Thank you for the introduction. Thank you to David, the time out of your, your, those online as well. So I'm Shaun Bagai here, CEO of RenovoRx, and I'm here to talk to you about some advancements we've made to cancer therapy and very exciting new recent announcements of the commercialization effort that's peers and ahead schedule for our technology therapy platform. Just to touch on very high levels, we're, we're a therapeutic company focused on a better way to treat cancer. As we will probably do all too well, we're trying to always balance the systemic toxicities that patients are given when giving chemotherapy versus actually tackling too early extending life. And we feel like we're actually accomplishing both of those missions. At a high level, we've developed a new therapy platform that we call a Trans-Arterial Micro-Perfusion, or TAMP.
We have FDA-approved drug designation for two indications, and we're about to get a parallel effort both on the commercialization front and with the phase III assets. We've got two amazing shots on goal in the very near term. From the commercialization standpoint, we have an FDA-approved catheter called the RenovoCath device, and our first purchase orders were received early in 2024, late 2024, ahead of schedule for commercialization efforts this quarter. In parallel, we're well into a phase III trial called TIGeR-PaC, studying the accommodation of the RenovoCath with gemcitabine and both the advanced angio-LIN. On the commercial standpoint, we're pursuing an initial market opportunity of about $400 million of revenue, annualized, and that initial interest area of the RenovoCath.
As this is a delivery system for drug agnostic, there's potential for much larger market opportunities outside pancreatic cancer, other solid tumors, whether agents involved in the gemcitabine. We definitely have an experienced team in place, both in clinical research and commercialization up front on both the board and management team. Before I go kind of into numbers, I want to talk about what the therapy is, why this works, what the challenges are. If you think about chemotherapy delivering solid tumor treatments, most tumors or many tumors in the body have large blood supplies. These highly vascularized tumors intake nutrients to the tumor, but also serve as conduits for therapy to reach there. If you take liver cancer as an example, chemotherapy circulates the whole body, and it actually hits the tumor because there are tumor feeders that feed the tumor.
This also provides for local target. A physician under X-ray guidance can place a small, simple microcatheter inside the tumor feeder and deliver chemotherapy directly to the tumor. Unfortunately, many tumors inside the body do not have this type of morphology. For example, pancreatic cancers are relatively hypovascular, and they do not have these large tumor feeders, and thus chemotherapy is relatively ineffective because it circulates the whole body. As we all know too well, the side effects really just fool away cells in the body except for the tumor. Chemotherapy flies by, very little gets to the tumor because it does not have these direct connections to the bloodstream. We overcome that with our process we call Trans-Arterial Micro-Perfusion, which is predicated upon the backbone of our delivery system we call RenovoCath.
Under X-ray fluoroscopic guidance, an interventional radiologist can place our delivery system through an artery of the leg and adjacent to a tumor. With a proprietary mechanism, we can adjust the distance between two balloon elements such that there are no side branches, or in this case, escape routes for chemotherapy, and then blow up two balloons. We then give an entire dose and volume of chemotherapy or therapeutics. Imagine 120 mL of fluid and that small space of about one to 2 mL volume in one vessel over 20 minutes. Not having any escape routes of chemotherapy is pushed through the vessel wall using pressure, thereby saturating the tissue of chemotherapy. You can think about it, what we're seeing is a hundred-fold increase in tissue concentration of the therapeutic at the tumor site versus systemic chemotherapy.
Tumors like pancreatic cancers, which had been ineffective when it comes to chemotherapy treatment, we're now seeing a much better effect in terms of saturating and bathing these somewhat invisible tumors in chemotherapy. Again, this is done by pressure. As an example, it's not unsafe for high pressures. If you think about your blood pressure, when we're running and hoping 120 over 90, let's say, a little bit higher otherwise, but we're looking at about 45-60 mL of mercury when we actually start to see diffusion through the vessel wall. Not getting to the high pressures, of course, but the vessel wall, we're able to diffuse the chemotherapy or other agents without causing damage to the vessel and again, saturate the position of therapy. Again, the goal here is to increase local concentration and decrease the systemic toxicities.
We've done some animal studies that I mentioned, and this is actually a proof of concept of using pulmonary arteries for potential lung cancer patients. In the animal tissue, we've seen a hundred-fold increase in tissue concentration in drug. If you think about drug combinations in the pharmaceutical world, generally we try to combine different delivery agents. We're looking at maybe three, four, five, 10 X, maybe 20 at best, not a hundred X, which is why we're probably seeing better results of all the puzzle trials. The flip side of this is a toxicity profile. The right panel is actually a subset analysis of a PK substudy or an ongoing phase III trial, showing a 50% reduction in systemic gemcitabine.
This is why our patients are feeling better after these T-P therapy compared to chemotherapy, because you have a massive reduction in systemic of what you're giving them by the studies. It's very important to think about adoption down the road for new therapy and new technology. Th s comes down to patient experience and also physician experience. For patients, this has proved to be relatively simple. It's an every other week treatment, so patients undergo up to eight treatments over the course of four months. If you compare this, the systemic chemotherapy standard of care, patients often go on a weekly basis. Usually three weeks on, one week off, in case of gemcitabine plus Abraxane for both the advanced pancreatic cancer. Less hospital visits for patients, and they're also from a procedural standpoint, it's an outpatient procedure. They're not staying overnight. It's not under general anesthesia.
They're just made to be comfortable during the procedure and discharged the same day. If you look at other therapeutic areas with complicated devices, usually the patients have to stay overnight and usually they are put under general anesthesia. From a physician's standpoint, simple is very important. We want to make sure this is adoptable by every potential interventional radiologist. From the procedural standpoint, it's about a 90-minute procedure, 20-minute infusion, and what's really easy with this procedure is the same skill sets these physicians use to deliver liver-directed chemotherapy to different liver therapies. Easily translatable, with very low training, i.e., we're there to proctor for the physicians for the first handful of procedures, and then they're free to go on their own, which is very important when you think about the cost economy. You don't need a large field force to train physicians, or many technologies.
You needed someone from the field to be there for every procedure in every case, which translates to a very expensive large pool of force. Our primary focus has been pancreatic cancer to date, with many patients treated with very strong, early success, but this is widely applicable to really any solid tumor next to the blood vessels, specifically where we have an advantage with these tumors that do not have the tumor feeders. The next potential markets for us would be on pancreatic cancer or the pharyngeal carcinoma, bile duct cancer, grouping as CCA, non-small cell lung cancer subsets, glioblastoma down the road, potentially sarcomas, uterine tumors. There is a lot of tumors beyond just pancreatic cancer where this technology is applicable. Moving into the commercial opportunity, this is something that actually came about just last year. There has been a large physician inbound interest in our technology.
It is really because a lot of these tumors are untreatable with current technologies, and physicians and stuff look, I've had patients who have gone to chemotherapy, they've had radiation, they're not responding, we can't take the tumor out, can we give them something different? Based on our early data, they're asking us, can we just buy your catheter? This FDA- cleared, right now it's been only available in the clinical trial to date. Based on reimbursement tailwinds that changed last year, inbound physician interests and our ability to scale manufacturing, we're finally saying yes to physicians. Commercializing a few years ahead of schedule to drug device accommodation and still be studying. This is a bad parallel effort, but we're now looking at commercial leverage that should hopefully get us to capital break even in the not too distant future.
This is based on a new reimbursement code that came out last year. Analogous technologies in the liver space are charging between $6,500 per device. If you think about the fact that each patient has between five, eight, or even more procedures, this is really near therapeutic level pricing. It is not an inexpensive device, but pretty much we're selling a therapy to patients. With this, if you look at where we have experience currently within clinical trials, it's about a $400 million revenue opportunity for some patients. One test from this, from a patent perspective.
From a device standpoint and procedural standpoint, we have eight patents issued in both the catheter design, and then a lot of this is around the Trans-Arterial Micro-Perfusion platform, on how we use pressure to force drug across the vessel while we use radiation ahead of time to pre-treat the tissue bed and around the combinations as well. Another interesting aspect of this commercial record is the cost of commercialization. When we think we're going commercial, you think a $30 million-$50 million raise, not the case here. In fact, we're reporting out initial first quarter revenues, just scratching the surface without a sales force in place at all. If you look at the focus of where we have to put our sales efforts, we don't need a large sales force to tackle the bulk of the market.
Using pancreatic cancer as a, as a, potential example, there are about 200 centers across the U.S. that treat the bulk of non-metastatic pancreatic cancers, 100 of which treat probably 60-70% of them. With a small sales force of three to five sales reps, we can tackle a wide share of the market. In addition to how pop-up we guided that we're in conversations with potential strategic partners that have very deep distribution channels. There are several ways to get to cash flow break-even without any major capital expenditures. Just to touch on the phase III clinical trial, as I mentioned, this is kind of a dual parallel now. We've got the commercialization effort underway with a phase III asset, are TAMP novel. This is studying locally advanced pancreatic cancer with the combination of RenovoCath and gemcitabine.
If you think about the bar to actually achieve success here, when you look at pancreatic cancer, the last major advancement we've seen is the addition of nab-paclitaxel to gemcitabine back in 2013. The addition of the second agent gave us seven weeks survival life. As you can see, there's a very narrow window of benefit we see in this cancer space. This comes with all the toxicities. This unfortunately is a paradigm we see in GI oncology, where any new drug combination comes out with massive side effects and very little benefit. Yet despite the very little benefit, the seven weeks is important enough where this became pretty much standard of care within the first year of launch back in 2013.
This is the bar that's set for us in terms of what's considered clinical success at 68 weeks with more toxicities. We survey physicians and medical oncologists who refer patients for this on what's meaningful and important to them. They said, "Look, with this new therapy, it's a new treatment paradigm. It is a procedure based using catheter. If you show me three to four months of survival benefit, this is a complete block us. This will change the paradigm of pancreatic cancer. Getting out of this rut from 68 weeks, let's see a better toxicity profile, safer for patients, less toxicities, and three to four months makes a big difference to us." Keep that in the back of your mind as we look at our first bunch of data. From a trial standpoint, our randomized phase III TIGeR-PaC clinical trial is still underway.
We did announce our interim analysis, the first interim analysis in 2023. This is one of the treatment programs we see being used commercially as well. Phase III has come in, treatment naive. It is our first live therapy with a really pre-prescribed induction phase. The induction includes systemic chemotherapy, in this case gemcitabine plus Abraxane, plus SBRT radiation. It is about a four to five non-conduction phase. If the patients are still locally advanced, i.e., non-metastatic, and they cannot take the tumor out, they are not resectable after the induction phase, they go under randomized continuation of standard of care. That is gemcitabine plus Abraxane for four months versus four months of TAMP procedure, Trans-Arterial Micro-Perfusion, which is the infusion here of gemcitabine plus RenovoCath. Eight treatments over four months.
After the randomization phase, they go into continuation therapy until progression, and we follow a survival. As you probably seen, there are very few patients that have the hard endpoint of overall survival. Generally, there's surrogate endpoints, but here we're trying to find something meaningful for these patients. Survival being the key one, and of course secondary endpoints by quality of life and tolerability. From a status standpoint, the first interim analysis is complete. We demonstrated a six-month survival benefit and the 30% hook. The second interim analysis is right around the corner. The goal is to have a sample size to randomize a total of 114 patients. We have 16 centers active right now in the U.S. The first interim showed not just a six-month survival benefit, but a 65% reduction in toxicities and side effects.
The second interim analysis is this year, full enrollment completion this year with final data end of next year. This was the first cut of data. This gave us a lot of promise that what we're doing is really making a major impact. If you remember the gemcitabine plus versus Abraxane window would be very small. In the first interim analysis, we saw a six-month separation. It's rare to see this large of a window or spread in these types of cancers. The standard of care for locally advanced pancreatic cancer, we expect about 15 and a half months of survival. We're pushing two years. In a randomized prospective trial, we're actually showing there's a potential survival benefit here. The other side of the coin is not just survival, it's how do patients feel.
Not surprisingly, with a big reduction in systemic gemcitabine, we're seeing a 65% reduction in adverse events. It's very rare to get an efficacy benefit and a tolerability and quality of life benefit. If you step back and think about it, imagine a world where we can treat patients who are not destroying their lives, have miserable lives the last six, eight, 12, 15 months when they're taking therapy. These patients don't look or feel like chemo patients. If you talk to physicians who use our technology, they're back to normal daily life, pretty much a day after the procedure. Unfortunately, I have, and I'm sure many of you have been touched by cancer and family and close friends, it's debilitating to be on the couch, basically wasting away from chemotherapy. A very different paradigm that we're trying to shift in terms of this localized technology.
From a team's standpoint, we've got a very experienced management team and board of directors, and this really spans everything we're touching on. It's not just medical devices, it's not just pharmaceuticals, but also early clinical development into successful commercialization. My background myself, I started off in clinical research with a passion to drive changes in medicine after declining med school, and I really wanted to try to find something on the impact on patients. I've taken my career from clinical research to market development, physician training, sales, and then now building an organization that hopefully will have a lasting impact on industry. Beyond myself, I've got a few additions to the team on the commercial side, and deep experience in clinical research. The board is very similar. It spans across clinical development, sales, marketing, and most recently we added Dr.
Robert Spiegel to our, as our, board of directors. He was a previous Chief Medical Officer at Schering-Plough . He's helping drive more efficient pathways on how we actually get more data out there without having to go through long expansive clinical trials, given the robust nature of a randomized ongoing phase III trial. Our recent data has attracted larger members to our excited advisory board, including Dr. Margaret Tempero, who's a diehard medical oncologist. She's actually chair of the NCCN Guideline Committee, who writes the guidelines on pancreatic cancer treatment, and Michel Ducreux, who's internationally famed for his work in cancer research as well. He's actually looking at, hey, what's beyond gemcitabine, what's beyond pancreatic cancer. As we start to expand the potential for the platform, we have the key members in place to do that.
From a highlights perspective, as I mentioned, I touched on this but maybe more detail. Our goal was to commercialize in Q1 this year. After a year of research last year on reimbursement, physician demand, potential of scale of manufacturing, we've actually not just recognized revenue this year. In December, we had a few early purchase orders for RenovoCath posting $43,000. I have got it publicly. We anticipate this first quarter, again without a sales force, to post revenue that we'll report out next month. This is, again, RenovoCath has a standalone basis today while the phase III trial is ongoing. One of the reasons why we delayed commercial efforts, given the inbound interest, is I want to make sure we don't jeopardize the ongoing phase III trial.
Now that you're planning a rapid enrollment this year, like we that we can actually treat patients outside study as well, we see that interest also. I anticipate that we see quarter-over-quarter growth of revenue. This is just scratching the surface right now, so it'll be exciting to watch us turn this into a commercial company with great success throughout the year as we wrap up the clinical trial for TIGeR-PaC. With these first indications, we're expect usage. Again, we look at a $400 million peak revenue. And from a cash position, it's great to have these commercial opportunities in front of us. We're basically completely funded for our operations with that in the near future. We exited 2024 with $7 million at the bank. We raised a high-quality deal in February, right before the crazy economic history we've been having so far.
It's great to be well capitalized with a $12 million common-only bill of mortgage. For the first time in the history of our company, I really institutionalized a shareholder base. I'm looking forward to the first year of filings coming out next month, so people can also see who's really backing the company. This is really an interest based on this commercial story of our transition. From a shareholder's outstanding standpoint, we're at $36 million. A couple of other things to touch on. Our window opened on Monday, so we do have insider and board purchasing activities in the open markets. You'll see form fours out there. There's an awesome opportunity there. Another interesting piece is, as we look at the tariffs really facing us, our catheters aren't built in the U.S.
We have such little risk, and it's almost, you know, if you could say recession proof, local manufacturing, pancreatic cancer is where we spent the bulk of our time, and we've already developed some initial commercial success. We are really primed to build out a great year for us despite all the headwinds in the entire global market scene. It is great to be well capitalized and well positioned to both achieve our commercial results and our phase III results on the back end of that. Thank you so much for your time. Any questions? Thanks.
Good. I'll do it. [audio distortion]The question was, can catheters be used by others as well? And do other physicians outside of radiologists or other indications?
Yes, so far it's been primarily pancreatic cancer to date. That's where we're focusing our efforts, has been that meet their potential.
The catheter has been used before we launched the phase III trial at Columbia University. Dr. David Madoff started experimenting with the catheter for a subset of liver tumors. As you remember the cartoon and how we're looking at these non-vascularized tumors, this cartoon simplifies and shows that there's like one major tumor feeder. There's a subset of liver tumors that actually have little tiny tumor feeders, and there's not one good target. If you can imagine our catheter system flanking all the little tumor feeders with four skeletor beads. That's been done commercially and clinically about several years ago. Now with the commercial efforts, I've been interested in using the catheter for those indications and also in bile duct cancer and as it behaved by pancreatic tumors and so forth. We will see that this year. Any questions? No questions?
I've added the investor basically the best.[audio distortion] The question is, how are you going to manage, DC by the market as a device company, I guess, and/or a pharma company?
It's actually a great question because when you look at Analyst coverage wise, there's a confusion of are we follow or are we commit device? What's great is that we get the best of both worlds. We actually have a commercial opportunity with a device today. It's got hundreds of millions of opportunity. To complete the study in a few years from now, let's say we finish final data end of 2026, potential to approve with the drug-device combination in 2027, we can behave more like a pharma company with a JFL reimbursement.
What you see today is going to be very analogous, like the training and labor reward evaluation wise to a company called Delcath, one TriSalus and NOLF here. If you look at Delcath, it's a drug device combination using a generic drug, localized treatment, specifically for a very small subset of liver tumor systems. You know liver metastases. Valuable for $500,000,000 today as a drug device combination. As we go for approval with the combination, we can see that is a potential upbeat. Parallel, we behave almost like a TriSalus. Remember the TriSalus, CSLI? They've been a major directed catheter that they're commercializing. They posted about $30,000,000 in rarity last year. It's almost like we've got this parallel effort on both sides. We actually fit great for Pharma and Biotech investors who are looking for that finery outcome and then potential revenue.
We actually fit great for the med device investors who are looking for, okay, what's the de-risked medical device potential revenue and acquisition for the device companies. To me, in one piece, Boston Scientific led our series of funding of a program company, still remaining our shareholder. We will want with several competitors that express interest in both distributing for us with short-term distribution agreements and potential acquisition down the road. The third potential is a bit over here. A multi-billion dollar company has a device in addition to liver space. It gives us multiple shots to hold. The question was, any plans of a CE mark of the device? Once they abolish the MDR, absolutely have. In all serious, the U.S. market is so large and so lucrative from a cost perspective as well.
There's about $400 million opportunity, I'd say within a few years from us. The idea is to tackle the U.S. market first. There is interest in Asia and in Europe as well. As we start to scale and become self-sufficient, you could imagine right now our burn is about $750,000 a month is what we reported last year. With less than $1 million a burn and with a revenue potential of $6,000-$10,000 per procedure, five to 10 procedures per patient, it wouldn't take many hospitals to get to a breaking out. I'd like to get completely capital efficient first, self-sufficient, and then sort of go answer the U.S. and use efficient here. Thank you for your questions.