Vincent Capponi: Sure. Thanks, Phil. Sean, thank you for the question. So there’s a couple areas that we’ve already started preparation and one is in the manufacturing facility. So we’re preparing that facility to meet all the requirements within FDA. So any potential inspections, et cetera, that were up to snuff with everything. And we’re completing, obviously all our validations, et cetera, necessary to produce DrugSorb-ART. On the commercial side, we’ve hired Jim Komsa, under Vice President of Sales and Marketing; and Scott Brown, our Director of Marketing and Senior Director. And we’ve already developed the go-to-market plan with phase gating with respect to bringing on the resources to build the infrastructure versus we’ll work on back office first, which is again building all the essentially customer services that are training and like.
And then we’ll focus on sales as we near closer to approval. We’ve not pulled the trigger on those additional hires yet. Obviously, we’re waiting till we get the readout. And then based on that will determine when we’ll start bringing those hires in. That answer your question?
Sean Lee: Yes, that’s very helpful. I’ve had a follow up for the START-T, I know you guys have a CE Mark approval for ticagrelor removal already in Europe, would the results from this T — from STAR-T be useful for you to secure reimbursement in the major European countries?
Phil Chan: Absolutely, Sean. I think that was part of the goal. I think we talk about opening up this $650 million TAM in the United States and Canada. But in fact, the data given that DrugSorb-ART uses an equivalent polymer technology, the CytoSorb that data would be directly transferable potentially to the world market with high-quality, randomized, controlled trial data that should hopefully support, not only clinical usage but also reimbursement as well. And so certainly, we believe that will be the case.
Sean Lee: Great. That’s all I have. Thanks again for taking my questions.
Phil Chan: Thanks, Sean.
Operator: [Operator Instructions]. And we will take our next question from Josh Jennings with TD Cowen.
Josh Jennings: Hi, good afternoon and thanks for the questions. Wanted to ask about potential reimbursement for DrugSorb and how you envision coverage in the early commercial period after approval. Will that be reimbursed through DRG? And is with breakthrough designation, can you — are you anticipating a filing for an end cap and potentially having the technology add-on payment in place for launch or shortly thereafter?
Phil Chan: Yes. No, thanks, Josh. That — it’s a good question. As we’ve discussed in the past, at a very base case, we could certainly fall under the DRG because what we are trying to do is actually reduce significant costs from either waiting in the intensive care unit, or in the hospital to wash out the drug, or by reducing significant bleeding complications that are common in cardiac surgery patients undergoing surgery with these blood thinners on board. I think that we, however, seek line item dedicated reimbursement for this and as you say, because of the breakthrough device designation, it gives us the ability to file for the end cap or new technologies add-on payment as a separate reimbursable payment for hospitals, and we are currently pursuing that with consultants.
There’s also another program that we’ve discussed in the past called TCET program or the transitional coverage for emerging technologies program. And this is a program that was proposed by CMS or Medicare & Medicaid and just actually put out for public commentary. And that commentary period is over and we’re waiting for the final version of that program. But that program is designed to — for breakthrough device designated devices that are applicable to Medicare patients. so elderly patients essentially, which CytoSorb and DrugSorb absolutely is given that it’s typically the elderly population that are having heart attacks and are having open-heart surgeries for that problem. And that is designed to guarantee coverage of breakthrough device designated product, devices that qualify for at least three years after FDA approval.
