First of all, congratulations on your listing.
Thank you so much.
Could you please tell us more about Sedana? What are your business?
Yes. So Sedana Medical is a medical device company, and we're bringing a new generation of sedation to intensive care. So if you are a patient that needs to be treated in an intensive care unit and you can't breathe by yourself, you need to be mechanically ventilated because you maybe had an accident or a surgery or a trauma or a sepsis, then it's quite likely that you need to be sedated, so put to sleep or relaxed down a little bit so you can cope with the situation, the fear, the anxiety, the pain, and also to tolerate the plastic tube that's down your throat and the machine forcing oxygen into your lungs. So it's a very, very uncomfortable situation.
And what we've shown in the big clinical trial is that patients that received inhaled sedation with our Sedaconda products were better off than with the old standard of care. They woke up faster, they recovered faster, they needed less opioids, and they also have better chances of breathing spontaneously. And importantly, they were also shown to leave the intensive care unit several days earlier. So very fantastic results, which was the basis for approval in 17 countries so far. So now we're working hard on becoming the new standard.
Sounds good, and why should one investor look at your business? Why should one invest in Sedana?
Yeah. So from an investor perspective, the company has been through a roller coaster ride during and after COVID, with first a very, very steep increase and then a dramatic decrease in the number of patients in intensive care units. So now we are gradually moving into a new normal after COVID, and this is really the time to refocus on the fundamentals of the company, which I think are very, very attractive. So we have quite high gross margins, around 70%. So by definition, when we reach scale, this can become a very profitable company. And we already have the proof of concept for that because more than half of the intensive care units in Germany are already our customers. So we have shown that it can be done. We've reached sales levels that allow us to be quite profitable on a local level.
Now it's really about replicating that success in more countries. As I said, 17 countries where we have the full approval. Lots of places for us to grow, which is very exciting. On top of that, we're already preparing for the U.S. market, which is our largest potential market. Clinical trial is ongoing. FDA has granted us Fast Track designation, which is fantastic. We've already run a trial in Europe with the same endpoint. We are really optimistic that we can repeat these results and hopefully bring this to American patients in 2025.
Why was the step to the Main Market an important step for you?
Yeah. Well, first of all, as I said, it's a quality stamp for us. It's a very rigorous process, a lot of work by my team that has gone into this. Very proud of my team that we've gotten to this point. But from a business perspective, we're becoming more global, as I said, full approval in 17 markets. We've sold the devices in more than 40 countries. We have the U.S. as the next growth horizon just around the corner. So the story is becoming much more interesting, much more appealing to investors, of course, in Sweden, but importantly, also outside Sweden. So we're hoping to broaden our shareholder base internationally.
Thank you so much.
Thank you.