Great. Good afternoon, everyone, and thank you for joining us. My name is Jon Young, and I am a MedTech research analyst here at Canaccord Genuity. Welcome to our MedTech, Diagnostics, Digital Health, and Services Forum. I am very pleased to introduce our next presenter, Shaun Bagai, Chief Executive Officer of RenovoRx, and Mark Voll, CFO. For those less familiar with the story, RenovoRx is a commercial-stage company that sells the RenovoCath, an FDA-cleared dual-balloon catheter that delivers chemotherapy locally across the arterial wall near the tumor, and is running a phase III trial of its drug-device combination in locally advanced pancreatic cancer. Shaun, thanks for being here.
Thank you for the introduction. Thank you for everyone joining here in person and online as well. Shaun Bagai here, CEO of RenovoRx, and I wanted to give you an update on where we have come with our new TAMP technology, both commercially and clinically. Just a very high level, we have been looking at cancers very differently than most companies. If you think about new therapeutics, it is a fine balance between destroying the patient and destroying the tumor.
What we are after is, how do we actually treat cancer in a manner that does not destroy the entire body while you are trying to tackle the tumor itself? With that very high level, we have got an FDA-cleared device called the RenovoCath. Currently, we are in 26 active customers around the country, and we are accelerating market penetration with a small, lean sales force that is now fully active.
The estimated annual target revenue for the device alone product is estimated to be at $400 million per year. In parallel, we are developing a proprietary technology via our TAMP mechanism, otherwise known as Trans-Arterial Micro-Perfusion, in a phase III trial right now called TIGeR-PaC that is fully enrolled. This TIGeR-PaC trial is specifically looking at the combination therapy of gemcitabine through our RenovoCath device, and I will give you more detail after that in a minute here. From a leadership team perspective, I will walk through that towards the end. We have got the right team in place, both on the clinical development side, on the commercial side, and spanning biotech and medical devices. Let us step back and first talk about the issue we are trying to tackle, and one of the biggest unmet needs and the issue with therapy today in specific tumors like pancreatic cancer tumors.
When you think about solid tumors, you usually think about balls of blood vessels with tumor cells. This poses a great entry point for chemotherapy to reach tumors. On the panel on the left, what you are seeing there is an animation of what looks like a liver tumor. You can see a blood vessel that feeds that liver tumor and ends directly in the tumor. This serves as a vascular highway, if you will, where chemotherapy can circulate the body, but also reach the tumor itself, and it also provides a target for physicians to place a small microcatheter or plastic tube inside the liver tumor feeder. Unfortunately, many tumors in the bodies do not have these types of tumor feeders. If you look at pancreatic cancers, glioblastoma, cholangiocarcinoma, certain non-small cell lung cancers, they do not have a large direct connection to the blood supply.
The tumors grow very slowly, they die on the inside as they grow, and they get very little nutrients from the body. This poses really a resistance or a barrier of success of chemotherapy and standard therapies today. These are considered hypovascular tumors, not having large blood supplies. The whole crux of our system is to overcome this challenge to successful therapy. Our mechanism is called TAMP, or Trans-Arterial Micro-Perfusion, and the way this works is a physician places our proprietary RenovoCath device under X-ray fluoroscopic guidance. This is done by an interventional radiologist.
They place the catheter adjacent to the tumor, and then using the proprietary nature, change the distance between the balloons to isolate blood flow specifically to a small part of the artery or blood vessel without any side branches or vessels that are leading away from the tumor between the balloons, where the chemotherapy can drain away and wash away. By that isolation, they give a full systemic dose and volume of chemotherapy over 20 minutes. Imagine a liter of fluid, and that small space is about 1 mL or 2 mL in volume over 20 minutes. That creates a pressure head that forces the therapy across the vessel wall and the tissue. What this results in is a very high concentration of the drug or the therapy at the tissue or tumor site, versus just washing away systemically. We do this using pressure.
Once the pressure starts to increase when that small space fills up, it doesn't get to very high dangerous pressures, but enough to push the drug through the vessel wall into the tissue. The result is, what you see in an animal study is about 100 times the concentration of the dose. You can imagine what effect we can have on the tumor cells with a much higher dose at the tumor site. On the flip side, what we're seeing is a much less systemic volume, which makes sense because we're not exposing the entire body to the drug. It's starting at the tissue side of the tumor. The panel on the left was actually a proof of concept in lung tissue, to see if we can use this in lung cancers in the animal model.
The panel on the right is actually human data from our phase III TIGeR-PaC study. We did a subset PK analysis. This paper was just published within the last couple of months, showing almost a 50% reduction in systemic chemotherapy when delivered locally via our TAMP mechanism, versus giving it systemically. What this translates into patients from a procedural standpoint is that patients come in every other week. It's usually a treatment course of up to eight treatments over four months. Compared to other new technologies, it's not an overnight stay in the hospital. Generally, these patients are outpatients, and they're given just local anesthesia to feel comfortable. They don't have to be put under general anesthesia for the most case. From a patient expectation and a patient experience, it's not difficult.
In fact, they prefer this mechanism to standard of care because they don't see the chemotherapy side effects. It is an outpatient procedure. From a physician standpoint, it's the same exact skill sets they use to treat local liver tumors. It's just a matter of having a proctor there for two to three procedures, and then the physicians are free to go on their own or train other doctors. We don't need a big field force to train and drive the adoption of the technology because it's relatively simple to use for the physicians as well. So far, we've seen usage to date in locally advanced pancreatic cancer. We have the most data. As far as what's coming next, the market itself for pancreatic cancer is about 60,000 patients per year. We've been focusing in our clinical trials on locally advanced pancreatic cancer.
That's considered non-resectable, not yet metastatic. You look at the entire market, we're talking about $1 billion of TAM or several billion dollars of TAM. Next, we're looking at cholangiocarcinoma or a bile duct cancer. There's been interest from physicians looking at, okay, where can this be used outside of pancreatic cancer given the success we've seen? Biliary tumors or bile duct cancers are one that behave like pancreatic tumors. They don't have large blood supplies, and the same drugs are being used. Beyond that, there's a lot of potential. We look at this as a platform play, as we can deliver almost any agent to almost any tumor. The tumors that make the most sense to physicians on next steps are going upstream and downstream of locally advanced pancreatic cancer. In fact, we've already launched an IIT, an investigator-initiated trial, in borderline pancreatic cancer.
That's patients who are slated to go for surgery, but not yet resectable. Metastatic pancreatic cancer is a larger part of the market, and we have an IIT about to launch in metastatic pancreatic cancer as well. Beyond that, we have treated our first sarcoma patient, which we announced a few months ago. Physicians, as they're adopting this FDA-cleared technology, are finding other uses where this could be beneficial to the patient population. Longer-term non-small cell lung cancer, glioblastoma, pelvic tumors, and other indications are on the horizon as well. It gives us a lot of optionality in terms of where this could be used as a platform. As newer drugs are developed and come out, we can actually put those through our device. It gives us a leg up on really having no competition.
We've developed and invented a new mechanism of action on driving high doses of chemotherapy in the tumors. With that, I'll have Mark talk about the commercial opportunity of the device we have today.
If we look at the market opportunity for our product, I will take you through how we view the market itself. Our device sells for $8,000-$8,500 per device. Typically, a patient will go through 5-10 procedures. We see an annual revenue opportunity for us of approximately $400 million. Not only is it a significant market opportunity, but it is a high-margin business. Currently, our product drives a gross margin of 85%. Our next-generation product we will introduce sometime next year. We believe that we can even improve on that. It is really a low-overhead model. We only require five field sales representatives to sell our product. As a result, we see a very high-margin operating margin business, and we think that longer-term, we can generate 30% in operating margins for the business.
Also, we have a robust patent portfolio, which we think provides a significant defensible barrier for our product. Why would we think that there is a low overhead business? We believe that we currently have five salespeople in place. We believe that is sufficient to cover the total market. There is approximately 200 hospitals that treat most all of the pancreatic cancers in the U.S. It is really a concentrated market. The top 25 generate over 40% of the diagnosis in the United States on an annual basis, and even the top 100 represent more than three-quarters of the total market. We think that, again, our sales force that we have in place is sufficient to drive revenue for our company.
We have been quite successful the first three quarters of this year, generating last quarter $1.1 million in revenue, our first quarter in which we generated more than $1 million in revenue. We have generated $2.5 million for the first three quarters, and we think now that our sales force is in place and their experience on the product will be able to generate future growth that will surpass our current growth.
Thank you, Mark. Where is that growth today? To give you an example of the market that is coming, we have 26 centers, as I mentioned, that are actively treating patients. These are not centers that have just purchased devices, but have actually started treating patients, and most of them have repeat orders. After doing the first procedure, they continue on for additional procedures and have started treating additional patients as well. Beyond that, we have up to over 40 centers in the customer pipeline.
These are centers who have either already begun to start purchasing the device, looking for their first patient, or they are in the VAC process, or otherwise known as Value Analysis Committee, where they are assessing the product versus reimbursement and then putting this on the shelf and starting to look for patients, as well as additional physicians and other hospitals that are interested in the technology and just now beginning that process. We have a robust pipeline of customers already interested in moving this through to start treating their patients. Beyond that, we did finish completing the TIGeR-PaC phase III trial enrollment. Many of those centers have already started transitioning to becoming commercial customers and coming on board as well to be able to treat patients after the trial is done enrolling. That happened earlier this year.
Just to give a heads-up, Mark will go into more detail, but our annual revenue guidance for 2026 is just around the $4 million mark. I touched on a few of these earlier, but to talk about where the expansion we see in the very near term, we have publicly announced we have launched three investigator-initiated trials, namely in metastatic pancreatic cancer, also borderline resectable or soon to have surgical resection patients. Beyond that, in extrahepatic cholangiocarcinoma, otherwise known as bile duct cancer, where physicians see the utility. What is interesting about these studies is they do purchase the devices, so we do get revenue from the commercial standpoint within the studies, and these are very low-cost studies to run versus large randomized studies. This data can actually generate future sales.
It is a great approach to be able to academically study where we are going next, publish additional data, and also drive revenue for the company. Let us take a step away from commercialization efforts and talk about the data that is driving all this. When you look at pancreatic cancer as an example market, the unmet need is there as any new therapeutic that comes out may have weeks or months of survival. Unfortunately, we are not talking about cures, but these are multi-billion dollar therapeutics that add a little bit of survival to patients, and unfortunately, with a lot of side effects, and that is one of the things we are trying to solve for.
In talking to the referring physicians or medical oncologists, they say, "Look, if you can give me more than two months of survival benefit, I will send most of my patients for this therapy." It is crazy to think that two months moves the needle, but unfortunately, in these types of patients, this is something that is considered a big win. As far as what we have seen so far, just to touch on the phase III trial design, we finished enrollment in the trial, but the way this was designed is patients get upfront systemic chemotherapy. These are treatment-naive, locally advanced pancreatic cancer patients.
They get three months of chemo, get a radiation sandwich in between, and if they're still stable after that first about four or five months of induction, they get randomized to continuation of standard of care chemo versus our therapy, which is locally delivered via the TAMP mechanism, and then they follow for survival. It's up to eight treatments with our treatment. We were looking at the first interim analysis back in 2023. We did an early look when about 30% of the events had occurred, and what we discovered was a six-month survival benefit. Again, this is in the world where a few weeks to a few months makes a massive difference. Unfortunately, that window was actually considered quite large in terms of benefit over current standard of care. We expect patients with locally advanced pancreatic cancer to live around 15- 16 months.
Our control arm behaved pretty much as expected at 15 .5 months in survival since diagnosis, and our treatment arm was about 21 .5 months. Pushing the two-year mark for pancreatic cancer patients is a big win. This is just to go through the slide a little bit. There's an induction phase of chemo and radiation that's about five and a half months, and so when you total those numbers, we're looking again at 15 .5 versus 21 .5 months of survival. This is promising, not significant yet, but trending towards significance. But the big driver on the commercial side is the side effect profile. Generally, patients, when they receive that initial chemotherapy and radiation, it's difficult for them to tolerate any more treatment, and we're seeing our patients have a massive reduction in side effects.
Again, not what you normally see with a new therapeutic. Usually, it's that trade-off. We're seeing a 65% reduction in toxicity and side effects, and this is the driver, the main driver behind physicians wanting to treat patients today, is after that first induction phase of chemo, if they haven't metastasized and they haven't downstaged, it's another treatment option for patients where they don't feel the same side effects and toxicities for most patients as they would with the standard of care therapy. With that, I'll hand it over to Mark to talk about the financial highlights.
To touch on our financial results, and our third quarter results, approximately $1.1 million in revenue. Again, our first quarter exceeding the $1 million threshold. That was a fourfold increase from the same period a year ago. $2.5 million in revenues for our first three quarters represents a 186% increase over the same period last year. If we look at one of our core principles was to grow out our active centers, so we targeted 36 centers for being placed by the year end. Through the third quarter, we're at 26. We had a couple that just came over into the fourth quarter. We believe that we'll be at or near our goal by the end of the year. If we look at our cash, we currently have $10.4 million in cash at September 30th.
We believe that's enough of a runway to take us into the second half of next year. And we reiterated our outlook for revenue for the year at $3.75 million-$4.25 million revenue range.
Thank you, Mark. So in closing, what's the team behind this that drives us here? As I mentioned earlier on, our management team is highly experienced in everything from clinical development through successful commercialization, and this is both on the pharma/biotech side supporting the phase III trial and also on the medical device side where we see our device used today. On the board, it's very similar. Very successful exits for a lot of the board members, both in the public and private sectors, also covering the oncology side. And then on the advisory board, it's very important, as we all well know in medical technology, you have to have the luminaries driving adoption.
We've got a diverse team of specialties that treat these types of patients, from surgical oncology to medical oncology, radiation oncology, interventional radiology, and these physicians are helping educate and drive awareness to the market as well. Namely, one of the most recent additions with Dr. Margaret Tempero, who's on the chair of the NCCN Guideline Committee for Pancreatic Cancer. So it's the right physicians, luminaries to bring this technology to market. As we're commercializing the device itself, we've built a separate medical advisory board of luminaries in the interventional oncology space. These are the physicians that actually, the proceduralists doing the procedures and educating their colleagues as well as the benefit for their patients.
I started off the talk about why this is so impactful for patients on reducing the side effects and hopefully extending their survival, and we actually have several stories on our website bringing it back to the patients in the news where they were interviewed for their experience with RenovoCath and TAMP. So I'd urge you to go in there to see what the patients are saying, because ultimately, it's the patients that will drive this technology forward given the successes they're seeing directly. Thank you for your time. Any questions? Go ahead, Jon.
Yeah, really great presentation.