Greetings, and welcome to the PAVmed Inc. 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] Please note, this conference is being recorded. I would now like to turn the conference over to your host, Mike Havrilla, PAVmed's Director of Investor Relations. Thank you. You may begin.

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, Chief Executive Officer; and Dennis McGrath, Chief Financial Officer. Before we begin, I’d like to caution, 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 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 any of its products. New risks and uncertainties may arise from time-to-time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and 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 1, Item 1A 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 statements to reflect changes in expectations or in events, conditions or circumstances on which those expectations maybe 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 to turn the call over to Lishan Aklog. Dr. Aklog?

Thank you, Mike. Good afternoon, everyone. And thank you for joining us on this quarterly call. We look forward to updating you on our business and to discuss our recent financial results. And as always, I'd like to begin by thanking our shareholders for their support, especially our long term shareholders, and to welcome new shareholders to the PAVmed family. We're fortunate to have a strong community of engaged investors who share our vision for this company, as well as our strong and abiding confidence in the commercial and clinical value of our lead product portfolio. This portfolio is anchored by CarpX, and EsoGuard, which we believe have blockbuster commercial potential but also includes other innovative and commercially valuable products, which have demonstrated major breakthroughs in recent weeks, most notably NextFlo and PortIO. I will reiterate that we remain deeply committed to full transparency and robust communications with our investor community, through regular and ad hoc press releases and through other channels. Mike and our team have worked hard to enhance our investor communications and relations activity over the past six months. I know many of you on this call are appreciative of his efforts, his efforts to be responsive to our investor needs. We'd also like to encourage all of you, who have not done so, to sign up for our email newsletter and follow us on Twitter, LinkedIn, YouTube, and on our website to receive interim updates on topics of interest and other pertinent news. Also feel free to contact Mike directly at jmh@pavmed.com, jmh@pavmed.com com really at any time with questions or other requests, he does a great job. I'd like to now proceed with an update on our business. Dennis will then provide an overview of our financial and we will then open the line for…

Thanks, Lishan. Good afternoon, everyone. I'll be brief as our financial results for the year ended December 31, 2018 were reported to the SEC on Form 10-K earlier this week, and our related press release was published this morning. The Form 10-K is available at sec.gov as well as on our website, where we also posted the press release. So with regard to the financial results, research and development expense for the third quarter of 2018 were $1.4 million, up from about $555,000 for the same period last year in 2017 and also about $200,000 higher sequentially. Consistent with remarks we made last quarter through the end of the year, R&D increased as we pushed CarpX towards FDA clearance, EsoCheck towards its initial 510 (k) filing and PortIO to complete this GLP seven day animal study. Compensation related expenses were higher including costs and increased headcount, earlier in the year as well as in the last quarter. G&A or general and administrative expenses were $1.9 million for the fourth quarter of 2018, compared with $1.3 million for the same period in 2017 and higher by approximately $500,000 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 financing activities, pre-commercial launch activities, including trade shows, travel and key opinion leader event. PAVmed reported an operating loss for the three months ended December 31, 2018 of $3.3 million and a GAAP net loss attributable to common shareholders of $6.9 million or a loss of $0.26 per common share. The difference between the two -- and it's a large one, principally reflects the interest expense of $684,000. Not all of it was cash. In fact, the lion's share of it was non-cash. And non-cash charges of approximately…

At this time we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from a line of Anthony Vendetti with Maxim Group. Please proceed with your question.

Good afternoon, Antony.

Hi, Anthony.

Good afternoon. Hi Dennis, hi Lishan. I just wanted to follow-up on CarpX. So I understand there was a little bit of a delay which you elaborated on the call. Did you say at 20 patients, you think will be treated by the end of next week.

Yeah, at the end of the coming week.

I thought that was a little quick, okay

In the coming week. So, just to just to elaborate on that a little bit as we had announced some date in our previous press release, the surgery -- these are not long procedures. So, the surgeons are able to approximate five a day relatively. We have four days scheduled that extended through today and we have four days that are mapped out in the coming week. So all of those patients should have been -- should be -- the procedure should be completed and then their follow up period really in the near future.

Okay, so it even with the delay, is there still an expectation that you would submit after doing the studies and getting back the data, would submit for an FDA 510( k) in the third quarter and then a CE mark in that third quarter as well.

So yeah, so if we map it out 90 days from when the procedures are completed. We'll have the follow-up period will have been completed and some short period of time to put together the package for submission and the FDA will have 90 days to review that. So I think you could sort of map that out, I guess goes into the late Q3, early Q4. So we have -- this delay will have some impact, but hopefully not too much related to the timeline we have mapped out before.

And that assumes the FDA takes full 90 days or thereabout [ph].

That is true. Yeah. So this is just to recall this is a re-submitted, just to elaborate on that this is a resubmission. So they've -- we have had extensive opportunities to review all of the preclinical testing, all the manufacturing, all of that has already been done. So we certainly have -- and also the protocol, they signed off on that as well. So as Dennis hinted, our hope is that it would not take them the full 90 day review period.

But it sounds like you're saying worst case scenario is that it pushes into early 4Q, but it's still possible that you have it submitted by late 3Q and then if that's the case…

I think submit it -- we should have it submitted within Q3. And then what I was referring to is if they take the full 90 days, that would push it into Q4.

Got it. So it is still possible as if everything goes well, FDA clearance, sometime in 4Q ’19.

Oh yeah, so that's definitely our current hope and expectation, and you’ve mentioned a CE mark submission around the same time. So as we've mentioned last time, we're going to line that up concurrent with the clinical study, because we'd really like to submit the clinical study with our CE Mark.

Okay, good. Okay. And then, so I try and understand the -- I know you talked about EsoCheck and EsoGuard. Just, it seems like everything's on track there. Can you tell me a little bit more about the difference between the two? And does that have any impact on the submission, which we also have in our timeline for FDA pre submission any way, Phase 2 pre submission. I have that in 3Q ‘19. Is that still accurate?

The submission for -- sorry for the – well actually before I answer the question, let's go back and do the nomenclature a bit. So the nomenclature has no impact on any of the processes. What we decided to do, as I said was to -- we're getting some confusion because we were referring to both under EsoCheck. And in conversations frankly, with gastroenterologists there was a lot of interest in using EsoCheck for diseases other than Barrett’s Esophagus, for Candidiasis or eosinophilic esophagitis and others. So what we decided to do was to call the diagnostic test as EsoGuard, and keep EsoCheck as the name for the cell sampling. So is that clear. That doesn't change anything with regard to our strategy or the timelines or any of that.

Okay, so just to just to clarify, I know you've been working with the Cleveland Clinic, but the FDA 510 (k) submission for EsoCheck should be by when?

For the device, we've already submitted that. So EsoCheck is a cell selection device, that was submitted back at the end of last year. We are in the process. The FDA came back. We were provided an additional response letter where they asked us to do some small GLP animal study. That animal study we completed. We got good results from that. So we're just about ready to submit our response. Once we submit our response -- the data from the GLP animal study, they will have another 30 days on their clock to clear it and we expect that they will clear within that 30 days.

Okay, so the response is going to be submitted pretty soon here and then 30 days after that is when?

Yes. So I really do think we'll get it cleared this quarter. We've done everything they've asked us to.

Okay. And then just moving on to PortIO, CE Mark submission should be in this quarter, here in the second quarter.

That's a little bit challenging. I don't if you -- the verified bodies, because of the European MDR have been really strapped. And so there's a bit a challenge getting done, to initiate their audits and so forth. But we got in touch with them today and looks like we will be on target for our submissions this quarter.

Okay. And then in terms of the FDA for PortIO, just give me an update on that real quick?

Sorry. Could you repeat Anthony please?

Sure, for the FDA for PortIO?

Yes. So just to reiterate, the FDA -- so we're pursuing that through do novo in a pre-submission screening last year, the FDA asked us to do an animal study for the 7-day indication that we're pursuing. That GLP animal study was completed. And we did a parallel pilot study along with it. The animal study gave us excellent results, we've come up with some additional cadaver work. And that is being put together as part of a pre-submission package, where we expect we will go back to the FDA and say, here's our GLP animal data and our expectation. Although they haven't formally requested it, is that they have asked us to do a 20 or so person study of PortIO, which we would anticipate doing in New Zealand just like we're doing with CarpX. In parallel with that, we did this pilot study, where we showed that going -- what we're trying to do is even though we're pursuing a 7-day indication is to develop an evidence base for longer term applications, which we think is where the value is here, particularly at this sort of 6 to 8 weeks point where patients get long-term intravenous antibiotics. So as I said, we're really excited about that 50-day data where unlike, as you know all implantable works [ph] on long-term tunnel catheters require regular maintenance, flushes of heparin on a regular basis to keep them open. We implanted one of our devices, left it in for 60 days without touching it, and without flushing it. And it was perfectly functional at the end of the 60-day. So that's always been the previse from the underlying thesis for this. I think that's where the market opportunity is and we think it's really a profound breakthrough on that. So based on that, as I mentioned, we're actually going to do a non-FDA study in Columbia. Well, we hope to get that started this quarter. We have a FDR there that's ready to work with us and a vascular surgeon. We're going to target dialysis patients, as well as patients with poor veins and implant PortIOs for 90 days for their -- for use in a variety of intravenous applications.

Okay. And then so the de novo submission, I have in my timeline by third quarter '19 still?

It depends -- well, it depends on what the FDA comes back with, when we do. So we'll do the pre-submission, we will show them the data, they will come back in and say okay, we'd like you to do -- almost certainly will come back and say we'd like you to do a small clinical safety study. Assuming they let us do it OUS, like they did with CarpX that's something we can actually pull together rather quickly. We have the infrastructure in place in New Zealand, and we could do we could do that rather quickly. So I don't really have the ability to give you sort of per month based on that, because it depends on how they respond.

Okay. And then…

I don't think that's completely out of that -- that's certainly in the range.

It's in the range, okay. And then DisappEAR, you said, you completed three month study and now you're going to start the full study?

So we have a three month study, we have some animals that we are continuing out to 6 and 9 and 12 months. But we believe the 3 months, the 3 month data which we don't have the final report on that, we'll submit, we'll let the world -- we'll let you guys know, as soon as we get it -- as soon as we get the final results. But we believe based on the 3 months study, we can actually begin some of the validation of the application work. And begin some of the establishing the manufacturing process and so forth. So I'm still looking for a 510 (k) submission towards the end of this year. But we're collecting longer term data along the way. And as I sort of hinted out in the press release, the early reports in the three month study, like are really intriguing as it relates to certain expectations with regard to clinical events, adverse clinical events that are kind of routine in these cases. So will pull all that data together and report on that I think in the coming week.

Perfect. All right. Thank you so much. That was helpful. Appreciate it, Lisan.

Okay, great. Thanks, Anthony.

[Operator Instructions] Since, there are no further questions is in the queue, I would like to turn the call back over to Dr. Aklog for closing remarks.

So, thanks everyone for joining us this afternoon and for your questions, Anthony. We are -- we will again look forward to keeping you abreast of our progress via news releases and periodic conference calls such as this one. Again, I also encourage you to contact Mike directly with any questions at jmh@pavmed.com. Everyone have a great day. Thank you very much.

This concludes today's teleconference. You may now disconnect your lines. Thank you for your participation.