Jeff Cambra, SpinaFX - Intravertebral Injection Using Oxygen and Ozone Gas | LSI USA '24

Jeff Cambra  0:00  
Hi. I'm Jeff    Cambra, I'm the CEO for spine effects. Happy to be here again at LSI. Second presentation. One of the things that I think we value most in the medical device industry is patient outcomes. And before I get started, I want to share a patient's story about about a patient outcome.

Ryan B.  0:27  
Before trio ejection, I was in pain day to day that I would have told most people four to five, but I had normalized it to the point of I want to say had a couple of injections, I was feeling that I was probably more likely to eight or nine, and I push through for so long. So when those injections were off, and I went into taking on trio injection, and having that procedure done, I was hesitant, but I was hopeful. And they put a nerve block in to reduce some of the pain that had come back at the same time. And as that wore off, I had some pain come back. And then the result was the pain went away again about a week later after the pain returned. And then I was in for some follow up diagnostics at about week six and a half. Where it showed in an MRI that the herniation had completely retracted back to the point where if someone had been looking at that imaging, they wouldn't have suspected I'd ever had a herniation in the first place. Which in turn, having no pressure left back on my spine had relieved that pain out of my leg and my lower back. And I was probably about 90 to 80 to 90% pain reduction from that cause.

Jeff Cambra  2:02  
So Ryan is just one patient that suffers from back pain. So if you think about all the patients in the US alone, about 40 million patients suffer from a herniated disc. And really our focus with spine effects is addressing container NHS, that is our focus. Obviously back pain, you see it in the news, it's the number one disability of in the US alone, versus cardiovascular and diabetes. In fact, it's $100 billion annual cost to the health care system. So it's a it's a significant unmet need. If you look at the publication in the Lancet, that just was just published last May of 2023, you can see that the increase in back pain, it's not going away, it's not going away, it continues to be a challenge. In fact, almost a 40% increase from now until 2050. For for global opportunity, the the overview of the company who we are what we do, and really where we want to go spine effects as a medical treatment solutions company. And we're focused on minimally invasive image guided procedures. That means anything that's done under fluoroscopy under X ray, that is our focus and how we're getting there is we're focused on a patent technology that we have IP called tree ejection as the product. And we're focused on our clinical data that's just published to help eliminate back pain and, and leg pain associated with containing herniated disc. Our goal is to be the global standard in regards to treatment in the therapeutic gap. And what that therapeutic gap means is that patients today when they get diagnosed with back pain, they go in, they see a primary care physician, or they may get referred for a conservative care, that would be anti inflammatories, it could be antidepressants, it could be any types of medications, and or they get physical therapy, it physical therapy doesn't work. The next logical step is injection therapy. And injection therapy really focuses on pain and pain. It's focused on the pain management, and really eliminating the inflammation that's caused with the nerve. Our focus is to fill that therapeutic gap because if patients don't respond to those treatments, the next logical step in the treatment paradigm is getting surgery getting a micro diskectomy or diskectomy for that contained herniated disc. And our goal for trio ejection is to focus on filling that therapeutic gap and offering another product in the care continuum. And so we've talked with a lot of spine surgeons, a lot of neurosurgeons in this space, and they're very excited about this opportunity as there's nothing really else in the marketplace today to help these patients and it's a huge unmet need. So I'll share a little bit about how the technology works.

Video Playing  4:45  
Tree objection is a sterile metered oxygen and ozone injection that shrinks contained herniated lumbar discs to relieve pain. The trio ejection system consists of a computer controlled console for oxygen delivery and precise spectroscopic measurement, and an ozone generating syringe inside a sterility case. Following standard conscious sedation, prepare the patient for trio ejection. Under image guidance, introduce a standard spinal needle into the center of the contained herniated disk. Once the syringe cartridge is charged with oxygen and ozone, close the stopcock and detach the cartridge from the console oxygen supply. Remove the cartridge from the drawer. Then remove the sterile syringe from the cartridge and close the second stopcock. Attach the syringe to the needle and open the stopcock. Inject most of the ozone oxygen gas into the disk slowly. Slowly withdrawal the needle tip injecting remaining gas as you go until it is just outside the desk annulus. An optional nerve block may then be performed for immediate pain relief and the needle removed. The ozone will take effect over the next days and weeks providing long term pain relief after the nerve block wears off. Over time be injected ozone reduces the disc herniation that was causing compression of the nerve. The procedure is quick and recovery is almost immediate contact spine effects for more information.

Jeff Cambra  6:30  
So you saw the mechanism of action we're actually doing something mechanically to the disk instead of just treating the symptoms of the pain. This is done with a 20 to 22 gauge spinal needle. It's done if a physician knows how to do a disco gram without contrast. There's notes surgical technique that we're teaching here. And it's done in an outpatient clinic. This procedure takes about seven minutes to do it takes longer for to prep the patient to get the patient ready for the for the procedure. It's all done. As I mentioned under under image guided under fluoroscopy. Minimally invasive and conscious sedation, there's no general anesthesia for the patient, the patient waits about 3045 minutes after the procedure goes home the same day. So there's no hospital stay required. If you look at the way this works the before and after the ozone oxygen about 2.2 point 4% of the oxygen ozone breaks down the gags proteins within the disk and shrinks the disk about 8% Removing that impingement from the nerve. As you saw in the video, we have a console. And we also have a disposable syringe it's a one time use our indication as it is today we're it's a single use L one through L five lumbar. What's neat about our technology and innovative is it sterile, it's repeatable, and it's precise. So you get the same dosing of the oxygen ozone every time that it's used. We have over 35 patents, exclusive rights in multiple countries. And that's our focus now is we're looking to commercialize. We have a very strong patent portfolio and our syringe device, our system and our method for delivering oxygen ozone. And of course, when you think about patient outcomes, you think of patient data, clinical evidence is very, very important. And so we published a paper in the spine journal in January of 2022. We one abstract to the year in at SAR in in June of 2022. And really what this what the study shows is that 71% of patients that were involved in the study versus microscopic mi noninferior study 71% of those patients avoided surgery after two years, shorter procedure, shorter stay, lower costs and a higher percentage of patients that are eligible for the procedure, because it's moving more up the continuum of care. These are some pretty impressive images in regards to the post operative changes within the disc, we have a six month follow up here and a 24 month follow up the before and after. What's key about this technology is it not only reduces the herniation, it also does not violate height restoration within the disc or preservation, which means it's not going to cause or expedite the degeneration process of the disc. Of course, when you look at the economic incentive for the technology, you want to focus on the stakeholder benefits. And we've looked at this extensively across the patient, the physician, the facility and the payer. And obviously the goal is to reduce patients that are taking opioids, long term Pain Physicians, this can be done ozone day you can do multiple injections in one day versus a surgical procedure that takes multiple hours to do. And then obviously the facility and the payer there's an economic incentive there as well. Our goal is to really focus on our customer segmentation in regards to interventional pain. You'll see in the trends that there's a lot more technologies in the interventional spine interventional pain business. So we know the lion's share of our business is going to be interventional pain, which means pain specialists and interventional radiologist so that's our focus too. To date, obviously, we're not going to ignore the spine surgeons and neurosurgeons we're going to build advocacy with them to drive the referral process. across that segmentation, where we sit today in regards to our roadmap for commercialization, we're looking to secure our last tranche of the 8 million of the 16 million in our series B, we're looking to close that shortly. And that's why we're obviously here is to look for the $8 million to to close that round. We are doing cases right now in Canada, we are a Canadian based company. So we are doing procedures under special access to date, we've done over 30 cases. And our clinical outcome data is actually better than what we've seen in the data we did in Europe for the publication, this fine journal, we did do our see MDR submission just this last December. So we hope to be in Europe market early next year. That's the plan, we did get signals from our notified body that our submission looks great. We're waiting for the audit process. And then obviously, the $8 million is going to help carry us to get to the commercialization we know we have some work to do with the FDA. Our plan as we're working with with them is to do a PMA with a with a 510 device, we know it's going to be a six month trial with about a six month follow up. And obviously we're going to carry on another six months for market access because reimbursement for this is going to be very, very important. We have a very experienced executive team. myself I've been in the space for over a decade I was with Medtronic I ran the interventional pain business, the kyphoplasty and osteo cool business. And before that did m&a access assess this technology back in the day when I was at Medtronic and always thought highly of the technology. We also have a very extensive executive team in regards to years tenure with the business over 20 years average for each of the executive team members. And then we're building the best of the best medical advisors in regards to our our interventional radiologists are our pain specialists. And also we'll be bringing on some spine and neurosurgeons as well. So really trying to build some advocacy with some Kol to build this up and to get some feedback on how we move this forward. So in conclusion, you know, our investment highlights big global opportunity for us. Obviously, we have a proven and effective technology. We're ready to commercialize. We have product available adoption incentives. I talked about the incentives and the stakeholder benefits. We have validated revenue models across the board globally on how this will work from a razor razor blade model and how we'll sell this strong patient patent dominance and then obviously, expertise as it relates to academic scientific and operational expertise. So appreciate your time. If you have any questions whatsoever, please feel free to reach out. I will be here until Friday morning. Thank you