The 510(k) goes faster generally, and so we’re currently evaluating opportunities to see if we can accelerate this process using that approach. There’s some technical issues associated with that that we need to work through with the FDA. But in either pathway it’s really development of the device in showing that you can write instructions on how to use it appropriately. Not a lot of big hurdles. This is a €“ although the device is quite novel and how we’ve €“ can designed it. The general concept of a vial access needle is extremely common, and the amount of education or instruction in order to use it will be really minimal.
Serge Berlanger: Thank you.
Operator: We’ll take our next question from Kelly Shi with Jefferies.
Unidentified Analyst: Hi. This is Claire on for Kelly. Thanks for taking my question. So my first questions on ZYNRELEF. So I wonder if you can give us more color on your strategy on getting more uptick from those accounts already have consistent ordering? And what do you think will be the inflection point in terms of the sales trajectory for ZYNRELEF? And also, can you share a little bit more about the progress on the EU launch? Thanks.
Barry Quart: Yes. John, do you want to take the first part?
John Poyhonen: Of course. So our focus right now is in our existing accounts, making sure that our representatives are able to really maximize the number of surgeons using a product. So oftentimes in these initial evaluations that are coming about, they’ll start with maybe two or three orthopedic surgeons, and there may be five to eight in practice. So our goal is to really leverage the positive results at the initial trial period had and expand to those other surgeons. The other thing that we’re looking to do is expand within the procedures that we’re doing, so if we’re starting with total, someone maybe could go on mute, there’s an awful lot of background noise there. Thank you so much. So the other thing that we’re doing is looking to expand the surgical procedures.
So if someone’s starting in TKA, we’re obviously looking to do hips. We’re also then looking to expand within an account to other surgical lines. So if it’s going well in orthopedics, what can we do in general surgery and pediatrics, what can we do in C-section, where are additional places that we can grow the business. And we are beginning to see good traction on taking that approach. Some of the flexible resources that we’re adding like the medical device reps are helping a lot too, because they have such a strong relationship with orthopedic surgeons, there may be some that we don’t have strong relationships and are harder to convert. And we’ve already seen growth coming from accounts by using that. So there’s a variety of really strategies that we’re using there.
But I think most of it is just making sure that we’re leaving no stone unturned within accounts that already have existing business.
Barry Quart: Yes. And on the EU question, really no update. We have continually seen a challenging process to find an EU partner, and we have no intention of launching the product ourself that’s an expensive endeavor, and we certainly would not want to use our cash for that at this time.
Unidentified Analyst: Got it. That’s very helpful. And on the APONVIE the launch, you have talked about the early signals you have seen from the launch two weeks ago. And could you maybe give us more color on APONVIE ramp-up? And like what are the additional cells or you might need to support the APONVIE ramp-up? And how should we expect the cost increase associated with that? Thank you.
Barry Quart: Yes. John, do you want to take that?
