EDAP TMS S.A. (NASDAQ:EDAP) Q3 2023 Earnings Call Transcript

Frank Takkinen: Okay. That’s helpful. And maybe just the last one for me. Excited to hear the update on endometriosis. Can you just drop the time line? What that might look like if you do achieve that enrollment completion by the end of this year? When could we see a readout? And then maybe it’s too early to speak specifically to commercial strategy, but maybe broad strokes, how you’re thinking about that market commercially, assuming everything goes to plan with the clinical trial?

Ryan Rhodes: Yes, so we’re excited about the study in particular, and the fact that we’re through a lot of the enrollment already. As mentioned, we want to finish enrollment by the end of the year. There will be some analysis and follow-up, of course, on the patients. And I would say sometime later next year, we would be in a position to use that data, or have that data presented, in the form of as submitted a manuscript to a major journal. But equally, we are working through the process to get ready for getting in front of the FDA. We’ve got some very compelling data. Remember that this is the Phase 3 study. There was a safety study, the Phase 2 study, and that data was around was reflective of 60 patients treated. And that study included, and we’re looking to get that data out sometime probably in the early second quarter of next year.

So we’ve got lots of great data that’s coming out. We’re excited to close the remaining study, the randomized controlled trial, and again, post-closing patient follow-up statistical analysis. And we’ll move forward with that data in the form of a submission. So again, we’re bringing our best people together to make sure we get this closed out and we look forward to being able to share the data and outcomes in the broader community.

Frank Takkinen: Great. Thanks for taking the questions.

Operator: This concludes our question and answer session. I would like to turn the floor back over to Ryan Rhodes for closing comments.

Ryan Rhodes: I want to again thank everyone that joined us for today’s call. If you are unable to join us in New York at either Morgan Stanley or H.C. Wainwright investment conferences, in September, we will be participating in the Jefferies Global Healthcare Conference in London, or Piper Sandler’s Conference in New York City in November. We look forward to updating everyone on our fourth quarter and full year 2023 results early next year. Thank you.

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