For joining us for a conversation with Shaun Bagai , the CEO, and Mark Voll, the CFO of RenovoRx. I'm Charles Wallace with H.C. Wainwright. RenovoRx is a commercial stage drug device delivery oncology company with its RenovoCath device focusing locally advanced pancreatic cancer. Without further ado, the floor is yours.
Thank you. Thank you, H.C. Wainwright, for hosting us and everyone for joining today, both here and online. At RenovoRx, we're looking at cancer a little bit differently. When we think of cancer treatment, it's usually that balance of destroying the body and destroying the tumor. Unfortunately, we've been hyper-focused on destroying whatever we can to get to the tumor without a really good focus on the patient. What I'd like to go over with you is the background on our technology that actually can focus on both, and some of the results we've had, and now the more exciting news on the commercial launch we've recently had. If I can get this to click over. These are our forward-looking statements online. At a glance, we have two assets, really. We have a commercial opportunity we've embarked on last year.
We are a commercial stage company with a new delivery system technology that's now commercialized in several centers across the country, and we have a phase III asset in the background that has completed enrollment. On the commercial side, we've now launched the FDA-cleared RenovoCath device. This is now in 21 centers across the country as of the last quarterly readout. More since then, and we're growing rapidly in terms of bringing new centers on board, commercially utilizing our delivery system and mechanism. This initial market that we're looking at for the RenovoCath device is about a $400 million peak sales opportunity based on a much larger TAM, as you look at where this catheter could be used and is interested in being used today.
In addition, we're developing drug device combinations that are really based on our proprietary mechanism called TAMP, or Trans-Arterial Micro-Perfusion, that aims to drive high doses of chemotherapy or therapies in the tissue while reducing systemic toxicities. From a phase III asset perspective, we are just finished enrollment in the TIGeR-PaC phase III trial. We'll go into more interesting data on that as well. We have an experienced leadership in place to really drive both the commercial and the clinical fronts forward. First, let's talk about the platform and how it works and why it's different. If we think of tumors, generally, we think of large balls of tumor cells that have a lot of blood flow and blood vessels to them. Many tumors in the body do behave like this, where they have large tumor feeders or blood vessels that actually end inside the tumor directly.
If you think of liver cancers, that's one example. In these cases, these hypervascular tumors accept systemic chemotherapy as much as you do have side effects and toxicities, but also you're getting a lot of drug in the tumor outside the body as well, but there's also local targets. You can place a simple microcatheter in that tumor feeder and position that inside the tumor to give direct therapy. Many tumors in the body don't behave like this. We consider these hypovascular tumors, or tumors that don't have a large blood supply. Pancreas tumors, for example, glioblastoma, non-small cell lung cancer, pelvic tumors, bowel duct tumors behave like this, where there's not a large blood supply because they don't have these large blood vessel tumor feeders feeding them. This poses a major barrier to success for current therapies, as most of them are systemic.
Very little of the drug or therapy gets inside the tumor itself, and there's no local target for a radiologist to position the device or catheter. We found a way to overcome this with our delivery system, and what we've seen is 100 times the tissue concentration at the target site than you would if you gave it systemically. You're getting much higher concentrations of drug at the tumor site. On the flip side, we're seeing much less drug exposure, which is not surprising. The panel on the left was actually an animal study we did for proof of concept in lung tissue. The panel on the right was recently published in a peer-reviewed journal. This was the PK sub-study in our phase III trial, which showed a 50% reduction in systemic exposure to the drug, which would make sense why it's leading to less systemic toxicities.
How does the technology work? This is done under X-ray fluoroscopic guidance by radiologists. Our proprietary delivery system, called the RenovoCath, is positioned adjacent to one of these tumors that doesn't have a large blood supply feeding it directly. Then the radiologist, under X-ray guidance, is able to position the catheter and actually adjust the distance between two occlusive balloons such that they isolate flow so no flow will escape down other feeders or side branches. What that does is it creates a pressure head within the first couple of minutes of filling up the space between the balloons that then forces the agent through the blood vessel wall into the tissue. This results in very large concentrations of drug at the tumor site.
This doesn't really cause damage to the blood vessel wall that we've seen cause any issues, because there are little micro tunnels that exist, called the vasa vasorum, that give us access to get outside the blood vessel. At these pressures that are not very high pressures, we're able to force drug and chemotherapy into the tissue. If you think about the pressure we're delivering, this is about 6 mL/min . The pressures we're seeing are probably in the 40- 60 range in animals and maybe 100- 200 range in humans. It's not very high pressures to force drug out, but enough to get that penetration into the tumor outside the blood vessel.
From a patient and physician experience, this is a little bit easier than other systems in the sense that patients come in and out the same day, so it is an outpatient procedure, unlike many new technologies that require an overnight stay. Also, the patients are not put under general anesthesia, generally. It is under conscious sedation. They are made comfortable, but again, you do not have the side effects and a lot of the longer-term issues with going under general anesthesia multiple times. The patients end up having eight treatments over the course of four months, is what the clinical trial prescribed. That is a little bit different than a lot of chemotherapy infusions, which require weekly visits, and then, of course, the several days of the side effects you see from that. From a physician standpoint, the training is relatively simple. These physicians are well-versed on liver-directed therapies.
We have proctors there for the first couple of procedures just to teach them how to use the device, how to position it, and then they are free to go on their own and even teach their colleagues. It does not require a big field force to train the physicians and work with the physicians on a continual basis. From a market perspective, I mentioned the TAM a little bit earlier. If you look at where we have got experience today, so namely pancreatic cancer, our addressable market will be about 30% of the broader 60,000-patient market on the pancreatic cancer side. By achieving a penetration of about 7,000 patients in that market, so just roughly 10%, along with other potential areas, we can assume a peak U.S. sales revenue recurring at about $400 million. That is based on where we are seeing this being used today. Next steps.
The next steps also, bile duct cancer and cholangiocarcinoma is a big area of interest, so we are looking at IITs to launch it there. Beyond that, there are other tumors that behave like these hypovascular tumors that could be an area of expansion for us down the road. That would include expanding into the large blue bar into other areas of pancreatic cancer and borderline resectable pancreatic cancer and metastatic pancreatic cancer. Beyond the stage three locally advanced pancreatic cancer, where we have the bulk of our experience to date, there are already IIT studies underway to explore those. Let us talk a little bit about the market of where we can see this $400 million market. With that, I will turn it over to Mark.
Let me take you through the market opportunity for RenovoCath. First, taking a look at the market. We command a $6,000- $8,500 per unit. Our patients average approximately six treatments in total. It is a very attractive economic model. If we assume a modest market share of their total addressable market, we are looking at a revenue opportunity of about $400 million per year. Just as importantly, it is a high-margin business. We are generating 85% gross margins right now. We have a lean operating model, which we believe that we can generate 30% operating margins as we scale the business. In addition to that, we have a highly defensible patented platform. We have 20 patents in place. We have 13 that are pending. This takes patent protection through 2045. We have a portfolio in place that allows us long-term exclusivity for our drug delivery platform.
Great. Thank you, Mark. How do we get to this capitalization of this business? Looking at the market and the way we're able to stay lean is because it's a very focused, condensed market. If you look at where these types of tumors are being treated, there are only about 200 centers in the U.S. that treat the vast majority of these non-metastatic tumors. It is that classic 80/20 rule, where 100 hospitals treat the vast majority of these, and 50 hospitals treat about 50%-60%. With a small sales team of roughly four to five sales reps, we can cover the entire country.
Unlike many other novel technologies, we don't need a large expensive sales force of 20, 40, 50, 80 reps to be able to tackle this market and drive towards those hundreds of millions of dollars of revenue in this initial application. We do have that team in place. We put the team in place early this year. With the Q2 revenue of $909,000, it looks like that is coming to fruition. Doing about $1.5 million the first half of the year was greater than our $1 million of revenue last year before we put the sales infrastructure in place. The teams in place is lean, and they are performing both on the marketing perspective to create awareness and also driving sales penetration. One of the good KPIs to look at beyond just revenue is where we're growing in terms of bringing new centers on board.
We exited 2025 with really six centers active, 11 in the first quarter. We've grown that as of the last quarterly announcement in mid-August to 21 cancer centers now utilizing the technology commercially. It's more beyond that, and we anticipate over 35 centers by the end of the year. To get there, we have many centers in our customer pipeline. As we know with medical technology adoption, we have to go through the internal approval process for the hospitals to look at the reimbursement. This is a highly reimbursed procedure, and their volumes, and we have a total of 63 centers that are either active customers today or somewhere in that process of ordering catheters and starting to treat patients. We're well on our way to achieving deep penetration as you look forward. Where has this gotten us so far?
We did increase guidance from $3 million-$4 million to $3.75 million-$4.25 million this year based on this growth of active centers and seeing the upswing in revenue as well. Another driver behind this future growth for the rest of this year is we wrapped up enrollment in our phase III trial, which brings us 15 centers experienced to our technology that have the referral patterns that have already begun transitioning to being pure commercial customers, and that's going to be part of our commercial ramp for the latter half of this year. From a pipeline perspective on where we can see this being used, I mentioned that right now, locally advanced pancreatic cancer is a primary. From a clinical development plan, the phase III trial is fully enrolled. We have launched two investigator-initiated trials namely at Moffitt Cancer Center in City of Hope.
One's in borderline resectable pancreatic cancer, actually at University of Vermont, where they're looking at earlier stage pancreatic cancer. Not waiting for patients to advance so long, but catching them before surgery to treat them. Then on the other side of the locally advanced is looking at metastatic pancreatic cancer. That's a trial that's being launched at Moffitt this year, which is double the market size of locally advanced. Beyond that, I mentioned cholangiocarcinoma or bile duct cancer. There's a lot of interest around there because these tumors behave very similar to pancreatic cancers. There's a lot of potential for the platform, both in terms of what drugs could be used or what agents, immunotherapeutics down the road, and also what tumors can be used.
Just to touch on the phase III trial, to put this in perspective of where we got the most clinical experience. When we look at pancreatic cancer and you think of first-line therapy, the last major advancement we made was the addition of Abraxane to gemcitabine. This gave us a very narrow, two month survival benefit. Not a lot of benefit in terms of survival. This comes with toxicities during their entire treatment course. You can imagine these patients having only maybe six months to 18 or 24 months to live, and the entire time they're beat up with chemotherapy toxicities. These new drugs extend that life by just a narrow window. You can see the bottom and top bars on the graph here, but they have a toxicity throughout the entire treatment course. That's the low bar that we have to overcome.
In talking to medical oncologists, where the interest lies for our technology is if we can see at least a few months of benefit. Novocure just got it cleared by the FDA with a two month survival benefit in locally advanced pancreatic cancer. If we see something in that two to four month range and see that major reduction in toxicities we expect, we anticipate deep market penetration, and we're starting to see that today on the device side. Quick snapshot. I'm not going to go into full detail here, but on our phase III trial design, we were enrolling treatment-naive, locally advanced pancreatic cancer patients. They get frontline chemotherapy and radiation. This is prescribed from the beginning, so we still look at our technology like a frontline therapy versus second line.
Not waiting for progression, but after a discrete four month induction phase, they move on to randomization to our treatment, which is eight treatments over four months, versus four months of systemic chemotherapy and follow for survival. In 2023, we did have the first interim analysis of the phase III trial that was presented as a late-breaking study at ESMO GI, showing a six month survival benefit. This is what's driving interest today, is seeing a six month window where patients are potentially improving survival. Unlike other therapies, it's without the toxicities.
This is the biggest driver where oncologists say, look, I can tell my patients that they will feel better because they are not getting the side effects of chemotherapy, and they may live longer as well. It is a great alternative to treat patients with pancreatic cancer and other solid tumors, and that is why we are seeing such deep adoption in our technology in the market today. Just a snapshot on this slide, we are seeing a 65% reduction in these systemic toxicities.
As I mentioned, we are continuing to support our registry and investigator-initiated trials. Just to skip over this quickly, several major cancer centers have started to look at how else they want to study this commercially. One of the benefits from a business perspective is these are post-market studies or are used with an approved device. They are paying customers, and we do pull in revenue for these procedures in addition to getting data out and publications out. To switch gears for a minute, I would like to have Mark give a summary of the financial highlights of the company.
Let us look at our financial performance for the first half of the year. Q2 revenue was record revenue, $909,000. It was a 115% increase over the prior year, a 61% increase over the prior quarter. For the first half of the year, $1.5 million, so it was 138% over the first half of 2025. At the beginning of the quarter, we established three milestones we wanted to achieve. First of all, record revenue in the quarter. Second of all, commercial momentum as we continue to sign more commercial centers up. Then third one is technology expansion as we expand our applications to other cancers other than locally advanced pancreatic cancer.
If we look at the outlook for the year, as we said, we see increased momentum in our business. We have raised our guidance to $3.75 million-$4.25 million. We see strong commercial center increases, and so we targeted at least 36 cancer centers this year, up from essentially five that we had most of last year. We believe this will be driving our revenue growth for this year and next.
Great. Thank you, Mark. Just to round out from a team perspective, we've got an experienced team that are both well-versed in clinical research, clinical development, as well as commercial launch and deep market penetration. Also on both sides of the pharmaceutical side and the biotech with a phase III trial, and on the device side, with the RenovoCath device. The board is same story with players on both sides of the clinical development and commercial, and as well on the biotech side and medical device side. We've also put together more recently a team of luminary advisors. Our scientific advisory board includes specialties from surgical oncology, well-known medical oncologists, including Dr. Margaret Tempero, who's the Chair of the NCCN Guideline Committee on Pancreatic Cancer, and then Timothy Donahue, surgical oncologist. Michel Ducreux from Paris and is looking at local therapies as a medical oncologist.
Michael Pishvaian, the PI for our TIGeR-PaC study, and Dr. Karyn Goodman, a luminary in the radiation oncology side, which helps our technology. More recently, we put together a board of scientific advisors specifically for the RenovoCath device as we look to scale and launch the commercial application of RenovoCath in different areas. Upcoming milestones, just quickly. We have several IITs I mentioned that we're launching. We anticipate announcing first treatments, first patients, launch of those studies, and then additional case studies and white papers and data as that comes out. The TIGeR-PaC trial has completed enrollments just last month. We anticipate top-line data second half of next year. Of course, we're scaling revenue and application of RenovoCath, and we'll give progress updates both on the commercial side and all these clinical fronts as we go.
As you've probably seen so far, if you're following, there's constantly a lot of news flow on the great progress we're making, both in the clinical and the commercial side of the company. The last piece I'll leave with is we entered this company and this business to really focus on trying to change the way we treat cancer patients, and I'm very proud to see a lot of our patients being featured on news stories more recently. If you get a chance to take a look, if you go into the investor section of the website under clinical news, there are several news stories highlighting the positive benefits and effects we've had on our patients. This is really what's been driving the commercial adoption, and I feel like the ultimate success of our business. Thank you so much for your time.