Alejandro Covalin [00:00:01]:

Have you ever wanted to know the full story of a medical device company? From the initial spark of an idea to launching FDA approved product. I'm Doctor Alejandro Kovalin, chief technology officer at Spark Biomedical. With me are my co founders, Daniel Powell, CEO, and Doctor Navid Khodaparest, chief science officer. Welcome to Spark a conversation.

Daniel Powell [00:00:24]:

One of my first employee emails quoting Mike Tyson. Everybody has a play until you're punched in the mouth. Right. And so, you know, we had a vision, we had a lot of people excited about it and we did go to launch it and we kind of got punched in the mouth because there was just two fundamental challenges. And that is while everybody on opioids wants off opioids, the brain kicks in and the fundamental fight or flight fear. And everybody has this underlying fear of withdrawal kicks in and suddenly the patient population's a lot less motivated. Whether they're a pain patient on high doses of opioids or somebody with substance.

Navid Khodaparast [00:01:09]:

Use disorder, I think it's another tool we're giving. I always thought of it as like, you have all of these different medications that patients can try, right, to help them either go through withdrawal or to have like, long term recovery. But they've been around for forever, but the disease still exists.

Alejandro Covalin [00:01:29]:

Yeah.

Navid Khodaparast [00:01:30]:

So, you know, we've always wanted to see how do you add another tool, how do you add another tool that can help patients that don't want to go on a drug? Right, right.

Alejandro Covalin [00:01:39]:

But the fear, the fear kicks in. And I think this population, I think a lot of, I mean, they are to some degree misunderstood. I mean, they have a problem and we need. People need help. Right. And the fear aspect is such fundamental. I mean, decision making really goes south when you have a problem, when you're dependent and you start the fear, the fear starts weighing in a lot. So, of course, if you're afraid of withdrawal and you come up with a new staff, a new thing, and it's like.

Navid Khodaparast [00:02:16]:

But you know, the other thing is.

Alejandro Covalin [00:02:17]:

You know, the other thing works, right.

Navid Khodaparast [00:02:19]:

But the other thing is it's not their first time. Yeah, right. Unfortunately, so many times you hear from the doctor, the family, the patient there, it's a revolving door.

Alejandro Covalin [00:02:30]:

Right?

Navid Khodaparast [00:02:31]:

They're relapsing. They're coming back in with a disease that relapsed within 80% within the first twelve months. You know, it's un, it's not uncommon that that person's going to go through withdrawal many times and try all those different options and then fail every time they try those new options.

Daniel Powell [00:02:50]:

But we always did have a vision, that beachhead into withdrawal, that acute, painful, heightened fight or flight, fearful duration, which has changed. So when we started this, an average person trying to come off heroin, it's about a five to seven day process. Heroin isn't on the street anymore. It's only fentanyl. Fentanyl takes 14 to 15 days. So we've had to reconfigure the product to accommodate a longer withdrawal process and longer post acute withdrawal. And then we always had the vision. Can we use it long term after detox to curb relapse, which we're on target to finish that study this summer and hopefully show that we can.

Alejandro Covalin [00:03:40]:

It's interesting how that vision changed, right. Because we thought we solved this problem. But you're right. I mean, the vision extends, but not only that, you have upstream and downstream.

Navid Khodaparast [00:03:50]:

When you look at the previous devices, too, that were FDA cleared, you know, they were set duration, correct. Five days under 120 hours.

Alejandro Covalin [00:04:00]:

Right.

Navid Khodaparast [00:04:01]:

Six days. But we know, to your point, what heroin, five days of acute withdrawal treatment isn't enough. You know, the patient is still going to have withdrawal symptoms, or they may have post acute withdrawal symptoms, and it continues. So that went into the vision when we looked at it from the beginning. There was, again, all those different medications that are available, buprenorphine, methadone, naltrexone, vivitrol, lofexidine. All of those are good treatment options for the patient, but it's not everyone.

Navid Khodaparast [00:04:30]:

Wants maybe a non-pharmacological solution,

Daniel Powell [00:04:33]:

something without side effects.

Alejandro Covalin [00:04:35]:

That's the problem. Pharma is systemic. Right. You take it in and it goes everywhere.

Navid Khodaparast [00:04:40]:

It goes everywhere, yeah.

Alejandro Covalin [00:04:41]:

And the nice thing about neuromodulation is that it is targeted. You only affect the area that you want.

Daniel Powell [00:04:49]:

Yeah.

Navid Khodaparast [00:04:49]:

Neuromodulation is inherently safer than pharma. And the fact that, to your point, it's targeted. Now, if it's invasive, there's risks there, again, with a wearable device, you know, the only issues that we see are skin irritation. Right. Yeah.

Daniel Powell [00:05:06]:

Which, you know, which is why we made a right earpiece. So you can go from left to right and change it out.

Navid Khodaparast [00:05:11]:

Exactly.

Navid Khodaparast [00:05:13]:

We leared that along the way.

Daniel Powell [00:05:14]:

But the epidemic was huge. We were watching the death toll go up. We knew there was an unmet need. And then we fundamentally, you ask the question, why is there an opioid epidemic and there's an opioid epidemic, because to get off opioids, you have to go through withdrawal, and to go through withdrawal, you literally will believe you're going to die. I mean, it is the barrier of all barriers. And it was weird because we said, why is there an opioid epidemic? Because of withdrawal.

Navid Khodaparast [00:05:43]:

Yeah.

Alejandro Covalin [00:05:43]:

Oh, yeah. They were afraid of going into it.

Navid Khodaparast [00:05:46]:

Well, it's the barrier. It is literally the barrier, physiological and mental barrier, that you don't want to go through withdrawal.

Daniel Powell [00:05:51]:

So it has to be the start of any recovery is to combat and get through that.

Alejandro Covalin [00:06:00]:

Allowing people to go through the process of detoxification without actually having to go to withdrawal.

Daniel Powell [00:06:08]:

My favorite patient quote, "Easiest detox ever", wrote on our website, I think our number one lesson learned, I'm a Texan, and my dad would always, we go deer hunting, and he would say, go where the deer are. That would be. And we said, well, where are the deer? They must all be in inpatient rehab. Of course, that's. And that's where 1% of them are. 99% of people do not want to go to rehab or can't. I was just looking at the Reddit sub addiction, the subreddit on addiction, and someone was saying it just now at the break, and they were saying, I have two kids. I can't take off work.

Daniel Powell [00:06:49]:

I can't be away from them. What do I do? And so that really pivoted us to make a product that could be home use. That really became an absolute priority is meet people where they are. And that became a big evolution, which just four months ago, did we accomplish that goal by getting the second gen approved.

Navid Khodaparast [00:07:10]:

Yeah.

Alejandro Covalin [00:07:11]:

I still wish that we be reimbursed by now so more people can actually get.

Daniel Powell [00:07:18]:

That's our other problem, is reimbursement. Pharma reimbursement is just totally different than medical device. And it is a long, long process for us. We get angry comments on the website all the time. You know, why, why, why does this cost so much? Why isn't it reimbursed? And, you know, I wish.

Navid Khodaparast [00:07:37]:

Well, that's part of the goal, right?

Daniel Powell [00:07:39]:

That's part of the process. I want to get this in the hands of as many people as possible.

Navid Khodaparast [00:07:44]:

It's, you know, what someone told us once is it takes whatever you thought in terms of how hard and complex it was to go through the FDA. Get ready for CMS. Get ready to get your product reimbursed, because the level of evidence to be.

Daniel Powell [00:08:00]:

You need one study powered correctly to go through the FDA.

Navid Khodaparast [00:08:05]:

Right.

Daniel Powell [00:08:05]:

And then center for Medicaid and Medicare Services, what we call CMS, you need five. You need five times the evidence, five times the work, five times the money spent for something that the government already deemed safe and efficacious, .

Navid Khodaparast [00:08:22]:

But, yeah, the level of evidence to get to reimbursement is a lot higher.

Alejandro Covalin [00:08:26]:

I mean, the thing is, you have evidence. That's why you got FDA approval.

Navid Khodaparast [00:08:31]:

Well, we have safety and efficacy and randomized control, but I think.

Alejandro Covalin [00:08:34]:

I don't know. The reimbursement needs also, I guess, an economic study. I.

Daniel Powell [00:08:41]:

Well, and when you're a novel, new, groundbreaking product like we are, there's no. There's no. You got to go create your own codes, your own swim lanes, your own reimbursement pathway. You have to build your own body of evidence. We can't just say, you know, it's kind of. Building a me too device has its advantage. Some other big companies already spent all that money, but really pioneering something, this is. It's frustrating.

Daniel Powell [00:09:07]:

I wish we could get to reimbursement faster. So we're cash pay, which means only people who can afford this.

Alejandro Covalin [00:09:13]:

Yeah.

Navid Khodaparast [00:09:14]:

Yeah.

Alejandro Covalin [00:09:14]:

That's unfortunate, but that will change. I mean,

Daniel Powell [00:09:18]:

Well, you know, we have a nonprofit that's come on board that's buying devices for underprivileged families to try to keep families together and all. And I think we can find more of those pockets that. And then we deeply discount the product and under those circumstances, because we want to help as many people as possible.

Navid Khodaparast [00:09:38]:

And opioid relief funds, too, that we're working with as well, to help patients get the device. Yeah, but it's going to take time. But eventually, I think the overall goal is that it gets reimbursed, and then that way we can help as many patients as possible.

Alejandro Covalin [00:09:50]:

Yeah, no, I think hopefully we'll get there fast.

Daniel Powell [00:09:55]:

My hope is to save lives.

Alejandro Covalin [00:09:57]:

My hope is also easy to use. People can. Don't have to. You know, that is, they just put it on, it works.

Daniel Powell [00:10:04]:

That's what you and your team have spent so much time on thinking about. Usability, form factor. How do we ship this in a box to somebody's house, overnight it, so that's to them as quick as possible, and they can. And then they can easily get it on. And again, we. The topography of an ear is tricky. Right. No matter how you make the picture on, like, this is where it goes.

Navid Khodaparast [00:10:27]:

I look at a lot of ears now.

Alejandro Covalin [00:10:30]:

Yeah. You're an expert in ear anatomy. Yeah.

Navid Khodaparast [00:10:34]:

I've never thought I'd say that. Yeah. No, but for me, it's just simply, you know, addiction is a big issue. Can we treat other draw, Check? I think we can. I know we can. But then. Now what about long term addiction? What about cravings? What about relapse? What about, you know, overdose?

Daniel Powell [00:10:51]:

What about alcohol? What about cocaine?

Navid Khodaparast [00:10:53]:

Different substances. How does help with those? Different indications? Yeah. So it's a good place to be in, though, because we're definitely headed the right way with that type of clinical trials.

Daniel Powell [00:11:05]:

We're making a lot of progress.