Jeff Cambra Presents SpinaFX at LSI Europe '23

Transcription

Jeff Cambra  0:05  
Okay, good morning, everyone. Whoo, that's light is bright. Good morning, everyone. I'm Jeff Cambra. I'm the CEO for SpinaFX medical. I've been with the company now for about three years. I was with Medtronic for over a decade, I've been in the interventional spine space for quite some time, been working with interventional radiologists, pain specialists, spine surgeons, and neurosurgeons and I'm here today to talk about our technology tree objection. One of the things that we really focus on as a company is patient and customer. And what I'd like to do right now is talk a little bit about a patient of ours, introduce you to Ryan B. RYAN b is a patient that was treated in Canada.

Ryan B.  0:50  
Before trio ejection, I was in pain day to day that I would have told most people four to five, but I'd normalized it to the point of I, once I had a couple of injections, I was feeling that I was probably more likely to an eight or nine, and I pushed 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.

Speaker 1  2:25  
So just a little bit about Ryan Ryan is was a patient 37 years old, he had significant back pain for about 18 months was out of work firefighter family man also has children. And what we're trying to do here and what we're achieving with spine effects medical is we are the spine of treatment solution company to really focus on rapid and sustained pain relief for patients with back pain. You'll see in a moment here we're focused on contain herniated disc, if no surprise if you see in the news, the last couple of days interventional pain, especially within the spine is a big market opportunity right now. It's a hot market. It's a hot market. And so what we do is we're using our patent technology and our clinical data to drive this technology forward within the marketplace, again, contain herniated disk is one of the biggest disabilities back pain is one of the biggest disabilities in the US alone. It's number one over cardiovascular and over diabetes. And we want to be the global standard you're you'll hear in a moment here, you'll hear from us in a moment in regards to the therapeutic gap and the continuum of care. And our focus really is to drive and address the therapeutic gap gap within within this space for patients like Ryan they get get caught up in different treatment modalities, potentially going to surgery, and there's no treatment in between for for a patient like Ryan. So this is when we talk about the therapeutic gap. Many patients will go through diagnosis early they will have their MRI to determine what their back pain is actual back pain, chronic back pain, ddd. And it's very easy to tell if a patient has an epidural, excuse me has a has a containing herniated disc. And so there's different treatment options. There's conservative care, there's epidural steroid injections, there's nerve blocks, there's radiofrequency ablation if those things don't work, the next logical type of procedure out there in the marketplace today for a container a desk is surgery. It's a micro diskectomy and so a surgeon would go in and remove pieces of the desk within within the disk space. So what we're working on and developing and commercializing is a technique technology called tree ejection.

Video Playing  4:43  
TRiO injection 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 by periscopic measurement and an ozone generating syringe inside a sterility case. Following standard conscious sedation, prepare the patient for trio injection. 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. 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 and 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  6:26  
Okay, so the procedure is doesn't require open surgery. It doesn't require general anesthesia, it's conscious sedation. It's about a seven minute procedure. It can be done in an outpatient clinic, not it can be in an or hospital but most of the most of our focus is going to be with pain specialists, interventional radiology physiatrist. There's no serious adverse adverse events to the procedure. And again, as mentioned, our focus is really on minimally invasive image guided procedures. It's rapid sustained, we have clinical data I'll share with you in a moment in regards to publication we did in Europe. You can see here the before and after how it works. It's an oxygen ozone therapy that basically dehydrates the desk shrinks the desk to get the impingement away from the nerve within the within the spinal canal. You saw the console we have a console disposable syringe which produces the oxygen ozone about 2.4% ozone that's injected into the desk. As I mentioned, it's about a seven minute procedure. It's done in our x ray under fluoroscopy as part of the procedure. This is our clinical data we did when abstract of the year last year with the Society of interventional radiology, we are happy and excited that we got this publication publication done in the spine Journal last January this was published. The clinical evidence is 49 patients and within those patients it showed that 90% lower cost versus a surgical procedure was a non inferior study over diskectomy. The patient criteria 70% of patients were eligible. 71% of patients avoided surgery later. What's neat about this, this procedure is it doesn't burn any bridges. So there's no implant that's required for a surgeon to have to remove if let's say a patient needs a surgical procedure down the road so it doesn't burn any bridges with the spinal surgeon. Shorter procedure time is mentioned about seven minutes and shorter stay in the hospital. The patient stays for about 3040 minutes after the procedure in an outpatient clinic and they go home the same day. These are some post op post operative follow up. This is a six month subject three a one and 24 month follow up subject of 111. You can see the before and after there's circled in green, a significant reduction at six months and significant really almost complete resolution at 24 months. Ryan, the patient that I shared with you Ryan had complete resolution about six, six weeks after as MRI, he was back to work firefighting after two months after being out of out of work for almost 18 months. This is our value proposition in regards to stakeholder benefit from the patient, shorter recover. We talked about that physician two times more revenue per hour facility 2.4 times more revenue per hour. And then from a payer perspective, this is 24% lower cost and let's say a micro diskectomy or diskectomy. Within within the marketplace. All right now our commercialization strategy. This is our roadmap to take commercial. We closed a Series A round 5.4 million in US and 2022. We just closed our $8 million out of the 16 million we're looking to raise for this year. We're seeking a total of $16 million for this round. And then as we move forward with our clinical data and our globalization, we'll move forward with the 15 $15 million. We're right here. We're focused on Health Canada submission now we'll get into EU MDR. We're focused on getting the MDR next month and then our pathway to FDA. We have a pretty significant executive team that we're working with across the board and with our medical Advisors, a large group of folks from across the board with interventionalist spine surgeons, pain specialists, and neurosurgeons. These are investment highlights. We have 35 patents to date. sturge shirt jurisdictions we're focused globally if you're interested in taking a look more at our company please do so we have the QR code here that takes you directly to our website this is my information feel free to reach out thank you very much.