Now, beyond clinical research, it's beyond to commercialize as well. I thought it might be helpful. They say a picture's a thousand words. Maybe I can share my screen here and give you a couple of slides, give a little background on the technology and the company. At high level, we've got kind of this dual approach. One is we've got a therapy we've developed called TAMP for transarterial microperfusion. We have orphan drug designation with our drug-device combination product in two different indications. The more recent exciting news, which I believe is starting to get some activity in the stock price as well, is given a lot of interest from physicians last year, changes in the reimbursement landscape, which has been very positive for us, and initial positive readouts in our phase 3 ongoing trial.
We've determined to commercialize the device component of our therapy platform that's been FDA cleared for a few years now with our first full quarter of revenue in Q1 this year. I mentioned the phase 3. In parallel, we've got this phase 3 asset, this very late stage. It's our pivotal phase 3 trial for drug-device combination. We've had one positive interim readout so far, another interim analysis coming, final data next year. On the device side, we're pursuing a $400 million potential peak revenue in the U.S. That's with the currently approved FDA or cleared FDA device alone that we've begun to commercialize in the last quarter. Of course, we have the right team in place for this. It's really interesting to show how the therapy works. I always like to start with this just as a reminder of what we're doing differently.
We've developed this new approach to be able to localize chemotherapy with our delivery mechanism and delivery system. One of the issues with systemic chemotherapy is it circulates the whole body and very little gets into tumors. Specifically in tumors like pancreatic cancer tumors, there's not a direct blood supply to the tumors. Other tumors might have blood vessels that connect to the main vessels that feed them at high doses. Tumors like pancreatic tumors and bile duct tumors do not. Our delivery mechanism called TAMP or our device called RenovoCath aims to isolate a segment of vessel adjacent to the tumor. Once we've isolated it, we give a full dose and volume of therapy between the balloons over 20 minutes, creating a pressure head that then forces the chemotherapy through the vessel wall to really saturate and bathe the tumor in therapy.
You can imagine if you're giving systemic chemotherapy, it's circulating the whole body, attacking all the cells, creating all the toxicities and side effects, but it's very little that's getting into the tumor itself. The crux of our platform is to force drug across the vessel wall and bathe these specific tumors that don't have great blood supply and wouldn't uptake drug as much. That's the crux of how our whole platform works. We patent the technology, the therapy, late phase 3, as I mentioned as well, and now commercializing the product. Really, it's the physician experience that drives a lot of this. It's an outpatient procedure. It's not overnight stay. It's not a lot of—it's conscious sedation. They're not put under from a physician standpoint and simple. As you know, with any new technology, you need to make sure it's simple to use.
Patients or physicians can adopt it quickly, and they don't have the chemotherapy side effects. Just to touch on the new commercial opportunity, we just launched this quarter with initial revenues, actually with early POs coming in December. There are about 7,000 patients that we see this initial application applicable to with a current FDA clearance, which is a peak US market of $400 million. We just posted our Q1 earnings this last quarter as well. What's great about this commercial opportunity, unlike many therapies and technologies, is it doesn't require a large sales force. We'll probably go into more of this in the chat, but just to target on it, if you look at the cancers where we see initial volumes, there are about 200 centers in the U.S. only that treat these at high volumes.
With a very focused small team, we can attack this without raising a lot of capital to get there. I'm going to go through this very quickly, but we've got experience so far in our phase 3 trial and previous trials in locally advanced pancreatic cancer, but there are several other tumor types that behave like these pancreatic cancer tumors that don't have high vascularity or tumor feeders. That's really where we're seeing physician interest in using the device as a standalone and potentially for additional studies down the road. I just want to give a little high-level overview of the company, and I'll stop there, Scott, and let you take it away.
Okay. Thank you, Shaun. We had a lot of companies to choose from for these fireside chats. The reason we chose RenovoRx is you have a late-stage pipeline compound with a proven molecule, but you also have a revenue-generating platform. I think that combination of high potential at lower risk is very desirable in these healthcare markets. Thank you for coming. Let's talk a little bit about the company in the Q&A right now. To start, tell us about selling the catheter. I know it's approved and can be used as desired by the physicians, but how do you kind of steer them into using it in the right ways?
You know, it's interesting, Scott. I appreciate the question. The catheter is FDA cleared for the delivery of diagnostic and therapeutic agents, including chemotherapeutic agents. It's a broad-labeled device. Really, they call it tool claims. It's a broad-labeled catheter, so they can use it for anything delivering these agents or any agents in the peripheral vasculature, so in the blood vessels basically. Where we've seen inbound physician interest is really doctors coming to us saying, "You've got an FDA cleared device. Nothing works in pancreatic cancer and other cancers like pancreatic cancers. Can I just buy your catheter? It's cleared." These are a lot of physicians earlier on where they had patients who wouldn't qualify for our very robust, strict phase 3 trials saying, "Look, they already had chemotherapy outside institutions. They're not treatment naive. Maybe they're not exactly locally advanced. They're borderline resectable cancers.
Can I just treat them?" That has really been the drive behind it. As far as use cases, it is really delivering anything anywhere outside the brain and the heart. The initial interest has been where we have clinical experience in both pancreatic cancer, liver cancer, and other tumors that behave like them. It is really delivery of local agents, not seeing the big side effects and toxicities, that has been the drive for physicians to come to us. Now we meet a lot of these physicians. We have a lot of podium presentations that you will probably see in the news flow. We are getting the word out there to physicians that, "Here is where we have experience." It is inbound interest and then word of mouth between physicians.
As I mentioned, from a sales perspective, we've got zero sales reps full-time right now, and we've already got some revenue posted. It is a lot of word of mouth and physician interest so far that's driving this.
Okay. Great. In first quarter of 2025 was the first full quarter for selling this catheter, generated around $200,000 in revenue. How do you anticipate building on this first quarter to drive continued sequential growth?
You know, it's great because I mentioned that exceeded our expectations. We were hoping to get some points in the scoreboard without a sales force in. We've already begun targeting, I think you mentioned this earlier, we've got 10 hospitals in the pipeline that are in the purchasing process, which means they've either already bought catheters and used catheters and treated several patients. Everything to they're getting through the VAC approvals and the committee approvals to get this on the shelf. Another 20 hospitals in the pipeline behind them. We have 16 hospitals in our TIGeR-PaC phase 3 trial, which we're aiming to wrap up enrollment later this year that are perfect potential customers for us. They're trained. They already understand the technology, the referral pathways. They're already buying the catheter, actually, under the guise of the trial.
We've already got a pipeline of, I'd say, 20, 30, 40 customers built up. It wouldn't take much to drive that revenue growth very fast. Again, keep in mind, each patient that comes in represents between 5-10 device sales because they have between 5 and 10 procedures with this disposable catheter. I've mentioned before that the reimbursement generally fetches prices for analogous technologies where they can charge between $6,500-$9,000 per device. It adds up pretty quickly in terms of revenue. Each patient almost represents potentially $40,000-$70,000 of revenue that we can really drive that $200,000 mark, which is just scratching the surface in the beginning to show sequential growth quarter- over- quarter.
Okay. That's great. What gets us over here at AGP excited about that is that most of the time you launch a product, you lose a lot of money doing it. This is a situation where there's very few incremental costs. It's accretive almost on day one and can really represent what is truly non-dilutive financing to help build the company's pipeline. I think that's pretty exciting. It adds a degree of duration to the company and allows you to build value in other ways. There's not a question in there, Shaun, but we will shift over to the pipeline, RenovoGem. That is how the company was really started. How is that different from the catheter as a standalone? Tell us a little bit about that program.
Yeah. The TIGeR-PaC trial is a phase 3 locally advanced pancreatic cancer with the drug combination you mentioned. It's basically gemcitabine as a generic drug plus the RenovoCath FDA-cleared device. We have orphan drug designation for pancreatic cancer and bile duct cancer. That's wrapping up our phase 3 trial. The intention there has always been to commercialize a drug-device product that's reimbursed as a drug. Those of you familiar with the Delcath story, for example, similar in the approach where they're taking a generic drug, melding it with their system in a kit and as a J code. The two major commercial shots in goal I see is, A, we've got a catheter business that we're launching that could, to your point, fund all of our research and development activities and get to cash flow positive, hopefully, in the not too distant future.
The second big commercial shot on goal is fast forward end of the phase 3 trial. If we have a positive readout, get FDA clearance or approval on the kit, we can commercialize a drug-device combination at a much higher price or ASP. We have a great time to determine. Do we build out the catheter business for other cancers? Do we look at drug-device combinations? We pull back on catheter sales if the drug-device combination reimbursement could be much more lucrative. It gives us a lot of optionality with a lot of downside protection at the same time.
Okay. Great. If one's a physician treating these patients, what are the main advantages to RenovoGem versus traditional chemotherapy?
Traditional chemotherapy is delivered, as we all know, systemically. It goes through a vein in the arm or a port in the chest, and it circulates the whole body. That causes a lot of side effects. What we actually saw in the first interim analysis of the TIGeR-PaC phase 3 trial is a 65% reduction in side effects and toxicities compared to the systemic chemotherapy standard of care. The big win for physicians they see is the patients do not go home feeling like cancer patients. Unfortunately, I think we have all been touched by cancer in our lives through family and friends. The side effects of our current standard of care systemic chemotherapy are debilitating. You cannot get off the couch. You cannot eat. No energy.
It's great to see patients who have received our therapies across several trials and commercially who are actually feeling much better. That's the major advantage, that we're reducing that systemic level. On the flip side, we're also hopefully keeping the tumor at bay and hopefully extending life. We get to using the TAMP mechanism for so much drug locally to saturate the tumor that it looks like the patients are actually able to live longer potentially. We've seen that with our early data sets in the phase 3 trial as well, but really increasing local concentrations and decreasing the systemic toxicities.
Okay. Great. Any bull case for RenovoRx shares likely starts with the TIGeR-PaC pivotal trial reading out positive. Tell us in the brief amount of time we have, why you're optimistic that that trial will read out positive.
There's always risk with any clinical trial, of course, readout. What gives us confidence is a few things. Earlier on, we're taking a drug, gemcitabine, that is so well profiled. This is a drug that's been around for decades. It's standard of care and used in several solid tumors. We know it has a very high effect on killing tumor cells in the lab, in a petri dish, in animals, and in many patients as well. The biggest challenge in tumors like pancreatic cancers is that they can't get the drug there. We found delivery to be the biggest issue. Just theoretically, conceptually earlier on, we had high confidence that if we get the drug to the tumor, we should have a better effect. Through our phase 1/2 trials, we demonstrated patients were living longer.
The interim analysis of the phase 3 demonstrated a survival benefit and we had a positive readout. Even within the ongoing phase 3, we've got an indication that we're trending towards significance and we're trending towards success. Both scientifically and with the early data we've seen, we have confidence that we have a high likelihood of success at the end.
Okay. That's fantastic. One of the bigger catalysts in the company, in addition to the quarterly revenues, is you have this second interim analysis for TIGeR-PaC coming, it sounds like, third quarter of this year. Tell us about that interim analysis and how we should set our expectation.
Yeah. Thanks for the question, Scott. The second interim analysis, just as a reminder, this is an event-based trial based on survival. That was predicated upon the 52nd event, which occurred this quarter. Now there's a whole data cleaning process where they monitor the data. It goes to the data managers, to the statisticians, and they have to check and they have to fact-check everything from CT scans, when progression was, not just survival itself, all the adverse events, side effects, concurrent medications. We expect, given all that data crunching and cleaning, that this should go to the data monitoring committee to review the data in the third quarter of this year. We look forward to the recommendation regarding the continuation of the study and their guidance on interpreting the data and sharing the second interim analysis.
We're waiting for that DMC or data monitoring committee to read out and go from there.
Okay. Great. We're just about out of time. You know, Shaun, one of the things we like to see is a management that eats its own cooking, if you will. On that category, insider purchases, anything that you'd comment on from management or the board buying shares of the stock, particularly in the open market?
Yeah, absolutely. I'm glad you mentioned that, Scott, as we're very, very close to the projects. You asked about the question of confidence of a positive readout. Obviously, we have confidence in the commercial rollout of this as well. Being valued at less than a couple of hundred million is interesting when you look at analogs like Delcath and Novocure, even TriSalus for that matter. We believe as a management team, obviously, we're undervalued. At the last open window, many of us took an opportunity to purchase shares open market. We're in a closed window right now, but at these levels, it seems very attractive to us as well. We can see the potential major value build here.
Okay. Great. Shaun, we are now out of time, but I want to thank you for participating. If investors would like further information, they're welcome to contact us here at Alliance Global Partners or reach out to RenovoRx, the company. On that note, thank you again. Enjoy the rest of your day.
I appreciate the time and the questions, Scott. Good to see you again, as always. Thanks everyone for listening in.