Spinal Fusion and Pain Management

[Upbeat Guitar Music]

Mike: Welcome everybody. This is Avoiding the Addiction Affliction, brought to you by Westwords Consulting, the Kenosha County Substance Use Disorder Coalition, and by a grant by the state of Wisconsin's Dose of Reality Real Talks reminding you that opioids are powerful drugs and that one pill can kill.

Mike: I'm Mike McGowan.

Mike: Anyone who has experienced chronic lower back pain knows that relief is sometimes difficult to find. Our conversation today is about a groundbreaking new procedure being developed to help those with chronic lower back pain. Dr. Rohan Lall is a neurosurgeon specializing in robotic and minimally invasive spine surgery, complex spinal surgery for the brain and spinal tumors.

Mike: He's been a leader in robotic spinal surgery and is actively involved in the development of a new technique, new technologies in spine surgery. He's the chief medical officer of SynerFuse, a Minnesota based medical device company innovating the spine industry with its integrative approach to spinal fusion and chronic pain.

Mike: Welcome Dr. Lall.

Rohan: Thanks, Mike. Appreciate you having me.

Mike: Well, and forgive me ahead of time for being a lay person. All right.

Rohan: No, all good.

Mike: So let's start with the problem first. 'Cause everybody says, oh, my back hurts. But can you define chronic lower back pain for us?

Rohan: Yeah, absolutely. When we think about back pain, we really divide it into pain in the low back itself, and then nerve pain which travels into the legs.

Rohan: And so people who have spinal issues would potentially have that pain either in the low back or pain traveling, nerve pain traveling into the legs. When we think about how common this is out there. Approximately 50% of US adults will actually need to take time off of work in any given year due to an issue in their back or neck.

Rohan: So it's a major issue out there. And a substantial percentage of the US population is regularly seeking treatment for back pain and feeling hindered in terms of their daily activities by it.

Mike: And I'm sure we have the old, rest, see what happens, PT sort of thing. But spinal fusion works, but that sometimes comes with neuropathic pain, right?

Rohan: Yeah, absolutely. So most patients, a majority of patients, a significant majority of patients if we think about. Several million, let's call it, 10 to 20 million a year are having significant back pain to where it's limiting their life. And then a two to 4 million of those patients are having, frankly, disabling levels of pain, where it's now reached a point where they're having difficulty collecting groceries or going to work or doing normal activities in their life.

Rohan: Out of that subset of people. Again, a majority may be able to get better with injections physical therapy, chiropractors, acupuncture, yoga, weight loss. But a significant percentage, potentially about a million people per year will essentially fail all conservative management where they have completely disabling levels of back issues and they have attempted all the nonsurgical management and they can't find a way out. And so ultimately that's a huge percentage of people. For those people, we tend to look at the imaging and we try to identify the problem is the main problem. Instability or degeneration of the spine where the discs have worn out, you're bone on bone.

Rohan: The vertebra are slipping and are moving in subluxing in an unstable way. Versus...

Mike: (points at himself)

Rohan: Yeah, exactly. Unfortunately, too common out there.

Mike: Yeah.

Rohan: And what percentage of patients are just having a buildup of stenosis, of arthritic changes that are compressing the nerves, and then the majority of patients who really have some degree of both instability and pressure on the nerves.

Mike: I know several people who have had implanted neurostimulators in their back.

Rohan: Yeah.

Mike: So how is your new technique different, and can you describe the procedure?

Rohan: Absolutely. So conventional spine surgery is either putting in screws and rods to fixate the spine and realign the spine to take care of that mechanical instability.

Rohan: Or else a lot of times patients are having insertion of spinal cord or direct nerve root stimulators where they are having electrical impulses along the neurological elements to try to modulate the way that the pain signals come through. One of the challenges with the fusion or the conventional spine surgery is that although we take pressure off of the nerves, a lot of times those nerves will continue to send aberrant pain signals, and so people, their nerves may be free, but they're still in pain because the nerve has scar tissue and chronic injury within it.

Rohan: What is novel about our procedure, our surgery, is that we are the first company ever to combine those two types of surgery together, where we are putting in the screws and the rods and realigning and fixing the spine, but we're directly implanting neurological leads that sit on top of the nerves.

Rohan: And what I've found with that is, is that a lot of times if patients continue to have some degree of chronic nerve pain, even once the nerve is surgically decompressed, what we can do is we can use the settings on their phone and change the stimulator settings around to allow them to basically be able to modulate with a remote control how the pain is feeling.

Mike: So it's it they end up controlling it on an app on their phone.

Rohan: Yeah, it's amazing.

Mike: Amazing.

Rohan: Pertinent to this conversation, Mike, unfortunately, as someone who does a lot of conventional spine surgery like any other spine surgeon, what is not uncommon is that after surgery, the recovery is a rollercoaster.

Rohan: So people will have very good days and they'll have very bad days. And early on, any patient just due to the cut and the trauma and the drilling and whatnot, is gonna have significant post-surgical pain. And so the pain medications that we have today tend to be opioids, but the goal of surgery is to get patients off of opioids, typically as quickly as possible.

Rohan: And certainly spine surgeons in general are trying to get their patients off of opioids fairly quickly. The challenge becomes that, let's say that I do a successful surgery on you. Everything looks good in about four to six weeks. I'm able to get you off of Oxycontin or Norco or Vicodin or whatever, and we're improving.

Rohan: What happens now when two months, three months after surgery, the patient has a flare of pain. As the nerve is reinnervating and coming back online, patients are having increasing nerve pain for a while, increasing flare of back pain as the fusion mass is growing. All these changes in the body are painful after surgery and right now, unfortunately, for a spine surgeon, our only real way to manage when these patients have these flares of pain is opioids. And so what happens is someone was on opioids for six weeks after surgery, then they get another dose at two months, another dose at three months, and that's what starts this addiction cycle.

Mike: And like you said, the tolerance builds up.

Mike: It's not nearly as effective. Doctors are much more reticent to give prescriptions for opioids nowadays. Did I read in your literature on your new procedure that you've seen a dramatic decrease in the need for opioids with your new procedure?

Rohan: Off the charts. Yeah. By basically, 80, 90% of our patients are off of opioids just within a few weeks and even out to a year.

Rohan: So it's been really dramatic that way.

Mike: That's just incredible. I saw a statistic that failed back surgery and continuing pain costs our healthcare system around $20 billion every year.

Rohan: It's, yeah, it's terrible. And unfortunately, it's one of the greatest sources of opioid addiction out there . Is actually back surgery. And there are absolute horror stories of, really just tragic things that you see really that are part of the addiction struggle. Certainly, I know I'm, as you tell stories about this all the time, a lot of times addiction can lead to suicide, can lead to violent acts, can lead to people basically, losing their jobs, ultimately losing their families.

Rohan: All these downstream effects, I've seen, unfortunately I've had friends and colleagues who've described incidents where patients come into the, or the clinic, ultimately, unfortunately in the cycle of addiction, not really themselves, not right and in their fight to try to get medications, can be violent in the clinic.

Rohan: There have been incidents with guns. I know of unfortunately two incidents where people were killed, it's really awful.

Mike: How long does your procedure take and how long is the recovery?

Rohan: The surgery is about three hours. And the worst of the recovery is the first week after the surgery. Typically it can be very sore in the back for about a month by the four to six week mark. We tend to find that patients are improving quite a bit and starting to regain activities. And at the three month mark is when we like to basically see things take off and we remove the restrictions and we want to try to really get back to normal.

Mike: Everybody you talk to has back pain. The remedies are not always successful. The back seems to be a one of those things, unlike a knee replacement, which I've had, right?

Rohan: Yeah, absolutely.

Mike: The back is sometimes traditional surgery just doesn't work.

Rohan: You nailed it, Mike. Unfortunately, overall what we see is that the outcomes for spine surgery at large are substantially worse than the outcomes for other orthopedic surgeries, such as hip surgery or knee surgery.

Rohan: And part of the real reason for that is the element of the nerves. When you do a knee replacement, it's just bones and ligaments, and those are much more predictable in how they react to surgery. And at the end of the day, with the spine, there's two real problems. When you think about the knee there's really three bones or four bones that insert there.

Rohan: And it's one fixed. You have a left knee and you have a right knee. You've just got one of those. So in the spine there's two issues. One would be that you've got five lumbar vertebra and sacral vertebra and thoracic vertebra. And so when we're doing a surgery, a lot of times we're just picking one or two disc spaces, or two or three vertebra to focus on, what about the arthritis and the other vertebrae?

Rohan: So we're not addressing those surgically. And we're surgically altering part of the spine, but the normal spine has to live next to the area that we've now surgically altered. And that isn't the, sort of God-given version of the spine. That's one challenge. The other challenge is the presence of the nerves there.

Rohan: The nerves are there. They have been chronically injured by the arthritic tissues that have been compressing them, and then they're also surgically altered. So when we do a surgery, we go in, we remove tissues, we expose these nerves, and then ultimately those nerves over time are gonna be covered in coated in scar tissue.

Mike: Okay. I was explaining to those of you listening to Dr. Lall before we started this, that coincidentally yesterday I had an MRI on my spine and they found two whatever you Spondylothesis or whatever.

Rohan: Yes. Spondylothesis. Okay.

Mike: Okay. Pushing in.

Rohan: Yeah.

Mike: And so I've had neuropathy. Do the nerves ever regenerate themselves so that you can eventually feel or is the destruction permanent once it happens?

Rohan: It depends on how long the nerves have been compressed and how long they've been sending the pain signals. That is one of the dilemmas that we frequently see in spine surgery in general, is we don't want to be too aggressive and operate on everyone right away because many people are in pain and some people will get better with time.

Rohan: Having said that, the counter argument to that is when you leave a nerve compressed and sending pain signals for too long. All that time that the nerve is pinched and angry, it's getting injured, and then once the nerve has been injured and develops scar tissue and microscopic changes within the nerve, sometimes even once the nerve is freed surgically, it doesn't totally return to normal.

Rohan: That's really the source of a lot of this neuropathic pain. If someone has a technically successful surgery where the nerves are freed and the nerve is now has enough space and room, we see it really go both ways. Certainly nerves are capable of healing but it's not a sure thing.

Rohan: And a lot of times, what we find after surgery is, about 50% of patients will get everything back and they'll be really perfect and really normal on the other side. About 40% of patients will be better but not perfect where they have some improvement and maybe it's 50, 60% better than it was, but they have quite a bit of lingering symptoms and about 10% of patients may continue to have significant symptoms.

Rohan: So when you compare that again to orthopedic surgeries, it's really not quite the same level.

Mike: How will you measure pain relief?

Rohan: There's multiple different ways to do it. One would certainly be opioid usage. Another would be general pain scores. So just a one to 10 score and describe your pain and what's the severity and, oh, it used to be eight out of 10, now it's three out of 10.

Rohan: There are other activity scores that are more, objective if you think about it. Where they look at your daily activities or different activities and how far could you walk? What would limit you? Would you, you know, if you made it a mile, what kind of pain would you be in if you made it three miles, four miles?

Rohan: And that is where a lot of times what we will see with patients, after even a really successful back surgery is someone who before surgery could. Was really struggling to make it to the mailbox and back after surgery. Maybe they're saying, now I can walk a mile or two, but they can't walk five miles.

Rohan: That sort of thing. And, but then we see many people who are really back to normal. And although we always struggle in a smaller trial, like the first clinical trial we perform for the SynerFuse procedure. We don't want to extrapolate over much. I will tell you that anecdotally, some of the patient stories we were hearing were off the charts.

Rohan: We had patients who were calling us at six weeks after surgery and saying, doc, I'm having some pain today. And we're saying why is that what happened? And the patient is saying I redid my entire bathroom and now my back hurts.

Mike: (Laughs)

Rohan: Wow! You redid your bathroom at six weeks after surgery. I don't know that we cleared you to do that, but, so it's really special that we're even having people trying to take those kinds of things on.

Mike: Where are you all at with the approval of this?

Rohan: So we are currently in the FDA regulation process. So we have done our first quality and safety trial where we implanted 15 patients with the surgery and we're able to track them out to a year and look at how they did.

Rohan: And the data for that is submitted to the FDA and things are trending in a great direction there. The next step will be a national trial where we actually enlist 20 hospitals around the country to perform a couple hundred of these surgeries. And that's where we will be able to scale the effect.

Rohan: And after that trial, we have our final FDA approval.

Mike: I just have to ask you your opinion on this and do anything you want with it. Several, most people I know, doctor, have had to jump through numerous insurance hoops to get procedures okayed, right?

Rohan: Yeah, sure.

Mike: Sometimes they have to go and sometimes they denied.

Mike: They go from physical therapy to radio frequency ablation, maybe even the neurotransmitter hoops. What is the process to eventually get insurance to cover this, and will you still have to jump through all of those hoops?

Rohan: Very much Mike. Unfortunately it's one of our real challenges in medicine today, is we and at the company level, we think about that all the time.

Rohan: That if we are adding something to the procedure where there's a new technology, there's additional implants being placed, certainly there's gonna be some degree of expense associated with that. And you'd like to think, and we would like to think that if we can just prove that it works quite a bit better, then that should be enough.

Rohan: But unfortunately in modern medicine it really doesn't work that way. So a lot of the steps that our company is taking is in addition to trying to prove the efficacy and how well it works in the data. We also need to prove actually that indirectly, by working so much better, it decreases disability, decreases return to the hospital, improves outcomes and actually ends up saving the healthcare system money and over the one to two year range.

Rohan: Just because people are doing so much better. And we're actually, we have a model for how we're gonna prove that, or we're confident in that. But that's our burden to do. And really in many ways the FDA wants to see that, but in more so it's the insurance companies who will demand that in order to be able to cover this type of procedure.

Mike: Or not cover it.

Rohan: Exactly. There have been a lot of promising spine companies out there that had interesting technologies, but ultimately just couldn't achieve insurance coverage. And so that is an important part of our journey too.

Mike: Yeah. How long before you see this widely available then? What are your, as you guys talk, what is your timeline?

Rohan: Yeah. Our hope is certainly to be commercial in the next couple years, two, three years.

Mike: Wow.

Rohan: That'll be the goal. Yeah.

Mike: So if people are interested in it, doctor, what do they do besides looking at the links that I'm gonna put at the end of the podcast?

Rohan: Yeah, certainly. Our hope here is fairly soon to get the next round of the clinical trial going.

Rohan: And once that is live, that's when we will be enrolling patients from around the country to meet doctors who are performing this surgery and to be evaluated and to figure out if it makes sense for them. And so certainly, we would will happily be able to provide some insight to patients about which doctors might be close to them and doing it.

Rohan: And in the meantime, certainly our company SynerFuse is continuing to put out educational information, content like these videos that are telling people who are interested about the story of where we have going on. And so a lot of that would be on our socials, our LinkedIn, our website, those kinds of formats.

Rohan: It's definitely out there.

Mike: As you go to the next phase and look for other folks across... What are the criteria you're looking for? Who are the candidates for the surgery?

Rohan: Predominantly, I think that it'll be best for most patients to go in and have a clinical consultation with one of the surgeons who performs the surgery because there are numerous in inclusion, exclusion criteria that those surgeons will be able to look at and figure out does this fit or does this not fit?

Rohan: But predominantly it would be patients who are having really disabling levels of both back pain and nerve pain in the legs where they have MRI findings that are compatible with a one to two level fusion surgery. And those are really the sweet spot where we think that with implanting the stimulator, in addition to surgically fixating and decompressing the spine, that's where we believe that we're seeing the best outcomes.

Mike: And just a couple more quick ones.

Rohan: Oh, absolutely. Yeah.

Mike: The stimulator will stay right? And I know how these work, right? Its battery you have to recharge, I would think.

Rohan: Absolutely. So our battery is really excitingly tiny. It's a fraction of the size of any of the current stimulator batteries.

Rohan: And that we are very excited about that battery. And I think once people see it, it'll be amazing. And that actually allows us to place the battery slightly closer to the skin than a lot of the current stimulator batteries. And it'll be smaller so most patients won't be able to feel it quite as much.

Rohan: The leads sit in permanently. And so they are fixated to the rods in a way, and they can be removed if needed. But ultimately the plan is for the leads to be potentially lifelong and we are excited about some possibilities for how the leads could even help with preventing against some future spine related symptoms.

Rohan: Because what we're finding in our research is that the nerves talk to each other to some extent, and so electrically stimulating the L4 nerve, you may get a little crosstalk into the L3 and the L5 nerves as well. And so if someone was to have some arthritis at the level above or level below, it's possible this might even help as a long term protection to some extent.

Rohan: But to answer your question, we expected that the battery would last approximately five to 10 years similar to a lot of the current spinal cord stimulator technology. What we did find was because in the surgery we're directly visualizing the nerve and we're removing the ligament that's sitting on top of the nerve. We are then placing the lead much closer to the nerve than it's ever been placed.

Rohan: And so we are actually stimulating at much, much lower impulses than even we anticipated in our original modeling. And back of the napkin math would be that for some of the patients who've had this implanted, when we did the math and looked at this is how much input they're having and this is how long the battery lasts, we're like, wow, this might last like a hundred years or something like that.

Rohan: I think that it will actually last a very long time.

Mike: Different people must have different tolerances. I was doing a talk for veterans a couple of months ago and talking to a gentleman who had a neurostimulator. He said he had he only liked it if he turned it up so high that his toes tingled.

Mike: And I couldn't, I could not fathom that level of stimulation, but I guess everybody is different, right.

Rohan: That's a lot of electricity! (laughs).

Mike: That would seem like it, right?

Rohan: Yeah. But it's very nice for patients. We found a lot that patients really like having the agency to be able to control it themselves, and I think that is exciting for people.

Mike: I hope you're successful 'cause it would be a great substitute for the opiates right now. And we're still dealing with an opiate crisis, so anything we can do would be great.

Rohan: Absolutely. And in many ways, you look at the medical boards, the medical community, their answer to the opioid crisis has been to just stop prescribing opioids,

Mike: Yeah.

Rohan: Y ou could argue that's better than the alternative in some ways, but it doesn't really fix the underlying problem, which is that people are in pain.

Rohan: What about that? Okay, someone's in pain. You don't want to give them Oxycontin. I can have sympathy to that idea but what are we gonna do for people?

Rohan: And that's really where this company is trying to change something.

Mike: Thanks not only for your work, but thanks you so much for taking time and explaining this to us today, and really appreciate it and contact you down the road and see where you're at with it.

Rohan: We would love that.

Rohan: No, thanks for having me on and yeah. Appreciate this. This was a really nice conversation.

Mike: Yeah. For those of you listening, there are links to SynerFuse attached to the podcast.

Mike: For those of you listening and watching, we hope you find health wellness wherever you are. As always, thanks for listening. Be safe and take care.