Katya Sverdlov: We want to demystify autism. We not only want to provide an effective home-based treatment for families. We want to make it personalized because every child on the spectrum is unique.
NY Launch Pod: Listen to the episode to find out how Jelekalite works the obstacles Katya and her are overcoming to bring a new medical device to market and a whole lot more.
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NY Launch Pod: So what is JelikaLite?
Katya Sverdlov: JelikaLite is a company where we are developing an intelligent medical device for children on the autism spectrum. Autism rates keep rising across the world. There is no cure. The cause remains unknown and parents are desperate. We believe the children of this spectrum can lead a fulfilling and productive life and that is why we are developing Cognilum, an innovative solution to reduce children’s autism symptoms. It is an intelligent medical device that combines the non-invasive brain stimulation with near-infrared light, EEG sensors, and an intelligent personalization platform. The results are improvement of autism symptoms, improvement of speech, improvement of responsiveness, and we can’t wait to bring this to market.
NY Launch Pod: So you’ve said a lot there. Autism rates are rising; we certainly see that and can certainly feel that. How did you see that in your own life and decide to start this business?
Katya Sverdlov: So my co-founder Dr. Eugenius Steingold is a clinical psychologist, and she has been working with children on the spectrum for many years when she saw the utter desperation that families have right behavioral therapy and medications. Behavioral therapy requires a presence of a highly trained specialist who comes to your house, requires 20 to 30 hours a week for many years, and it’s highly controversial now because many children who later grow up believe that ABA actually hurt them as opposed to help them. Many children simply do not even respond to ABA therapy and medications treat some of the symptoms such as irritability and maybe anxiety, but doesn’t work on the underlying cause of autism. I, in my own life, work with families of special need children and in many cases, these children are adults. Their parents are aging and they come to me because at this point there’s no hope for their children and they realize that as the parents are aging, the children are adults and there is no one able to take care of these children and there are no solutions. So both of us saw the desperation and the families and Eugenia read a very promising study done by Whitey University, using the technology of transcranial photobiomodulation on children with autism. She was very excited, she started looking for a product that she could recommend to her patients, and there’s nothing available. There’s absolutely nothing available in the market right now, even though there were some promising academic studies. She told me about it and I usually like to get things done. So I said, well, if there’s nothing available and I understand the need for this solution, let’s do it ourselves and that’s how we started JelikaLite.
NY Launch Pod: So you said a medical term. I think if I’m not mispronouncing it’s transcranial modulation?
Katya Sverdlov: Transcranial photobiomodulation.
NY Launch Pod: And so how do you know that your device is actually working?
Katya Sverdlov: Excellent question, and it’s a question that applies to many medical devices, as well as wellness devices that people are pushing. Autism life, autism parents are tired and sick of being promised many, many voodoo hero’s that promised the moon, but in the end to tell clear whether it actually doesn’t. So we went the medical route, which means that before our product is available widely to the market, one, we’re going through the FDA approval process and two we’re running clinical studies to make sure that, running our device compared to placebo, compared to a sham device, to see whether the improvement that children are getting when they’re using our device is bigger, better than children who are getting exactly the same type of treatment, but not ours. So this is what we’ve done to date, we’ve run one clinical study, which was small, but it was double blind placebo controlled trial with 30 children of which 16 received treatment and 14 did not. All children had the same experience. They would come into the office, they would put on the device over their head, but for some of them, the device was turned on and for others, it was not. The parents did not know whether the children were in the active group or in the placebo group and then we compared the results. The children were rated on child based on childhood autism rating scale before the treatment started and then at the end of the eight week period, when they were receiving the treatment and the results for the children who received the treatment were spectacular on several different categories. One was autism symptoms, two, just as exciting as the actual symptoms were EEG data. We measured E electro and telegram symptoms of the brain and the children who have autism have high Delta waves, which are usually a sign of brain inflammation, usually a sign of neurological disorders, when present in wakeful states. The children who received the treatment and improved had the Delta waves decreased much more than the children in the placebo group. So that was incredibly exciting. And third therapists of the children who received the treatment, therapists who didn’t even know that the children were receiving treatment, started calling the parents of these kids, telling them we don’t understand what’s going on with your son or your daughter, but whatever you’re doing, keep doing it because there’s such huge improvement. And I can talk about specific kids and what happened to them, but this was incredibly exciting and so to it, that was a very long answer to your question, how do we know this is working. This is what we’ve done to date and of course, to get the FDA approval De Novo, we have to do a much larger trial and that’s what we’re working on right now. We are going through the FDA process and we will be running a trial with over a hundred participants in the future.
NY Launch Pod: So you talked objectively about the study with 30 participants, but in addition to that definitive feedback, I also understand that you won a national science foundation award recently.
Katya Sverdlov: So yes, it’s not an award, it’s a grant, it’s a national science foundation, phase one, SBIR grant and it’s a very prestigious grant given to approximately 10% of the applicant of small businesses and it’s for the future. So it’s not for something that we’ve done in the past. Although of course they don’t give grants to companies that are just starting out, they want to see some form of already traction. So they looked at what we’ve done in the past, and they gave us a grant for future work, which is what we are starting now, which, because we want to study much more the correlation between the autism symptoms, the EEG data, and autism symptoms reduction as done by our device.
NY Launch Pod: And you talked about your connection to autism, even though, you don’t have a child who has autism or has experienced autism, but you’ve worked with families where there is autism. A lot of people see a problem and want to solve it, but entrepreneurs and founders are different. What made you take the steps from seeing this problem, connecting with a doctor, to being a founder in this space?
Katya Sverdlov: I don’t have a child with autism; however, I do have several friends who have children with autism and their symptoms range from severe autism, meaning nonverbal children who continue to wear diapers at the age of 15 to high functioning autism, where children later in adults are not able to function in today’s society, be fully independent. I saw a need and I could not believe to be honest that this need has not been solved to date and so we wanted to help really because it’s mental, this is taking too long saving and trying to heal the world. So this was a need to be honest, we had no idea what we were doing when we were starting, we did not realize what whole journey this is. We did not realize what a painful process it is to go through the FDA approval, we did not realize how painful it is to raise funds. Every single step has been a challenge, but because there is such a need for what we are doing and because we saw the results in the families that were coming through our clinical trial, we keep doing this. I mean, there’s so many companies out there that are attempting to fix small little things and these small little things may be important and in the end, I want to spend my time on something that I can feel proud of and see the greatest good. So that’s what powers us through at this point.
NY Launch Pod: One of the things that’s interesting about you in particular as a co-founder of this company is that you are a non-technical founder in a very technical and certainly the medical space. What has that experience been as someone who doesn’t have a medical degree working in this space?
Katya Sverdlov: Humbling, absolutely humbling. One of the first things that we did was we went through accelerators, a Westchester county biotech accelerator, which was the absolutely greatest thing that we’ve done, I’m incredibly grateful to them. They’ve taught us so much and I’m really grateful for them taking a chance on us and I think I was the only non-technical founder there at that point and I think it made me realize that, you know what? People need somebody like me because doctors and scientists can talk about the medical stuff and the science stuff forever and they can look at it like this and they can look at it like that and it’s absolutely fascinating, and in the end, nothing gets done. And so I’m the one who listens humbly and then I’m like, okay and so what’s the decision and I’m the one who’s pushing them to finally, think and decide and make and so I think you need both. So again, my co-founder is the technical one and I say of the two of us she is the smart one and I’m the organized one and we’re a great team because we both need each other. I would not have been the one able to read the science and come up with this idea and continue pushing the science through. On the other hand, she would never have been the one who would persevere and continue following up with everyone who needs to be followed up on and would organize and would just get lost in all the paperwork and would just keep talking about an idea. So I think as a combination, we’re quite perfect.
NY Launch Pod: And the business model, at least in a medical field has to be a little bit different than a consumer good or a direct to consumer. How has navigating the medical marketplace in terms of a business model end user distribution been in terms of your business?
Katya Sverdlov: So we’re not there yet. We’re not distributing the device yet because we right now have FDA breakthrough device designation, which means that FDA has looked at what we’ve done and said, you have something that looks to be amazing that fulfills a need in the market, which is true, but it does not mean that it’s approved for sale. To get a full approval, we will need to run a much larger trial with over a hundred people. Going forward once we have that approval, we do plan to sell. This is going to be a medical device. It will be prescribed for by the doctor, ultimately purchased by the parent of a child with autism. Eventually, of course, we want to have insurance reimbursement so that the device will be paid for by Medicaid because half of the families with children on autism are on Medicaid. That is a long journey to get insurance reimbursement for a novel product may take a few years. So there are various options that we are looking at. One, we figured out how doctors will be reimbursed for this device, but prescribing this device and monitoring the usage of this device, which is already a big part of the problem because doctors don’t want additional, even though doctors really want to help their patients, they also don’t want to be burdened and so we figured out how they can be compensated properly for their time. As far as parents are concerned, unfortunately, initially the device will have to be paid for privately and there is a very large population of parents, percentage of parents who are willing to pay as long as there are studies that show that the device actually does something useful while it’s getting, we’re also looking at potentially other solutions, for example, New York state has a self-pay option where the state, pays for medical devices for families who could not afford. Other states have different solutions, and we will be going through the insurance reimbursement process.
NY Launch Pod: And you mentioned from the outset that autism is a growing problem, why do you think that you are the first company to tackle the problem using transcranial photomodulation?
Katya Sverdlov: Honestly, because it’s hard to bring a novel technology to market. It’s hard, it’s expensive. 2% of children are now diagnosed with autism, which is a huge market. However, a third of the population is expected to develop dementia later. So when medical device companies and pharmaceuticals are choosing which market to focus on, they’re focusing on the larger one and 33% versus 2% is a big difference. So a lot of companies have been studying this technology for neurological disorders, but focusing on diseases of the aging, such as Alzheimer’s. There are companies that are now looking at this technology for autism as well. It still amazes me, but we seem to be ahead of everyone. Given the FDA recognition, given the NSF funding, given the double blind clinical study, I mean, I have to tell you, it’s still mind boggling to me about how slow people are moving. We’ve started this three years ago, we are still both working part-time in that I have a low practice and my co-founder has a psychology practice. We’ve raised just a bit over $1 million dollars in funding compared to other companies who’ve raised over $10 million dollars of funding over $20 million dollars of funding and yet given these limitations, we still seem to be ahead of everyone in where we are. So I don’t know, I think maybe because we have a great team, I mean, aside from myself and my co-founder, we now have a CTO and he has over 30 years of experience in specifically this technology and bringing medical devices to market. We have a COO and she has over 20 years of experience in developing software products and project management, so she has been a huge help. We have a wonderful scientific advisory team and we have AI specialists. And so I’m incredibly grateful to the entire team who has been working without pay, but really just based on pure enthusiasm of what we are doing and abusing this technology and again, I think the combination of both scientific and business background is a wonderful combination.
NY Launch Pod: And I think we know the answer based off of what you said, but I certainly want to hear it from you. What does success and the ultimate goal for JelikaLite look like?
Katya Sverdlov: We want to demystify autism. We not only want to provide an effective home based treatment for families. We want to make it personalized because every child on the spectrum is unique. Some are verbal, some are not, some are hyper, some are withdrawn. Some have mitochondrial disturbances. Some don’t have any genetic abnormalities. You know, some children receive therapy and some don’t. Some have medication, some don’t. Every child needs to have his or her own treatment. By doing brain stimulation and simultaneously looking at the child’s brain on the inside by doing EEG, we are looking at effect, we are correlating with symptoms, and we want to develop a program in an algorithm that really enables each parent to choose the treatment that’s right for their child. Do we want to have these children integrated into life and to have a fulfilling life in today’s world?
NY Launch Pod: Well, that is a wonderful note to end things on Katy’s Sverdlov. Thank you for stepping on to the New York Launch POD and sharing your time with us. How do people find out more about you and JelikaLite?
Katya Sverdlov: Please feel free to go on the website, JelikaLite.com. Thank you so much for having me here. Really appreciate it.
NY Launch Pod: And if you want to learn more about the New York launch POD, you can follow us on social media @nylaunchpod and visit nylaunchpod.com for transcripts of every episode. And if you’re a super fan, Katya you a super fan of the New York launch POD?
Katya Sverdlov: I am now.
NY Launch Pod: If you are a super fan like Katya, please leave a review on apple podcast. It is greatly appreciated and does help people discover the show.
