Video Transcription
Timothy Murphy 00:02
I'm Dr. Timothy Murphy, CEO of Summa Therapeutics. This is my second career. I was a clinician for 25 years, practicing interventional radiology, a full professor of research at Brown Medical School. I was an NIH-funded clinical trialist in vascular disease, one of the top funded NIH clinical trials in vascular disease of all time. I was a past president of SIR. This is a human factors product. It's a multifunctional revascularization tool designed for complex peripheral vascular procedures, in particular, below-knee revascularization procedures for limb salvage for patients with ischemic tissue loss, gangrene, at risk of amputation. It's a fairly conventional-looking angioplasty balloon catheter for anyone familiar with it, except for the jets, which the catheter functions replace a microcatheter in that it acts as a crossing catheter. It acts as a diagnostic catheter and can inject contrast or vasodilators at any time during the procedure while maintaining guide wire access without any exchanges. It also replaces the need for long sheaths that might be used sometimes to supplement contrast injections, and I'll go into some of the procedural and clinical benefits as we move along.
Timothy Murphy 01:37
As I said, it's a BTK play. There are lots of technologies that are being used for BTK, but on average, there are two angioplasty balloons used for each procedure. So regardless of whether there's any atherectomy or cutting balloon or biodegradable stents, there are, on average, two balloons in every procedure. There doesn't appear to be on the horizon any way to displace those. It's a new product category, as I said, a multifunctional revascularization tool. It's a volume play. There are about three and a half million of these that are used worldwide each year. So the total market is over a billion dollars. It's not a transformational technology in that when you show it to people, they don't say, "That's crazy. It will never work," like some other devices you might see. Most of the time, when we show it to vascular specialists, they say they can't believe it doesn't exist already. This is the brief demo. All that it does is it gives very good hand injection of contrast or vasodilators at any time during the procedure while maintaining guide wire access at all times. The below-knee procedures are often done from femoral access around an aortic bifurcation down into the calf, even into the foot. The idea of this is to eliminate catheter exchanges, make the procedures easier to perform, and enable patient access by having more providers be interested in doing the procedures. Of the 150,000 or so lower extremity amputations done in the US each year for peripheral arterial disease, 80 to 90% of them could be spared amputation if they see a vascular specialist and undergo an attempt at revascularization. So there's already a large number of a couple hundred thousand patients that undergo those procedures in the US each year, but there's almost double that amount. So it's a growth market, and we intend to help the practitioners expand into that market. As I said, there's a convenience factor that makes it easier for the providers to perform, less chance of loss of guide wire access, shorter procedure time, and shorter room times. This is probably one of the top expenses for a hospital or an OBL is their room time during the procedure. It's an all-in-one. Contrast is an important concern. About half the patients at risk of limb loss have diabetes mellitus or chronic kidney disease. Those patients are at risk of contrast-induced nephropathy. Any time you can lower the contrast dose, you're potentially helping the patient. If we can show in our clinical trial, which we're hoping to start in November, that we lower contrast, it could be a game changer for those patients—that's half of the patients in this space. If it becomes the standard of care for that half of the patients, it's probably going to become the standard of care for the other half as well. We have broad issue patents and pending patents that will give us protection, hopefully into the late 2030s. We have FDA clearance. We've had our initial design cleared. We had KOL use a limited release. We got user feedback. We did design changes. We also got those through the FDA. We're building up our manufacturing capacity now and building up our inventory, planning a limited market release imminently, and starting the clinical data collection this fall. As I said, there are a couple hundred thousand patients, 450,000 small vessels, small balloon catheters in the US. It's not an expensive item; again, it's a volume play. However, there are two of them used in every procedure. It's not a niche product that's below the knee. We have another product in development, which is above the knee, basically bigger balloon sizes, but the same multifunctional, ergonomic make the procedure easier kind of product that's in the US. This is the distribution worldwide. Again, it's 3.5 million peripheral angioplasty balloons for a market of over a billion dollars. These are the KOL feedbacks. We've never shown it to a vascular specialist who hasn't looked at it and understood all the parts. They don't need any orientation; they are ready to use it. 100% of them say they want to try it. That's helpful because we need to have people on the ground to help get us through the value-added committees at the hospitals. I don't know if they're going to buy it, but at least they say they want to try it. This is the feedback we got from product evaluation forms on the first 15 cases, and what the users are telling us is that it is doing what we think it's supposed to do. In fact, they have incorporated the product into the workflow a little more fluidly than we thought that was going to happen right off the bat, and that if they can't even get across the total occlusions in the calf, they're using it as a single device, putting the wire down, the wire gets stuck, advancing the balloon down to it, opening the balloon, tenting the lesion, putting the wire down, rewrapping the balloon, and basically just serially marching down the calf. We have one of the live cases that we fortunately recorded by one of our KOLs in New Jersey. New Jersey was a 14 and a half minute calf revascularization procedure, which is pretty fast. This is a calf angiogram done with one cc equivalent of contrast. The injection lumen is right near where you're working at all times; you don't have to inject from the groin or put a diagnostic catheter or be working with a long sheath from the groin that you're moving back and forth. You're bringing the injection port with you everywhere you go. There's some value added here; it's really the procedure time. But there are also, in more than half the cases, they're not using a microcatheter, which is a $100 to $200 product. So there's an argument that it's a break-even for the hospitals, and we're looking for breakthrough designation for the OBLs to offset their extremely price-conscious nature. They don't like hearing that something costs $1 more. So we're working on that. We are a lean team. We've raised less than $3 million. I'm the only full-time employee. We have very good contractors, consultants, and a very good advisory board of the world's experts. But we have been very disciplined so far and have gone pretty far on that. These are the milestones we're hoping to achieve. Our registry—we're told we're going to enroll the first patients November 1, early November. Once we get preliminary data from the registry, we're going on to an RCT. We have our pre-IDE meeting with the FDA in October. If all goes well, we'll have data in the first half of next year. Clinical data will also have some hopefully market feedback at that time as we open up limited markets in the US. I thank you for your attention.
