Sean Lee: Thanks for that.
Christian Steiner: Sufficient.
Sean Lee: Yes, I do expect this, just as a quick follow-up and do you expect this growth to continue for the rest of the year?
Christian Steiner: So, I think that the stabilization and the big market in Central Europe will continue. Of course, the underlying market situation with the post-pandemic situation is not clearing overnight, but there is a lot of very strong initiatives from our side where we address new customer groups and expand to different indications. So, I think that we can create growth out of this. And the growth we have seen in the direct sales countries in Europe and also distributor countries, I very much expect to continue to develop nicely.
Sean Lee: I see. Thank you for that. My last question is on the PuriFi system. So, with the launch imminent, I was just wondering how is the commercial structure for that set up and what sort of impact can we expect in this year or in the next several quarters?
Phil Chan: I think that the PuriFi pump is really a means to an end, right. As I mentioned in my comments, is meant to help to build an infrastructure of blood purification in distributor territories where they don’t have an existing strong infrastructure in dialysis or dialysis technicians for that matter. This is a pump that we are actually using for the vet market in the United States and we have gotten lots of feedback that it’s a very easy to use pump that requires very little in the way of maintenance. So, we are very excited about this because what it’s intended to do is to drive more sales of CytoSorb, obviously in places that have plenty of critically ill patients, but does not have that infrastructure. The other thing that it’s intended to do, as I mentioned, is to really drive earlier usage and more frequent usage of our technologies, because what we have found is that when you treat people early and you try to catch this deadly inflammation more rapidly before it has time to cause destruction to vital organs, outcomes are typically much more reliable and much better.
And so, again, we think that having this PuriFi pump out there will be able to really – is actually a major key driver of growth hopefully going forward. We haven’t made our expectations public on what we expect that pump to do, but again, the goal here is an enabling technology to sell more CytoSorb devices, it’s very similar to the printer or printer cartridge model.
Sean Lee: Thank you. That’s all the questions I have.
Phil Chan:
Sean:
Operator: Your last question now comes in from the line of Tom Kerr with Zacks Investment Research. Please go ahead.
Tom Kerr: Hi guys. Quick question on the DrugSorb submissions, I understand they will be submitted roughly at the same time to FDA and Health Canada. But are the approvals independent or are they done in conjunction, or put another way, is the Health Canada approval timeline also six months to a year?
Phil Chan: Vince, maybe you would like to try to answer that.
Vincent Capponi: Sure. So, this is Vince Capponi. So, the approvals are independent. They are not dependent. The Canada – Health Canada is not dependent upon the U.S. approval. We will use the same data, but we will structure the submission slightly different as required by Health Canada than what U.S. FDA requires. So, they can be done in parallel and independently.
Tom Kerr: So, it’s possible you could start in Canada in six months and U.S. in a year, and there would be just different timeframes in that regard?
Vincent Capponi: Yes, that’s correct. I mean Health Canada has timelines as well. I mean they follow closely to the U.S., but they are generally faster than the U.S. But it is possible that it could be introduced in the U.S. or it could be introduced – excuse me, into Canada sooner than the U.S.
Tom Kerr: Great. And one more on that topic, I think you had said in the past the addressable market is about $325 million for both countries. Is that still a good number, and can you break that down between the U.S. and Canada?
Phil Chan: Yes, that is still a good number. I think that although, as you heard from Makis, that our focus will be on the isolated CABG population. Recall that isolated CABG is the most common cardiac surgery in the world, right. This is being driven by coronary artery disease and people having heart attacks, which is one of the leading diagnoses in hospitals among any illness. And so the major use case is not to go in for one of these more severe surgeries, right. If a person is thinking that they are having a heart attack, most of them are really having a heart attack and will need if they don’t qualify for a stent, they will need CABG surgery. And far fewer will be actually having a different diagnosis like a ruptured valve or a dissecting aorta.
So, the fact that we are going after the isolated CABG market is, and we have data that we believe supports a favorable benefit to risk assessment in that population is a really positive thing for us and positive for the overall market opportunity. Now, from U.S. to Canada split, it’s roughly a 10-to-1 split. The U.S. market is 10x larger than the Canadian market. However, what is very fascinating about the Canadian market and what you may have heard Dr. Whitlock say on the call, on the KOL analyst call on Monday, is that in the guidelines, and he again reiterates how data-driven the Canadian physicians are. So, in the official guidelines for blood thinner treatment in people having a heart attack, it is recommended that they only be placed on Brilinta and not on the major competitor in the United States, which is Plavix.
And we have also understood that, Effient, the only other major competitor in the United States to Brilinta and people having a heart attack is actually not distributed anymore by its manufacturer in Canada. So, pretty much everybody is on Brilinta in Canada. And Canada has some very interesting dynamics. One of the major reasons why you put someone on dual anti-platelet therapy is because you are trying to temporize them and trying to prevent that heart attack from getting worse by thinning the blood and trying to prevent that clot from propagating and getting bigger. And in Canada, the dynamics are such that there are far fewer major cardiac centers in Canada. And you find that many people are in far-flung areas of Canada that require transportation or intervention for a heart attack, either PCI or CABG, to these major cardiac surgery centers.
And so are out there suffering from these cardiac symptoms for a long time while they are in transit. And this is one of the reasons why the use of dual anti-platelet therapy in these heart attack patients is so high because they need to be protected as they get transported to these major cardiac surgery centers. So, Canada is a – we believe, will be actually a very strong market for us. And maybe with that, maybe, Makis, if you had any other color that you wanted to give, that might be helpful.
Makis Deliargyris: No. Thanks Phil. No, I completely agree with the remarks that you made already. Canada has a very uniform treatment paradigm that they actually have implemented on a national level where they try to adopt best therapies. They quickly come up with a national guidelines and [indiscernible]. And CABG is a great example. And again, I urge everyone to listen to our webinar and to hear directly from Dr. Whitlock. But there is a very, very systematic approach to care in Canada. And what we are hearing is that one of the major issues is a bottleneck that is created in some of these large volume institutions. So they are very enthusiastic about a solution that can potentially alleviate that congestion that patients are just sitting there waiting or causing in their care pathways.
Now, in regards to the total addressable market and the number that you quoted, I mean, if you want, you can take the discount similar to that we saw in the breakdown of surgeries in STAR-T, where 92% of patients wear isolated CABG, which obviously will be the target intended population in our submissions. But on the other hand, you may want to counter that with the fact that this is the year that exclusivity ends for ticagrelor, which would mean an ongoing reduction in price, which has been one of the reasons why ticagrelor – I am sorry, clopidogrel, Plavix and older generation, not as effective medication is still in use in some places due to a much more favorable price with clopidogrel being generic now for a long time. So, we think it’s going to be fluid, but probably the upside will be greater due to the greater adoption that is happening anyway and the availability of generic ticagrelor going forward after 2024.
