Bruce Voss - MD/Principal, LHA, IR Lishan Aklog - Chairman and Chief Executive Officer Dennis McGrath - EVP and CFO.

Anthony Vendetti - Maxim Group John Levin - Levin Capital.

Welcome to the PAVmed Business Update Conference Call. [Operator Instructions] As a reminder, this conference is being recorded, August 22, 2018. I would now like to turn the conference over to Bruce Voss. Please go ahead, sir. .

Thank you .This is Bruce Voss with LHA. Thank you all for participating in today’s PAVmed business update call. Joining me from PAVmed are Dr. Lishan Aklog, Chief Executive Officer, and Dennis McGrath, 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 cost 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 SEC 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'd like to turn the call over to Lishan Aklog. Dr.

Aklog?.

Thank you, Bruce. Good afternoon everybody, and thank you for joining us on this call to discuss our recent financial results as well as update you on our business.

I see that we have a record number of participants on this call, which is consistent with the strong surge in interest in our company and its products from the Investor community over the past few months. I like to thank our shareholders, especially our long-term shareholders for their support, and to welcome our new shareholders to PAVmed.

Many of you have contacted me by email with questions over the past and encouraging words and expressed your long-term commitment to our vision. Some of you in fact have taken the time to visit our offices in New York.

We are grateful for having engaged investors and remain committed to full transparency and frequent updates as we drive head along to enhance shareholders value.

Since we provided a detailed business update just eight days ago in the press release announcing our quarterly results, I'm going to structure this call a bit differently than previous calls.

I'll initially focus on the topic of greatest interest, which is CarpX, then have Dennis provide an overview of our financials, and then provide a more systematic but truncated review of all of our products to make sure those of you are new to PAVmed or who did not see the last press release are fully up to date.

So I'd like to first provide a detailed update on the status of CarpX's application for FDA's 510(k) submission. To briefly recap, we submitted our application at the end of 2017 and received the FDA's request for additional information earlier this year.

The lead branch assigned to review that application was the general surgery branch, and we've had numerous conversations with the lead reviewer to assist us with our responses and resubmissions. The orthopedic branch was assigned as a consultant branch.

The time the FDA requested additional information, as I've noted several times before on the zone of thermal injury and provided us with a target of less than 1.5 millimeters for this to assure that other structures were well protected during the procedure.

We performed extensive animal testing under a protocol approved by the FDA for this purpose and documented a maximum zone of injury of 1 millimeter much less than that in most specimens and clearly well below the target that the FDA had presented us with.

As requested, we also had multiple surgeons each successfully perform the procedure multiple times in cadavers all with excellent results. These outstanding data form the basis of what we believe was a robust and complete response to the FDA's request for additional information, which was formally resubmitted to the FDA last month.

We've been participating with the FDA call’s interactive review since then, including multiple conversations with the lead branch reviewer.

To our, and to the lead branch's frustration, the consulting orthopedic branch presented us with the moving target, with multiple new requests over the past month that were not part of the original written response.

Thoroughly confident in the device’s performance and safety profile and with the strong encouragement of the lead branch, we persisted turning around additional bench-top testing and cadaver testing over the last month really in record time.

We believe, and the lead branch agreed, that the sum total of the data we provided documented that CarpX was safer than the predicate.

We showed that the CARPX zone of injury was narrower, that the CarpX balloon provided better anatomic separation and protection of the cutting element from other structures and that was equally safe even in the case of rare anatomic variance.

The lead branch commended the quality of the data, acknowledged that we had gone above and beyond to unequivocally address the issues raised by the consultant branch and that clinical data would not be necessary or helpful in establishing substantial equivalence.

If it was solely up to the lead branch, CarpX would have received 510(k) clearance today. Instead, the lead branch notified us today that they are at a standstill with the consultant branch sharing our great frustration and puzzlement with their resistance.

They even acknowledged that our surgical advisors had vast experience with thousands of carpal tunnel surgeries, that they showed great enthusiasm for this groundbreaking, less-invasive procedure for which both surgeons and patients are clamoring.

So where do we go from here? The challenge we and the lead branch now face is that the FDA has used up the 90 days that is allotted to review the submission under its rules and regulation. Today, the lead branch recommended that we take the appropriate steps to continue this process through a resubmission which we initiated today.

We plan to remain closely engaged with the lead reviewer in preparation for a pre-submission meeting which we will request and hopefully secure in the next 30 to 45 days. We also plan to engage DC-based FDA counsel to assist us with this process and any potential appeals.

We’re greatly encouraged by the fact that the lead branch remains strongly supportive and said, and I quote "We want to work with you, and make this happen." In the meantime, we’ll be pushing relentlessly on all other fronts for CarpX.

These include, as we have described before, proceeding with pre-commercial qualifications of our manufacturing line, our first-in-human series in New Zealand in the fall, European CE Mark submission later this year, and are continuing to lay the ground work for the hybrid commercialization channel and accelerated clinician engagement and education activities, including participating in the American Society for – for Surgery of the Hand meeting next month in Boston.

So I’ll reiterate that we are as committed as ever to get this ground-breaking device into the hands of surgeons for the benefit of millions of patients with carpel tunnel syndrome, who are demanding a modern, safer, less-invasive treatment with shorter recovery times as an alternative to traditional invasive approaches which have not advanced in decades.

I really believe it's quite unfair that patients with this debilitating condition are stuck with circa 1990s treatments, while modern technologic approaches, such as CarpX have revolutionized the care of patients across the spectrum of clinical conditions. So now, I’ll turn the call over to Dennis McGrath to review our financial results.

I’ll provide an update on the development of each product and give you a sense of where we expect to be over the second half of 2018 and early 2019 when he is done..

Thanks Lishan and good afternoon everyone, I’ll brief as our financial results for the three and six months ended June 30, were reported to the SEC on Form 10-Q on August 13, and our related press release was published the following morning. Form 10-Q is available at sec.gov and also on our website, where we have posted the press release.

With regard to the financial results, research and development expenses for the second quarter of 2018 were $1.1 million, up from about $700,000 for the same period in 2017.

Higher R&D expenses are primarily due to the $273,000 license fee we incurred in connection with EsoCheck transaction with Case Western Reserve University, which by license agreement, will be paid over several quarters.

General and administrative expenses were $1.6 million for the second quarter of 2018 compared with $1.3 million for the same period in 2017. Increases due to higher headcount and increased in outside professional services.

PAVmed reported an operating loss for the three months ended June 30, 2018 of $2.7 million and a GAAP net loss attributable to common stockholders of $5.1 million, or a loss of $0.27 per common share.

The difference between the two principally reflects interest expense of $500,000 and non-cash charges of approximately $1.9 million, related to the excess of fair value over Series Z warrants, issued upon the exchange of Series W warrants in the modification of Series Z warrant agreement; all simply accounting convention and non-cash charges.

Our press release and the 10-Q provides substantially more detail related to these non-cash charges.

Also the press release provides a table entitled non-GAAP measures, which highlights these amounts, along with the interest expense and other non-cash charges, namely, depreciation stock-based compensation, to enable a better understanding of the company’s financial performance.

You will notice from the table, that after adjusting the GAAP loss by these charges, the company had a non-GAAP adjusted loss for the three-months ended June 30, 2018 of $2.4 million or $0.12 per common share. PAVmed had cash and cash equivalents of $11.1 million as of June 30, 2018 compared with $1.5 million as of December 31, 2017.

You'll also recall in January 2018 the company completed a public offering of its common stock for a net proceeds of $4.4 million and more recently in June of 2018 the company completed a rights offering for net proceeds of $9.2 million. The completion of the rights offer has extended our cash runway considerably.

With that, I'll turn it back over to Lishan. .

Thanks Dennis. So now I'll take the opportunity to backtrack a bit and provide those of you new to PAVmed with a broad corporate overview and limited updates on the other products in our pipeline.

PAVmed is a highly differentiated multi-product medical device company that's built on a business model designed to advance an expanding pipeline of innovative medical devices to commercialization, much more rapidly and with significantly less capital than the typical medical device company.

Our current pipeline consists of seven products across a broad spectrum of conditions and target specialties. Five were internal innovations and two are outside innovations licensed from academic centers using a creative partnership model designed to streamline the transfer of innovation into the commercial sphere.

We have five lead products, which are moving towards commercialization. In addition to CarpX these include EsoCheck, PortIO, DisappEAR and NextFlo, and I'll talk about each one separately. Let's start with EsoCheck our newest lead product.

This is a revolutionary office-based alternative to endoscopy we've recently licensed -- that was recently licensed by our subsidiary, Lucid Diagnostics from Case Western Reserve University. We believe EcoCheck has the potential to save many lives with the early detection of Barrett’s Esophagus.

Barrett’s Esophagus is a precursor to esophageal cancer that occurs in patients with chronic heart burn or acid reflux, also known as gastro-esophageal reflux disease or for short, GERD, G-E-R-D. EsoCheck is a five-minute office based test, which combines a non-invasive targeted self-sampling device that's swallowed with a DNA biomarker test.

Together, these have been shown in the landmark clinical study to be highly accurate in detecting Barrett’s Esophagus which can be then carefully monitored and treated with non-surgical approaches if detected before cancer develops.

We believe EsoCheck screening to prevent esophageal cancer has the potential to replicate the widespread adoption and impact that routine pap screening has had in preventing cervical cancers.

Such widespread screening will eventually target the estimated 50 million at risk Americans, with and without heart burn representing an immediately addressable domestic market opportunity of more than $2 billion. We've crafted a two pronged strategy for the development and commercialization of EsoCheck.

The first is a shorter term strategy, which is to launch the first commercial EsoCheck product in the U.S. in the late first quarter of 2019 next year. We are seeking FDA 510 clearance for EsoCheck self-sampling device along with laboratory developed test or also LDT designation, which does not require FDA clearance of the EsoCheck DNA biomarker test.

And we're making really good progress on these processes and anticipate FDA submission of the self-sampling device in December of this year.

Once the device is cleared and the LDT process is complete, we will commercialize EsoCheck, initially to gastro-neurologist as the mean of selecting which moderate to high-risk patients with GERD are candidates for endoscopic assessments of Barrett’s.

The second prong is a longer term strategy to establish the definitive clinical evidence for widespread EsoCheck screening of Barrett’s Esophagus. This process is already underway and on schedule. The ongoing multi-center NIH funded clinical study has enrolled over 80 patients at 8 leading medical centers.

Lucid recently retained a veteran biopharma CEO as a consultant to help us with a comprehensive overview of the current trial and overall regulatory strategy.

His will help us assure that Lucid is providing all necessary support to accelerate enrollment and ensure that the data being collected in the NIH study is of the highest quality for future subsequent regulatory submission.

With regards to some of our other lead products our implantable intraosseous vascular access device, PortIO, which target patients with poor vascular access. That continues to progress along the FDA's de novo regulatory pathway.

As I previously mentioned, the FDA has approved the protocol for the GLP animal study, that it requested and we will be initiating this study as well as preparing an IDE application for an anticipated small safety clinical study in the coming weeks.

We have also completed the design of the second generation PortIO device, which greatly simplifies and streamlines the insertion procedure. We recently have had early but encouraging conversations with potentials, strategic partners including the market leader in this space.

Next, our resorbable, antimicrobial pediatric ear tube product called DisappEAR also continues to progress well. Each year about 1 million children undergo placement of ear tubes, to treat persistent ear infections on middle ear fluid collections. This is the most common surgical procedure in the U.S.

DisappEAR eliminates the need for our post-operative ear drop regimen which is a major challenge for patients for the kids and their parents and eliminates the need for a second operation under general anesthesia, to remove retained tubes.

We have finalized the protocol for a three-month animal study to assess resorption rates of antimicrobial coated or impregnated tubes machined from silk rods, which will allow us to advance the development towards an FDA submission next year. We have recently advanced NextFlo, our fixed-rate infusion set, to lead product status.

This technology is based on a proprietary variable flow-resistor, and we had we hope to have a design finalized and ready for testing in the fourth quarter.

We believe this technology will permit hospitals to return to gravity-driven infusions and eliminate expensive and troublesome electronic pumps for the vast majority of the over 1 million hospital infusions performed in the United States every day.

So to wrap up, I was hoping and frankly expecting like many of you to announce FDA clearance of CarpX today and but for one hold out consulting review, or where we would have been celebrating that milestone. That said, this is a challenge we will overcome, and fortunately we will be doing so with PAVmed and its strongest position ever.

We have several important CarpX and EsoCheck milestones, as I mentioned, coming up this fall and in addition to strengthening our balance sheet and expanding our management team, we have solidified our capital market position by regaining compliance with NASDAQ’s continued listing requirements.

We also continue to explore opportunities to restructure or payout some of our debt, and remain vigilant for additional opportunities to enhance shareholder value whether through M&A activity or the licensing of ground breaking technologies like EsoCheck. So with that, operator we can now open the call to any questions. .

Thank you. [Operator Instructions] And your first question comes from Anthony Vendetti. .

Good afternoon Anthony. .

Good afternoon guys, good afternoon Dennis, good afternoon Lishan. So just to, I guess, follow up on CarpX. So this orthopedic branch, it seems like there is one particular person there that you know wants further testing or additional information.

So effective today, you resubmitted to the FDA, what they requested, is that correct?.

No, just let me be clear about that. So, the first rating part for both -- for the lead branch is that it's not clear what they are actually requesting. So they did -- they made some additional request to us during this 30-day interactive review.

We snapped on it and did some additional bench-top testing which was successful and addressed some issues around temperature -- the temperature profile. We did some cadaver testing to assess anatomic variance and document definitively that the balloon creates better separation and better protection of the various nerves in the carpal tunnel.

And really as of today, it's not clear to us, and I believe to the lead reviewer, what more they are looking for. And that -- and we have to determine that through this process.

That’s frankly part of the frustration is that everything we have been asked to do, going back to the original request for additional information, we haven't just provided, we provided really overwhelming data that's not just equivalent but superior to the predicate, so the challenge that the lead branch has, is that, as you know, they have a cumulative allotment of 90 days to review a submission.

So that 90 days ended -- ends tomorrow.

So to continue this process, which is what they recommended we do, we will prepare a resubmission, but do so as part of -- along with a pre-submission meeting, because that's really the only way we're going to find out from the consulting orthopedic branch and the part-time reviewer for that branch what more they want from us to -- because we frankly have done everything, and we've unequivocally shown the substantial equivalent.

So the logistical steps are we'll talk to tomorrow to the lead reviewer. And as I said, we'll consult with the FDA counsel and NDC, but what we'll do is request a date and put a pre-submission package, which will fundamentally be what we've already submitted to them, so we can get a face-to-face meeting.

We are hopeful to get that within about 30 to 45 days to sit down face-to-face with both branches and just get a straight answer as to what more they can ask us.

So, just to reiterate one point that I mentioned which is that we don't believe and the lead branch concurs that there really is any clinical data that will address any of the concerns, because we have a predicate, we have established that this is safer.

The predicate actually it has a cutting element that cuts outside of the ligament completely out of view. And we've documented that in a cadaver and an human study just simply would not add any information, and it would be difficult to perform.

So we continue to believe that this will not require clinical data, we have -- in front of both branches and come to a determination again hopefully sometime in the next 30 to 45 days. .

Okay. So let me see if I have it all correct. So, tomorrow the 90 days is up. You expect to be speaking with the lead reviewer tomorrow, and you're going to -- PAVmed is going to request a date to hopefully get clarification as to what else is required. .

Yeah, basically that's a pre-submission meeting, right. So, in anticipation of resubmitting either what we have or what we have plus what anything additional that comes up at that meeting. And then the 90-day clock will start all over again. It doesn't mean that they haven't -- that we won't hear from them in 90 days.

They'll just have that much -- that allotment, the clock will restart, that allotment will get reset. .

No, understood. But at this point, you're in the dark as to what specifically the orthopedic branch is requiring or has issue with, but you don't believe it's going to require human trials. .

Yeah, we are bit in the dark because the concrete things that they requested, specifically and we can get into a little bit of the wait [ph] specifically around this very rare anatomic variant of the nerve that all carpal tunnel surgeries have to address by careful assessment of the anatomy.

We documented that in the cadaver lab that CarpX is at least as safe, likely safer at protecting certain anatomic variants. So, everything specific that they've asked us for, we've addressed.

So, we are really at this point really somewhat in the dark as to what more they could ask us, and there really is a consensus on the lead branch side that clinical data won't add anything to the strength of this application. .

So let's say the orthopedic branch agrees with the lead branch that you don't need human clinical data to support this, maybe there’s some other minor request.

Assuming best case scenario, they grant your request, it's a resubmission occurs, 90-day clock starts, if it's not a significant request and you have the data available to submit to them, does this -- do you think this pushes things back instead of a 1Q '19 launch, pushes it back to 3Q end of --.

Well, that's sort of interesting because in the ideal world actually if we can sort of get our hands around what remaining information they want us to get, and we believe we can deliver it because we have done it every time they’ve asked us before.

That -- the steps that we were -- that we need to take for a commercial launch in Q1 2019, as I mentioned are still moving forward, so it really depends on what we hear from them in September and if it's what it should be based on our conclusions as well as the conclusion of the lead branch, then we should be able to get that through to them at a time for a Q1 launch, but there is no way to know that until we actually can get them face to face and nail down what that additional information is.

But [multiple speakers] yeah, that's right..

So even with this delay, it's still possible as long as it's not an extensive request, it's still possible that you could still have a Q1 launch -- 1Q, '19 launch for CarpX. .

Yeah, no, I think that’s true because, even though the 90 day -- I want to reemphasize something, even though that you should think about it, and you know this but this is for others on the call, the 90 days is sort of like money in the bank, that they can spend, they can -- that’s the days that are allotted to them.

So just because they have a new 90 day clock does not mean that if they make some modest request that we have shown, we can turn around literary in days, that they are going to -- it will take them 90 days to review that. And that hasn’t been the case.

So in the past 30 days since this -- since our last resubmission, we have submitted two sets of data, one set for bench top test and one for cadaver test and they have turned around their assessment between the two branches coordinated and gotten back to us generally within a week or so.

So really blurred [ph] and the timing which I know you’re trying, we’d like to sort of be able to give you a little bit better sense of that. It completely depends on sort of the outcome of this -- our face to face meeting. .

Understood, totally makes sense. Let’s shift gears to PortIO.

Has anything changed there? Or is everything on track, maybe for a second half 2019 launch, if there is everything goes according to plan?.

Yes, I think, let’s just – I think that’s a reasonably timeline. Everything is going according to plan. So the protocol and this is -- it's much more formal with the de novo process. So we actually had to formally submit the written protocol for the animal study. They formally approved that. We’re gearing up in coming weeks to get that started.

If you recall that seven days devices -- and plan it for seven days and we show that we can infuse it every day and show that the device could be expanded at the end of seven days. The pilot for that went extremely well and we expect this to go as well. Then there is an IDE, for the -- small expected, although they haven’t officially requested it.

We expect they’ll ask us for a small clinical study and that can be either -- moving on that should be fairly quick. We have centers that are already lined up and ready to go, including several of our advisors and we really don't anticipate a 30 day follow up for that.

So if you add all those up in sequence I think late 2019 second half is the reasonable target. .

Okay good. And then….

But just to recall again, our strategy with regard to PortIO includes ongoing discussions with strategic partners to -- we would act upon the opportunity to engage with those strategic partner well before that and that’s why we've continued to have those conversations. .

Understood.

And then lastly on DisappEAR, is that also on track for 1Q 2019 submission and then hopefully commercial launch?.

Yes, I think that’s fair. There is still some elements that we have to de-risk as it relates to the resorption rates. So, the main -- one of the main challenges that frankly we’ve been struggling with for a little while, which is the processing of the silk in to these, into these rigid silk rods from which we can machine the tubes.

So we believe in partnership with Tuff [ph], which is the laboratory that created this technology.

We have that -- that process has been established and so the next step is to do the three months study to make sure that the current preparation of those tubes -- that silk that makes those tubes has a long enough resorption rate -- well enough resorption rate to be clinically useful.

So this three months study if it goes well than should lead to fairly accelerated design validation testing and all the steps that are required to get to an FDA submission. .

And then lastly Dennis, more for you, I guess. So we were modeling R&D to move up on a sequential quarterly basis. But it was significantly higher in the second quarter than we had modeled. I'm wondering if that is a onetime aberration or is that the new sort of quarterly norm we should expect going forward. .

Well, in the second quarter as I mentioned in my prepared remarks, there was a $273,000 charge related to the past patent expenses incurred by Case Western that under contract we are to reimburse and get expensed in that quarter, even though we are only going to pay it $50,000 per quarter after the initial financial in side that.

So payments are long term but expense was recognized in the second quarter. However, with all of the items that Lishan identified in terms of expanding NextFlo to a lead product and some of the other initiatives, we will be increasing some of our cost in R&D over the next 5 or 6 months. .

Okay. So if we take out that 273, the remainder is a good run-rate to use as we go forward and then incrementally add on top of that. .

That's correct. That would be the good way to think about it..

Okay, good. Okay, I'll hop back in the queue. Thanks guys. .

Okay. Thanks Anthony. .

Your next question comes from the John Levin from Levin Capital. Please go ahead, sir. .

Hi Lishan.

If clinical testing is required, is it feasible and at what cost and what time period?.

It's a hard question. I don't have -- because it really depends on. We certainly don't expect them to request and it would be absurd for them to request full-blown PMA with randomization and all that. So it's hard for me to answer that John.

I'm not dodging your question, because as I said we talked to the lead examiners and there really is no clinical study that we can point to that will provide additional information relative to where we are. So if they did come with something it would be something very narrow and I would suspect that for short small sample size.

And I think that's something that we could absorb within our current budget. But we'll just have to see what they say at this meeting to really have a have better grasp for that.

Because the cadaver is anatomically the same as the human and so -- and we can you can do more manipulations within a specific procedure in a cadaver to mimic various scenarios than you can and but you couldn't in human study.

So we're going to resist that notion as hard as we can, because we don't think it will enhance the -- it will provide us with any information. .

May I have a follow up question?.

Yes obviously. .

So suppose there is some demanding inquiry.

Would you consider or could you effectuate a joint venture on this product with some major company that might be able to for whatever reason move the approval process forward in a different way?.

Yeah, and that's a great question. I think I'll answer that by starting off by saying that we have had discussions and we continue to on all the way products at CarpX and EcoCheck, on PortIO even in DisappEAR. And so we have had some conversations with some larger companies that are, that have expressed some interest in CarpX.

And if we come out of this next window with the FDA with a plan that would be most conducive to that kind of a partnership, that's not uncommon in the industry and it's something that we would explore. But I really hope and don't expect that that's the path we're going to have to take I really don't. I think we were damn close today to be frank.

And I'm just hopeful that with all of us together in the room that sanity can prevail, that data can win out because the data is really above and beyond what should have been expected to provide and what's necessary to improve substantial costs. .

Great. Thank you for answering the questions, thank you. .

Yeah, thanks John. .

[Operator Instructions] Your next question comes from Mike [indiscernible]. Please go ahead, sir. .

Hey, good afternoon Lishan. Thanks for taking my question. I think you had recently consolidated the multicenter study for EsoCheck in clinicaltrials.gov data base and as of now has estimated completion date in April of 2022.

Do you guys have an estimated timeline, for when you might be put some of the initial data that would support widespread use of EsoCheck as the Barrett’s screening to test and also would this be some that requires another like FDA review process, beyond the initial plans. .

I think, at this point, could you identify yourself again, sorry, we got --.

Sure, it's Mike [indiscernible] from (multiple speakers). .

Hi, Mike, how are you. Nice talking to you, I thought it was you, but I wasn’t sure. I don’t want to be presumptuous. So let me expand on that a little bit, because there is some -- I did include some information in our prepared remarks about how we’re looking at the clinical trial.

So what the main thing about this technology one of this opportunity -- one of the reasons why we [indiscernible] when it was presented to us, is the fact that there is this multi trial NIH funded – sorry multicenter NIH funded trial that is ongoing that’s enrolling at a very accelerated grade, rather just to the target and the 22 days, as you mentioned, as sort of officially within that NIH protocol is probably longer than it needs to be based on the current enrollment rate.

But that said, that trial is really part of as an academic goal, and we have a commercial goal here and a regulatory goal here.

So we are right now at the very earlier stages looking very carefully at the -- at that protocol, at the inclusion criteria and then how interplays with our regulatory strategy for this longer term second pronged strategy, as I mentioned, which will require a PMA, just to be clear.

So in order for us to be able to get an indication beyond what we’ll get in the first quarter of next year, which is a cleared balloon and an LET [ph] designation that does not require FDA clearance for the test.

What we are seeking with the second prong is trying is really the – is really the Holy Grail which is to have EsoCheck be indicated for detection of Barrett’s Esophagus and some defined subset of this sub 50 million patients, right. And so that require a PMA.

And so what we would -- obviously what we are -- what we would love to do is to have this clinical trial be the data that supports that and present that protocol to the FDA and have the data being collected along the way, but Lucid is prepared to provide whatever additional support is necessary or to take other efforts to supplement the data, in order to make sure that the data is in the best shape it can be for that submission.

So that’s why we retained this biopharma consultant, Dr. Wharton [ph] who has the ton of experience with clinical trial design and FDA submission to basically look at where we are right now.

We are hardly three months after this -- after founding this company -- this subsidiary and look at where we are with the protocol and make sure that anything that needs to be done to buffer that and to make sure that it's in the best shape possible for PMA submission, is really done now prior to going to the FDA and presenting the protocol and the plan for the PMA.

So that’s sort of a more detailed answer maybe than you’re looking for, but I thought it’d be a good opportunity to expand on that point of it. .

No, thanks that’s great. And I guess just if I can have one quick follow-up, I guess.

You mentioned you’re meeting with the lead branch of FDA tomorrow talking with them, is that correct?.

We’re going to – we have a – we’ll just talk to them tomorrow and get its recommendation on how to structure the package for the pre-submission meeting. And then we’ll put in that -- we have to put in our request, we’ll putting a request for that meeting, as soon as we have talked to them. .

Okay, and then -- I know you had mentioned that you’d be exploring all alternatives appeals I made just seems so odd with basically like you had mentioned that the FDA lead branch basically would have cleared it, if not for the consulting brand.

So is that something we could possibly hear about?.

Yes, I mean we’ll pursue all avenues and get some -- there are obviously are folks in DC who deal with this a lot. We haven’t in our experience had to go down routes with appeals and so forth, and I hope it doesn’t come to that. But we’ll -- we want to get those ducks in row, in advance of the meeting. .

All right, thanks a lot. .

Thanks Mike. .

[Operator Instructions] There are no further questions at this time. You're free to make any closing remarks. .

All right. Hey so thank you all for joining us this afternoon and for the great questions. We look forward to keeping abreast of our progress via news releases and pediatric conference calls such as this one. I do want to mention that we plan to present at Dawson James Smallcap Group Conference in Jupiter, Florida at the end of October.

And for those who are not attending we plan to webcast that presentation hopefully based on that, on the timing of that will have significantly more information on the status of CarpX. I also encourage you to contact us directly with any questions through the IR portion of our website or by emailing us at info@pavmed.com.

So everybody have a great day. Thanks again. .

Ladies and gentlemen that concludes your conference call for today. We thank you for your participation. And ask that you please disconnect your lines at this time..