Unknown: 0:00

So we are really proud of our 60 days sprint peripheral nerve stimulation system. That is it's used for just 60 days, and it is then removed after those 60 days. But the data has shown that about 70% of patients will have significant relief not only during the 60 days, but for many months, two years after the 60 days. The medical ally podcast is brought to you by mentor mate, mentor made empowers healthcare clients to deliver on their mission and transform the human experience through technology. for over 20 years, clients have trusted mentor mate to guide their vision, design innovative products, and build secure solutions while understanding the specific nuances of their industry. Mentor mates global team in the US, Eastern Europe and Latin America helps clients in all sectors of healthcare transform their organizations, from Fortune 500 pharmaceutical companies and commercial payers, to hospital systems, medical device manufacturers and beyond. Learn more at mentor meet.com/healthcare.

Frank Jaskulke: 1:23

Good morning, good afternoon and good evening to everyone out there in Medical Alley. This is your host Francesco key on another episode of the Medical Alley podcast. We're continuing our semi regular series on pain and pain management, this time with Maria Bennett, who's the president CEO and founder of SPR therapeutics, a longtime medical ally member that's been working in the pain management space for a number of yours. Maria, thank you so much for being on the podcast today.

Unknown: 1:51

Well, thank you, Frank, I really appreciate you all, including us and this series on pain and just all the support from medical alleys. So thank you so much for having us participate.

Frank Jaskulke: 2:00

Indeed. And you know, I had read that you all recently received a pretty significant milestone with 20,000 patients treated. How's that feel? And how long has it taken to get to that point?

Unknown: 2:13

Yeah, it feels really amazing. So our goal here at SBR has always been a very patient centric focus and which the reason we're here is to improve the lives of pain sufferers with our sprint, peripheral nerve stimulation technology. As far as how long it's taken to get here, I started this work and the idea behind the proprietary technology back in my graduate studies at Case Western Reserve University in Cleveland, back in the late 90s. And so it's uh, you know, I've had some stops and starts along the way and worked for a couple of different organizations since that time, but picked it back up in about 2009 2010 and did some validation work in the pain space, and really saw an unmet need for a solution that was non opioid, non destructive, not implantable, that could be used early in the pain treatment continuum, to treat multiple different types of pain. So we embarked on a mission to carry this product forward all the way from benchtop. And idea in academia, to now you know, commercializing the device back in about 2016, when we got our FDA clearance, and then ultimately now treating over 20,000 patients across the US. So it's really just a wonderful feeling. And it's something that drives us here on a day to day basis. And what we all know, is a challenging industry to be in the device industry. But to achieve that milestone is very rewarding.

Frank Jaskulke: 3:46

Oh, yeah. Well, that is fantastic to hear. And kudos for the persistence to bring such an important treatment option to patients. And you mentioned challenging med tech is challenging indeed. And you're in one of the most challenging parts of it in the pain space. Maybe for our audience who isn't as familiar. Could you just talk a little bit about the the pain management space? What what exists? What's out there? And what do we know about pain? What Why is it so challenging to treat effectively?

Unknown: 4:16

Sure, I'd be happy to. So I think we know a lot and we probably don't know as much as we want to know. And so we continue to learn, as we develop new technologies and new treatments and partner with our health care professionals, those interventional pain specialists, they're out in the field, treating these patients on a daily basis, and what we know, or what we believe, as far as the science and the mechanism as to what causes pain, is that if there's an injury or if there's a disease that impacts a nerve, those are nerves that carry both pain causing fibers as well as pain relieving fibers. And so, you know, the simplest example is that you slam your thumb with a hammer and And what do you do immediately you start to rub that thumb. So you're what you're trying to do is, you know, calm down the overactivity or those pain causing fibers that's occurred because of that injury that has occurred. So what happens if we don't get ahead of that pain or try to treat that pain is it those negative signals or that pain causing signals are feeding this negative feedback to the brain. And over time, that brain feels as though our brain feels as though it's in the state of chronic pain. And so unless there's some sort of intervention or treatment, to cause down or reset that negative feedback to the brain, the pain will continue. So what our product does, and what other products do that are in the neuromodulation space, is that we target the pain relieving fibers to send positive signals now to the brain, to calm down that over activity of those negative signals, and reset it into that healthy state into a balanced state that then can be calm, you know, pain relieving for that patient. So it's, it's a complex problem. And many times, patients, when they're referred for their pain treatments, are referred initially for things such as physical therapy or exercise. But it's hard for patients to be compliant with those types of therapies because they're painful. And it's hard to, you know, do those exercises many times. So that's when interventions come into play, in which we could, you know, really try to relieve the pain for the patients, so that they can become active again, can participate in physical therapy exercises, that will ultimately help them relieve the pain long term. So we are really proud of our 60 days sprint peripheral nerve stimulation system that has been it's used for just 60 days. And it is then removed after those 60 days. But the data has shown that about 70% of patients will have significant relief, not only during the 60 days, but for many months, two years after the 60 days. So it's something that is really an option for patients that can be used again, early in the treatment continuum, prior to maybe other technologies or other procedures, that more are more invasive. So we're really, you know, we I think we've found an unmet need, and our understanding more and more the science. And I think when you ask the question about what do we know about pain? And then how do we really validate, what we're doing is working is that, you know, we have a theory around the science that I just described, hopefully that made sense. And then we marry that with the data, the clinical data that we capture, and really prove out the outcomes. And we're seeing those outcomes, not only in prospective clinical trials, but we also recently published a dataset of over 6000 patients that use the device commercially. And it mirrored what we saw in our controlled clinical trials. So that's very compelling. And, you know, but there's a lot more that we need to learn and happy to answer, you know, additional questions on that topic, as it makes sense.

Frank Jaskulke: 8:04

And I'm curious, the, you mentioned, non implantable non opioid, and that, but it also still provides durable relief, even after the treatment, or the device is removed. How are the doctors reacting to that is this trick changing their prescribing behavior or kind of their treatment pathways?

Unknown: 8:24

Yes, it has been a educational journey for us with with our health care professionals and partners, because historically neuromodulation has been in the form factor of an implantable device, and then believed to have to be on all the time to experience pain relief for those patients. What we found in the design of our technology, and then how we've been able to use it in patients, is by targeting the specific nerves that are causing the pain. So for example, take inoperable shoulder pain. We are targeting specific nerves in that shoulder with our fine wire lead, and we are then able to focus and stimulate the nerve, you know, that is causing the pain and then provide this pain relieving effect. Other implantable technologies have been more diffused because they've targeted either the spinal cord or the DRG, or something that's more centrally located versus in the periphery. So because of that focal and robust stimulation that we're delivering to that target nerve, we're able to see this changing effect as far as the long lasting effect after 60 days after the devices is removed. So there were a lot of head scratching and the beginning with our health care professionals, a lot of doubts and skepticism. But as I mentioned, as we have proved it out through our clinical trials, and through the commercial use, they now you know, really understand and have partnered very willingly, you know, with us, so to speak, as far as introducing a new technology and neural modulation Technology. Earlier in the treatment continuum, we have some great academic partners and physicians that have done these studies with us, and ensure that we're capturing the outcomes that are going to move the needle for them as far as believing in the technology, and demonstrating not only pain relief amongst their patients, but also improvement of quality of life. So there was more objective pain measures that really show okay, yes, you're telling me that your pain reduced perhaps from an eight to a four or a two a two. But now, are you sleeping better? Are you walking? Are you getting? You know? Are you more productive? Are you going back to work? So all of those things we have included as well in our studies. And we really see the commercial adoption and the demand now for the product. And using neuromodulation. And again, earlier in the treatment continuum.

Frank Jaskulke: 10:50

It sounds like a very robust post market program. Has that helped on the payer side as well? Or what? Yeah, what's been the payer reception to this technology?

Unknown: 10:59

Yeah, great question. So market access, and you know, payer coverage and payer policies. It's the biggest challenge, of course, in our industry, not unique to us. And it. Fortunately, there are many older policies that exists today that have a confusing language, so to speak, of peripheral nerve stimulation. Because up until really the kind of when we commercialized in 2016. And around that same time, a few other peripheral nerve stimulation products came onto the market. There were older policies that spoke to whether it was PNS, or Penn's technologies, field, simulation, etc. So just recently, we had a publication, the Dr. Tim deer was the lead author on that was called birds of a feather. And it delineates these different types of peripheral stimulation, so that we can be very clear to the payers, what has been studied, what has been shown to be effective. And then ultimately, you know, hopefully what can be written into future policies to be paid for. So it's been an educational process on that front as well. But to your point, that real world evidence is certainly a tool in our toolbox. So I'm in conversation with the payers, as well as we have an ongoing large prospective, double blinded, randomized control trial and low back pain, that is really a unique low back pain opportunity. It's not the same back pain market that the spinal cord stimulation devices or treating or other technologies, it's really that non surgical, Virgin back. And so it's a new market and new opportunity and its largest segment of what we're treating. And this 230 patient trial will help us to support market access as well. So we're fortunate that there's an existing code and the payment on that code continues to increase because we believe that payers are ultimately seeing the benefit of peripheral nerve stimulation in the market. And now the challenge is continuing educating the payers on those coverage policies, and what data we have to support ultimate coverage,

Frank Jaskulke: 13:02

I have to say, I really appreciate that you're taking that approach that the you're building the evidence up, you're driving the adoption, you're doing things clearly the right way. And it's something that I've been very happy to see across the pain industry, so much new evidence being generated, to really establish where there are beneficial therapies that can help a condition that has been debilitating for so many millions of people where the the options have been kind of poor, right? Like, opioids have their place, but they're generally not something a person wants to be on for an extended period of time. So I appreciate the work you're doing. Thank you. And I'd be curious. Yeah. So now your commercial, the company's growing? What about you as a leader and as the team itself, you went from, you know, starting with the idea back in grad school, developing a company growing a pre commercial company now commercial? How have you changed during this journey?

Unknown: 14:01

That's, I could unpack that in a lot of different ways, Frank, but I think that, you know, starting as a first employee and the organization with an idea to really impact patients lives. And then now to see where we are in an organization of over 250 people across you know, we're headquartered here in Cleveland, but we do have our offices in Minneapolis, which with predominantly our marketing team, our professional education team and our market access and patient access teams. And then we also have an office in Chapel Hill, which really houses our research and development resources coming out of the Research Triangle, of course, and a lot of our scientist and product development and clinical study, work out of there. So to see that growth, and not only the company size, but what has truly been, I believe the secret of our success to navigating this challenging industry and this growth Experience is our culture. And a lot of companies, I think, and leaders will speak to culture. But we have been really rooted in a company credo that our VP of regulatory and quality came to me about during COVID, actually about 2020 2021. And said, I think we could really benefit from a company credo. And I said, Okay, well, let's take a look and see what that would speak to. And first and foremost, it's about, you know, putting patients first and where whatever the role is within the organization, we ultimately are impacting a patient's life and their family's lives in their friends lives. And so thinking and grounding ourselves in that core aspect of our credo is paramount, and then also our partnership with our health care professionals. And then, ultimately, our team and our values amongst the team and empowering communication and transparent communication, so that we can navigate all the twists and turns that this industry may bring our way, and try to be ahead of those twists and turns is so it's something that, you know, I think, as a leader, I am very proud that our culture has been able to be maintained through our explosive growth. We've doubled in size in just the last 12 months. And so that period of growth brings, of course, its challenges. But it also brings opportunity of bringing on resources that, as our chairman taught me, that are always better than us. And so with new ideas and new experiences, that can make us more efficient at what we're doing as an organization. So getting really proud of what we've built and proud of how we really do, you know, resonate with our credo. So much that we recently had an all company meeting in which we had both physicians, partners and customers come as well as patients come and tell their patients story. And, you know, I get chills, even just, you know, thinking about these patients stories, and you know, then all of our employees being able to hear those stories and the impact that their day to day work, their hard work has had in those patients lives, to the point that one of the patients that participated in the panel, had excruciating knee pain for just several several years and was impacting his ability to work. He was taking opioids he was trying all different types of therapies, ultimately got sprint ultimately had significant pain relief. And that evening, when we brought the company together for dinner, and you know, celebration, he was on the dance floor with us. So that was I love to dance. And so that was really special to me, too. And, you know, that picture of him on the dance floor with us and our employees. And it was just just, you know, that one of those Wow, moments of like, okay, this is really why we're all here.

Frank Jaskulke: 17:45

But yeah, that is everything right there. And it is so well said, and I'm so glad that you're reinforcing that from the top where you think everyone in the industry, we did it like that is why we're here. But it's still so important to refresh and remind ourselves of it. Because we get caught up in the day to day work. We get buried in things and making sure we stay connected to the fundamental idea of this is about helping people live better lives is so important. Yes, absolutely. You mentioned being based in Cleveland. And I think a number of our listeners may not be familiar that the Ohio commute, Ohio is a state but Cleveland in particular has had quite a med tech industry develop over the last I'd say about 20 years at least that I've been around it. Could you tell our listeners a bit about the Cleveland area med tech community and what's been going on? Yeah, sure,

Unknown: 18:39

I'd be happy to so yeah, so I came to Cleveland for graduate work at Case Western, as I mentioned, and focused on biomedical engineering. And what attracted me to the area was the program that case had in Biomedical Engineering, because they were developing all different types of technologies and medical devices that would advance this, you know, to hopefully the standard of care, and ultimately treating really unmet needs. So one group in particular, was focused that I was a part of, and was focused on restoring function in patients that had lost motor function either due to spinal cord injury or to stroke. And so we were, you know, using neural stimulation to restore that function. And ultimately, that's where spread was born, in which we were using it to treat patients that had as a stroke and treat their shoulder dysfunction. But the most compelling result that we found out of the research was the impact that we were having on the pain. So it kind of was born out of that area. But beyond that group, which was that case, there are multiple other groups within case as well as across Cleveland that have spun out new ideas partnering with the Cleveland Clinic partnering with university hospitals that have just advanced biomedical research and advance the science to a point that has carried forward In some really strong scientific clinical data, to support new technologies, so So really, it is a hub here, and it's nice and fully, you know, kind of located and easy to get to Minneapolis easy to get to these coasts and, and were able to, you know, attract quite a bit of talent to, you know, Cleveland. However, as I mentioned, you know, having our satellite offices in Minneapolis in North Carolina, allows us to attract, you know, talent from those areas, as well, as in those disciplines.

Frank Jaskulke: 20:27

We love seeing that the, it seems more and more the trend of, you know, even startup companies having a presence in multiple hubs, you've drawn a bigger pool of talent, you have other markets, you can access. It's been fantastic to see the growth here, but also to see the growth in North Carolina in Ohio that ultimately is good for the patient, which is why we're all here. Yeah, exactly. Last thing I'll ask you, because I think a lot of our listeners will want to be able to find out more if, if our listeners do want to learn more about what the company is up to where can I direct them?

Unknown: 21:00

Yeah, so our website has a wealth of information for both physicians and patients. It has a list of all our different publications, we have over 40 peer reviewed publications that speak to our data, we have different instruments different so to speak of the educational material for patients, as well as the Patient Testimonial stories. So if somebody is suffering from shoulder pain, they can go and hear somebody that has a used sprint, and been able to, you know, experience pain relief from using sprint that had shoulder pain, if they have low back pain, and there's you know, low back pain stories, if they have knee pain, there's knee pain stories, a new area that we have been exploring is head and neck pain. And that's something that we expanded our labeling our FDA clearance back in the end of 2021, excuse me, and we were able to now treat head and neck pain, which is headache, and you know, all that big, you know, bucket of different types of pain that patients experience throughout their head and neck. So there's, you know, stories around that and information around that for patients, as well as just you know, pictures of the technology, how it's used procedural videos, so that they can get comfortable and talk to their family, and talk to their physicians about whether this could be an option for them. So that website can either use our company name SPR therapeutics, or also the product name, sprint pns.com. And they can find out more information by going there.

Frank Jaskulke: 22:26

Wonderful. And folks, we'll make sure we'll have that in the show notes. So that if you want to learn more about it, you can easily track them down. And Maria, thank you so much for spending some time in the medical ally podcast today.

Unknown: 22:37

Well, thank you so much, Frank, I really appreciate your questions and allowing us to share our story and our journey with you and look forward to you know, keeping in touch with all of the great things that Medical Alley is doing,

Frank Jaskulke: 22:48

right, really appreciate it. And, folks, that's been another episode of the Medical Alley podcast. If you're not already a subscriber, make sure you head over to Medical Alley podcast.org where you can find this on Apple Spotify are now on our YouTube channel, just search for Medical Alley. And hey, do me a favor. Would you share this episode with at least one other person? It would help spread this story in so many other great stories about the technologies coming out of the Medical Alley community further. I'd really appreciate it. Until next time, have a great day.