Video Transcription
Jeff Cambra 00:02
Jeff, first of all, I'm Jeff Cambra. I'm the CEO for SpinaFX. We are working on an innovative, disruptive technology for contained herniated discs. And you see that in a moment, we're addressing a significant unmet need. If you think about what's happening in the marketplace today in regards to pain specialists, the shift from spine surgery to more pain management. We're filling a therapeutic gap, a need within the marketplace. We're addressing a significant unmet need in regards to contained herniation. It's the number one disability, higher than cardiovascular, higher than diabetes in the marketplace today, and it's a huge, huge burden to the healthcare system—about $100 billion in the US expense for this disease state. If you see, by 2050, there's a significant increase in regards to patients that will experience some type of back pain, and again, you know, it's not going away. There are a lot of new, innovative treatments in the marketplace today that are early on, or they're working on getting commercial, but not a lot of things when it comes to a contained herniated disc. So that's what makes us truly disruptive and innovative in the marketplace. So what we do, we're a minimally invasive image-guided company. We focus on procedures that are done through fluoroscopy, so through X-ray. That's our focus. You'll see here in a moment when you move up the continuum of care. You want to eliminate the incision size when you're doing any type of back surgery. And so this is an injection-based therapy. It uses a 20 to 22 gauge needle that goes directly into the disc for an interventional procedure. What we do is we're leveraging our clinical data that was published in June of 2022 in the Spine Journal. That's really what put us on the map. We won Abstract of the Year at SIR, and where we're going is we want to change the standard of care for back pain treatment, moving up the continuum of care. So this is really our story. When you think about moving up the continuum of care and thinking about the therapeutic gap, this is where we fit in, in regards to the diagnosis paradigm. Think about patients that have back pain. They get diagnosed, they get prescribed physical therapy, conservative care, anti-inflammatories, opioids. If those things don't work, they go to an epidural injection. They go to an RFA (radiofrequency ablation) or a nerve block. If those things don't work, the traditional flow within back pain treatment right now is a discectomy, or a microdiscectomy, where it's removing pieces of the disc, which expedites the fusion process quickly with patients, especially with younger patients as well. So we're filling the gap here in regards to an unmet need, a therapeutic gap, so patients that are not at this point in stage, maybe not a candidate for surgery. They can get this treatment and, or, you know, avoid surgery altogether. Our goal is not to replace surgery. We've talked to tons of spine surgeons at SIR already. They're super excited about this technology because it gives them another treatment option in their toolbox without having to do surgery early on. This is the procedure. We'll kind of walk you through what the animation looks like. Do you have sound?
Jeff Cambra 03:07
Triojection is a sterile, metered oxygen and ozone injection that shrinks contained herniated lumbar discs to relieve pain. The Triojection 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 Triojection under image guidance, introduce a standard spinal needle into the center of the contained herniated disc. 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, injecting most of the ozone-oxygen gas into the disc slowly. Slowly withdraw the needle tip, injecting remaining gas as you go until it is just outside the disc 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, the injected ozone reduces the disc herniation that was causing compression of the nerve. The procedure is quick and recovery is almost immediate.
Jeff Cambra 04:48
So the procedure takes about seven minutes. It takes a little bit longer to actually prep the patient in the outpatient setting, to get the patient ready to go. It's done under conscious sedation, so the patient stays in the recovery room at an outpatient clinic for about 35-40 minutes, and then they're free to go home as long as they have a driver that's taking them home. Again, this procedure does not burn a bridge for the continuum of care, which means that a surgeon, if they need to do a procedure down the road, there's no implant involved. So there's no need to remove an implant. Again, it's minimally invasive, and no general anesthesia is required as part of the surgery. And again, it's mostly done in an outpatient setting. That's going to be our focus: outpatient ASCs and outpatient procedures. We do have a console, and we have a syringe. This is a capital piece of equipment, and then we have a disposable syringe as well. The console, it's a razor-razor blade model. We'll focus on placing the console for free with our customers. If they want to purchase it, they're welcome to purchase that. We will sell it as capital equipment. But where we'll get the annual revenue is from the syringes, selling the syringes to our customers. What's different with ours, and what makes our technique unique, is it sterile. It's measured, you know, the exact dose every time that's going into the disc that backs up the clinical data that we have. And it's repeatable. It is indicated for single use, single level at this time, L1 through L5 is our indication. We do have 35 patents today, and that covers all of our syringe, the acrylic syringe, which is the secret recipe that's within this syringe cartridge. And it also covers the software, the algorithm, as part of the console as well. And then we have the methods patents for the surgical technique I spoke about. This is what was published in the Spine Journal in June of 2022. We won Abstract of the Year. This really put us on the map with interventional radiologists who are very, very excited about this. This procedure, along with the pain specialists as well, if you see here, shorter procedure time, shorter stay. This was a non-inferior study against a microdiscectomy, and it shows that 71% of the patients that got our Triojection procedure over microdiscectomy avoided surgery altogether after two years. We are working on five-year data right now, assessing those patients as follow-up. This is six-month and 24-month, and you can see the before and after—a significant improvement with their disc. Please note that this does not cause any height damage to the disc or further dehydration, nor does it expedite the process for black disc syndrome. We've done some analysis here on stakeholder benefits of Triojection with the patient, the physician, the facility, and the payer. You can see here the significant benefits across all four of these categories. Again, we are focused on our customer segmentation and go-to-market strategy. We're focused on the pain specialists, interventional radiologists. If you think about the technologies that were just acquired from Boston and Stryker, Vertos Medical, and Relievant, that's our focus here as well, moving up the continuum and driving more focus into that specialty. We know that there are going to be some spine specialists that are going to be doing this procedure. Those are going to be spine specialists that are trained in fluoroscopy and doing more minimally invasive procedures. Our focus right now is securing our regulatory pathways. We are a Canadian-based company. We're based in Toronto, and so right now we're working on Health Canada approval. We've done 50 cases under special access, all with very, very great clinical success to date. We're working on our EU MDR; we did our submissions this December, we have an audit with our DQ s, who's our notified body next month, and we hope to be in Europe early next year. And we're working on a PMA device pathway for the US and hope to be in the US commercial launch in 2027. This is my team. We have a very small team. Myself as CEO, we have Dr. Karen Murphy, who's my Chief Medical Officer, John Solonka, who's our Chief Technology Officer, and Alex Doug Ness. I'm very proud of this team. They've all been very, very successful entrepreneurs in the past, so I'm proud to work with this team. These are our medical advisors. We have some of the best of the best across interventional radiology and pain specialty. So we're proud to work with some of the best folks globally in the world. And these are investment highlights. We're looking right now to secure to close our Series B at $4 million. We're looking to close it out with $4 million as our ask here at LSI. So thank you very much. Applause.
