Sam Eiber: Got it. Thanks for taking the questions.
Operator: Your next question comes from the line of George Sellers from Stephens. Please go ahead.
George Sellers: Hey, good afternoon and thanks for taking the question. Maybe, to start with Flora, I apologize if I missed this. but I’m just curious what that commercialization might look like, what you’re anticipating and including in your guidance in the fourth quarter and how we should think about maybe the cadence of that in 2024. And then also, I’m curious on the market in the U.S., do you need to have Motiva approval for Flora to see or to really take off that physicians typically use the same tissue expander as the implant that they’re going to use or how does that — what does that market look like in the U.S.?
Juan Jose Chacon Quiros: Yes, of course. So first of all, just as a reminder, the market for tissue expanders in the U.S. is approximately $180 million and it has the highest average selling prices in the world. We will start generating revenue from Flora in the U.S. in 2024. And with the technology that we have based on science, the unique technology with no magnets, which really changes things for these centers. because now, they can do MRIs, they can potentially reduce the amount of radiation oncology, it opens up new opportunities for them in many different ways. So, it is an important change for these centers in the United States. So, as we look forward, if you think about what does Flora do, it creates this very nice interaction with tissue inside a patient that is recovering from breast cancer.
So that tissue is going to define the type of capsule that you have and thereafter, that capsule can be the host for an implant that is already approved for breast reconstruction in the United States or eventually for our motiva implants. But there is no reason to believe that surgeons, who understand this would not see it as a benefit that the initial capsule is created in such a healthy manner by our flora Tissue Expander.
George Sellers: Okay. that’s really helpful. And then maybe, on the Motiva FDA process, you touched on the manufacturing inspection, just curious what steps are left after that manufacturing inspection. And have you seen or been given any timeline on when you should expect that?
Juan Jose Chacon Quiros: No. we have not given any timeline, because it is not in our hands. But we continue to make progress week to week in terms of the question-and-answer process with the FDA. Like I said before, we have provided answers to every single one of their questions now. And that tells you that the process is coming along quite well. They have not yet scheduled that inspection, but we have all the questions of module three, which is manufacturing that have been answered. So, we expect that to happen hopefully sooner than later.
George Sellers: Okay. that’s really helpful. Thank you all again, for the time.
Operator: That is all the time we have for questions today. I will now turn the call back over to Juan Jose Chacon Quiros for closing remarks.
Juan Jose Chacon Quiros: Thank you for joining us on today’s call. We will be attending the Jefferies London Healthcare Conference and the Stephens Annual Nashville Conference next week. We look forward to providing our next quarterly update in the New Year and we wish everyone continued good health.
Operator: This concludes today’s conference call. Thank you for your participation and you may now disconnect.
