Outcomes Rocket Podcast_Jason Hannon: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Saul Marquez:
Hey everybody, welcome back to the Outcomes Rocket. Saul Marquez here and I’m so excited to introduce today’s guest to you. His name is Jason Hannon. He holds the position of Chief Executive Officer and executive director at Mainstay Medical International and Chief Executive Officer, and Mr. Hannon is also on the board of Ortho Fix Medical, and in his past career, he held the position of President and Chief Operating Officer at NuVasive, and Executive Vice President of International at NuVasive, just an incredible innovator and a fantastic leader in medical device and now changing the game again in the space of pain. So, Jason, such a pleasure to have you here on the podcast today.
Jason Hannon:
Thanks Saul, great to be here, and for all the good work we’ve been doing the last, it’s taken 14 years to get to this point. Happy to share it with you.
Saul Marquez:
Ah! So excited, and so you know, before we dive into Mainstay Medical and how you guys are changing the game there, what inspires your work in healthcare? Tell us a little bit about that.
Jason Hannon:
So I came to healthcare really by happenstance. I’m, for the bizarre background to do what I do today, I’m a lawyer by training. I came into the workforce basically during the tech boom and the mid to late nineties and ended up in on the West Coast being a corporate lawyer, helping people raise venture capital and go public, and it was all healthcare clients that I worked with, and so I came to it that way. NuVasive was actually one of my very, very early clients, and quickly developed an affinity in healthcare. Just, it’s no more complicated than, you know, at the end of the day, if we do our jobs right, some poor soul is wheeled into an operating room and comes out substantially better for it, and that’s just, that’s become something that I can’t live without in terms of work, that secondary purpose. And anyway, that’s, once I got a taste of it, that’s what I wanted to be part of and ended up going straight from there into NuVasive for a very long time, and will never leave this industry as long as I still keep working.
Saul Marquez:
That’s fantastic Jason, yeah, and, and folks, I had a chance to overlap Jason during his time at NuVasive. Got to experience him as, as, as a leader and just, just incredible work and somebody that I admire tremendously. And today, the work that you’re doing, Jason, is focused still in the pain area, but I’d love for you to level set with us. Talk to us about how Mainstay Medical, you, and the team there are adding value to the healthcare ecosystem.
Jason Hannon:
So this is a different approach to helping patients with back pain. The way I think about it is, if I’m a pain physician or a spine surgeon who treats people with back pain, the majority of patients who come through my door have pain of a mechanical origin. It’s in their back. It’s not, they don’t have compressed nerves, so their pain radiates down their legs. It’s in their back, it’s what most people suffer with, the treatment options are not great. You, basically you manage their chronic pain, you manage it through drugs, you manage it through hopefully physical therapy, other interventions. Some of these patients go on to get surgery, but they’re not the ones who do well with surgery, it’s a management, chronic management process and it’s tough. And it is who fills up the clinics of these physicians. We’ve taken a different approach. We have a wonderful founder named Danny Sacks, who did the initial research trying to figure out what this group of patients who suffer from back pain have in common, and what resulted is the device we now call ReActiv8, but it’s the first therapy truly focused on cause, truly focused in trying to identify why a group of these patients suffer the way they do, and trying to actually reverse the cause. ANd it’s why we call it a restorative treatment, it’s rehabilitative in the way it functions, but the patients who respond ultimately, the way I think of it is, what’s possible with this therapy in terms of the quality of an outcome? Returning someone back to fully functional life that they haven’t experienced in sometimes decades isn’t possible with other therapies. When you’re just managing chronic pain, you’re just trying to get a patient through the day. And so the value we’re adding to the system is we have patients and not onesie, twosies. 40, 50, 60, 70% of our patients are back to the ability of 50-mile bike rides. People are running marathons, back to work full-time, who hasn’t been back to work full time in 20 years, caring for grandchildren, all the activities of daily life to a different degree. And we can get into the details of how, but that’s the value being added. It’s truly identifying the cause of why some people suffer and giving them an option to reverse it.
Saul Marquez:
That’s fantastic, Jason, and, you know, it’s no more chasing the symptoms. Get to the cause, find out exactly what’s happening. Talk to us about what makes this different and better than traditional approaches.
Jason Hannon:
So different and better, probably practical, the way to think of it. Again, if I’m the clinician and a patient comes through my door, how do I figure out if you’re a ReActiv8 candidate? We have, we’ve learned how to track the history. So you, absolute with back pain, you want patients to go through conservative treatments. If you can respond to physical therapy, please, please, please go and work hard in physical, if physical therapy hurts, please work through the pain. That’s the only way you’re going to get back to decent health on your own, and all of those things should be tried. ReActiv8 is different in that it requires participation from the patient. This isn’t, you don’t go into surgery and then pray your surgeon does a great job and come out much better for it. It requires participation from the patient, so it’s different in that patient activates this therapy twice a day, 30 minutes each time, in the morning, at night. It becomes part of their daily routine, almost like physical therapy, almost like a significant workout program. And ultimately we are, through neural stimulation, we are activating a muscle. That muscle’s sole purpose, the multipotent muscle, is to generate stability, create stability in your spine, keep the segments of your spine from being hyper-mobile because that mobility hurts. And when the patient interacts with the therapy over weeks and months, we see this stability return, and then the patients resolve from their underlying symptoms of pain. That’s, it’s fundamentally different, I will tell you, clinicians hear about this therapy, and they nod their head and they completely understand, and then they go back to practicing medicine the way they’ve practiced medicine. And it takes two, three, four, five, six interactions to really get people to see it because it is different, it is better, but it is different. And who likes change? Not that many people really like change.
Saul Marquez:
Yeah, well said. Yeah, and being able to get people to understand the value here is critical. So I’m glad we’re spending time on this, Jason. Let’s dig into outcomes and how things have gotten better. I understand there’s a three-year study now, three-year research results. Talk to us about some of the specifics that have come out of that.
Jason Hannon:
So we’ve invested an unbelievable amount of money in clinical research. That’s, the view when this business was started from the original team and the investors was if we’re going to create an entirely new class of therapy, which is what ReActiv8 is, it’s an entirely new class of therapy, it’s got to be driven by research or it will never be adopted, it’ll never be paid for. And so early feasibility study was performed in humans, then a single-arm study of 50 patients to make sure that the therapy works, that’s what ultimately got us access to the European market, that study. And then a big 200-plus patient level-one study that was done internationally, US, Australia, European sites, that was what led to FDA approval, and about seven additional clinical studies we have going on now. This will be a research-driven therapy forever in time, going forward. Best data I can share, so we’re about to have in publication the three-year results from that big study, and we take patients at baseline. So our patients were 7.3 VAS pain scores. So when you classify pain scores, that is severe pain, fully classified as severe pain, right on the border of moderate to severe disability. Younger patient population, so our average patient in these studies was 47 and 14 years of chronic pain. The natural history will tell you these patients are not going to spontaneously resolve, get better, go back to work. 40% of them were on opioids when they started the study, just about 100% had been on opioids. This is chronic long-term, non-resolving back pain. And fast forward out to three years, the average patient is about 2.3 on the pain scale, which is, anything below a 2.5, people generally call it remettre, or resolution of back pain, average patient at that point. More than 70% of the patients have either dramatically reduced or stopped taking their opioids. And we, roughly 80% of them are responders to the therapy, meaning it’s huge reduction in pain, huge improvement in disability, and interesting stat for people, we measure quality of life on the EQ-5D. So the internationally recognized health-related quality of life scoring system. The average patient in the study almost reaches the US population norm. So just the average person running around in the US, we get people back to that level. It’s pretty incredible to see and to see this out to three years. For those of us who’ve spent our careers in back pain, patients are not better at three years than they were one year in back pain treatments, but that’s what we’re seeing, it’s incredible to see.
Saul Marquez:
Wow, that’s tremendous, Jason. It’s the opposite of what you would expect and really impactful to think about the underlying things that happen too that, that, look, we’re through COVID, but the opioid epidemic hasn’t gone anywhere, and in fact, it’s worse. Mental health is worse. And you’re talking to me and you’re talking to the audience here about a therapy that makes all of that better.
Jason Hannon:
Yeah. I’ll tell you, we’ve seen what’s happened with the opioid epidemic, which, frankly, was going the other direction, I mean, going in a, trending in a more positive direction pre-COVID. COVID’s made it worse, and these patients, chronic back pain sufferers, are often the number one cause or number one reason for prescription of opioids. It’s the number two reason people go to the doctor, and it’s the number one reason people miss work. Like this is, unfortunately, when you look at these patients, you don’t see back pain, right? They’re not wearing a cast, they didn’t have a broken bone, you don’t see back, and it’s this massive drag on society, productivity, health, mental health. So I totally agree with you. And it just, if we’re able to identify a sliver of these patients and get them back to full activity, that’s a huge value to the system.
Saul Marquez:
Tremendous, tremendous. Thank you for sharing there. And so, you know, it’s been clinically focused, driven. You got the FDA approval here in the States, there’s opportunities to continue growing. But as you guys have been working on this for so long, what’s been one of the biggest setbacks and a key learning that you took out of that?
Jason Hannon:
So I would say the biggest learning, the philosophical way to say it is shifting from a research organization to a commercial organization is hard. And it, the team that’s running it and doing all this great research is viewed, views that the research is going to translate into the market and physicians are going to understand it and it doesn’t work that way. You, running a clinical study, it’s one thing to get a site to be willing to be involved in a clinical study, very interesting research, novel therapy, people want to be part of that. At the end of the day, though, we’re changing behavior. The biggest learning is, and I don’t know how to do it faster or better, but the biggest learning is there are patterns in the way back pain patients are treated when they go to the doctor, their patterns, and we have to break those patterns in order to identify the right patients. Unfortunately, in our system, if you and I, Saul, have the same back pain symptoms and we go to two different clinics for relief from our symptoms, we’re very unlikely to get the same treatment paradigm, we’re very unlikely to get sent down the same pathway, that’s just back pain, because there aren’t great solutions. We have to, we’ve educated clinicians, I think really well on the therapy, how it works, the clinical data and people are compelled by the therapy. The learning was we didn’t immediately focus on here’s the prescriptive way you integrate this therapy into your practice, here’s how you identify the patient, here’s how you send them down the right pathway. That’s what we’re doing now. We’ve had some European experience early on that helped us learn that lesson, that was Germany where we launched first. I think we’ve refined it a bit in Australia and the UK, and now we’re trying to implement all those learnings in the US, and there’s significant learnings, but it is all about a new therapy doesn’t just sort of find its home inside of a physician’s practice. You have to make it prescriptive.
Saul Marquez:
I love it. Yeah, I appreciate that. And there’s a lot of examples of this, right? I mean, that we’ve gone through in healthcare. … was one of those things, right, that we dealt with it. And so you’ve been there and done that. And so I think it’s exciting to have a leader like you that’s been there and done that to help pave the way for Mainstay here, for, as a solution for clinicians and patients in the future. What are you most excited about today?
Jason Hannon:
So the patient outcomes are the most exciting. I can’t, I get goosebumps just being able to talk about it. This is, we talked about it before. To have patients statistically better at three years than they were even at one year. We all know in back pain, when you intervene with a patient, you expect the patient to be doing pretty well at a year. Even major surgery, they’ve recovered from that in the first six months and they really start to improve. We all can’t say with confidence that we believe the patient’s going to even be as well at three years as they were at one, let alone better, and our patients are meaningfully better at three years, it speaks to the restorative nature. So the excitement is continuing to show that and continue to refine who the right patient is. We obviously have a very high response rate to the therapy, but that’s just, it’s exciting to see patients better than they were even when they remember themselves being in a good place, so that’s exciting. It’s exciting to build a therapy, it’s exciting to be able to go out and bring people in from prior lives who, you know, are great and can have a huge impact. To grow the speed, we’re going to grow, and a new therapy that has the potential we have is, we’re going to grow rapidly for many years. We’re going to be under-resourced every day. You can’t grow at one rate and resource ahead of it or you never will. Great people are the way we get there, and the commonality we have is just the passion for the clinical aspect, and bringing those people in and building this team has been awesome so far and we’re just getting started.
Saul Marquez:
I love it Jason, and so excited for what’s to come as well. Thank you. Thank you for what you are doing. Thanks for sharing the work that you and the team are working on. Before we conclude here, I’d love if you could just leave the listeners with a closing thought, and then the best place that they could learn more about ReActiv8, Mainstay, and all the great things that you guys are doing.
Jason Hannon:
So I would say closing thought is this is a, it’s an overused term, but this is a paradigm shift. It’s a paradigm shift for spine surgeons, it’s a paradigm shift for interventional pain physicians who we’re going to saying, we know we’re not asking you to manage the chronic pain of your patient. We’re asking you to identify the right one and help, hopefully, resolve it. And that paradigm shift is a huge opportunity. It’s a lot of work, it’s not easy, but the opportunity for patients is massive and we’re going to activate patients directly and let them know that there are newer options for them. And I think if people want to learn more, our website is very, very patient-focused. Come on, learn about it at a basic level. Animations, videos, I think you’ll get a good sense of it. We’ve been getting to trade shows, look up the publications. I would say in our industry, generally, research has not been uniformly invested in, probably is the nice way to say it. Don’t read the studies. There’s great clinical literature out there, and for the physicians, come learn, come genuinely learn something new that can change your practice. It can teach you to help patients who you today can’t help. And I would tell you, spine surgeons have generally tried to not have these patients come to their practice because by definition, we don’t do surgery. Our implant is not appropriate for someone who has a surgical indication. That’s who the surgeon is typically used to see. Now we can help them treat those patients. So it’s good for their practice, good for their overall approach to patient care. Come learn. The website’s a great place to get it, MainstayMedical.com, or call me. I’m happy to take your call.
Saul Marquez:
I love it, Jason, thank you. And folks, if something today resonated with you, which it better have, because there’s a lot that did, don’t just sit there and listen, take action because that’s how we make change happen. That’s how we improve outcomes. Jason, thank you so much. Really appreciate you spending time with us.
Jason Hannon:
Awesome. Saul, thanks for the interest and your time as well.
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