PAVmed Inc.
Q2 2019 Earnings Call Transcript

Published: 6 Sep 2019

[Operator:]

Greetings and welcome to the PAVmed Business Update Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.I would now like to turn the conference over to your host, Mike Havrilla, Director of Investor Relations for PAVmed. Thank you. You may begin.

[Mike Havrilla:]

Good afternoon, everyone. This is Mike Havrilla, PAVmed's Director of Investor Relations. Thank you all for participating in today's business update conference call.Joining me today on the call are Dr. Lishan Aklog, Chairman and Chief Executive Officer; and Dennis McGrath, President and Chief Financial Officer.Before we begin, I'd like to caution that comments made during this conference call by management will contain forward-looking statements, regarding the operations and future results of PAVmed. I encourage you to review the company's filings with the Securities and Exchange Commission, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Factors that may affect the company's results, include but are not limited to, the uncertainties inherent in research and development, including the costs and time required to advance products to regulatory submission; whether and when products are cleared by regulatory authorities; market acceptance of products once cleared and commercialized; the company's ability to raise additional capital; and the competitive environment. PAVmed has not yet received clearance from the FDA or other regulatory bodies to market many of its products. New risks and uncertainties may arise from time to time and are difficult to predict. All these factors are difficult or impossible to predict accurately. Many of them are beyond the company's control.For a further list and description of these and other important risks and uncertainties that may affect future operations see Part I, Item IA, entitled Risk Factors in PAVmed's most recent annual report on Form 10-K filed with the Securities and Exchange Commission and any subsequent updates filed in quarterly reports on Form 10-Q. Except as required by law, PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any changes in expectations or in events conditions or circumstances on which those expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.With that said, I would like turn the call over to Lishan Aklog. Dr. Aklog?

[Lishan Aklog:]

Thank you, Mike. Good afternoon, everyone, and thank you for joining us on this quarterly call to update you on our business and discuss our recent financial results. I should be clear for those of you who read today's press release we have a lot to cover on this call. First, however, I'd like to thank our shareholders especially our long-term and new shareholders for their support and reiterate our commitment to transparency and timely robust communication. I actually believe these efforts will be further enhanced by our new partnership with KCSA Strategic Communications, the external investor and public relations firm we recently engaged to assist us in raising our profile within the investment community. The team has done an outstanding job so far and we're excited to work with them to tell PAVmed's unique story to the new and existing audiences within this community.As a reminder, the best way to keep up with our news is to -- and updates, is to sign up for our e-mail newsletter and to follow us on Twitter, LinkedIn, YouTube, and on our website. As I stated in this morning's press release, the past five months have been extraordinarily active for our team. We've made solid progress on multiple fronts across our lead product portfolio with the most important being successful completion of the CarpX clinical safety study procedures and receiving FDA 510(k) clearance for EsoCheck.The remainder of the year promises to be packed with major milestones. I'd like to actually start by highlighting some of the most important ones before doing a deeper dive into some of our lead products. We expect to complete the postoperative clinical follow-up of the remaining patients in the CarpX clinical safety study in New Zealand. Soon thereafter, we will use the data from the study to resubmit CarpX's FDA 510(k) application. We expect to complete transfer of the EsoGuard assay from University Hospitals, Cleveland Medical Center's translational laboratory to ResearchDx, one of the nation's leading commercial contract diagnostic organizations located in Irvine, California. We then plan to begin the full commercial launch of EsoGuard as a laboratory developed test or LDT, which will make it the first commercially available targeted DNA test designed to detect Barrett's Esophagus.Concurrently, we plan to formally launch the commercialization of our EsoCheck esophageal cell collection device. We also expect to complete the CMS process to secure reimbursement code for the EsoGuard LDT. On October 9, we are scheduled to participate in an in-person pre-submission meeting with the FDA to present and get sign-off on the protocol for Lucid clinical trial that's required to elevate EsoGuard to an FDA-registered in vitro diagnostic or IVD. We expect to complete what's now an intense ongoing effort to build a clinical trial operations infrastructure that's required to begin recruiting sites and enroll our first patient in the clinical trial.We expect to initiate at least one pilot human clinical trial using EsoCheck in other prevalent diseases, including eosinophilic esophagitis and infectious fungal and viral esophagitis. We hope to complete an ongoing formal M&A process to secure a strategic partner or acquirer for our NextFlo infusion set to provide us with a potential source of non-dilutive capital.We will participate in a second in-person pre-submission meeting with the FDA. This one is to secure their sign-off on a protocol for a small clinical safety study of our PortIO intraosseous infusion device in support of its FDA de novo application. In a couple of weeks, we expect to have completed the PortIO animal study, which will document unprecedented 6-month maintenance-free patency and functionality. This will lead to a second concurrent PortIO human clinical study, this one in Colombia, South America to demonstrate long-term PortIO use in dialysis patients and those with poor venous access. And finally, we will complete a 6-month GLP animal study of our DisappEAR resorbable ear tube to support its future FDA 510(k) submission.So, as I said, we have a lot to look forward to in the coming months. Just to do the tally

[Dennis McGrath:]

Thanks Lishan. Good afternoon everyone. I'll be brief as our financial results for the quarter ended June 30 were reported to the SEC on Form 10-Q earlier and our press release on these matters was published this morning. The Form 10-Q as I'm sure you're aware can be available -- is available at sec.gov and on our website where we've also posted the press release.So with regard to the financial results research and development expenses for the second quarter 2019 were $1.4 million, up from about $1.2 million for the same period in 2018 and about $50,000 lower sequentially. Consistent with remarks we made last quarter during the first half of this year, R&D increased as we pushed CarpX and EsoCheck towards FDA clearance, PortIO and DisappEAR completing their animal studies as well as milestone breakthroughs for NextFlo.Third-party contract development and manufacturing expenditures accounted for nearly 70% of the year-over-year increase and with the balance of the increase related to compensation costs due to increased headcount focused largely on EsoCheck and EsoGuard.With regard to general and administrative expenses, they were $1.9 million for the second quarter of 2019 compared with $1.6 million for the same period in 2018 or higher by about $220,000 sequentially. The increases are due principally to compensation-related costs including increased headcount stock-based compensation expense as well as other operating costs largely related to our pre-commercial launch activities including trade shows, travel and key opinion in leader events.PAVmed reported an operating loss for the three months ended June 30, 2019 of $3.3 million and a GAAP net loss attributable to common shareholders of $3.7 million or $0.13 per common share. The difference between the two principally reflects changes in the fair value and other related non-cash charges affecting GAAP accounting for the convertible debt.Our press release and the 10-Q provide substantially more detail related to the non-cash charges occurring in the current period and also in the prior year. Also the press release provides a table entitled, non-GAAP measures, which highlight these amounts along with interest expense and other non-cash charges namely depreciation and stock-based compensation.It gives you a better understanding of the company's financial performance when it's presented that way. You'll notice from the table that after adjusting the GAAP loss by these charges the company reported a non-GAAP adjusted loss for the three months ended June 30, 2019 of $2.8 million or $0.10 per common share.And as you'll also note from the press release and from the Q, PAVmed had cash of $6.9 million as of June 30 which is an increase of approximately $2.7 million from the second quarter.So with that either turn it back to Lishan or have the operator open it up for questions.

[Lishan Aklog:]

Open it up for questions.

[Dennis McGrath:]

Operator, please open it up for questions.

[Operator:]

[Operator Instructions] Our first question comes from Anthony Vendetti with Maxim Group Research. Please state your question.

[Dennis McGrath:]

Good afternoon Anthony.

[Lishan Aklog:]

Hi Anthony.

[Anthony Vendetti:]

Afternoon Dennis. Good afternoon Lishan. How are you?

[Lishan Aklog:]

Great.

[Anthony Vendetti:]

It seems like CarpX is moving along very well now. I was wondering, if you could just talk about -- if you see any other hurdles. It seems like the last thing you're waiting for is just the electrodiagnostic testing at 90 days and to make sure that they've met the study's primary safety endpoint. Is there anything else that needs to be done that you can anticipate or see at this point?

[Lishan Aklog:]

Really, frankly not. So, as you highlighted there, the remaining patients will get their 90-day -- during their 90-day follow-up they will undergo this electronic diagnostic testing. We were very careful as I mentioned to really narrow the scope of the portion of the test that constitutes the primary safety endpoint. So it's a test of motor function a subset of sort of a broader panel of tests.And the fact that the patients are doing clinically fine that they don't have any motor nerve -- evidence of motor nerve injury now really makes it extremely, extremely likely almost – frankly, almost certain that those tests will come back normal.Frankly, our biggest challenge is just making sure we chase down all the patients and make sure they show up for their follow-up. There were a couple of anecdotes where patients have done so well they've gone off on -- I don't know what you do on Australia or New Zealand safari, but they're out in the woods and they've -- we have to track them down and get their follow-ups.So I really -- we really -- I mean obviously you never know once you submit to the FDA, but certainly between now and getting our -- and filing the resubmission, we expect things to be relatively straightforward and frankly in our control which was one of the challenges with some of the operating scheduling and so forth that we looked up.

[Anthony Vendetti:]

Okay. So you'll be getting back those results and expect to file the resubmission by the end of the year. Correct?

[Lishan Aklog:]

Yes. I think that's about right. So the 90-day follow-ups will -- should wrap up in mid-November. It will take us a few weeks to collate the data and sort of fill in the resubmission documents. It's possible that with the holiday there's often a situation where you're better off, if you're approaching the holidays to file on January 1, instead of December 7th or something.So it may -- we may end up doing it the first week of January, but I don't really see any problem with reaching those targets.

[Anthony Vendetti:]

Okay. Great. And then in terms of commercial launch of EsoGuard, can you get a little more specific on when you think that will happen?

[Lishan Aklog:]

Right. So right now as I've -- so really the gating item for that is this transfer of the assay. So as I mentioned the LDT is actually active and available and -- in Cleveland right now. We're working through the transfer of the assay to this commercial laboratory ResearchDx in California. That's going really well. It's ahead of schedule. And that's all an internal process. It doesn't require any kind of external validation.So it's simply performing all of the CLIA and CAP certification steps internally to have it be officially available as an LDT as a laboratory developed test. So our goal for that is early fourth quarter, so late October, mid-November sometime in that range. And once that's done, we'll be -- it will be available and we'll be able to market it. We are actually -- we have a fairly active awareness program right now that our current Chief Commercial Officer, Shaun O'Neil has implemented. The American College of Gastroenterology will be in October. We'll have a strong presence there. And we will be -- and we have a -- really a backlog of distributors who call on gastroenterologists who were waiting in the wings for us to turn on the switch and launch this.So as you know our model is using independent representatives. There are plenty of them out there that have contacted us. They are excited to move forward where we will have some clarity on reimbursement by then. And if we're successful in achieving code then we'll be able to seek reimbursement through that. If not and it requires a little bit longer to get that reimbursement code, we will be able to market it and have -- and submit under -- currently under our list of codes. So we really expect things to be full steam ahead come November, so.

[Anthony Vendetti:]

Okay Lishan. Just last question on that. In terms of recruiting these independent sales reps, do you have some -- it sounds like you already have some of them lined up. But by mid-November, how many of them do you think you will have signed up as independent sales reps to market EsoGuard?

[Lishan Aklog:]

Yeah. I mean I'm not sure we're prepared to give specific guidance on that, just to say that every week Shaun gets a call from a rep really covering the entire country. They understand the value of this. They understand the demand amongst the gastroenterologists of these engagements are relatively straightforward, given the expected margins.But it's really hard to know from launch what the ramp trajectory is going to be. I don't think we're in a position to do that. We know what the market opportunity is. We know how many patients are out there. But predicting a ramp will be a little bit premature at this point.

[Dennis McGrath:]

And the key opinion leader group is pretty robust. So there are a number of events coming up. The podium will be active. That also will spur the whole network of independent reps. So there'll be a lot of positive momentum to speed that up. And as Lishan said it's just premature to give guidance on that and to give the numbers.

[Lishan Aklog:]

Again just to reiterate but there -- everything we see at the meetings and the publications in the literature there's a real hunger for a Barrett's screening test, Barrett's detection test and this is the only one out there. There is nothing else out there that we're competing with. So we know -- we're really confident that people will embrace this and we'll be able to get off to a great start.

[Dennis McGrath:]

Coming on our Medical Advisory Board and how frequent they get to the podium.

[Lishan Aklog:]

Yes. So we've talked about this before. We like to brag about our MAB but the head, Nick Shaheen is the -- really the most active clinical researcher in this area. He's an editorial member of the American College of Gastroenterology, and he also wrote the guidelines for Barrett's Esophagus and the other authors as well. So we really are in great shape to get the word out with regard to this. And frankly again the word is already out. People know about -- people know this is coming and they are really hungry for the ability to do the screening.

[Anthony Vendetti:]

Sounds great. Okay, I’ll hop back in the queue. Thank you.

[Lishan Aklog:]

Thanks, Anthony.

[Operator:]

Our next question comes from Dave Tahase [ph]. Please go ahead with your question.

[Lishan Aklog:]

Good afternoon Dave.

[Unidentified Analyst:]

Good afternoon. So my first question was for NextFlo. I know you mentioned a little bit about the update on that process, but can you give us a little more insight on where we're at and what time frame we're looking for as far as NextFlo official partnership and acquisition process?

[Lishan Aklog:]

Yeah. Well, I'll have Dennis fill out some of the details. But we have -- as we mentioned we have a formal process. We've engaged a firm that is starting the outreach on this. We have -- they are fortunate that they're already armed with this Deloitte report, which was really fantastic, which gave a ton of ammunition for us to present this opportunity to the strategic. There is some -- they have a long list. There are some obvious suspects on that list we'd be strongly interested in. And as I mentioned one already contacted us. We have a commercial ready packaged devices that we can use in demonstration. So we're looking forward to get started.I'll let Dennis add anything. I'm not sure…

[Dennis McGrath:]

Not much to add. But it's structured to have a very competitive process. So we selected a financial adviser that has the reach both nationally and globally. Its some folks that I have some personal experience with doing transactions with in the past. The results from the Deloitte study both in the market analysis and the models that were developed were very robust and the opportunity clearly was even better than what our anticipation going into that process.It's hard to comment on the time line as I'm sure you're aware with other companies. It could be a fast process. It could be an elongated process. There are many components to it from narrowing down the field to developing a right LOI, so that you start to incur the costs in an intentional way and then how long the process for a definitive agreement. It could take weeks to months and it's hard to pin that down into some degree of specificity. But we're very encouraged about where we're at in the products' maturity and then also with the market intel that we're now equipped with that we're optimistic on where this is going to lead.

[Lishan Aklog:]

Yeah. I mean, I would say we've been talking about initiating a process for a little while here. But boy we really are preparing. We knew we had a good sense as to the impact of this technology. But the content of the Deloitte report, I think it's 40 or 50 pages with a very complex model really, really arms us well for this process though. I feel really good about it going in. It has real disruptive groundbreaking potential. And there are definitely players in the field who should be interested in it.

[Unidentified Analyst:]

Great. Thank you. And my next question was around the lead products EsoCheck as well as CarpX. Can you give us a sense of strategy for marketing for both of these? I know you talked about EsoCheck, but is this something that you're looking to potentially partner with another device company to market these? Or is this something that you're solely approaching it from…

[Lishan Aklog:]

I just want to make sure you're still referring to marketing and not sales right?

[Unidentified Analyst:]

Both actually.

[Lishan Aklog:]

Okay. Yeah, so they're slightly different. I mean we did list and do sales first because we realize it expands on what we told Anthony a minute ago, which is our model is a hybrid sales model. Both of those products and as well as CarpX have -- are a natural fit for this because they have an ecosystem of independent sales reps who span the country and call on the specialties that will be ordering and using these technologies. We'll build up slowly over time sales management. We have a Chief Commercial Officer. We have some candidates for regional managers that we would implement as volume grew.So that model I said as I mentioned to Anthony, we have independent reps ready to go upon launch. I think you might have been hinting at more of a distribution partnership-type agreement, which we don't really anticipate needing in the short-term. We certainly would consider that at a later point if it really -- if we thought it enhanced our value and our ability to ramp revenue but the model will work in the short-term. And as I said the same is really true with EsoGuard and EsoCheck. They have a natural ecosystem of reps as well.Marketing actually is much more straightforward. We have an amazing marketing team already. Shaun O'Neil has put together a remarkable plan for both EsoGuard and EsoCheck. Last month's primary journals of gastroenterology called Gastroenterology, we have a full-page ad in the back cover of it, highlighting EsoCheck. I think a few -- the physicians will start to see an increasing attempt in our marketing materials to differentiate EsoCheck from other devices, which reports do the same thing but with EsoCheck it's clearly superior too.So we plan to be aggressive. We are very much focused on market awareness within the physicians. And as Dennis mentioned, obviously, we have very close ties to the leadership, the KOLs in this field and expect to have them up on the podium and encouraging people to look at these products. So that's really how we look at it and we really intend to be aggressive on that.

[Unidentified Analyst:]

Great. And my last question just around short-term and long-term capital funding. Are there plans that you're looking at?

[Dennis McGrath:]

Yeah. It's a great question. And I'm sure many of you want to know specificity. It's hard to give that level of specificity but a few general comments. One, we nearly had $7 million at June 30th and plenty of milestones coming up. And that's a sufficient fuel to get through those initial milestones.Our financing strategies over time have evolved with our escalating maturity of the company. So the Board will be opportunistic when it makes sense. There's a timing thing here in terms of all the things we just talked about between NextFlo, and I think we've all had conversation around there's three products that all provide themselves for this non-dilutive capital possibility NextFlo being one.Shortly behind it is PortIO. A little bit further down the pike is DisappEAR. PortIO will probably move to that process after the regulatory pathway is cleared. We talked about the upcoming meeting with the FDA, and then the patents that will be issued for PortIO surrounding some of the claims that have been allowed. So there are a number of those things. Any one of them could be sufficient to finance our needs for the foreseeable future.With that said, we will be -- a lot of entities institutions are very interested in PAVmed. And there are opportunities for us to finance now if that makes sense from the Board's perspective. But it makes sense to continue to play out some of these things, before we look at the longer-term financing need of EsoGuard IVD in 2020. We'll need some fuel to push that along, and we'll make sure that's available. But we don't have to press that button today.So I know that's not exactly the answer to the question that you were looking for, but it kind of sets the things we're thinking about in trying to balance out with the opportunities that are in front of us.

[Unidentified Analyst:]

That makes a lot of sense. Thank you so much for the response. And I actually have one last question. I appreciate your time here. You mentioned about EsoCheck launch in early Q4. Can we expect to see revenues in Q4 2019?

[Dennis McGrath:]

I didn't hear that.

[Lishan Aklog:]

Second part is revenues, there is probably not much. We really need to look to early 2020 to start seeing revenues.

[Unidentified Analyst:]

Early 2020, okay.

[Lishan Aklog:]

I think this does -- this brings quite a perhaps meaningfully.

[Unidentified Analyst:]

Perfect. Thank you so much for your time.

[Lishan Aklog:]

Thank you. It’s a great question.

[Operator:]

Our next question comes from David McCarty [ph]. Please go ahead with your question.

[Lishan Aklog:]

David, how are you?

[Dennis McGrath:]

Hi, David.

[Unidentified Analyst:]

Yeah. I just had a quick question regarding CarpX and Sonex Health and their Meerkat Technology. It seems to be very similar to your technology. Do you think that your patent is going to be of use?

[Dennis McGrath:]

I didn't -- you said…

[Mike Havrilla:]

Sonex.

[Dennis McGrath:]

You said Sonex? Is that what you said?

[Unidentified Analyst:]

Sonex and their Meerkat, the SX-One MicroKnife.

[Dennis McGrath:]

Yeah.

[Unidentified Analyst:]

It seems to be very, very similar except it uses a knife rather than the RF and what -- the technology to push the nerves aside, et cetera. Do you think that your patent is going to provide you enough protection?

[Lishan Aklog:]

So the simple answer to your -- to the final question is an absolute yes, okay? So in all that I can -- I could probably elaborate a bit, but we feel very, very confident about our IP position as it relates to any other device that has a balloon feature to it, and we feel very confident about that.We get asked this question a lot as you might imagine. So I'll just give you a couple of bullet points. I can't really cover it to a large extent, but I think to the extent to which the two technologies appear to be similar that similarity is rather somewhat superficial. I'll just point out a couple of things that others have pointed out to us that are worth noting.We are pursuing and we're putting the time and effort and resources and capital into getting a 510(k) clearance for this device, because we believe that unequivocally that a device that is inserted into the carpal tunnel in the vicinity of nerves and other structures and cuts is a Class II device by the FDA classification. And once CarpX gets cleared it will be -- it will -- amongst the products you mentioned will be the only Class II device. I'll just leave it at that.The other significant issue is that the other device you mentioned requires ultrasound for visualization and has some other features in terms of how they're marketing it in an outpatient setting, which we think will limit their ability to move forward. We are perfectly happy that there are other products out there that are trying to perform carpal tunnel release in a minimally invasive way. I think that's a good thing in terms of advancing the entire space, but we are highly confident that we have the best technology for this, and that we'll prove that in the marketplace.

[Unidentified Analyst:]

Okay. Thank you.

[Lishan Aklog:]

Great. Thank you. Great question.

[Operator:]

Our next question comes from Masood Ahmed [ph]. Please go ahead with your question.

[Dennis McGrath:]

Good afternoon.

[Lishan Aklog:]

Hi, Masood.

[Unidentified Analyst:]

Hi, Lishan. This is actually for Dennis if I ask you. I'm a recent investor in the company. And just want to ask, I mean, Dennis, I understand you went over all of these stuff, but what are your plans just to make sure for this year? And how soon you might need to fund or raise -- do a capital raise or, I mean, how close are we to get one of the deals down so we can sell something and maybe we don't have to do any more raises?

[Dennis McGrath:]

Yeah. I'm not sure I can add any more specificity to my prior answer. It makes sense for any financing that is not one of the non-dilutive financing that we outlined with NextFlo or one of the other two products further down the line to have any of those financings surround some of the upcoming milestones the achievements of that. So stay tuned. There's not much more I can give you in terms of the timing. We're highly confident that when the need is presented in terms of financing the business, the funds will be available from one of the multiple sources that I outlined for you.Obviously, position A is to do a non-dilutive financing by the sale of one of these products. And as I previously mentioned, any one of them could be of significance to fund us indefinitely.There is plenty of institutional interest surrounding PAVmed as well as Lucid Diagnostics our majority-owned subsidiary. And with -- together with the Board, we'll be opportunistic about it. We're in parallel with all of the other shareholders as the significant inside our ownership. So, the management team as well as the shareholders at large are highly aligned. So, we want to do whatever financing is required that provides the highest and best value for the shareholders.

[Lishan Aklog:]

I'll just add one comment, which is really targeted to the long-term investors, because as Dennis mentioned we are all in this together. I think, hopefully, it should be clear from our press release and from the opening in my comments, we have a lot going on and there are a lot of -- any one of those -- there are really multiple balls in the air here any one of which has significant upside in terms of value.And it's just -- as I just keep saying, I hope, I'm making it clear that we're really very confident that we'll move these along and create enough value so that over the long-term that this will be a -- will create a much more valuable company than we are today.

[Unidentified Analyst:]

Okay Lishan and Dennis. Thank you so much. And I really think from my point of view what -- how you guys are taking the company, I mean, you guys are doing an amazing job, hosting the bottom rate. All this stuff are very low compared to many other companies.So thank you so much and hopefully looking forward taking this very far. Really appreciate all your time. Thank you, gentlemen.

[Dennis McGrath:]

Thank you.

[Lishan Aklog:]

Thank you for your question.

[Operator:]

Our next question comes from Peter Kelly [ph]. Please go ahead.

[Dennis McGrath:]

Hey, Peter.

[Lishan Aklog:]

Good afternoon, Peter.

[Unidentified Analyst:]

Good afternoon gentlemen. I have two relatively quick questions. The first one is, you've mentioned the commercialization plans for CarpX -- for the EsoGuard and EsoCheck products. Is the CarpX commercialization plan similar to that? Or is there any differences? And then my second question is as far as I see on the investor presentation there is the plan to submit a 510(k) for both DisappEAR and NextFlo. And you've mentioned that both of those two are potential acquisition products that you guys are potentially going to put out there. And the question that I have regarding that is it seems from my perspective that the 510(k) approval would make them both much more attractive to potential acquisition targets.

[Lishan Aklog:]

Those are both really good questions. Let me see if I can -- let's move quickly through the CarpX commercialization question, because the simple answer is, yes. It's really the same model. It's obviously a different cohort, a different ecosystem of independent representatives, but there are -- we have in our pocket, basically a network of independent reps who call on -- typically on hand surgeons and ambulatory surgery centers who would do this procedure, who are really sort of ready and willing to jump in as soon as we get clearance which we hope will happen early next year. So the model is really the same. The other question is actually a good one.So when you -- as a general matter with these products, if you look at our portfolio, when you look at CarpX and EsoCheck and EsoGuard, which are products that we intend to create significant value internally and to really push forth with a full commercialization, the other three products as we mentioned are ones that we're positioning for a potential strategic partnership or acquisition. But to be clear, when we do that, we're not sort of sitting around and waiting for someone to show up that. Even with this M&A process that we started with NextFlo, we are pushing full steam ahead with regard to the development processes all of the work that needs to be done Phase I, Phase II, Phase III that need to be done as part of verification and validation and all the steps that are required to get through to a 510(k).So I want to make -- I think your question makes it -- I think gives us an opportunity to make an important point that we're not pausing anything that we're moving forward frankly as if we were intending to self-commercialize it because we understand that every step of the process derisks it from an acquirer's point of view. And obviously, if we can be close to or have a clear path towards FDA clearance it will be a more attractive acquisition target to a larger company.So I hope that makes sense in terms of the way we're looking at it. And I would say there's a slight difference between them. The one that's quite clear has a -- where the pathway to 510(k) clearance is really fairly straightforward and that's NextFlo. So the -- from a -- if you're on a strategic acquirer's point of view look at that and you see the functioning prototypes and engineering you can clearly see a path towards the basic blocking and tackling that would be required in terms of testing to document and to get you through 510(k) clearance. So hopefully, that answers your question.

[Unidentified Analyst:]

Yes. I believe so. Just to be clear, so what you're saying the difference between those two products that I mentioned DisappEAR and NextFlo, is that NextFlo because it's a minimally invasive type of device in contrast to DisappEAR which actually has to be implanted in the body. The difference between those two is from an FDA perspective you anticipate on the 510(k) process?

[Lishan Aklog:]

Yes.

[Unidentified Analyst:]

The much easier for NextFlo.

[Lishan Aklog:]

One way I would characterize it is that NextFlo is clearly a low -- our 510(k). Not all 510(k)s are equal right? Some are -- some have a lower -- some of them are higher, right? And the tests -- the testing that's required for an intravenous infusion is really quite straightforward even though it is a 510(k).

[Unidentified Analyst:]

Understood. Thank you so much.

[Lishan Aklog:]

Great. Thanks a lot.

[Operator:]

[Operator Instructions] Our next question comes from Rabbi Gellman [ph]. Please state your question.

[Lishan Aklog:]

Good afternoon.

[Unidentified Analyst:]

Hey good afternoon. Thank you for taking the time. My question is related to CarpX. I've been an investor for a few years and I've been hearing about the plan to sell this globally and I've been hearing about European CE mark. So what is the plan for that? And when do you see that submission and approval for CarpX in European markets? And my second question for CarpX is assuming we get approved end of Q1 2020, when do you see CarpX getting in hands of the patients and some revenue coming in on the CarpX side?

[Lishan Aklog:]

Great. I'm actually glad you brought up Europe, because we have every intention and we have every expectation that we will be able to get our lead products into the market in Europe. It's really sort of an important part of any commercial medical device endeavor. What we're up against is what every medical device company is up against, which is these new regulations called the MDR that are working their way through Europe which is -- actually to be perfectly blunt has become a bit of a regulatory nightmare for all medical device companies even ones that already have cleared products.So what that means from a practical point of view, from our point of view was that we are moving forward with what we can do with regard to CE mark submission for several of these products which is really getting our quality system ready and in place for an audit which is how CE mark works. They come and audit your quality system. The problem is that there is a bottleneck with these entities called notified bodies, which are required to process these applications. So there's a huge backlog right now across the industry which is frustrating everybody's efforts to get new clearance within Europe.So we're ready to go. We have our notified bodies in position to do the audits, but everything has kind of slowed down to a very slow pace right now as they try to figure out how they handle these new regulations. So that's Europe. So we do plan to be there. And if the process can be streamlined, we will be there and will have our submissions in place as soon as we are allowed frankly. Your second question was the timing from clearance to launch. I think the analogies are very similar to what we described with EsoCheck. We have between now -- the manufacturing site is ready.We will have commercially available products actually this year. So that won't be a limiting factor. We already have the cohort of independent reps that are ready to go. So the time window from achieving clearance to a commercial launch and revenue we expect that to be short. I'm not sure I can give you a specific sort of number of weeks and -- but I would say on the order of weeks to a couple of months before we're -- no more than that before we're really fully on the market.Now how that ramps again the same caveat holds. We still have to get into the clinical sites, the ambulatory surgery centers, the hospitals. I mean there is work that needs to be done to get a ramp -- sales ramp going. But in terms of starting that process, I don't anticipate that that will be very long after that we receive.

[Unidentified Analyst:]

Right. Right. Thank you. So it sounds like 2020 will be the year we'll start getting some good revenue in and growing as a company.

[Lishan Aklog:]

I believe so.

[Unidentified Analyst:]

Thank you Dr. Aklog for everything you and your team is doing and we really trust that [indiscernible]. Thank you.

[Lishan Aklog:]

Thank you so much.

[Operator:]

Thank you. There are no further questions at this time. I'll turn it back to management for closing remarks.

[Lishan Aklog:]

Great. Thank you very much. I appreciate everybody taking the time. Really, a great set of questions today. We're always excited by how engaged and how knowledgeable our investors and shareholders are. So we really enjoy having these conversations. So again, please make sure you sign up for our newsletter and keep up-to-date with our social media posts. And we look forward to continuing to update you as I said as we have a very, very busy remainder of the year. So thank you very much.

[Operator:]

Thank you. This concludes today's conference. All parties may disconnect. Have a great day.