Daniel Litwin:

Hello, everyone. Welcome to another episode of Vital Spark, a Spark Biomedical podcast. I'm your host, Daniel Litwin the voice of B2B and folks. Thanks so much for joining us on another episode of the show. As we continue to throw our company's weight behind solving the world's addiction crisis, understanding some cutting edge treatment methods and technologies and the professionals behind them. We're really looking forward to bringing you some more concrete thought leadership on this topic. Before we do so, I want to make sure you're all caught up on our previous conversations. We've got another great podcast we did before this one. I want to make sure you're tapped into so head to our website at sparkbiomedical.com. Again, sparkbiomedical.com and make sure you're subscribing to the podcast on apple podcasts and Spotify. Just look up Vital Spark, hit that subscribe button, and you'll have a full catalog of previous conversations plus notifications when we drop new ones.

Daniel Litwin:

So team let's go ahead and jump in. The title of our episode today is this is your brain on electricity, right? Our audience of clinicians probably remembers this is your brain on drugs campaign, classic fried egg commercial. I know I remembered it during elementary school dare campaigns, right? And today's episode is definitely not trying to scare you out of anything. It's the opposite actually, we're going to be evangelizing something and providing you with a lot of solutions, but just like the ad, we are going to be talking about the relationship between the brain and drugs addiction, and we're going to be bringing neuro-stimulation into the conversation today. We'll get in the weeds, but we'll keep it accessible. So this is your brain on electricity. We're going to be making the case today for how and why a very specific kind of neuro-stimulation. More specifically transcutaneous Auricular neuro-stimulation is making important strides in improving opioid withdrawal, alleviation, treatment, and methods.

Daniel Litwin:

With our guests today, we're going to be breaking down why we think clinicians should really consider this as an essential part of their tool belt of treatment methods. And then we're going to break down the science behind neuro-stimulation, some of the innovations and use this therapy method and the impact on staff and patients alike. So I'd like to go ahead and welcome our guest for the day. Joining us from the Spark Biomedical team is one of the three co-founders and chief science officer, Dr. Navid Khodaparast. Dr. Navid, great to have you on. How are you doing?

Navid Khodaparast:

It's a pleasure to be here. Thank you.

Daniel Litwin:

Yeah. A real pleasure getting to source your insights and we had a great with your colleague, another Dan in the house. And we really got to tap into the ethos of the company, how you as a company and as a team, see the work you're doing. And what I think today is really going to help do is intersect how that manifests in practice and in the science itself and in evolving and expanding the treatment tool belt for clinicians. So I want to start with, I guess, painting that wider picture. So if you could, for our audience today, what are some of the typical treatment methods that we typically see in the industry today to alleviate withdrawals? You know, just give us that high-level overview and intersect a few touchpoints of what you think works well and maybe what's missing and what could be improved?

Navid Khodaparast:

Yeah, that's a great question. So there's several treatment options that patients have today.

Daniel Litwin:

Yeah. Right.

Navid Khodaparast:

Most of them are FDA approved. Some of them are not. Some of we use off label, but for the most part, there are different categories of FDA approved products or opioid agonist type medications. So if we're talking specifically about opioid use disorder, these are the medications that they would use to help patients that are experiencing withdrawal or treat their addiction. These opioid agonist medications, or as they sound. They're in opioid and they bind your opioid receptors in the brain and they can relieve your symptoms associated with withdrawal. And sometimes they can be relieving the systems with cravings. These are medications known as methadone, okay. Methadone is an opioid agonist. And then there are also medications that are partial agonists, meaning that these are, they have an opioid agonist to them and an antagonist, so they can bind the receptor. But more importantly, they provide relief. This is buprenorphine and Suboxone.

Daniel Litwin:

Okay.

Navid Khodaparast:

On the other side of the picture, there are medications that are also FDA approved that are antagonists.

Daniel Litwin:

Okay.

Navid Khodaparast:

So their job is to block the opioid receptor. This medication is Vivitrol. It's widely used and very well accepted.

Daniel Litwin:

Okay.

Navid Khodaparast:

However, when you're on Vivitrol, you cannot have an opioid on board. So if you're experiencing withdrawal symptoms, you have to go through acute detox before you can receive Vivitrol, which is usually around seven to 10 days. This is the landscape that we live in currently. So most patients that undergo opioid withdrawal treatment, or want to go through long-term addiction management, they will be on one of these medications for not just months. Sometimes it can be years.

Daniel Litwin:

Now, why do we see medication being the core response or withdrawal treatment of choice? Is there a specific motivator there, is there a legacy of using medication over other kinds of therapy or treatment methods? What's the context there?

Navid Khodaparast:

I think there's a number of reasons for that. You know, it's also how physicians are trained. So pharma definitely has provided excellent opportunities for their physicians to use these treatment modalities to help their patients.

Daniel Litwin:

Yeah.

Navid Khodaparast:

And they've been trained to them. Neurostimulation has also been around for a long time, but it's starting to gain traction in other indications, other diseases that have been able to show safe and effective therapies for these patients who love that.

Daniel Litwin:

Well, you brought up neuro-stimulation. Let's go ahead and intersect that now for the podcast. As we think of neuro-stimulation as a treatment method for withdrawals, I think it's also important to just reemphasize the science behind this. So let's get a recap for our audience. One of the biggest challenges to solving the opioid addiction crisis is finding solutions to how opioids hijack the brain's reward system. So I want to and our audience is probably pretty familiar with this, but just give a quick refresher here, let's start with what is brain reward, right? Both at a high more figurative level and then more in the material science and what makes it so critical for daily functioning.

Navid Khodaparast:

So I always think of reward as just an instinct that you have that gives you some sort of pleasure and motivation. But the more I thought about it as I started diving into the addiction space, reward is a survival function. Right? So if I were to ask you and say, what are two survival functions that your brain performs?

Daniel Litwin:

Maybe, I don't know.

Navid Khodaparast:

The top two actually come up of cardiac and keeping your heart going.

Daniel Litwin:

Okay. Fair. Yep.

Navid Khodaparast:

And respiration.

Daniel Litwin:

Oh, right. That's straightforward. Yeah.

Navid Khodaparast:

Breathing.

Daniel Litwin:

Yeah.

Navid Khodaparast:

Breathing. And these are involuntary functions that are survival functions for you to keep you alive. Most people don't consider reward a survival function. And let me give an example of why it is. You actually mentioned it earlier. So when you consider reward in relation to eating and having sex, the two reasons why you have to eat is what? To stay alive. Right?

Daniel Litwin:

Right. Yeah.

Navid Khodaparast:

Keep your body alive, keep it full of nutrients. And you can continue on.

Daniel Litwin:

Right.

Navid Khodaparast:

In terms of sex and procreation, this is extremely important for our species to be able to stay alive. And so the system of reward, the function of reward in your brain is a survival function. And it is primarily driven by one specific neurochemical called dopamine.

Daniel Litwin:

Right.

Navid Khodaparast:

Right. Most people know this as the pleasure hormone.

Daniel Litwin:

Right.

Navid Khodaparast:

And however, but it is a very vital hormone and neurochemical in the brain it does provide us with the ability to understand that when you eat something, you should do it again.

Daniel Litwin:

You get rewarded for it.

Navid Khodaparast:

You get rewarded for it. Exactly. But not only that, it can reward you for the motivation. So if I show you an image of something that looks edible or something that you may like, a lot of examples, chocolate, food, fried chicken.

Daniel Litwin:

Oh, hell yeah.

Navid Khodaparast:

Whatever it may be. Right?

Daniel Litwin:

Yeah.

Navid Khodaparast:

Your brain is going to give you a little bit of dopamine and say, you should probably go eat that. You're getting hungry. Maybe you should go eat that. And then when you eat it, you get a sense of fullness.

Daniel Litwin:

Right.

Navid Khodaparast:

Society as they call it. Fulfillment. Fulfillment.

Daniel Litwin:

Right.

Navid Khodaparast:

I feel better.

Daniel Litwin:

I achieved my mission. Yeah.

Navid Khodaparast:

And then you have less dopamine and you continue on, but then as the cycle continues, you will go and seek for it again.

Daniel Litwin:

Interesting. So then what is the role then that dopamine plays in the brain's chemical balance and ecosystem and how do opioids disrupt that flow?

Navid Khodaparast:

Right. So obviously, we're talking about how dopamine works in a normal brain, right? A healthy brain. As you start introducing substances of abuse and for this topic and for this conversation, we're mostly focusing on opioids. As you introduce an opioid to the equation, well, an opioid can go and bind directly to an opioid receptor in the brain. And the consequence of that binding to an opioid receptor is that it releases dopamine, right? So as you start taking in opioids from your world, they call it exogenous opioids. You're taking it from outside of your body and putting it inside your body. Well, now you're supplanting the need of dopamine. Essentially, you are going to create your own dopamine surges. So they call this hijacking in some ways, opioid hijacking. And as you begin to take an opioid for longer periods of time, your brain can become dependent onto the opioid. And so it was interesting. There was a thought process that as you would take opioids, you would just get more and more dopamine.

Daniel Litwin:

Sure.

Navid Khodaparast:

It's actually quite the opposite. So even though you do get pleasure as you take an opioid, you have euphoria in the beginning stages.

Daniel Litwin:

Yeah.

Navid Khodaparast:

As you continue to take it for longer periods of time, your brain will stop producing as much dopamine. It'll actually pull back on those dopamine receptors. And this is a classic term. Everybody's heard this term and this is tolerance.

Daniel Litwin:

Right. Your tolerance goes up, so you got to take more.

Navid Khodaparast:

So you have to take more. And what's unfortunate about this is for people that suffer from addiction. You do build more tolerance, but the issue is, at some point, there's not enough of a drug or a substance of abuse that you can take for you to actually get pleasure anymore. So then you're taking these substances primarily just to function and to stay in life.

Daniel Litwin:

Right, right. Because they're no longer reaching new peaks for you. They're just filling this cavern of the basic foundation of what you need to even get through the day.

Navid Khodaparast:

That's exactly right.

Daniel Litwin:

Right. Right. And I mean, obviously, that creates massive issues. And we talked about the trends in opioid addiction in our last episode with Dan, but I guess just as a quick refresher, I do recommend everyone go watch that episode. I don't remember the number, but there was a sharp increase in not only addiction but also addiction-related deaths during the pandemic. And so you see not only addiction patients struggling with their issues, but a lot of the natural kind of surges of dopamine that you get out of the basic lifestyle of living in a society of being interacting with your community. You pull all those away too, and you get the double compound issue. Is that something that you've heard from clinicians that you work with or from the medical side of the industry, the more technical granular side of it?

Navid Khodaparast:

Absolutely. You know, the pandemic has definitely caused a massive surge in our opioid epidemic.

Daniel Litwin:

Yeah.

Navid Khodaparast:

Right. I remember when we first started Sparked by a medical just over three years ago. We were talking about overdose rates in the 40, 50, 60,000. Right? Now we're at 90. And then now it's a hundred thousand that they report. And it's not just opioids, this is all substances that lead to overdose. But the underpinnings of addiction are not surprising. It's depression, it's PTSD, it's anxiety. And when you put people in a stressful situation, such as a pandemic and they lose jobs, and their families are distraught, these symptoms begin to arise and they begin to self-medicate.

Daniel Litwin:

Yeah.

Navid Khodaparast:

And when you self medicates, unfortunately, it can get to a place where you can't return. You're kind of in a dark place.

Daniel Litwin:

Right. Because you know of that science layer of you start to raise the tolerance, you start to clock out what sort of natural dopamine in your body can even produce and intake. So you start to become even more dependent, et cetera. Right. Yeah. So then how does the science behind addiction and specifically opioid addiction, how does this impact some of the treatment methods that you see in the field today? Are they specifically trying to respond to that science behind it? Are there other layers of addiction that they're trying to treat or address? Give us that context.

Navid Khodaparast:

Right. So most of the addiction treatments out there specifically that are pharmacological as the ones I mentioned are buprenorphine, Suboxone and methadone, these are in the category of substitution treatments. So the idea is, this is an example, if you have someone that is addicted to heroin, they come into an inpatient treatment facility to go through the detoxification procedures and they will start them on one of these medications, and so you're essentially taking away a narcotic, an illegal narcotic, and you're substituting it for a prescriptive medication that a physician can control.

Daniel Litwin:

Sure.

Navid Khodaparast:

They're very effective, but it is a substitution, right? You are eliminating one and replacing it with another. So there is that type of treatment. It is successful and we have saved a lot of lives with these medications. On the other side of the equation with Vivitrol, again, it blocks receptors.

Daniel Litwin:

Yeah.

Navid Khodaparast:

And this is more of a sober living type of application. So you've decided I do not want to have an opioid anymore, and so I will undergo the tough withdrawal process.

Daniel Litwin:

Just more of a cold Turkey process?

Navid Khodaparast:

It is. They do provide you with medications. They're just not opioid-based medication.

Daniel Litwin:

Sure.

Navid Khodaparast:

So they call it to comfort medication protocols, and it does help patients get to their finish line. But not as many can get there because it is difficult. You are going to have to unfortunately suffer through some of the withdrawal symptoms before you can get on Vivitrol. And this is something that Spark really focused on from the very beginning. Right.

Daniel Litwin:

So then how do those dynamics, maybe some of the double-edges of the medication treatment sword, what challenges does this pose for clinicians out there, right? How does that having to maneuver the realities of the positives as well as some of the downsides of that treatment method impact their day-to-day, how many times they have to see these patients, the relationship between patients, et cetera?

Navid Khodaparast:

Well, it just depends. It's different from every patient to every patient. And you know, I'm not a clinician, but I do speak to many physicians about this topic.

Daniel Litwin:

Yeah.

Navid Khodaparast:

And it's not easy. The physicians do wish they had another tool in their toolbox. Right? For example, for patients that want to get on the Vivitrol, it's not easy. And so having a non-opioid solution that can reduce your withdrawal and have easier transition on the Vivitrol is highly desirable by most clinicians.

Daniel Litwin:

Yeah.

Navid Khodaparast:

In addition to that, Suboxone works fantastic. But at some point, patients will need to come off of it.

Daniel Litwin:

Right.

Navid Khodaparast:

It can lead to other physiological issues, constipation, there's a lot of other issues that they can have from it, cardiac issues. So if a patient does want to come off Suboxone, which is an opioid, unfortunately, they will experience withdrawal. And that's where we think neuro-stimulation plays a fantastic role in being able to help patients get to a medication or to get patients off of medication.

Daniel Litwin:

Right. Something that doesn't just act as a substitution, but that alleviates the transition away from the opioid. Right? So let's go ahead and bring in this neuro-stimulation treatment into the conversation. Again, transcutaneous auricular neuro-stimulation. How does tan therapy compare to other treatment methods used in the field, right? The agonist and the antagonist opioid-based treatments that you just mentioned, give us sort of a comparing contrast.

Navid Khodaparast:

Right. So the way that we try to understand how our products work is it's actually based on a lot of science before us. There's been several studies that have come out that have shown how neuro-stimulation, different forms of it. Some invasive, some noninvasive.

Daniel Litwin:

Sure.

Navid Khodaparast:

But talking specifically about just peripheral, stimulating a nerve on your body.

Daniel Litwin:

Right.

Navid Khodaparast:

Right? There're studies that have shown that if you can stimulate these nerves, you can release what are called endogenous opioids. So this is your body's natural opioid.

Daniel Litwin:

Okay.

Navid Khodaparast:

And most people know this as endorphins, right?

Daniel Litwin:

Yeah.

Navid Khodaparast:

Endorphins combined with your opioid receptors, and it's primarily been known to help with pain. In this scenario, we're using it for the other issue, which is withdrawal symptoms.

Daniel Litwin:

Interesting.

Navid Khodaparast:

So tan therapy specifically, its precision-targeted therapy in some ways, because we are targeting two specific cranial nerves. And these are two nerves that are extremely well studied. One is the vagus nerve. And then the other one is the trigeminal nerve.

Daniel Litwin:

Are those on the body?

Navid Khodaparast:

So the vagus nerve, if you're talking about the actual nerve itself, it's in your neck, you have two of them and they're right next to your carotid arteries.

Daniel Litwin:

Okay.

Navid Khodaparast:

Right? The trigeminal nerve is primarily on your face and it kind of wraps around and goes in front of your ears and tucks around by your jaw.

Daniel Litwin:

Interesting.

Navid Khodaparast:

And so these two nerves are cranial nerves. You have 12 of them. So they're very well integrated into your nervous system, but we have the ability to target both of them at the same time through your ear.

Daniel Litwin:

Okay.

Navid Khodaparast:

So our earpiece, Dan may have mentioned this on his podcast or on his interview with you, but nonetheless, we essentially have an earpiece that sticks to your skin, which is what transcutaneous means.

Daniel Litwin:

Gotcha.

Navid Khodaparast:

That delivers electricity to the skin. And it stimulates on and around your ear activating both a branch of the trigeminal and the Vagus. And so when you activate these nerves, our theory and we're testing this hypothesis out currently, is that as you stimulate both of these nerves, it releases endogenous opioids or endorphins and fills those opioid receptors. So for a patient that is coming off of heroin, and they're about to experience withdrawal. These withdrawal symptoms start to present within six to 12 hours after their last dose. And so we intervene and we provide neuro-stimulation to fill those receptors and reduce the amount of withdrawal.

Daniel Litwin:

Does the body notice a difference between filling those opioid receptors with dopamine versus endorphins? How do those compare?

Navid Khodaparast:

It's actually a little bit different.

Daniel Litwin:

Okay.

Navid Khodaparast:

So when you release endorphins and they bind to an opioid receptor, the subsequent release is dopamine.

Daniel Litwin:

I see. Okay. Right. Gotcha. So then basically what you're doing is you're providing a natural solution to that urge to fill this dopamine tolerance that you've built up through your opioid addiction. Now, how do you see that coupling with some of the medication and the long journey of leveling someone back off of that addiction they've built and that tolerance they've built?

Navid Khodaparast:

Right. So, we've really started focusing, or at least in our first studies that we focused on how to help patients during acute detox.

Daniel Litwin:

Okay.

Navid Khodaparast:

Right?

Daniel Litwin:

Sure.

Navid Khodaparast:

Getting a patient through that horrible barrier before they can get onto their addiction treatment. So five to seven days we've shown success in that. We've been able to help patients mitigate withdrawal, reduce withdrawal, and then move on into long-term addiction treatment. We have just received an NIH funded study through the NIH specifically NIDA and the healing initiative.

Daniel Litwin:

Okay.

Navid Khodaparast:

It's a two-year study that we're very passionate about because it allows for us to determine not only how we can help patients in acute detox, but then to your point, how do we help patients in long-term addiction?

Daniel Litwin:

Right.

Navid Khodaparast:

Helping with cravings, helping with some of the depression, the anxiety to PTSD, helping with protracted withdrawal, and also helping patients prevent relapse.

Daniel Litwin:

Yeah.

Navid Khodaparast:

Which relapse is one of the biggest and highly correlative numbers to overdose?

Daniel Litwin:

So then in that long-term path then, I guess what are some of the strategies that clinicians use now to avoid relapse and how do they weigh some of the factors of trying to prevent patients of getting addicted or dependent on just a new treatment or a new substance, right? How do you balance that with your earpiece and the endorphins and the dopamine that it naturally provides your system?

Navid Khodaparast:

Right. So we're just another tool in the toolbox.

Daniel Litwin:

Right.

Navid Khodaparast:

Right. We're definitely not trying to be a primary treatment.

Daniel Litwin:

Okay.

Navid Khodaparast:

For our patients and for the physicians to use. We look at it as if you have patients that are difficult to treat. Fentanyl is being pushed out everywhere now out, and it has made treating patients more difficult. So there are more difficult cases because of this and we believe that our device is another tool that can help physicians treat those more difficult patients. It can also be used for patients that just don't want to have any medications. Enough is enough. I don't want to be on an opioid. I don't care if it's illegal or prescriptive.

Daniel Litwin:

Right.

Navid Khodaparast:

I just want a natural approach to this that's safe and effective.

Daniel Litwin:

Yeah. I'm sure that matters a lot too. I mean, the psychological element of saying I'm trying to overcome this.

Navid Khodaparast:

Right.

Daniel Litwin:

And it's like, well, here's another pill, it's almost like, triggering to some degree. Right. So yeah, I could see that being very valuable in those kinds of treatment scenarios and to present some other options. We've been just casually talking about treating addiction and helping patients just at large. Now, what about when we compare adult patients versus babies, children, right? Children that are born addicted to opioids, secondhand basically. Is there a different strategy there? Have you developed a product differently for those two different demographics?

Navid Khodaparast:

Yeah. So that's something that we're very, very passionate about at Spark. It's helping babies that are born and suffering from neonatal opioid withdrawal syndrome or nows. And so nows, as the opioid epidemic gets worse and worse through the pandemic, it is natural that we see higher numbers in nows. And so we've had very good success in terms of running a clinical trial that we conducted at the medical university of South Carolina.

Daniel Litwin:

Yeah.

Navid Khodaparast:

It was a very small trial, but it was effective in showing that our device, which we shrunk down is the exact same system. We just shrunk the earpiece down to fit a baby's here.

Daniel Litwin:

Right. Easy enough.

Navid Khodaparast:

Super simple.

Daniel Litwin:

Yeah.

Navid Khodaparast:

The exact same stimulation parameters, the intensity was a little bit less because they're babies and infants, but nonetheless, the approach was a little bit different from in our adults. In adults we just deliver it and they can use it as they need it to help with the symptoms, which neonates, infants suffering from nows, their primary treatment is morphine to help reduce the amount. So again, it's opioid substitution and it's very effective. However, though, the national average is roughly around 23 days in the NICU. And some of the NICU stays depending on the studies you see can be up to 40, 45 days. It's extremely expensive and costly to treat this patient, this infant.

Navid Khodaparast:

And so the way that we've used neuro-stimulation for nows, is by looking at how do we replace morphine? Not that we stop morphine treatment, morphine is given on a schedule. And what we do is we deliver a short session roughly about 30 minutes of neuro-stimulation. And right before the morphine dose, and what we saw was babies were calming down, babies weren't crying as much. Their withdrawal symptoms were much less. And we were able to reduce the amount of morphine or at least in our study showed that national average is 23 days and our study was nine days on average.

Daniel Litwin:

Wow. That's a considerable cut.

Navid Khodaparast:

It's a considerable amount. Yes.

Daniel Litwin:

Yeah. And that's something to hang your hat on. That's for sure.

Navid Khodaparast:

It is. We're very proud of that. And we continue to expand on that science to be able to help babies with nows.

Daniel Litwin:

How are you continuing to develop the science and the rigor of those clinical trials? Do you have specific methodologies you're trying out or anything in the pipeline?

Navid Khodaparast:

Right. So all of our studies, at least, in terms of the adults and in terms of the baby suffering from nows is our randomized control trials. It's the gold standard. And primarily because we are looking specifically for nows to get that product to market, get it in the hands of the neonatologist and in the hands of the NICU nurses, allow this to be another tool in the toolbox for them to treat their patients.

Daniel Litwin:

Sure.

Navid Khodaparast:

And so for nows, we did receive also an NIH funded study to two-year trial that will be starting in I think the first part of 2022.

Daniel Litwin:

You know, there's actually a specific clinical trial that I want to highlight here with you today. Spark recently announced a new clinical trial to address long-term addiction using tan therapy, which we've been talking about. Right? And this is jointly managed with the Hazelden Betty Ford Foundation, as well as Gaudenzia clinics. Is that pronounced correctly?

Navid Khodaparast:

Gaudenzia.

Daniel Litwin:

Excuse me, Gaudenzia clinics. Now, both of these are leaders in behavioral health and addiction treatment and the trial has almost three million behind it from the national institutes for health initiatives and a grant you received from them, which is very exciting. So can you tap into that research for our audience? What is it that you're actually testing and how do you hope that this will continue to inform how clinicians can bring tan therapy into their larger ecosystem of treatment tools?

Navid Khodaparast:

Right. Yeah. This is a really exciting study for us because it's the first study that we're aware of that has actually three FDA approved treatment options.

Daniel Litwin:

Three? Okay.

Navid Khodaparast:

Those are all non-opioid based.

Daniel Litwin:

Oh, wow. Right. Great.

Navid Khodaparast:

And so the three are Lucemyra and so Lucemyra is a non-opioid FDA of medication for acute detoxification.

Daniel Litwin:

Okay.

Navid Khodaparast:

And then the other medication that we're using is Vivitrol, which I've already explained earlier. And then our therapy, which is neuro-stimulation non-opioid. So as patients start this trial, they will be enrolled. It's a randomized control trial. They'll be enrolled into the trial and they'll use our device with Lucemyra through the seven days of detox. And then as they move on to phase two, they will go on the Vivitrol if they agree to.

Daniel Litwin:

Sure.

Navid Khodaparast:

And then we'll have our device as well with Vivitrol to determine if we can prove relapse rates during a 90-day phase.

Daniel Litwin:

Noted. How do you hope that this can help inform some new strategies from the Spark Biomedical team? Is there anything that your team is hoping to take away from this to then inform future developments to your tan therapy solutions?

Navid Khodaparast:

Yeah, exactly. So our indication right now, currently with the sparrow device for tan therapy is essential to help mitigate withdrawal. Right?

Daniel Litwin:

Right.

Navid Khodaparast:

With this clinical trial, it'll allow for not only our device to expand its indications for use and to relapse prevention, but also it will give physicians again, another opportunity to help their patients and we have to be very clear after detox patients are extremely, they call it opioid naivety. So their chances of relapse and overdose go up tremendously right after detox.

Daniel Litwin:

Right.

Navid Khodaparast:

So they're in a very vulnerable state. So being able to control a patient in terms of their symptoms, their cravings, their depression, their PTSD, and helping on that and keep it under control is crucial for them to have a successful addiction treatment down the road.

Daniel Litwin:

Definitely. It's about building that reactivity, but proactivity too, it's something I said in the last episode too, but something that I think really works well for Spark is the fact that you've centered that in your treatment, in your development and in the ethos of the whole company, is how can we not only address the most acute aspects of withdrawals today but also develop a solution that can be part of a longterm treatment option of a long-term addiction therapy strategy that takes into account the potential for relapse, the long-term effects that your body's still going to have to take into account as it maneuvers a future post-withdrawal and post addiction.

Daniel Litwin:

So with all of that in mind, let's start to wrap up the conversation than by talking about how we can actually start to put this to good use. As we mentioned, this is just part of a larger ecosystem of treatment tools, but from what I've heard from you, it sounds like opioid-based treatments and pills really are still the core foundation of treatment today. Right? So would you say that clinicians at large are ready to take this on as something that is neurostimulation based? Or is there a layer of education that's still needed to bring this to the industry at scale? What are your thoughts there and what role is Spark playing and filling that education gap? If there is one.

Navid Khodaparast:

Definitely. There's still a lot of education that needs to be done on our part. And we take that very seriously. There are physicians to date that is just the no-brainer for them.

Daniel Litwin:

Sure.

Navid Khodaparast:

You show them our product, they see the unmet need and they're like, I don't want to use it, right? There are other physicians that just need more data, which is what we are trying to do. Bigger clinical trials, more data, more support, more peer-to-peers to get them to be believers in this type of technology. And sometimes they just have to see it to believe it. So yes, definitely education plays a huge role. Also, one of our biggest barriers into getting the hands of not only physicians and their patients is the cost, right? This technology is not expensive. However, it is not also reimbursed. So that's something that we are working on very hard to be able to get this reimbursed through private insurance and hopefully, at the federal level through CMS, which will then eventually be able to allow patients to get this technology much more easily and more reliably.

Daniel Litwin:

Do you feel that there's a second layer of domino affecting education that you have to consider too, which is not only educating the clinician and the physicians on how to use it, but then also helping them understand how to then educate their patients on proper use? Does Spark take on any of that responsibility as well to imagine the concentric circles of education that come from this?

Navid Khodaparast:

100%. Yeah. You know, we have a theme at our company. We stole it from other companies, it's the easy button.

Daniel Litwin:

Yeah.

Navid Khodaparast:

Right, right. You don't want technology to be hard because it just won't be adopted. So we do everything we possibly can. We listen to our patients, we listen to our physicians, we take that feedback very seriously. We modify our products to meet those standards and just to make it easy, we want this to be as easy as taking a pill.

Daniel Litwin:

Yeah. And it sounds like it's getting to that point. And it sounds like if anything, the experience is going to be potentially better than taking a pill, I guess, just to start to wrap up as well. What have you heard from patients that you've worked with or through the grape from clinicians, what they've heard from patients on their experience using the Sparrow device? Do they compare it to other treatment methods? Is it that clear of an improvement or difference for them? What have you heard?

Navid Khodaparast:

We've heard great experiences from our patients and clinicians in terms of withdrawal mitigation, it's fast. It's a very fast effect, right? Within one hour most of our patients actually fall asleep. It's incredible.

Daniel Litwin:

I love that.

Navid Khodaparast:

They're in a fetal position. And then 30 to 60 minutes later, they're falling asleep in the chair and they're relaxed and they're not experiencing withdrawal. And our physicians are echoing the same sentiment. So it's incredible to see how neurostimulation has another branch of treatment that it can provide patients.

Daniel Litwin:

Definitely. And I'm very excited to see how your clinical trial that you're in the middle of, with the Hazelden Betty Ford Foundation. And just any future research you're going to do, how that continues to improve that quality, speed, and comfort quality device. It sounds like you're really making strides already. So it's always a pleasure getting to tap into that.

Navid Khodaparast:

Yeah.

Daniel Litwin:

The last main point then, is there one action that you want clinicians out there to take away from today's episode? If they really had to internalize all of this new knowledge or refresher and put it to action, what would that be and why?

Navid Khodaparast:

Yeah, just as I said earlier, physicians love tools.

Daniel Litwin:

Yes.

Navid Khodaparast:

Right. This is just another tool. That's non-opioid, it's non-invasive, it's non-pharmacological that's safe and effective for their patients and they should just give it a try and see how it works.

Daniel Litwin:

I love it. And if anything, the results will speak for themselves.

Navid Khodaparast:

Right. Absolutely.

Daniel Litwin:

I love it. All right. Thank you so much for your time today. It's really been a pleasure getting to tap into the science behind Spark Biomedical, and add another layer and build off of our last episode to more clearly understand the ethos of the company, and how you view the science playing into that larger role of your company. And again, why this neuro-stimulation treatment, why tan therapy is going to be an essential part of the tool belt moving forward. So thank you again, for our audience. We've been chatting with Dr. Navid Khodaparast, he's one of three co-founders and the chief science officer at Spark Biomedical and Dr. Navid, if folks want to find out more about some of your work, they want to tap into your thought leadership, maybe just get in touch. How can they do so?

Navid Khodaparast:

They could definitely find me on the website and then they can track some of our work that's being done at the NIH.

Daniel Litwin:

Very good. All right. Dr. Navid Khodaparast, thank you again. It's really been a pleasure.

Navid Khodaparast:

Thank you so much. Thank you.

Daniel Litwin:

And thank you everyone for tuning in to another episode of Vital Spark, a Spark Biomedical podcast. If you liked what you heard and saw today, and you want to tap into some previous episodes or make sure you don't miss out on future conversations, as we continue to solve this crisis of addiction and more specifically opioid addiction in the world, make sure that you are subscribing to our podcast at Spotify and Apple Podcasts and make sure you're heading to our website Sparkbiomedical.com. Again, Sparkbiomedical.com. I'm your host, Daniel Litwin, the voice of B2B and we'll catch you on the next episode of Vital Spark.