We're good? All right, hi everybody. Try and squeeze in and find a seat where you can. Just a quick look at our forward-looking statements. So who is CorMedix? We are a publicly traded small-cap commercial stage biotech company in the process of commercializing our lead product, DefenCath. DefenCath is an FDA-approved, first-in-class, non-antibiotic antimicrobial catheter-lock solution, initially indicated to reduce the incidence of catheter-related bloodstream infections in the limited population of adult hemodialysis patients receiving chronic hemodialysis through a central venous catheter. The product was approved in late 2023. We began commercialization with a soft launch in April of 2024 and a full-scale launch in July of 2024. We are in the process of building the business, and we've given our first half revenue guidance for this year of around $70 million of net sales from existing purchasing customers.
We've also recently commenced a phase three clinical trial for an expanded indication in total parenteral nutrition. First patient in for that study dosed just this past month. It is a relatively small study, less than 150 patients, a 12-month study end-to-end. We're hoping to run it in around 18 months and file our NDA by the end of 2026 or beginning of 2027. In terms of our commercial launch, I do believe our commercial launch has gone incredibly well. In terms of the market opportunity for DefenCath, it spans two settings of care currently. The first, or largest from a volume standpoint, is in outpatient hemodialysis. The other is on the hospital inpatient side. In outpatient hemodialysis, we have a very concentrated customer base. The top five customers represent just under 90% of the market.
We currently have agreements in place with four of the top five outpatient dialysis operators and have begun implementing with three of them, those being the mid-size operators. We have an agreement signed with one large dialysis operator, and we are optimistic of beginning implementation in patients in the middle of 2025. Currently, DefenCath is being used in more than 4,000 patients across our existing customer base, largely on the outpatient hemodialysis side, but we are beginning to see utilization ramp up on the inpatient side as we recently rolled out a dedicated inpatient field team in the beginning of 2025. We anticipate continued upward growth in this setting of care over the next few years. CorMedix has a deep and experienced leadership team. Many of us have decades of experience across several different therapeutic areas in pharma, and I am joined here today by our CFO, Dr.
Matt David. Let's talk a little bit about the problem of CRBSI, specifically within the ESRD community or the dialysis community. In ESRD, about 800,000 patients are receiving hemodialysis every year. 80% of those patients start with a catheter for vascular access. About 25% of those patients are going to remain on a catheter for vascular access until they ultimately qualify for an organ transplant. On the hospital side, acute kidney injury patients also receive hemodialysis when hospitalized. Incidence of AKI is around 5 million admissions per year, but a smaller percentage of those, about 10% of those, receive inpatient hemodialysis while they are hospitalized. In terms of CRBSIs, catheter-related bloodstream infections are one of the most debilitating side effects you can get or that is associated with getting hemodialysis through a CVC. They happen incredibly often. About 25%-33% of patients will get a bloodstream infection.
Half of them occur within the first three months that a catheter is inserted. They lead to double the number of hospitalizations, four times the length of hospital stay, and double the length of hospitalization cost. Apologies. I think most troubling, though, a patient with a CRBSI is three times more likely to die than a patient without a CRBSI. If you look at these Kaplan-Meier curves and you can see how quickly they separate from each other, it really is a compelling unmet medical need in the ESRD space. CRBSIs are the second leading cause of death in the HD CVC community after ESRD itself. As I said, about 15%-25% of the patients that get a CRBSI ultimately will die from them. In addition to the patient mortality risk, it is a tremendous impact on the healthcare system from a cost standpoint.
Each hospitalization can cost upwards of $60,000 or more. The federal government itself, or the healthcare system itself, most of which is Medicare, spends about $3.5 billion a year on the hospitalizations and downward costs associated with CRBSIs. Let's talk a little bit about our solution and what it is. DefenCath, it's a combination of taurolidine and heparin. Taurolidine being a non-antibiotic antimicrobial that has broad spectrum activity, gram-positive and gram-negative bacteria, as well as fungus. It is not an antibiotic and has not demonstrated any antimicrobial resistance. It is combined with heparin. As a catheter-lock solution, it's instilled into the catheter in between times that a catheter is accessed. From a clinical trial standpoint, our Lock-It 100 study is the largest study ever run for a catheter-lock solution, just under 800 patients. The study demonstrated a 71% reduction in risk associated with CRBSI.
I think as impressive as the efficacy from a safety standpoint, no material difference in adverse events compared to the standard of care in this study, which was locking with heparin. From a market opportunity standpoint, as I mentioned before, the product currently spans two settings of care where it's predominantly used. The first is on the outpatient dialysis side, where, as I mentioned, five dialysis operators make up approximately 90% of the market opportunity. This is a sizable market opportunity. We believe about 40 million vials of DefenCath make up the total addressable market, or just under 40.
Other setting of care is on the inpatient side, where inpatient hospitals perform overall about 10% of the volume of dialysis treatments split between end-stage renal disease patients that need to be dialyzed when they go into the hospital or acute kidney injury patients who are crash-landing into the hospital and need to be dialyzed. From a commercial execution standpoint, as I mentioned, I believe our launch is going incredibly well. We commenced a soft launch in April of last year and a full-scale launch in July. We are very much an SG&A-light, in my view, platform. On the outpatient side, our sales team is comprised of a handful, predominantly market access and contract-related salespeople. On the inpatient side, we have recently built a dedicated inpatient field team. Currently, 28 field-based professionals are calling on roughly 875 facilities.
Those 875 facilities represent about 80% of the market opportunity that we see for DefenCath. We also recently announced a partnership with WSI to bring in six key account managers to call on VA facilities, which we believe could be a meaningful opportunity for DefenCath growth as well. We're currently in the midst of, as I mentioned earlier, looking to expand DefenCath to other therapeutic indications, the first of which is in total parenteral nutrition. Patients that typically receive IV nutrition through a central venous catheter have very high rates of infection, and those infections also often lead to increased mortality. In addition to the study we've recently kicked off in TPN, later this year, we expect to kick off a pediatric study in pediatric hemodialysis. We expect that study to span a couple of years. We've also recently stood up an expanded access program.
Beyond adult TPN, which is in our phase three study, in our expanded access, we expect to collect data on high-risk populations such as pediatric TPN, peritoneal dialysis patients, neutropenic oncology patients, and other patients that are at high risk for infection and have exhausted other options for infection mitigation. Turning back to TPN, as I mentioned, incredibly high infection rate, approximately 25%-26% of patients will incur a CRBSI or a CLABSI, a central line-associated bloodstream infection in this condition, which also leads to a higher rate of mortality, 12%-25%. In addition, TPN increases the risk for fungal infection, which is a much higher rate of mortality of greater than 30%. It's important to note at this point that DefenCath, in addition to having activity against gram-positive and gram-negative bacteria, is also active against multiple strains of fungus, most notably C.
auris, which is one of the most lethal strains of fungus. In terms of the total addressable market for TPN, we have sized the market at just under 5 million infusions a year, which we believe approximates to about 10 million vials of DefenCath 3 mL. We have also put out public guidance around the dollar size of the total addressable market. We see between $500 million and $750 million. We believe the peak annual sales potential for DefenCath in this market is $150 million-$200 million a year. Just a quick look at our financial metrics. Currently, based on today's or last week's closing stock price, fully diluted market cap around $850 million. We closed last quarter with just over $77 million in cash on the balance sheet. We obtained cash flow positivity late in the fourth quarter. We are cash flow positive for the first quarter of 2025.
Reported first quarter 2025 net revenue of $39 million and first quarter adjusted EBITDA of just over $23 million. We've guided first half of this year revenue, as I mentioned, to about $70 million, and that's from existing purchasing customers. And we've given full-year cash operating expense guidance of $72-$78 million. Relatively short presentation today. I'm happy to take questions from the audience. Going once? All right. Thank you, everybody. Appreciate your time and appreciate your interest in CorMedix. Thank you.