Hello, and welcome to the Sedana Medical announces positive top line results. Throughout the call, all participants will be in a listen-only mode, and afterwards, there will be a question-and-answer session. Today, I'm pleased to present CEO, Christer Ahlberg. Please go ahead with your meeting.
Okay, thank you very much. Also, participating in this meeting from Sedana Medical, we also have our CMO, Peter Sackey, who also will present a very close to me, and welcome all to this short webcast where we will introduce you and announce the first top line results from our pivotal registration study in Europe, the IsoConDa study. But before doing that, I would like to take the opportunity to give you some summary and some repetition of Sedana Medical, so I would like to go to the next slide, slide 2, where we are defining.
I think this is important because this pivotal study, top line results, support really our vision as a company where we are focusing on that inhaled sedation with our product AnaConDa. That is a delivery device that has been on the market for many years, and it's registered in Europe with long development, many years of development and research. But still, we needed to have the drug IsoConDa, the drug candidate IsoConDa. And these two together would definitely have the possibility to become a new global standard of care for sedation in intensive care units. And especially this day, when it comes to isoflurane and IsoConDa study, we have taken a giant leap towards our vision, I would say.
Going to the next slide, slide 3, we are showing that the blockbuster potential of this product. And as we have already guided, we see a potential approximately of EUR 2 billion -EUR 3 billion annually for this area, where we are calculating the market size in number of patients who are sedated and ventilated, and the average number of days of two to five days, with an average price of EUR 100 per day for both the drug and the device. Going to slide four, despite that this therapy is still classified as an off-label treatment, it's obvious that there is a medical need out there within the intensive care with the current treatment alternatives. We have seen an increase in the interest of using volatile anesthetics and AnaConDa to sedate patients in the intensive care. And currently, we have approximately 50% growth rate of the rolling 12 months. After the first quarter, we have 90% growth.
And we have approximately sold almost 500,000 units of AnaConDa to date. And I mean, as you understand, hundreds of thousands of patients have been treated with this treatment. And this is not only a German demand. We have seen a huge increase also in markets such as France, the U.K., Spain, Nordics, Benelux. To go to slide 5, where we are preparing ourselves for the full registration in Europe, you can see now where we have our direct-based market. We are also preparing ourselves to register in the U.S., where you have the biggest market, obviously. But also outside Europe and the U.S., we see huge potential in distributor markets such as in the rest of the world, in Asia, for instance. And here you can see that it increased during the first quarter.
Going to slide 6, the final slide here, just before going into the next presentation of the study. I mean, we have strategic priorities, and the first priority is, of course, to get the product IsoConDa together with the therapy fully registered in Europe by the second half year of 2021. And in parallel to that, prepare ourselves to launch this fully in the entire Europe. And of course, this study result shows definitely that we are coming very much closer to this strategic objective. Also, we are already looking into the U.S. registration as well, and we are working with. We'll comment on that a little bit later also. And also in the other world, the rest of the world, we have a huge interest in both China, Japan, India, and the Middle East. We have announced a registration of AnaConDa.
Looking into the financial targets which we have guided you, I can just repeat that. And still, we are saying that three years after registration in Europe, we are estimating that we should cover or reach approximately up to 10% of the market potential. And that gives you a revenue of approximately EUR 50 million. And with healthy gross margin, we will also have a very good internal margin on that. So that is the guidance which we have given. And this is European-based. And then additional to that, we will come back to the U.S. potential and also in the rest of the world. With that said, I would like to go into next slide, slide 7, and this is all about the IsoConDa study, the high-level results, the top line results from our study.
Going to slide 8, I just wanted to, before I let Peter continue, I just wanted to give you, I mean, we have already sent out the press release that we have a positive top line result. I would say that this quote that you see here on the screen, this is indeed one of the largest inhaled sedation studies in intensive care which we now have finalized with good results. This is definitely a milestone in inhaled sedation therapy. Also interesting to see that our investigators are really, really interested in this, and they're supporting this, and they look forward really to see that more patients will benefit from the advantages for inhaled sedation in the future thanks to these results.
And I also would like to think about this because, I mean, the reason why we started this study from the beginning was to get the entrance ticket to the market and to get a fully approved and labeled therapy in place, first in Europe. And this result shows that we have taken a giant leap now towards that possibility.
And I think with these words, I will leave that now. I will let Peter continue on slide nine.
So slide 9 shows the different clinical trials that are in support of approval, I would say, globally. The first study is one, the IsoConDa study, as you know, completed. And that will be a solid base for the future studies, the pediatric study, and also for the two U.S. studies that we will be conducting starting next year.
Besides our own studies, we are supporting a number of investigator-initiated studies such as the SESAR trial, which is a study of inhaled sedation in ARDS patients. We have the ISOC trial, which is a study that is in COVID-19 patients starting this spring, and the INASED trial, that's a study of inhaled sedation with delirium incidence as an endpoint. So if we move over to the next slide, slide 10, this is what this meeting is mainly about. It's the registration study in Europe, the IsoConDa study. This is a study that was discussed with the German Competent Authority over a couple of years before it started in 2017, and it's designed to meet their requirements for a registration of IsoConDa. The study started in Q2 2017, and it's a randomized controlled open-label study, randomizing patients in a one-to-one ratio to IsoConDa via AnaConDa or to propofol.
Patients were sedated for up to 48 hours, plus minus 6 hours, and followed during that period and for 24 hours also. Then we had a 7 and a 30-day follow-up. The study was completed in January this year. We plan to submit now after completing the clinical study reports and expect to have an approval in the second half year of 2021. The primary endpoint is the proportion of time with adequate sedation with IsoConDa compared to propofol. We have a number of secondary endpoints, including wake-up times, proportion of time with inhaled breathing, opioid requirements, and ventilated-free days , and also a number of exploratory endpoints. We can move over to the next slide. The top line results from the IsoConDa study.
We move over to slide 12. Here you see the primary endpoint results. We had a high proportion of time with sedation at target RASS -1 to -4 on the RASS sedation scale in those groups. And isoflurane 95% confidence interval for mean time of appropriate sedation with isoflurane was relatively tight. And what we see here is the blue line, the blue horizontal line, the non-inferiority margin of - 15% relative. And you can see that IsoConDa performed clearly well away from the non-inferiority margin. So I'd say that these are quite robust data. They were scrutinized not only with a standard approach, but also with non-parametric testing and bootstrap testing. So we feel confident that these data are solid and will be very supportive for us in our Marketing Authorization Application. Yes, that's true. That's good to say. We have one clinical study, and that's why that's very important also that these data are very significant.
We can move over to slide 13, which is the safety. We have listings of serious adverse events and adverse events, and we didn't see very many of them, and they were distributed evenly in the groups without any safety concerns or probability concerns in data. We move over to slide 14. I'm sure that very many are curious as well as we are when it comes to the secondary and the quality endpoints. These have not been analyzed yet. They will be analyzed in late summer and in the autumn, and we will be communicating them via publication interviews, journals, potentially also some congress, but we don't have those data at present.
Now we move over to slide 15, which is the timeline for registration activities in Europe and the U.S. As I mentioned, the last patient was included in the IsoConDa study in January. And we have just now presented the high-level data. We are starting our pediatric IsoConDa study in Spain, Germany, France, and Sweden in the end of Q3, and we expect to submit the marketing authorization application in Q4 in the first round. In 2021, the pediatric study is expected to be completed, and we expect to have a marketing approval of IsoConDa in the second half year of 2021, and we should likely have a pediatric marketing approval in 2022. If we look at the U.S., we are currently working with human factors validation program and also with pre-clinical studies. We expect to have an IND approval and start clinical trials in 2021, and these will be completed and we'll be able to submit our NDA application in 2023, and that would render an approval in 2024.
In 2022, we will determine internally how we will proceed with launch and marketing in the U.S.
Yeah. And then I also can comment on the, I mean, the European dossier now will be of importance not only for Europe. The European study, the IsoConDa study, will also be supportive in investigating the possibility of what kind of studies we will do in the U.S. We also will use the dossier in Europe for other markets all over the world. I think that's also a key for us in this because many markets and countries trust the European authorities. And we can more or less just repeat them and adapt them to the requirements that you have in the specific countries where you want to apply for. I think that is also important for us.
With that said, we now open up for questions on slide 16. So you are free to raise all questions you have in mind. Please go ahead.
Thank you. Ladies and gentlemen, if you do wish to ask an audio question, please press 01 on your telephone keypad. If you wish to withdraw your question, you may do so by pressing 02 to cancel. And just as a reminder, that was 01 on your telephone keypad if you wish to ask a question. And as there are no questions on the phones, I'll hand it back to the speakers.
Okay. That is, in a way, I mean, what kind of questions could be raised here? But I mean, I think, as Peter said, what I have heard during the first hours after the release is what will happen with the secondary endpoints. I think that's important to remember now that we will explore them and we will actually work to get this study published in a well-renowned, as good as much as possible publication.
I think with that, I think we can stop now. Thank you for your interest and support in Sedana Medical. I also wish you a fantastic summer as well. Thank you very much.
This now concludes our conference call. Thank you all for attending. You may now disconnect your lines.