Lucid Diagnostics at Canaccord Conference: Medicare Coverage in Focus

Lucid Diagnostics (NASDAQ:LUCD) presented at Canaccord Genuity’s 45th Annual Growth Conference on Wednesday, 13 August 2025, providing a strategic overview of its efforts to secure Medicare coverage for its esophageal precancer detection technology. CEO Lishan Aklog shared both optimistic and cautious insights into the company’s financial strategies and market penetration goals.

Key Takeaways

• Lucid Diagnostics is awaiting a critical decision from MolDx regarding Medicare coverage, with a Clinical Advisory Committee meeting set for September 4th.
• The company is maintaining a steady test volume to engage payers while keeping operating expenses flat.
• Lucid is confident about achieving Medicare coverage within a year, which is expected to drive significant revenue growth.
• Strategic partnerships and a scalable infrastructure are in place to support increased test volume and market expansion.

Financial Results

• Test Volume: Approximately 2,756 tests were performed in the recent quarter, aligning with the strategy to maintain volumes between 2,500 and 3,000 tests per quarter.
• Reimbursement Rate: The company receives about 17% on the dollar, mainly from out-of-network commercial payers.
• Claim Denial Rate: Currently, 83% of claims face denial, primarily due to the lack of medical policy or experimental status.
• Operating Expenses (OpEx): Efforts are focused on keeping OpEx flat, with a cash burn of $10 million expected to decrease slightly.
• Revenue Growth Outlook: Lucid anticipates solid revenue growth next year, with substantial growth potential in subsequent years.

Operational Updates

• Medicare Coverage: A decision from MolDx is pending, with a CAC meeting scheduled for September 4th as the final step in the process.
• Commercial Coverage: Lucid is gaining traction with regional commercial plans, including a recent policy from Highmark in Upstate New York.
• Partnerships: The company is forming partnerships with health systems and concierge medicine groups to boost revenue.
• Salesforce: The commercial team has fewer personnel than before but has increased productivity.
• Manufacturing and Laboratory Scalability: Facilities in Mexico and Irvine, California, are prepared to handle increased demand, with the capacity to scale up to a million tests per year.

Future Outlook

• Medicare Coverage: The company is optimistic about achieving Medicare coverage within a year.
• Commercial Coverage: Lucid expects to secure significant commercial coverage.
• Market Penetration: Aiming for at least 0.5% penetration in the total addressable market.
• Sales Team Expansion: Plans to expand the sales team following Medicare coverage approval.
• Focus on Traditional Sales: Shifting towards direct sales to primary care physicians and health systems.

Q&A Highlights

• MolDX Process: The current reconsideration request aims to change a non-coverage decision to coverage without altering LCD criteria.
• CAC Meeting Purpose: The meeting will provide clinical context rather than re-evaluate existing data.
• Draft LCD Timing: A draft LCD could be issued by year-end, pending the CAC meeting and MolDX processes.
• Backlog of Claims: Claims from the past year can be submitted retroactively once final LCD approval is obtained.
• Competition: Lucid’s EsoCheck technology is highlighted for its superior targeting and sensitivity compared to competing technologies.

Readers are encouraged to refer to the full transcript for a detailed account of Lucid Diagnostics’ presentation and strategic insights.

Full transcript - Canaccord Genuity’s 45th Annual Growth Conference:

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Canaccord Genuity Growth Conference. I’m Kyle Mixon. I cover life science tools and diagnostics for Canaccord. Really pleased to have, Lucid Diagnostics here with us for a fireside chat. Lucid offers a method to detect a pre cancer for esophageal cancer.

With the company we have Lishan Aklog, the company’s CEO. Thanks Lishan for joining us today.

Lishan Aklog, CEO, Lucid Diagnostics: Thanks Kyle, it’s great to be here.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: So you know, Lucid’s been around for a while but maybe some are not, like, you know, know the story that well. So just give you a walk through look and overview of the company and technology and maybe, you know, kind of the landscape of the Sure. Market you’re looking

Lishan Aklog, CEO, Lucid Diagnostics: Again, thanks. Great conference. Thanks for having us here. So yes, Lucid was founded in 2018. We licensed technology from your alma mater, Case Western Reserve University.

And this is technology that, as Kyle mentioned, relates to esophageal cancer. So esophageal cancer is the second most deadly cancer we have. It’s really a rough, brutal disease. It’s essentially a death sentence upon diagnosis. And that’s true for even stage one disease.

So there’s been a real need, a real unmet clinical need, a real thirst for having the ability to detect the precancerous conditions so you can actually do true cancer prevention. And that’s one of the things that we’re proud about, that we actually are truly in the business of preventing cancer, not just early detection of cancer. The good news is that even prior to the founding of Lucid, there’s a really good understanding of the biology of how it progresses from heartburn and reflux through these precancer stages ultimately to cancer. And that there’s a point at the late stage precancer where you can intervene and stop progression to cancer. So all of those elements have been in place.

The target population has been really well defined. We know who these patients are. It’s basically, heartburn and three out of six risk factors. You know, over 50 white male, obese smoker or family history, you have about a 10 chance of having a pre cancer. And so if we can identify those patients who have pre cancer, they can be monitored if they have an early pre cancer, and if they have a late pre cancer, you can intervene and prevent cancer.

Historically, endoscopy has not worked, even though guidelines for going back thirty years have said we should be finding these patients. People just don’t get endoscopies. It’s an invasive test and the compliance with that has been low. So now comes this molecular test that can be performed on samples that can be collected non invasively in an office setting with just a sip of water. There’s a little balloon capsule that you swallow.

And in a minute, you can have targeted samples from the lower esophagus that can be sent to a central laboratory. And there are these two genes where you can check methylation signatures on that have incredible performance, and really unprecedented performance at detecting particularly these early precancer. It’s not that easy. There’s just not that much abnormalities there. But the test is very sensitive at doing so.

Just the high level, it’s got a ninety nine percent negative predictive value. So if it’s negative, you know that it’s not that you don’t have these a very high probability you don’t have that, these conditions. And it works as a triage test. You basically get the biomarker test. If you’re negative, you’re good to go.

About 80% of people can avoid the invasive test. And if you do end up being positive, it increases the yield of finding disease in the positive patients. So we have a the cell collection device was FDA cleared quite a while ago. We’ve had a laboratory developed test available on the market. We’re approaching 40,000 tests performed to date.

And we got payment for Medicare that was attractive at $19.38 dollars That was issued in 2021. And we’ve been, over the last few years, have been working hard on coverage policy on Medicare, which is really the main event that we’re dealing with right now, as well as commercial payers. And just building up a clinical evidence package so that we can have meaningful conversations with payers. That package was pretty much done by the end of last year. That led to us submitting a request for reconsideration of an existing non coverage LCD, local coverage determination by the MolDx Group.

And now we’re coming to the end of that, we believe. We have a meeting coming up on September 4 where we think is really the final stages in this process as they’ve reviewed our data and are bringing together the other Medicare contractors as well as clinicians to discuss the clinical utility of the test.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Great. So let’s probably talk about the meeting in a second. But first, you had earnings this morning, I guess I announced results late last night. So you did like I think 2,756 or so tests. It’s kind of a, I believe like a step down from the first quarter.

Just talk about, like, you know, if we’re looking at the volume the past like several quarters, why is it, you know, is it like kind of lumping? Yeah.

Lishan Aklog, CEO, Lucid Diagnostics: So we’ve been in this mode where we’re waiting for coverage. We’re we’re billing. We’ll bill millions of dollars a quarter in testing. But coverage is at the end of the day, you you have to wait for coverage to get paid. And so one of our fundamental strategy, really going back over the last year or so, has been to try to maintain a sufficient amount of volume so we have the ability to engage with payers.

You can’t just sort of sit and wait and say, hey, give me a policy. You actually have to be submitting claims and going through engaging with the medical directors and having activity. But we’re trying to do so in a way where we’re cognizant of our cash burn and OpEx. And so our goal has been to keep our OpEx flat and to keep our test volume somewhere between 2,503 tests. Now sometimes that will go up.

We had a quarter in the fourth quarter of last year where we did substantially more than that. And some of that volatility relates to the fact that one of the ways we’re able to generate a meaningful amount of test volume without while keeping our OpEx down is to be a bit more sort of more highly efficient methods of doing that, which include these check your food tube events, these health fair type events where we can, you know, go off and make an arrangement to test a bunch of firefighters with one rep who’s there engaging with the physician who cares for them. And we can bring in, you know, dozens or hundreds of tests and so forth. So some of that up and down is related to that. And even on the revenue side, you know, some of those, it makes volume a bit more lumpy with regard to the payers you have.

But this is all sort of consistent with this level of being sort of mid throttle. We’re not trying to drive volume until we are at higher levels of reimbursement. Or generally right now we’re getting paid, you know, I think this quarter was about 17% on the dollar. And most of that is out of network commercial payers who will pay us out of network. They’re paying us pretty close to the Medicare rates, so the price is holding with regard to that.

And the story now is all about coverage. And as we start, once we secure Medicare coverage and as we start securing commercial coverage, then we’ll have the motivation to put our foot on the gas and really drive test volume and growth.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: So the denial, so like 83% of the claims were denied in the quarter?

Lishan Aklog, CEO, Lucid Diagnostics: It’s in various, yeah, that’s about where we’ve been. These are out of network, I think Dennis on the call today kind of broke it down. But it falls into a variety of categories. You don’t have medical policy, so you’re not covered. Sometimes they’ll say it’s experimental, in which case we can appeal and say, well, we have guidelines.

You know, we’re in all three of the major guidelines, two GI guidelines, we’re in NCCN. And sometimes on appeal, we’ll get them to reverse. But generally with commercial payers, if you don’t have medical policy and a contract in place, you are not going to, and you’re getting paid out of network, lots of times it’s hard to recover a meaningful amount of that. And in order to get medical policy, you need data. And so we’ve really only completed our clinical validity and clinical utility package of data, the clinical evidence package, really only wrapped up in terms of the stuff that was in peer review at the end of last year.

So it’s really only this year that we’ve been in the ability to have meaningful engagements. They know who we are, but to have meaningful engagements with the commercial payers. And as I said on the call this morning, you know, we’ve always, we’ve generally assumed that the commercial payers as a broad group are waiting for Medicare. And that’s probably true for the larger, the bigger payers, the ones that operate under these LBMs like Evercore and so forth. But what we’re learning is that the regional plans, the regional root cause for Shields and others, are very willing to talk to us and they’re not actually focused on Medicare.

So our, you know, we got, a Blue Cross plan in Upstate New York, Highmark, that, issued policy in the spring. That was really only after a few months of us being able to present the full data package and the health care economics. And as I mentioned on the call this morning, our pipeline for regional plans that are engaged with us, that are actually evaluating us for medical policy has really grown. And those conversations that we’ve had with the medical directors are very much sort of on the data, where’s your clinical validity, where’s your clinical utility, give us your healthcare economic models. And so they’re digging in the weeds and we think we’ll actually start securing more and more regional commercial plans for coverage even before Medicare is finalized.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Okay, and then you have some partnerships with like health systems, and concierge medicine groups, things like that. It’s not really affecting the volume right now, but maybe it is having an impact on the ASP or something, and then also maybe that’s a longer term

Lishan Aklog, CEO, Lucid Diagnostics: Yeah, so let’s start with the health systems first, because those are longer lead times. You go to a health system, you have typically a GI gastroenterology champion who believes in this, who sees the opportunity to have an impact. You know, unlike walking into a private, like a primary care practice where you’re just saying, you have patients, great, here’s the relationship between cancer and the heartburn, we have a test, a non invasive test, we can get them to kind of start being active earlier. The larger health systems have much longer lead times. So we’ve been talking to Hogue for a year and a half or so, which is the one we announced in the fall.

But when you do actually complete those and they actually launch these programs, they’re really exciting because it’s using our test as an anchor to a broader program for cancer prevention, esophageal cancer prevention, within their entire health system. They have 200 primary care physicians. They’ve got a couple of dozen gastroenterologists. We have the head gastroenterologist who’s a really charismatic guy who’s very, very much determined to wipe out esophageal cancer in that region. And so it’s a full fledged program.

We work with them to train their practitioners to do the cell collection part of things. It’s a fully integrated thing that just got online, as you said, but is wrapping. Is will start seeing the fruits of that in terms of volume and and then ultimately revenue. They do happen to have a concierge practice, within the whole health system. That actually is an interesting angle because there we’re not dependent on claim submissions and traditional insurance.

Those are contracted arrangements in the concierge practice. So we’re starting to see some traction that we think will start showing up on our numbers in the coming quarters.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Okay. Let’s talk about the Medicare situation. So first of all, the mix for Medicare within your volume currently or maybe trailing twelve months, whatever you think is more valuable. What is it like 1010%

Lishan Aklog, CEO, Lucid Diagnostics: to 15%. It’s bounced around in that area. But, I think this is really important, and we covered it a bit on our call today, which is that the population of patients who are recommended for screening, just the straight up guidelines, you know, how many people are out there who qualify for guidelines who should be tested, it’s about thirty million patients. And half of them, forty to fifty percent of them, are Medicare age. So that’s the population.

We just have made no particular effort to go to target Medicare patients in these early periods. So our levels, I think at one point we were at twenty percent, but they’ve generally bounced around between ten percent and twenty percent, just sort of the random nature of who we test. And in fact, our population tends to be a bit younger because, as I mentioned, a meaningful portion of our test volume is coming through these health fair events, which tend to be working firefighters, and so they tend to be, not retired on the younger side. But what that means for us now is that we have a significant opportunity, based on our own execution, without the whims of dealing with these commercial payers, to start driving more actively pursuing and driving the Medicare population. And there are other companies that have done that, you know, we’ve already started that process in anticipation of getting Medicare.

So that includes allocating resources in states and in geographies where we know there are higher concentrations of Medicare patients, such as Florida and Texas, Arizona, Southern California. And there’s lots of tools right now that are digital tools, whether through Facebook or through other means where you can actually acquire data. You can actually say, show me all the physicians in this particular zip code that have high Medicare, percent practices and also happen to be high prescribers of anti acid PPI medications. Boom. So that can feed directly into Salesforce and directly into how our team targets.

So we’ve started that initiative now in anticipation so we can start seeing those numbers go up in anticipation of actually. Then obviously once we get Medicare coverage, we can, our goal will be to get to fifty percent, you know, from where we are today in an active fashion.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Got it. That was, you kind of like touched on my next question of like, you know, can you, if you got coverage tomorrow, you like flip on, like flip the switch and just like.

Lishan Aklog, CEO, Lucid Diagnostics: Yeah, I mean everything about what we’ve been building as we’ve been, you know, going through this, you know, it’s a bit of a slog, right, to get through the coverage process as well as through Medicare. But everything we’ve done to date has been focused on making sure that we had a scalable, infrastructure. So that goes from the kind of the routine stuff like, you know, how, you know, the cell collection tool, the EsoCheck tool, the manufacturing. That’s scalable. They just need to add lines.

We have a high volume manufacturer in Mexico and Tijuana that can, you know, if we say we need a million next year, they can do a million next year. That’s not a problem. Our laboratory, in Irvine, just outside Irvine, California, same thing. Right now we’re doing 10 to 12,000 tests a quarter. They can we already know just based on spikes, can manage five times that volume with very with very minimal additional resources, human either human or capital.

And, to get higher than that, we’d have plenty of lead time in order to, to build extra capacity. So that’s fully scalable. And then the same is true for our commercial team. You know, we’ve actually kept the volume around where we are with actually less personnel than we had a year and half ago. And at one point, we were pushing 40.

We’ve kind of, you know, because we have longer tenures and there’s a bit more productivity, we’re right now operating in high twenties. And all of the training, all of the, know, just literally down to talk to her acts about how do you focus on primary care physicians, how do you focus on GIs, what is the pathway to get fire departments to get grants so you can do these events. All of that’s in place, and it’s pretty well locked down. I mean, they’re effectively SOPs at this point. So we, starting with Medicare coverage, I think we’ll have some momentum going into that because we’re starting to get folks to, we actually have new training to get folks to engage with the physicians on Medicare patients.

We’re not looking to just turn the switch on and suddenly add 100 reps. We’re going to be responsible about that consistent with our revenue trajectories and keeping our burn unlimited. But we we’re ready. Yeah. There’s no no everything is in in place for us to be able to dial that up at the appropriate time.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Okay. So just go back let’s provide some background. Like, so go go back to, like, 2022, 2023. When you did the first like draft LCD and the final LCD came out for for this kind of testing. You know, it’s a non coverage decision.

So there’s like a final, you know, policy either that does not cover your test. Look, maybe we just talk about what was missing.

Lishan Aklog, CEO, Lucid Diagnostics: Yeah. It’s interesting. Yeah. So nothing was missing. So, and I’ll hopefully can convince you of that.

So the, you know, the process of the LCD actually started in 2020. We came to them and said, we have one paper. That was the paper that, from Case Western, that led to we have no clinical utility data. We have the science behind this. But we really think that you guys should start the process of proceeding with a coverage determination because we’re going have the data.

And they didn’t have to agree to do that. They could have just said, come back to us when you have all the data, then we’ll start this process. And, they didn’t because we’re, you know, there’s been a clear sense from the beginning that there’s a strong interest within MolDX leadership, about this category of tests, this category of tests to detect esophageal precancer. So that culminated, as you said, a in few steps along the way. There was a CAC meeting actually in 2021 that led to a draft that led to ultimately the draft was a little bit of a mess, but there was a comment period that led to a final.

And if you read the final, yeah, the top line says it’s noncovered. But then you, if you kind of ignore that and you read the rest of it, it says, we will cover tests, and it gives the criteria and it matches. It’s a perfect LCD for us. It matches the ACG criteria. And it says there are no tests that currently have sufficient CVCUAV data.

Was true. We didn’t. Even at that point, we still just had that one published test. But we know from our conversations with the MolDX that the purpose of them putting that out was to provide a roadmap to us. Again, they didn’t have to do that.

They could have just said, you know, we’ve done our analysis. We’re not issuing any kind of an LCD. Come to us when you have the data. They put that out there so that it was clear what the pathway was, that they were open to the idea of covering tests within the guidelines according to the ACG. And when you’re ready to come back with tests, yeah, we would have loved that to be a foundational coverage LCD.

It ended up being a non coverage LCD. So to flip it, you have to do a reconsideration as opposed to just coming in with a technical assessment. So but still, we’re extremely happy that they did that because the alternative would have been we would be starting from scratch now, now that we have the full data. So that culminates into last year. At the mid midpoint of last year, data was coming together.

We had a few papers that still needed to, end up in peer review. And we engaged with with the with the MultiX team in, July. We had effectively a pre submission meeting where we showed all our data, you know, really positive feedback, multiple, you know, meetings with leadership culminating in the submission of the reconsideration to flip this. So my sense is that this was always the plan from their point of view to kind of give us a road map, wait till we have the data, go into a reconsideration. They’ve they spent the first half of this year reviewing it, And now we really believe that they’re at the last stages here with regard to the CAC meeting.

Because the purpose of the CAC meeting, as directly articulated to us from leadership, is to just add a bit of clinical context to the clinical evidence that’s already in place. It’s not to interpret the clinical evidence. They already understand that. Again, I’m just stating what we’ve been told. But to provide context from physicians who are in this space.

Gastroenterologists, primary care physicians, leaders in the field, as well as just people in practice to say, yeah, we’re part of the group that ordered these 40,000 tests. We’re building an entire program at Hogue centered around the clinical utility of EsoGuard. So these more subtle clinical utility matters that are not easily captured in a clinical utility paper that gets published. It’s to kind of fill in some of that context for them and we are very confident that that’s sort of a last box that they’re checking in that process.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Okay. So, the reconsideration request was accepted and now like, you know, Max especially MobX which Noridian is like a part of the program. You know, they’re now having this cocky hack meaning it’s like part of the the process. And there’s gonna be a, you know, a list of questions that’s announced. Yeah.

Maybe like three to five days before.

Lishan Aklog, CEO, Lucid Diagnostics: Yeah, I think maybe next week, but we expect it to come next week or so.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Next week. Okay. So I mean, we would not like it’s a nice lead time to look into that. After that though, like in the time line, it’s a comment period, I think it’ll be forty five days. But if you look at the last CAC meeting in, like, November or maybe it was October 2021, you know, you you didn’t get the draft LCD until the ’22.

Lishan Aklog, CEO, Lucid Diagnostics: So Yeah. But that’s it. But let’s make sure that there’s a different context if you think about it. Right? So then what what at that point, the the CAC meeting in in in 2021, there was no Yeah.

LCD at all. I mean, they were basically deciding should we proceed with an LCD in this space. Mhmm. And the and what the, what the physicians at the CAC meeting said, yes. It I was a little bit of a jumbled meeting, but there was wide enthusiasm for non endoscopic testing of pre cancer, and that led five months later to a draft LCD.

Right? Here, it’s completely different. There is a final LCD. The request for reconsideration is not asking for any changes to the LCD at all. It’s just saying flip non coverage to coverage.

Say there is now a test that has so we’re not asking for them to do any additional work. And so our expectation is that it won’t take that long, that they are at the last stages, that the CAC meeting is sort of filling in the final bits with regard to clinical utility, and that, know, look, there’s workflow issues, there’s other things. We can’t really predict how long it’s gonna take. Just one real correction. There is no comment period after the CAC meeting.

That’s after the draft. Right? So you go from CAC to draft. That’s just a waiting game until until they issue that. Once the draft is issued, which from our point of view, is the milestone because they don’t they’re not gonna issue a draft unless they intend to cover it.

If they don’t intend to cover it, then they’ll just tell us we’re rejecting your request for reconsideration. We don’t we obviously have no expectation that that’s going to happen. So once they have a draft, that’s a commitment that they intend to to cover this. There’ll be a comment period. They’ll they have to go, you know, allow that to happen by statute.

You know, that’s the forty five days of comment and and and so forth. And then a final will come will come at some point after that.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: So the draft could come, you know, like weeks or months after the the CAC meeting.

Lishan Aklog, CEO, Lucid Diagnostics: Like it

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: could, like by year end, basically.

Lishan Aklog, CEO, Lucid Diagnostics: It could. Yeah. I mean, I, you know, I I guess I, you know, I’m just careful not to not to predict things that are not completely in our control. But our strong sense is that we’re kind of, you know, at the very final stages of this.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: And they wouldn’t have you think they wouldn’t have had, like you know, so this kagging if it wasn’t too strongly consider Yeah.

Lishan Aklog, CEO, Lucid Diagnostics: Because let’s just kind of flush out a little bit. If there was an issue with our clinical validity data, for example, and they said, you know, we don’t really think you’ve proven, that the test is valid in Medicare patients. They wouldn’t call a CAC meeting. They would just say, we don’t think you have enough data. We have enough CV data, right?

And so, and by the way, that understanding is not just me speculating. You know, one of the really great things about this experience with with Multidex is we’ve they’ve they’ve welcomed our our direct discussions. I’ve had numerous meetings with leadership on some of these subtleties. So I’m walking I’ve walked away from it. My sense is based on actual discussions with the leadership as to what they’re thinking.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: And they’ve held on to this, like, you know, updated dossier from you for several months? Like, since I think

Lishan Aklog, CEO, Lucid Diagnostics: Well, yeah. We submitted it in December. They accepted in December. And they issued the CAC notice, you know, about halfway, about mid year. We expected to hear back mid year.

We obviously would have loved it to be to go straight to a draft. But but the timing is actually about what we had what what we were expecting based on feedback that we got that we would hear back from them about mid year. So we also found out that the early, you know, early part of the year, they were definitely slowed down. And you know this just from seeing the activity out of MolDX has really picked up since May in terms of the number of LCDs and TAs. They’re starting to come out much more rapidly.

So there was a bit of a backlog. There’s a sense that there was a bit of a backlog they were working through.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Got it. And then maybe, like, since this sounds like kind of imminent and it’s only a matter of time it sounds like, you know, how do you how do you think about, like, forecasting, what the revenue and the volume could turn into next year and so forth, and how that could help you? Because you’re not burning a ton of cash. It’s like $10,000,000 so.

Lishan Aklog, CEO, Lucid Diagnostics: Prior to Medicare, we do have some sense that we should see our burn come down a bit. Now, you know, we did say earlier in the year that we were launching the concerted effort on contracting and guaranteed payments around, as well as concierge medicine. And that’s starting to gain traction. And so we think we’ll see some fruits from that in quarter three and four, well before we’ll have a final Medicare approval. After we have Medicare approval, it’ll really come down to, you know, fine tuning how quickly do we ramp up without getting ahead of our skis and and, you know, having our our OpEx and burn go up and trying to do so in a way that’s that that’s opportunistic.

So, you know, I think I think, yeah, next year should be on an an annual basis should be a solid year for us in terms of revenue growth relative to this year. And then, obviously, in subsequent years, we think we’ll have the ability to really go after this large market opportunity.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: And there’s like a like a backlog of

Lishan Aklog, CEO, Lucid Diagnostics: Yeah.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Goes back

Lishan Aklog, CEO, Lucid Diagnostics: Why do remember that? The year, yeah. So from the date of the final LCD. So even after the final, there’s still a little bit of bureaucrat. You have to end up in the articles, and there’s some little little gap from that, you know, that goes through CMS.

But from the date of the final, you have a year’s worth of claims. You could literally submit that day, and you’ll get paid, based on that date.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: To me, that’s a reason to kind of crank up the volume a little bit too?

Lishan Aklog, CEO, Lucid Diagnostics: Right, exactly. Yeah. So that’s one of the reasons we’re trying to shift some of our business to Medicare. And really understand what does it take to get to drive, what works in terms of driving Medicare volume. We’re learning that right now actively as we speak.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Okay. So yeah, so like post Medicare or maybe even post the draft, let’s say. How does the commercial strategy really change then? Does it hurt? Right now you’re using health systems, you’ve had the test centers in the past, Salesforce, the check your YouTube events.

Yeah. It’s like, do you turn into more of like a traditional

Lishan Aklog, CEO, Lucid Diagnostics: Yeah, I think so. Yeah, I think we drive, we will go where they are, where the opportunities are. Right? And with Medicare coverage under our belt, we’re going to do more traditional direct sales, you know, to primary care as well as to health systems. We’re not going to walk away from the know, I’ve always said the concierge opportunity is really interesting.

At some point, it may end up being an niche, but it is nice to to to it’s a significant growing part of the market that we’ll continue to pursue. And our test fits well within the kind of menu of things that concierge practices like to offer. And even the contracted events, the contract events with employers as well as fire departments, those will continue. But clearly with Medicare on board and then subsequently with increasing commercial insurance, the whole traditional path of driving traditional volume will will accelerate much more rapidly.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Got it. And in terms of the the broader kind of ecosystem with where it’s esophagus, there’s, some pretty successful tests for the prognostic side of it. Yeah. You know, do you think, you know, the success that they’ve, like those tests have had is like indicative of like what could be?

Lishan Aklog, CEO, Lucid Diagnostics: I think so. Although, to be honest with you, I’d maybe flip that. Their success depends on our success, right? Because at the end of the day, there are very few patients, only five to ten percent of the population of patients who are recommended for screening by guidelines ever get an endoscopy. Right, so what we’re doing is we’re filling the funnel and obviously, you know, as we put our foot in the gas, we’ll be driving a lot more patients to endoscopic evaluation of their precancer of their Barrett’s.

And then, so the opportunity to do the prognostication to find more dysplasia than some of these other companies and other products are doing will be, they’ll just have more patients to to prognosticate on.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Yeah. Is there any like, you know, partnership potential as you sort of try to like scale really quickly?

Lishan Aklog, CEO, Lucid Diagnostics: Yeah. Know all that. We know, you know, we have good relations with with with company with all the companies in the space, you know, even companies that have sort of talked about maybe entering the space on the screening side. And so, sure. Yeah.

At the appropriate time, there’ll be opportunities to work together.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: And the sponge based devices, what do you think about those? I think you have some I

Lishan Aklog, CEO, Lucid Diagnostics: think we have enough time for that, but let me just start by saying that it’s old technology. It’s been around for thirty years. We own the sponge that was used for many of the clinical studies that have been published. We had to remove it from the market because it was FDA. Because of detachments and life threatening risks associated, we had to actually take it off the market.

And the data doesn’t pan out. I mean, there’s published data from two major groups, Mayo and Hopkins, that have published data. And their performance comes nowhere close to where you started. And it’s not surprising because these sponge devices, essentially like a Brillo pad scraping your entire esophagus, it’s not targeted to where the pathology is. So every molecular, any molecular test is always going to struggle to try to find that needle in a haystack if you’re sort of scraping the entire esophagus.

The beauty of EsoCheck is it’s boom, it gives you a targeted sample there. So great, there’s plenty of patients. We’re not, you know, we’re fine with there being a lot of activity in this space. But at the end of the day, when you look at the data, you know, how good are you at detecting a short segment? About seventy percent of these people just have less than three centimeters of abnormality.

How good are you at detecting those patients order to put them in the appropriate surveillance regimen and so forth? And the published data for all the other sponge based technologies, that sensitivities are like sixty percent. We’re at ninety in that, you know, for that particular category, the vast majority of people that you’re looking for.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Okay, the blood tests I’ve seen for esophageal cancer screening are pretty well, good performing, at least I thought. Eighty So percent plus why hasn’t that

Lishan Aklog, CEO, Lucid Diagnostics: been Yeah, fair think that’s maybe a bit overstated, but just to be clear, those are for cancer. So there are blood tests that can pick up a precancer. And as I mentioned, if you pick up a stage one cancer, you’re still facing a fifty percent mortality. So the opportunity to save lives here and prevent deaths has to be at the precancer stage. And so far there hasn’t been anything.

And we don’t really think there will be anything because precancerous changes are very subtle. They don’t end up in the bloodstream. You certainly don’t have mutations that you can pick up in the bloodstream related to that. So I think biologically there will always be a hurdle to doing a blood test that can pick up a pre cancer.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Okay. And finally, just a year from today, we’re going to be talking about at the conference Lucid’s got Medicare Yeah, coverage,

Lishan Aklog, CEO, Lucid Diagnostics: I think, yeah, great. So I think we’ll, you know, I think we certainly will have Medicare coverage, and we’ll be ramping that that volume up. Hopefully, we’ll be at some significant penetration of the medic you know, the portion of our our patients that are Medicare. And I think at that point, we’ll start you know, we’ll have a meaningful amount of commercial coverage as well. And so, based on those two factors, we’ll be a bigger company.

We’ll be growing our sales team and and trying to drive towards this market opportunity. It’s a huge market opportunity. So for us to to get, you know, half percent penetration in this market is a is a really substantial meaningful commercial opportunity for us.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Perfect. Okay. Thanks, Lishan. Appreciate it.

Lishan Aklog, CEO, Lucid Diagnostics: Thanks, Kyle.

Kyle Mixon, Life Science Tools and Diagnostics Analyst, Canaccord Genuity: Appreciate it. Awesome.

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