Lucid Diagnostics Inc. (NASDAQ:LUCD) Q4 2022 Earnings Call Transcript

The — our ability to respond to an updated LCD and seek — remember these are foundational LCDs, they’re general LCDs for the category of testing to translate a foundational LCD into a specific LCD 4. Lucid for EsoGuard will require submission of clinical utility data. So until we have the fishing clinical utility data, which is to respond to the LCD, which we won’t have until midyear. The timing of the LCD right now is not actually hurting us, because we won’t be in a position to do the technical submission to convert it to a test LCD until midyear. But we’re waiting. But the good news is and the reason we’re focused on the commercial side is that, the demographics of the patients being ordered for testing remain — to remain strongly tilted towards commercial payers with 10%, 12% of the patients being Medicare.

So we’ll just continue to wait on the Medicare side, while we’re pushing really hard full steam ahead on the commercial side.

Mike Matson: Okay. Got it. Thank you.

Dr. Lishan Aklog: Okay. Thanks, Mike.

Operator: Thank you. And our next question comes from Mark Massaro from BTIG. Your line is open.

Dennis McGrath: Hi, Mark.

Mark Massaro: Hey, guys. Thank you for taking my question. So, yeah, you guys were very clear about what you need to do to show clinical utility. The positives just need to get a confirmatory endoscopy and the negatives just need to not get one based on the clinician suggestion. So can you give me a sense and maybe confirm that, Lishan, that you plan to submit the clinical utility, was that midyear 2023? And then can you give us a sense for the numbers, I mean, are we looking at like 100 patients, a couple of hundred patients?

Dr. Lishan Aklog: Yeah. I’m going to go back to the previous slide. I hope it was going to show. Yeah. So let’s do — let’s kind of do a deeper dive into this. So just use the model. Oh, hold on a second, Mark, there is technical glitch here. I want to push in the audience. Hopefully, you can see the numbers there. So one quick minor correction to your summary, which is otherwise excellent, what clinical utility mean? It doesn’t even mean that they have to actually get the endoscopy. People fall through, they fail to show up and so forth, loss of falls and things like that. We just have to document that that what the physician did, that the physician ordered the endoscopy or they did not order an endoscopy. And even in negative, there are going to be times where in our endoscopy order for other reasons, right?

But as long as endoscopy was not ordered for screening of — for esophageal precancer then that shows — that demonstrates clinical utility. The numbers I show here are really intended to give you a picture of sort of a number of ways we’re approaching this. I mean this is an all-out effort, multipronged five different areas that we’re focused on there. I like to be more, because each new CheckYourFoodTube event will be another batch of clinical utility data. The main — the ones that are the strongest are the two Lucid registry and CLUE study. Those are the truly prospective studies, which will garner us the most attention from the payers. But all of them are important and all of them will be useful. The — so those are our estimates and our targets for midyear and we will be submitting data as they come in.