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

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Ryan Rhodes: Well I think it’s both, we’re working all the appropriate geographies the largest MSAs across the country, obviously, looking at all appropriate markets. We’re doing that in our expansion strategy with our commercial team. Additionally, any hospitals again, we’ve had a conversation with in the past, we have made it a priority to get back in front of them, and update them on this looming change here coming with reimbursement that’s important. And that allows us to reengage with them whether it’s a pure economic discussion, or a combined economic discussion with the clinical value and merits of Robotic Focal HIFU. So we’re excited. It gives us another opportunity to not only look forward to new markets as we’re already focused on, but also go back and retroactively look at accounts we spoken to in the past.

Sean Lee: Great, thanks for the additional color. My second question is on the clinical front with the rectal endometriosis study. I was wondering, since previously, for the prostate cancer, it took a while for and HIFU – and focal want to be approved because regulators want to see longer term response and longer term durability data. Is that something that you think they will also be concerned with rectal endometriosis?

Marc Oczachowski: Well, rectal endometriosis, endometriosis in general is a very symptomatic disease as opposed to prostate cancer. That’s not as symptomatic as endometriosis and that’s more also a slow evolving disease. So we might need to get less time of follow-up. And actually as we previously explained the Phase 2 trial as a six months period only of follow-up, which makes it much more – much faster than what it was in the prostate cancer environment. So of course, we need to bring clinical evidence and as you know the MDR regulation in Europe has strengthened the clinical part of the regulatory process. But again, here because we are speaking of preparation symptomatic disease, we might be able to give and to get – conclusion and follow-ups on the much shorter period.

Sean Lee: I see for the potential Phase 3 that’s coming up. Do you feel like a six months follow-up will be sufficient then?

Marc Oczachowski: Well this is, as I said just before, I mean, this is part of the discussions that we are having with the health authorities in Europe to build and get a protocol approved. So we’re not yet there.

Sean Lee: Okay great. Thanks again for taking my questions.

Marc Oczachowski: Thanks Sean.

Operator: Thank you. Ladies and gentlemen, that concludes our question-and-answer session. I’ll turn the floor back to Mr. Oczachowski for any final comments.

Marc Oczachowski: Thank you, operator. Well, that’s concluding our call this morning. Thank you again for your interest and support. And I look forward to our next quarterly update. I wish you all a good day. Bye-bye.

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

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