EDAP TMS S.A. (NASDAQ:EDAP) Q4 2023 Earnings Call Transcript

Ryan Rhodes: Yes, so RK, a couple of–let me try to answer those questions. When you first talked about markets, we received reimbursement in Switzerland in July of last year, so the Thun placement, Holmat Clinic, was a notable win coming off reimbursement. We see more opportunity in Switzerland, we have placements in other hospitals in Switzerland, so we want to take advantage of that. As far as France and, I would say, another market as noted, is the HAS recommendation from the French authorities, they are going through their review process to come back in reference to reimbursement. We hope to hear something sometime later this year – we’re not sure yet. We’re standing by, as noted, and so it’s going to be important for us to recognize what that reimbursement is and activate on that.

Changing over to endometriosis, again the study data, as noted, from the Phase III study, we completed patient enrollment at the end of January. We made a notable press release regarding that. We expect to have data to share in the second half of this year, as we discussed; but more importantly, I think as you were talking toward the end, about our breakthrough designation with the FDA, that allows us the ability to move faster in the conversations back and forth with the FDA, so our goal there is–you know, looking at a data plan that’s acceptable per the standards of the FDA, and being able to work as quickly as we can through that process. I cannot give a timeline right now because we’re so early in the process, but the good news is we have a fast-track process in place to be able to interact with the FDA through getting the clearance at some near future date.

Again, we’ll continue to provide updates on an ongoing basis as we get closer to milestones in receiving that clearance, and that’s kind of where we are.

Swayampakula Ramakanth: Thank you. Thanks for taking the questions.

Ryan Rhodes: Thank you RK.

Operator: Thank you. At this time, I’m showing no other questions. I’ll turn the floor back to Mr. Rhodes for final comments.

Ryan Rhodes: I want to again thank everyone for joining us on today’s call. We look forward to providing another update for everyone on our first quarter 2024 results in May. Again, thank you.

Operator: Thank you. This concludes today’s conference call. You may disconnect your lines at this time. Thank you for your participation.