EDAP TMS S.A. (NASDAQ:EDAP) Q3 2022 Earnings Call Transcript

Ryan Rhodes: Yes so, very good question. I think the way to look at it is, first of all, buying patterns certainly vary by institution, by region, et cetera and we see that commonly. I think, when we look at our story, and we look at the story of focal therapy, most physicians or urologist, in this case, would certainly say that this is a necessity to have a focal therapy treatment program or offering. And that, you know, in consideration of looking at what the options are HIFU now being called out in the reimbursement is a notable option. So again, I think this certainly is, is helpful and this process will help us as we look into 2023. But I would also say that when senior executives in the hospital think of focal therapy, and they think of HIFU, it is a strategic offering for the institution.

If you think of men with say, intermediate risk disease, you know, what are the best options for them? Well, many will argue that focal therapy is – should be a consideration. So if you don’t have a focal therapy option in your treatment paradigm, you may have a gap. And I think we fulfill that gap with focal therapy, but importantly with Focal One Robotic Focal HIFU. So we’re excited about this change in reimbursement. And again, I think it benefits certainly a lot of patients out there who want access to these types of procedures.

Jason Bednar: All right, thanks, Ryan. Yes and then maybe over on the there is some clinical pipeline items here and first on the rectal endometriosis indication I’m really looking forward to seeing that data next year? Can you remind us what we should be prepared to see when that data is presented at major medical meeting? And then, you know, what are the next steps that you’re contemplating for that indication whether it be in Europe or the U.S.?

Marc Oczachowski: So yes, I mean we’re looking at evaluating with the study the safety, and the efficacy of the treatment on those the factor an endometriosis nodules that’s what we’re expecting to show as the results and the endpoints of that study. Next steps will certainly work on starting a Phase 3 trial, as well as on working on the regulatory paths in both Europe based on the new MDR regulatory environment, as well as in the U.S. with the FDA. So that’s the issue that open us some doors to get studied in more concrete regulatory paths.

Jason Bednar: Okay, thanks, Marc. And then any sense on when that study might kick off just given the timelines we haven’t placed on the Phase 2 and presentation of that and working through the and preparing all the study protocols, and then any early sizing patient enrollment sizing on that study and assuming that would be a kind of a multinational RCT study just any clarification on any of those items?

Marc Oczachowski: Yes, we’re still working on that. And also working with the authorities in Europe to validate and work build a protocol. So we’re not yet there, but we’ll keep the market posted.

Jason Bednar: Okay, all right great. And then maybe one final point – similar question actually BPH study any timeline on when that study should close? I heard the two-thirds enrollment point, but which is a great update. But are – you trying to put bow on some of the timelines here on these items?

Marc Oczachowski: Yes, it’s always difficult to give, you know, timing and such information. I mean, most of you, unicity people that are running a number of clinical studies. So that makes always, as usual, a bit of a challenge to get patient. But again, it’s going well, so we’re confident that we might be closing that, potentially the enrollment at least potentially by the end of this year, if not early next year.

Jason Bednar: All right perfect. I’ll hop back queue. Thanks so much.

Marc Oczachowski: Thanks.

Operator: Thank you. Our next question comes from line of Frank Takkinen with Lake Street Capital Markets. Please proceed with your question.