Combatting the Opioid Crisis with Technology with Justin Zenanko CEO of SynerFuse

In this episode we're joined by Justin Zenanko, CEO and co-founder of SynerFuse to discuss groundbreaking technique combining spinal fusion and direct nerve stimulation to treat chronic low back pain, aiming to eliminate the need for postoperative opioids. Justin delves into the inspiration behind the technology, its clinical results, and the company's approach to quality and regulatory management. He also provides insights on raising funds in a competitive market and the potential future applications of SynerFuse's technology.

Justin's Bio
Justin Zenanko, CPA, MDiv, is the president, CEO, and co-founder of SynerFuse, Inc., a Minnesota-based company innovating the spine industry with its integrated approach which combines spinal fusion and direct nerve stimulation to address the chronic low back pain that is unaddressed in about 40% of the 500,000 traditional spinal fusion surgeries that take place annually in the US alone. The SynerFuse approach aims to eliminate the post-surgical need for addictive opioids. 

Link to SynerFuse website: https://www.synerfuse.com/

00:00 Introduction and Welcome
00:41 Meet Justin Zinenko: From CPA to MedTech Innovator
03:16 The Birth of SynerFuse: Combining Spinal Fusion with Nerve Stimulation
05:29 Clinical Results and Patient Success Stories
08:46 Quality and Regulatory Approaches in MedTech
10:29 Future Applications and Innovations
14:59 Advice for Aspiring Entrepreneurs
17:51 Fun Insights and Closing Remarks

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Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

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Music by keldez

Transcript

Meg Sinclair: 0:34

Hi everyone. And thank you for tuning in to, from the lab to launch podcast brought to you by Qualio. I'm Meg, your host, and I'm delighted to be here with you today. Before we dive into today's episode, we'd love it if you could take a moment to rate and share the podcast with your circle of science enthusiasts. And if you're interested in being a guest on the show, please check out the application in the show notes. Today, we're excited to welcome Justin Zinenko, CEO and co founder of SynerFuse. Justin's background combines finance, theology, and a passion for medical innovation. Under his leadership, SynerFuse is pioneering a groundbreaking approach to treating chronic low back pain by integrating spinal infusion with direct nerve stimulation. This innovative solution aims postoperative opioids, addressing a significant gap in current treatment options. We'll delve into his journey, the challenges and successes of centrifuge and his vision for medical, the future of medical technology. Please check out the show notes for his full bio and links to learn more. Let's bring him in. Welcome, Justin.

Justin Zenanko: 1:41

Thank you for having me. Happy to be here.

Meg Sinclair: 1:44

Great. Can you tell us a little bit about your journey from being a CPA to co founding Centerfuse and what inspired your transition into the med tech industry?

Justin Zenanko: 1:54

So I've always had a passion for helping people looking at problems and wanting to find solutions and you know it was really interesting as I was going through college and going through the whole the whole journey of, you know, what do you go for, for education or what do you study? The one thing that I was always told is, you know, business accounting, you know, economics, you know, those are consistent things in all businesses. All businesses have accounting numbers. And I was given advice from a lot of my dad's friends that was, you know, you should go into accounting and you can figure out what business you would like to be on. So I became a CPA and I started off in a biotech company where I left after 18 months to become the first CFO. And that was a gene editing company called Reconbinetics. And from there I really learned about how do you build businesses? How do you recruit doctors? How do you actually go after those big problems? And what I really found is that I really. Enjoy building things and, you know, finding a solution that people said couldn't be found or couldn't be done. And those solutions are what really drives innovation. And, you know, you gotta, you know, the bigger the problem, the bigger the task.

Meg Sinclair: 3:29

That's fascinating. So CPA to right into med tech then. Centerfuse has got a really innovative approach to combining spinal fusion with direct nerve stimulation. Can you elaborate on how this idea came about and initial challenges that you faced in developing this technology?

Justin Zenanko: 3:46

So the idea really stemmed from a pain doctor and a neuroscientist and myself coming together and really developing it. you know, saying, well, there's there's already stimulation out there. There's already back fusion, but the pain physician kept seeing back fusions at patients who were having pain and weren't getting treated and from injections. And eventually they might go in because fusion begets fusion. So they might go in for another spine fusion, but eventually They get you know, diagnosed for as, uh, a stimulator. And when we brought this to the neurosurgeons at the University of Minnesota, Dr. Michael Park, and then later, our former investigator, and now our chief medical officer, Dr. Lal, you know, as they thought about it more and more, they go, well, you know, fusion, you're fixing the back, But no one's doing anything with the nerves. And we try so hard to do an epidural approach, fish it up the spine to get as close to the nerve as possible. Why wouldn't we just combine everything together? And from my perspective, it was, well, why aren't we doing this? And it came to a simple thing of money and really no one ever thought about it. And there's no codes, there's no You know, this is going back to the way, you know, when you look at how ideas get started and get implemented and med devices goes all the way back to the Earl Bakken days of Medtronic. There's a problem and you go to solve it. And we were very fortunate to have the University of Minnesota in our backyard and having neurosurgeons who believed in fixing this problem.

Meg Sinclair: 5:39

And so with that, Centerfuse is aiming to eliminate the need for post surgical opioids through this integrated therapy. Can you share some insights into clinical results you've seen so far and how patients have responded to that treatment?

Justin Zenanko: 5:53

Yeah, so early data, uh, suggests that the combined approach procedure, the Centerfuse procedure, is safe. And based upon some news some, some, uh, recent media that came out maybe a year ago that we had a couple, several patients who were actually interviewed, you know, on local news stations and one patient, uh, was off of her opioids in less than a week and was back to work in three months. And you just don't see that in fusion patients. And based upon, you know, other early data that we're seeing, we're, we're very encouraged and motivated about what the future holds for this approach because, you know, seeing these patients, and we even had another patient who, for example, could barely walk, and now she's back to riding her motorcycle. And it's like, you take someone that looks disabled, and you're like, well, she's disabled. And granted, I don't know who any of these people are until you know, they get out of the trial and they get to where the media finds them, but, you know, you see a disabled person becoming, you know, going on a motorcycle and getting their lives back and doing the things that they're used to doing, like gardening, you know, the stuff that we take for granted. But for these people, they're getting their lives back. And that's what centerfuse is really about is how do we restore people and get them to their lives back where they don't have this chronic pain that overtakes their lives. And they're having to take opioids and, and go down this terrible this terrible road where, you know, everybody knows somebody who has suffered from the, You know, the opioid pandemic and and the crisis and how can we actually make it, you know, not happen. And the key is you treat the nerves early and by treating the nerves, you're actually you're taking away and our aim is to take away the need for opioids altogether.

Meg Sinclair: 8:02

That's amazing. It'd be amazing to see that apply to more pain method treatments and really prevent, you know, and mitigate the need for opioids altogether.

Justin Zenanko: 8:12

And that, and that's why we're, you know, we, we have to do, we did a, we did a small proof of concept study on 15 patients at the University of Minnesota and then South Bend Orthopedics. Um, but now. We are, we have to get ready to, you know, from this go through the whole FDA process for class three device and do a national multi center trial and really to get the efficacy, you know, statistical data points because, you know, what, what our primary goal was, was to show safety, which we have the box checked, but now it's. You know, can we get the efficacy data in enough patients where we can actually make claims? And that's, that's the next phase in our journey here.

Meg Sinclair: 9:03

So speaking of that, because we provide a quality management system software, we're always curious to get an executive's feedback. Take on quality and regulatory management. So we have to ask, how does Centerfuse approach quality and regulatory and its product development and its clinical trials, especially, you know, with your next hurdle coming up?

Justin Zenanko: 9:22

Well, quality and regulatory are really keys to our success. You know, it, it is a, it can be, and I would say as for a lot of companies, a blind spot, cause you don't know, you don't know. The way we mitigate that is by bringing the right partners in from the product. So everything is done and documented correctly, then bringing in the right regulatory people, which we have currently, and then it's making sure that the software that we are using, everything gets done correctly and, you know, you know, double verified and all the stuff so you can actually have publications of your data. So you're not missing things. And, you know, that's been a journey in itself because you know, you missed some key points and you know, in your regulatory that can be really detrimental to the company and to advancing therapies because, you know, dealing with the FDA or dealing, you know, to some of the highest standards and especially class three devices, uh, very high standards. So we, we, we take a very you know, a very thoughtful and dedicated approach to it and making sure that you know, we're trying to stay on top of it as much as possible.

Meg Sinclair: 10:42

Great. Thanks for sharing your take there on quality and regulatory approaches. Beyond the current applications of centerfuses technology for chronic low back pain, are there any other medical conditions or areas you think you could benefit, that could benefit from this integrated approach?

Justin Zenanko: 10:59

So we're, so right now, our technology is really focused on the first application, which is back fusions. Bye. Within our patent portfolio, we also have laminectomies, disectomies, anything where it involves a spine surgeon where they're opening up the back to fix the bone on bone, bone on nerve. Our technology, uh, plays a role in that. And what we did is we started with the therapy of last resort, which is spine fusion. Because the outcomes are so poor, from a pain perspective, doesn't mean that they didn't fix the mechanical issues, like structure, the autonomy, or the anatomy, but it's really about treating the nerves, and, you know, wherever you have pain, you know, you're dealing with a nerve. So, this can go to peripheral nerve stem. There's a lot of other applications, but the one thing that we as Centrifuge are primarily focused on and where we've, you know, we've raised the funds to deploy the technology is focused on lower chronic back pain and leg pain. And. You know, that's where, that's where we've started and that's where we have to continue. But the opportunities for us to address a lot of different pain is going to be is going to be there because we are building one of the world's smallest stimulators. And with that, and with that direct nerve approach, we're seeing power levels that we've never seen before, which means you can reduce size, which means less invasive. And, you know, the idea is the less invasive, the faster you can get through a surgery you know, the better, uh, the patient outcomes. We think could be and obviously we have to prove that out my disclaimer here, but the reality is, is that lower power and direct access to the nerve, I think, is the future of where we're going to see the spine industry go, but also stimulation in general,

Meg Sinclair: 13:17

and perhaps even maybe the larger pain treatment methodology too, with kind of an integrated approach and, and getting away from opiates and imagine too.

Justin Zenanko: 13:29

Yeah, I mean, there's 600, 000 patients per year that are getting backfusions. Wow. And then if you look at laminectomy and disectomy, you're probably at another half a million to 600, 000 patients. So right there you got about, you got well over a million patients per year that are Are

Meg Sinclair: 13:48

they being prescribed opioids?

Justin Zenanko: 13:50

Yes. And, and if we want to really go after this issue, this crisis, it's going to take the community and take everybody coming together to really address that issue because this is a crisis that needs to be dealt with firsthand and it takes all of us to make that a reality and it starts first with patients, then the doctors, and then it's the broader community and that is that's something that, you know, you know, we, we, we want to get serious in this country about health. Let's, let's take the surgeries of last resort and let's make them better, not worse. Let's make them better. And the sad thing is that technologies have been around for a long time that could do this. However, it was never attempted before, which is mind boggling to me because for me, there's a problem. Why don't we have a solution? Oh, it comes down to money. Well, we're the richest country in the world. And we're not trying to tackle these big crises, these big problems because of money, you know, let's get serious about it.

Meg Sinclair: 15:07

I think we need more CPAs and med tech, perhaps to help drive this innovation, Justin. That's what that's what it sounds like we need. You had mentioned raising capital. It's a competitive market out there, especially as the costs of borrowing are increasing. is relatively high these days. What advice would you give other founders who are looking to raise funds to solve their own big problems?

Justin Zenanko: 15:31

So the advice that I can give is that you first, first, it needs to make sense to you as the founder, as the leader of what you're doing. Is it fair from a pricing perspective? Meaning is, am I willing to pay for it? And then I think you have to lead by example, which is you have to put your own money in. And, you know, I've been fortunate enough being a CPA entrepreneur that I was able to lead every round with my own dollars into the company and to set forth that example because I'm not selling anything that I'm, I'm not buying myself. And if you're not willing to put your money where your mouth is, there's really, you know, if, if you, if you succumb to the VCs and the private equity. which most of the founders that I know and CEOs do, then you're, you kind of become, you know, um, you're subjected to what they think your value is. And that's how in my My experience and from seeing other people, that's how you lose your companies and you lose this vision. And you know, there's going to be challenges that come across and it's always going to take you more money than what you planned. And if you have the wrong partner, in a VC or private equity and not to demonize them because I'm sure there's some private equity and VCs that listen to this show that I'm sure are great people, but I would just say you have to find those investors and people that believe in what you're doing and want to join you on the ride and understand that, hey, not everything's going to go well and things are going to take longer and to. and to ride with you. And that's how you, that's how you build companies is you have the right backers, the right people that will support you through the ups and the downs. And I mean, we, we came out with a clinical trial during COVID. And, you know, talk about hospitals getting shutting down, you got a clinical trial, how are we going to get through this? And, and we've been very fortunate to have a very strong network of investors and shareholders that believe in what we're doing. And they recognize the greater need of solving these bigger problems.

Meg Sinclair: 18:03

That's great advice for our future investors and entrepreneurs out there. Our last question is more of a fun one. We like to ask each of our guests. If we ran into Justin at a bookstore or at your local library, in what section would we find you?

Justin Zenanko: 18:19

Oh, that, that's a hard one. You know, the theology background of my Masters of Divinity, I would say, you know, the religious section, but, But the reality is, is I love technology and new things, so innovation, if there's even a section like that, but, you know, at the end of the day I love learning about new things and applying new things. And, you know, as I keep going through life, there's always new things that I learned that I never thought I would learn. And. And you never know, you might even go past the poetry section or something and something might catch your eye there too.

Meg Sinclair: 19:01

There you go. Always wandering the bookshelves, I guess. Lovely. It was lovely to meet you today, Justin, and chat with you. Where can people go to follow along about your journey and connect with you?

Justin Zenanko: 19:14

So, they can find us on www. SynerFuse. com. And there we have our, you know, our website, we have our team, we have our therapy we even have, uh, links to the news the news that made with these patients. And we're also on LinkedIn.

Meg Sinclair: 19:38

Great. Well, we'll post those in the show notes. Thanks so much for joining us today, Justin. It was great having you.

Justin Zenanko: 19:43

Yeah. Thank you. I appreciate it. And thank you very much.