PAVmed Inc. (PAVM) Q4 2018 Earnings Report, Transcript and Summary

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 questions. The year-end financial calendar always stretches the interval between quarterly updates during this time of the year. My team, which consists of nine, soon to be ten full time employees, numerous world class consultants and outsource process experts spread across two continents has been very active and productive since our last update call in November. I'll do a deeper dive on a few of our lead products. But let me start with a key corporate and product highlight. In January, we refinanced $5 million of senior secured debt which was due to mature this coming July. We did so under terms favorable to the company, including a lower coupon rate and no attached [warrants]. This transaction strengthened our balance sheet by removing the overhang the upcoming debt maturity, and by increasing our working capital run. Several weeks ago we reached a consensus with the FDA on parameters in the first in human safety study for our CarpX minimally invasive carpal tunnel device. Earlier during our January meeting with the agency, we had agreed to amend a previously scheduled first in human study. Our team members are currently on the ground in New Zealand and have completed -- complex logistics. We will initiate and complete the treatment phase of the study in the upcoming weeks in a lot more -- I'll have more details on this in a bit. Last week, working closely with our laboratory partners in Cleveland, we completed the laboratory developed test or LDT validation process for EsoGuard, the various esophagus DNA biomarker test which we formally call EsoCheck Dx, again, more on that in a bit. This important milestone allowed us to file for a proprietary laboratory analysis or PLA diagnostic billing code through the American Medical Association. This is the first step in securing Medicare and subsequently private payer reimbursement for the diagnostic test. Last month, we also completed the GOP animal study as well as additional manufacturing verifications, which the FDA had requested as part of our 510(k) application for the EsoCheck esophageal cell collection device. Earlier this year, our subsidiary Lucid Diagnostics launched a world class Medical Advisory Board. This Board consists of the leading internationally renowned experts in gastro-esophageal reflux disease or GERD, Barrett’s Esophagus and esophageal cancer. They include the lead authors of books, that's the current published society guidelines on the management of Barrett’s Esophagus. The Group has already provided enormous strategic insights on Lucid's product in its upcoming clinical trials. Around the same time we appointed Dr. David Wurtman, a Harvard educated veteran life sciences industry executive to serve as Lucid's Chief Medical Officer. He brings extensive experience in the development and execution of clinical and regulatory strategy, including sophisticated trials 2 IP [ph] Last month we completed the GOP animal study for our PortIO implantable intraosseous vascular access device. The FDA had requested this study as the next step in the process of securing PortIO regulatory clearance through its de novo pathway. Perhaps even more exciting last month we also completed a pilot animal study of PortIO which proved our underlying thesis for this innovative device. We demonstrated an unprecedented maintenance free implant duration of over 60 days. In other words, unlike any other existing long-term vascular access device, PortIO remained functional and available for use for over 60 days, without the need for flushes or other maintenance. Dr. Tim Murphy is the former President of the Society of Interventional Radiology and not someone not particularly prone to hyperbole described this as a truly groundbreaking accomplishment, which would represent one of the most important advances in long-term vascular access. Finally, last month, we also completed a series of bench-top tests on our NextFlo Infusion set with groundbreaking results. We were able to demonstrate that NextFlo completely disposable gravity driven infusion set was capable of achieving flow accuracy comparable to expensive electronic infusion pumps, completely independent of intravenous IV bag height. And also, we completed the three months animal study of DisappEAR, our resorbable antimicrobial pediatric ear tube animal study. The proprietary silk ear tubes performed well and demonstrated certain additional unanticipated benefit, which if replicated in humans could significantly enhance their clinical value. We look forward to reporting on the full data set shortly. So a lot of really great highlights over the past month. I'd like to now proceed with a bit of a deeper dive on our sort of two lead horses in our stable, CarpX and EsoGuard, as well as a fast closing up NextFlo. So let's start with CarpX. Just to review, CarpX is our groundbreaking minimally invasive device designed to treat carpal tunnel syndrome. Carpal tunnel syndrome is a very common condition or scarring of a ligament under risk from repetitive motion, causes compression of a nerve, which in turn causes severe and debilitating symptoms. The clinical and economic burden of carpal tunnel syndrome on society is massive. We believe CarpX will dramatically reduce recovery times compared to traditional open surgery and target an estimated immediately addressable domestic market opportunity of over a $1 billion dollar. The total addressable market is likely even larger, as many people of carpal tunnel syndrome suffer in silence, but would likely chose a treatment option with shorter recovery time. CarpX is a single use device, which uses the proprietary balloon catheter with embedded electrodes to provide the same clinical relief as traditional surgery but much less invasive. Extensive animal and cadaver testing has demonstrated that CarpX is a safe and effective precision cutting tool for treating carpal tunnel syndrome. We've been working closely with the FDA to secure U.S. regulatory experience of CarpX through the 510(k) pathway. During our pre-submission meeting in January, the FDA requested clinical testing to definitively document procedural safety in humans. Importantly, the agency indicated that it would accept data from a clinical study outside of the U.S., which meant that we can fulfill this request without engaging in the FDA's time consuming IDE process for U.S. study. Coincidentally at the time we were gearing up to initiate our first-in-human study of CarpX in Christchurch, New Zealand. We offered to amend this study to meet the FDA's clinical testing request. Following multiple discussions about our that in late February we had reached consensus with the FDA on the parameters of the CarpX safety study as follows. Single arm study, in other words, no control group, just 20 patients undergoing the CarpX procedures by two surgeons at this center. We agreed to a 90 day follow-up period and a primary endpoint limited to device safety. It took a bit of time to iron out the pre and post-operative testing protocol, but we ultimately reached the consensus on that important parameter. We have a team on the ground and we're gearing up to perform the procedures this past week as we have previously announced. Unfortunately a brief logistical delay in one of the hospitals was later exacerbated by a temporary freeze on all elective surgeries, following the tragic events in Christchurch last month, the mosque terrorist attack you might have seen on the news. The logistical matters we will address when the elective surgery freeze has been lifted. Our team remains on the ground in New Zealand and we expect to complete all 20 procedures in the coming weeks. So we've been chomping at the bit to get started and I'm aware that many of you have been eagerly awaiting the results of the study. I look forward to rewarding your patience with an update very, very soon. Let me move on now to EsoGuard and EsoCheck. So 10 months ago, as you recall, we created a majority owned subsidiary of PAVmed called Lucid Diagnostics to license revolutionary technology from Case Western University consisting of a DNA biomarker diagnostic test, and a novel device to collect cells from a targeted region of the esophagus in a 5 minutes office based procedure. We had previously referred to the technology as a whole as EsoCheck, the diagnostic test as EsoCheck Dx and the cell collection device as EsoCheck CCD. And we recently decided to rename the diagnostic tests as EsoGuard to better distinguish it from the cell collection device, which we now simply called EsoCheck without the CCD modifier. So each technology was promising applications in the diagnosis of esophageal pathology that are at times independent of the other. This name change will be formally introduced at the major upcoming gastroenterology meeting, DDW or Digestive Diseases Week, where Lucid will have a strong presence including exhibits and presentations. So Lucid continues to pursue a two-phase regulatory and commercialization strategy for this technology, which seeks to maximize its long-term commercial opportunity while providing some near-term value-inflection commercial milestones. So the diagnostic test, again now called EsoGuard is a methylated DNA biomarker assay of 31 slides on two genes, VIM [ph] and CCNA1, which has been shown in a published gene study to be highly accurate at detecting Barrett's Esophagus, which is a precursor to highly lethal esophageal cancer in patients with chronic heartburn or acid reflux, also known as GERD. We believe that the EsoGuard diagnostic test, when performed on a sample collected by EsoCheck has the potential to save many lives through early detection of and treatment of Barrett's Esophagus and related pre-malignant condition. The estimated immediately direct domestic market opportunity for EsoGuard is at least $2 billion, based on tens of millions of U.S. GERD patients who are currently candidates for Barrett’s Esophagus screening according to published guidelines, including those of the American College of Gastroenterology. As I previously noted the Laboratory Developed Test or LDT validation process for EsoGuard has been completed at the central reference laboratory in Cleveland. And this has allowed us to start the clock on the process of security reimbursement for the test, initially from CMS and then subsequently from private payers. Towards that end this week the American Medical Association, confirmed the receipt of Lucid's application for a Proprietary Laboratory Analysis or PLA diagnostic billing code for EsoGuard, the first step. The next step will be a June 24 CMS Clinical Laboratory fee scheduled annual public meeting with pricing and -- excuse me, pricing of new and reconsidered clinical laboratory test code will be considered for the 2020 [indiscernible]. Recent efforts to secure a 510 (k) regulatory clearance for the other component of this technology the EsoCheck cell collection device are also progressing well. The FDA requested some additional manufacturing verifications and a small GLP animal study to document device effectiveness and safety relative to a commercially available endoscopic brush. This work has been completed with excellent results. The GLP animal study in particular provided really -- really excellent endoscopic confirmation of the EsoCheck device in action providing circumferential sampling of the lower esophagus, and then subsequent pathologic analysis demonstrated that we were getting large [indiscernible] yields that are actually higher than the conventional endoscopic branch. So these results will be submitted shortly as part of a formal response to the FDA's additional information or AI letter, after which the review clock will be started. The agency has approximately 30 days to complete its reviews, about 30 days left to complete its review, which -- again we expect to be positive providing us with final clearance within that window. The second phase of Lucid's strategy is to secure a specific indication based on published guidelines for widespread Barrett’s Esophagus screening using EsoGuard on samples collected with EsoCheck. I'm also excited to report that this phase is really progressing well and really at an accelerated pace. In addition to Dr. Wurtman, now Lucid's full time Chief Medical Officer who is focused on planning and executing the necessary Lucid sponsored clinical studies. Lucid has also recently secured multiple other world class resources for this effort, including two clinical operations consultants, a biostatistician and a team of regulatory consultants, consisting of a former FDA official. Address protocols synopsis have been finalized and will be a central part of the pre-submission package, which will soon be filed with the FDA along with a meeting request to discuss with clinical data requirements for a de novo or a premarket approval PMA pathway submission. So the remaining lead products in our pipeline are progressing well and we believe provide additional opportunities to enhance shareholder value while mitigating risk free diversification and offering potential sources of non-dilutive capital. I provided a couple of highlights of PortIO and DisappEAR earlier and would like to limit the remaining of my comments to next month. I've always been very bullish on the commercial and clinical prospect for our next growth technology and we've limited its development activities over the past couple years to focus our resources on products like CarpX and others. Reaching breakthroughs however have really got the door open on what this opportunity might be. Last month, our NextFlo disposable and intravenous or IV infusions set achieved a key milestone in its quest to eliminate the need for complex and expensive electronic infusion pumps for most of the estimated 1 million infusions of fluids, medications and other substances delivered each day in hospitals and out-patient settings in the US. So infusions are central element of nearly all episodes of inpatient care, and play an increasing role in our patient care. For much of the last century, nearly all infusions were driven by gravity. The nurse would hang the IV bag at a reasonable height and adjust the flow rate using a simple, lower clamp and drip chart. Any inadvertent change in the height of the bag during the infusion would lead to an incorrect flow rate and possible complications. More recently, however complex and expensive electronic infusion pumps are becoming ubiquitous, despite the fact that most infusions are simple boluses or delivered at a fixed rate, and thus do not require the complexity of these pumps. Dr. Engelman, a peri-operative, specialist in critical care physicians recently described this as one of the most [indiscernible] examples of technological overkill in healthcare today. Electronic infusion pumps have been plagued by Class 1 recalls and complications and even deaths associated with software glitches, poor training, malfunction and another problems. NextFlo is designed to simplify these infusions and reduce health care costs by delivering highly accurate gravity-driven infusions independent of the height of the IV bag, so no need for complex expensive electronic infusion pump, no need to adjust flows, the drip charts or keep the bag at a constant height. NextFlo maintains a constant flow by incorporating a proprietary passive pressure dependent variable flow-resistor consisting entirely of inexpensive, easy to manufacturer disposable mechanical parts. Bench-top testing of our NextFlo intravenous infusion set has demonstrated constant flow rate across a wide range of IV bag heights with accuracy comparable to electronic infusion pump. We recently shared a rough demonstration video of NextFlo on our YouTube channel. It showed the following. Two identical NextFlo infusion sets were each connected to an IV bag containing a specified one with saline fluid and attached to establish physiologic bench top models in the forearm vein infusion. For one infusion the bag was hung at approximately 50 centimeters or less than two feet above the arm, which would be unusual low for a clinical setting. For the other infusion the bag was hung at approximately 150 centimeters or 5.5 feet above the arm close to the ceiling, which would be unusually high. The two infusions were initiated at the same time. Both sets completed their infusions at the same time indicating identical average flow rate, despite the fact that one infusion was driven by approximately three times the pressure as the other infusion. NextFlo bench-top testing has also demonstrated several piece -- several key clinically significant safety features. For example NextFlo prevent dangerous air bubbles from inadvertently being introduced -- inadvertently introduced in the system from passing into the patient under clinically relevant condition. Flow also stops when meaningful resistance is encountered, which is important in preventing dangerous infiltration of certain medication when an intravenous catheter dislodges from a vein. Finally, the set is physically incapable of inadvertently delivering flows higher than a specified rate, the serious medication error associated with electronic and future pumps. This major technological breakthrough has generated significant interest in NextFlo from potential strategic partners in infusion stage. As a result, we've decided to initiate a formal M&A process for NextFlo in the coming weeks. So now I'll turn the call over to Dennis to review our financial results.

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 $2.9 million related to the debt financing as we refinanced our debt at the end of the year. Rather than digging for all those details, our press release and the 10-K provides substantially more detail related to these non-cash charges occurring in the current, prior periods, as well as the various security exchanges undertaken in the first half of this year to mitigate some of those events. Also, the press release provides a table of non-GAAP measures, which highlight these amounts along with the interest expense and other non-cash charges, mainly depreciation and stock-based compensation, to give you a kind of a better understanding of the company's financial performance. You'll notice from that table that after addressing the GAAP loss by these charges, the company reported a non-GAAP adjusted loss for the three months ended December 31, 2018 of $2.9 million as mentioned earlier, or $0.11 per common share. PAVmed had cash of $8.2 million as of December 31, 2018, which is a change of approximately $1 million during the quarter from the September 30 now. Cash in the prior year -- year-end was $1.5 million. Just one other thing to mention our annual meeting is scheduled for June 26 this year. You'll be getting the proxies in the mail sometime in early May. So with that operator, let's open it up for questions from our audience. Operator?

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.