Anthony Vendetti: Okay. And then, I just want to make sure I understood correctly. Are you — I mean, from what I understand from prior studies, the Hemopurifier is pretty safe. There haven’t been any adverse events in any of the prior trials. So, if you’re running a safety study now, is there any reason that you feel that, that is necessary or required?
Steven LaRosa: Right. Well, each patient population is a different entity. So, we’ve only dosed two prior patients in oncology. And so, it is important from a regulatory perspective to demonstrate safety and feasibility within that population. So that is a key — still a key feature of the trial, even though we — as you’ve mentioned, we have treated patients in over 160 sessions now of the Hemopurifier with a fairly benign safety profile. So — but it’s still important to actually look at the safety and feasibility specifically within the oncology population. But there’s more to this trial than — safety and feasibility is the main objective, but it’s also looking at exosome removal and dosing and downstream effects on the immune system. So, there’s a whole lot wrapped into the study.
Anthony Vendetti: Okay. And then lastly, the partnership with NAMSA, can you talk about how that — how that’s going to work from a cost structure or cost sharing as you move that partnership forward?
Guy Cipriani: Hi, Anthony. This is Guy. I’ll just kind of lead off and say it’s really a fee for service relationship. So, they’re providing service for us, we’re paying a fee. And it’s fairly typical of what you might expect for a contract research organization. So, we, obviously, looked at multiple firms. We picked NAMSA because they sit operationally and from an expertise standpoint with what we wanted to do. And frankly, the cost was in a range that we felt was very acceptable for this service. So, other than that, I don’t know, Jim, do you have anything to add?
Jim Frakes: The only other point — this is Jim, Anthony.
Anthony Vendetti: Okay. Got you.
Jim Frakes: For the work that’s going to be conducted in Australia — the Australian government could change the rules, I mean, there are many scenarios. But everything being equal, they don’t change their guidelines, we should be able to recoup 43.5% of money spent on R&D in Australia. So that chunk of the NAMSA fees potentially will build in our recoup.
Anthony Vendetti: Okay. That’s helpful.
Jim Frakes: And then, on the choice of NAMSA, so we did an exhaustive review. They have a footprint in Australia where they know the investigators quite well, those who’ve done the trial, they have a keen understanding of the regulatory process, and they also have particularly in their leadership, expertise, not only in devices, but in oncology and the combination thereof. So, we thought it was going to be the best team that would be that — a CRO could seal for this kind of trial.
Anthony Vendetti: Yes. No, it looks like — based on everything you mentioned, looks like a great choice. Lastly, just shifting gears to COVID. I think you said you have one enrolled in — I think that’s the one in India. But is that — at this point, based on keeping costs under control and so forth, do you believe that’s still worth the efforts to continue that trial? Or will there be a point where you might say what, this — is our resources are best utilized elsewhere? Maybe just give a timeline on that, or what the timeline is to make a decision whether to continue with that or shut it down?
Jim Frakes: This is Jim again, Anthony. The Indian trial is not cost prohibitive. We have a very reasonable relationship financially with the CRO. We may pull the plug at some point, but they are looking at additional hospitals. They do have a billion people there. And if the variants do become harsh in the future, it may make sense. We’re excited about the possibility. There’s no assurance we’ll find the right PI and center to do a similar oncology trial in India, but that’s pretty exciting to us. So, it’s a very low cost option that we have there with that COVID trial going on in India.
Anthony Vendetti: Okay. Thanks. All right, I appreciate the update. I’ll hop back in the queue. Thanks.
Jim Frakes: Okay. Thank you.
Operator: Our next question comes from Vernon Bernardino with H.C. Wainwright. Please go ahead.
Unidentified Analyst: Hello, everyone. This is (ph) calling in for Vernon. Thank you for taking our question. Can you please help us understand the current COVID landscape in terms of opportunity to continue advancing the Hemopurifier? And if priorities were to change, what are your thoughts on what it would take to continue development?
Steven LaRosa: Yes, thanks. This is Steve LaRosa. I’ll try to answer your question. So, as you probably know, the — although there are still a number of COVID cases, the incidence of severe COVID requiring hospitalization ICU stay has dropped dramatically, making it not a feasible population to conduct a trial in acute COVID. But as I mentioned, there is now evolving data about the role of exosomes in patients with this PASC, this Long COVID protracted symptoms for which there aren’t good therapies. A lot of this data came out of the University of California San Francisco and they have a file repository, which were of patient samples, where we’re now actually able to look at, are there specific features of those exosomes, and are those exosomes amenable to removal by our device?
So, the potential exists that we’ll learn something that will inform us that — provide us with the translational data to justify perhaps a potential clinical trial in Long COVID. So, I think that’s still an area that needs to be explored and we’re going to do that.
