ReShape Lifesciences Inc. (NASDAQ:RSLS) Q2 2023 Earnings Call Transcript

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I think they’re here to stay based on all the benefits they provide. Yes, that was the one comment. And that combination therapy, I think that’s — that was the point where we’re trying to collect data retrospectively of patients at NYU and other places that already have GLP-1s in addition to Lap-Band, so we can study retrospectively how well they’ve done in terms of getting off of that plateau, which is where they don’t get the weight loss several months in a row and then they look for an adjustment. But GLP-1s are kind of a way of giving other boost to their system so that obesity has shut down for a bit, making it back on the weight loss path.

Anthony Vendetti: Okay. Great. And then Paul, just a quick follow-up on Lap-Band 2.0. I know you gave an update, but can you give a little bit more of a time line of when you think that could potentially be approved, sort of like a window of comments back and then ultimately, approval?

Paul Hickey: Yes, sure. We’re all chomping at the bit, so to speak, with waiting for the FDA. So what we know with a PMA settlement that we submitted, the day we announced it in June, we actually waited — we gave it to the FDA. We waited until they checked all the boxes and looked for sort of adherence to what they — at a minimum they required. Once they assign a reviewer and they sort of check all the boxes, they tell us it’s not going to be rejected. So we got past that hurdle. We do have a reviewer that’s looking at it. We’ve had one softball question, I think, that we’ve responded to. But we expect over the next several months to start getting more interactive with the FDA in terms of their questions on our submission.

And we believe the submission is very comprehensive. And — but again, that’s the FDA’s job to look at those with a high level of scrutiny. Our expectation is that by the end of the year and at the latest, first quarter, we’ll have a lot of interaction ongoing with the FDA. And as we know more their concerns or questions, we’ll certainly share those as appropriate. But so far, it’s kind of we’re just — we’re waiting for that interaction to ramp up with the FDA so we can focus on hopefully getting it approved and starting the next phase of it, which should be how to commercialize.

Operator: This concludes our question-and-answer session. I would like to turn the conference back over to Paul Hickey for any closing remarks. Please go ahead.

Paul Hickey: Sure. Well, I hope you appreciate the candor and transparency shared during this call and hear our enthusiasm and excitement for the road ahead. We continue to streamline our organization to be more disciplined, sustainable and scalable. And we will continue to work diligently to build our commitment to provide evidence-based personalized devices in therapeutics. A special thanks to Dr. Chris Ren-Fielding for participating in today’s call and the Q&A as well. As always, I want to thank our employees, Board members, customers, consultant advisers, suppliers, existing and new shareholders for your continued support of ReShape as we progress on our mission to become the premier physician-led weight loss company. I do look forward to continuing to engage with our stakeholders, health care partners and shareholders.

Operator: The conference has now concluded. Thank you for attending today’s call. You may now disconnect.

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