We have three more presenting companies here at Redeye Medtech & Diagnostics event . First up, Sedana Medical with CEO Johannes Doll. Welcome.
Thank you, Oscar, for this kind introduction. Thanks to all of you for taking the time of watching this short company presentation of Sedana Medical. So who are we? Sedana Medical exists in order to improve life during and beyond sedation. That's our purpose. And in order to live up to that purpose, roughly 100 colleagues, including myself, get up every morning and work very hard on making inhaled sedation the standard of care in intensive care units. And of course, I will get much more into what that means and how that works. But if you're in medical devices, it's always a good place to start. Whose lives are you making better? And in our case, those are mechanically ventilated patients in intensive care units. If you look at the world, roughly 30 million patients every year need care in an intensive care unit.
And about 40% of those need to be mechanically ventilated. So they can't breathe by themselves, but they need a machine to breathe for them, a ventilator. That can have a number of different reasons. Could be they had an accident, a big surgery, multiple organ failure, sepsis. The list is very long. Could also be COVID during the pandemic, of course. And now most of us have been fortunate enough not to experience this ever, but it's very easy to imagine that it's a very uncomfortable situation. You're in an environment you don't know, the ICU, a lot of machinery around you, a lot of beeping, alarms going off. You're most likely in pain. And you have a plastic tube down your throat and a machine forcing oxygen into your lungs.
It's very easy to understand that a lot of these patients need to be sedated in order to cope with the situation. Sedana Medical is here to change the way that sedation is done. Historically, the current standard of care is intravenous sedation. A needle in your arm, typically a drug called propofol, and that works. You can sedate patients that way, but it comes with a lot of drawbacks. Most importantly, propofol accumulates in the body. The longer you're ventilated and sedated, the more you have in the system. You will see that these patients take a long time to wake up, take a long time to recover. Once they wake up, they often have neurological problems like hallucinations, being very disoriented, delirium.
And propofol even has its own syndrome, propofol-related infusion syndrome, which doesn't, of course, occur so often, but still in 1% of the patients. And if it occurs, it's very often fatal. Now, what we are bringing at Sedana Medical to the ICU is inhaled sedation. So sedation with a gas, as you would do it in an operating theater. And the big advantage here is a gas you breathe in and you breathe out. Only a very, very small fraction stays in the body. And we've run a big clinical trial in Europe, which was also the basis for our approval. And in that trial, we have shown that we are as good as propofol when it comes to the sedation as such. So nobody has to worry about the patients not being sedated, but there's clear benefits. So our patients woke up faster, significantly faster.
You saw that there was more spontaneous breathing, so more breathing out of their own strength, and they also needed less opioids. We even performed a post hoc analysis based on these data showing that our patients left the ICU four days earlier than a propofol patient. Just to give you a rough idea of what that looks like, inhaled sedation by Sedana Medical consists of a medical device. That's a real innovation here, the Sedaconda ACD, the little black thing you see on the slide here, and also our proprietary drug, isoflurane, Sedaconda isoflurane, and the beauty with that system is you don't, as a hospital customer, have to buy new capital equipment. It will work with the existing ventilator infrastructure here. So you're only buying the consumables from us, and you will insert that into the existing breathing circuit.
Now, we're living through a time where there's so much going on, both in the world, Ukraine, inflation, recession, energy crisis, supply chain crisis, as well as in our market, specifically the ICU, much less patients in the ICU after COVID, hospital staffing shortages, et cetera, and all of that is, of course, affecting how we're performing as a company. It's affecting how analysts are looking upon us, and it's also affecting how you as investors take investment decisions, so I sometimes find it helpful to take a step back, put away all the noise, and remind ourselves what Sedana Medical is really about. We do have products with a very attractive gross margin. This quarter, 70%, up from 68% a year ago, so by definition, once we reach scale, this can become a very profitable business.
And we already have proof of concept for that in Germany, our main market, where we're already generating EBITDA margins on a local level that are way above the 40% long-term guidance that we've given out. So it can be done. And the real question here is, can we reach scale? So do we believe in inhaled sedation as a concept? Do we believe in our technology? And do we believe in our ability to convert enough hospitals to use inhaled sedation as a standard of care? And here, I would argue we have the right ingredients in place. I talked about the clinical benefits already. On top of that, we have shown health economic benefits that were even confirmed by NICE in the U.K. So hospital actually saves money if they use our therapy. And we're not just targeting Europe.
We're also targeting what will be our largest potential market, the United States. Yes, sales were down this year quite significantly in the first half, but I do see very good momentum. So we are at a much higher level than we were before COVID because much more hospitals are experienced with our products now. We have shown sales growth in the markets in last quarter, where we have our own teams on the ground. And also, we are continuously adding new customers while being very successful at keeping the existing customers. Lastly, very important in this environment, we have a strong balance sheet. So we have SEK 676 million on the bank account, which allows us to execute on our plans without having to ask the market for more money, which, of course, is a big luxury in this environment. On the operational side, we have two big priorities.
One, I already said. In Europe, of course, we want to grow inhaled sedation as much as possible. We're doing that with a mix of our own markets in Germany, France, U.K., Spain, Benelux, and the Nordics, and a few distributor markets. So far, we've gotten approval in 15 countries. There's a few more, including the U.K., that we're still waiting for. And at the same time, while it's still a few years out, there's still also a big priority for us to already now prepare for the U.S. market. U.S. market, clearly the largest potential for inhaled sedation, five times as many ICU beds than our largest market, Germany, today. Also, the price level on a net basis for propofol, so the comparator therapy is three times higher. So very clear that there's a big potential.
There's two phase III trials ongoing, basically the same trial setup that we've already run successfully in Europe, and if all goes well, then we will launch in the U.S. in 2025, and here, we have taken an important decision that we will build up our own commercial infrastructure in the U.S., launch the products ourselves. Doesn't mean that we're not open for complementary partnerships, if somebody can help us get more access faster, a faster ramp-up, et cetera, but I think there's a big strategic value in having the destiny in our own hands. A quick look on what's currently happening in the market. I already said it. We're currently seeing much less patients in the intensive care units than a year ago. Part of the explanation is that there's less COVID patients. That's not a surprise. That was, of course, expected.
But what happened at the same time is a massive staff shortage in a lot of the hospitals. And what that means is if you don't have enough intensive care nurses, your intensive care unit will operate at a lower capacity. You will have to postpone surgeries that are not immediately life-threatening, which also contributes to the lower number of patients. And at the same time, we tend to forget that in Sweden sometimes, but in our main markets, people were much more adhering to the hygiene measures still. So wearing face masks in public transport, working from home, not moving around as much. So we had a very mild flu season, and you also see much less pneumonia patients in the ICU. So all of this together, a big decline in patients in the ICUs this year.
But the good news is it's most likely temporary because humanity will not all of a sudden be much more healthy than they used to be. That you also see reflected in the sales. I think that shows quite nicely the trend here. Before COVID, steady growth on a lower level. Then you really had this trend break during COVID because there were so many more patients in the ICUs. And now we see this downward correction in 2022, but we're still left on a much, much higher level than we were before COVID. So 70% more in the first nine months than 2019, which was the last year that was not impacted by COVID. And if you look one level below here, there's some very good indicators that I'm seeing. First of all, I already alluded to that in the third quarter that we just published the report yesterday.
We were able to show organic growth in the countries where we have our own teams, both in Germany and also in our own other direct markets. On average, we've added three new hospitals per week on average since the beginning of the year, which is a good number. And we're also quite successful in keeping the company, the customers that we have. So in Germany, for example, we looked at the top 100 customers we had in 2021, ranked by sales, and we checked how many of them bought again in 2022. And turns out we've actually not lost a single one. So if I take all of these three things together, growth in direct markets, new customer inflow, very, very limited churn, that causes me to look into the future very optimistically.
What I would like to leave you with is if we turn things around and we imagine inhaled sedation was already the standard of care. So every physician has learned this at med school. They're using this every day. It's the standard for decades. And then a new market entrant comes to the market called propofol. And all that they can say is, "Dear doctor, so we have this new sedative. It's not better. If you use it, your patients will need more opioids, more painkillers if you don't want them to be in pain. You will see that they breathe less out of their own strength. You will also see that it takes them longer to wake up, and they will recover a little more slowly. And by the way, they will hang out in your ICU for four days longer.
Then who do we think should be the standard of care here?" And that, I think, is really the ambition for us because we are convinced that we're really making a difference for these patients. A lot of them are really doing better and recover faster and wake up faster in a very critical situation. And that's why the ambition is really to convert as many hospitals to use inhaled sedation as standard of care as possible. With that, I thank you very much for listening.