PAVmed Inc. (PAVM) Q3 2018 Earnings Report, Transcript and Summary

Greetings and welcome to the PAVmed Inc. Business Update Conference Call. [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.

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 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, to 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 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'd like to turn the call over to Lishan Aklog. Dr. Aklog?

Thank you, Mike. Good afternoon, everyone, and thanks for joining us on this quarterly call to discuss our recent financial results as well as update you on our business. I would actually like to start by welcoming Mike to his first quarterly call as a member of the PAVmed team. Mike you played an important role in enhancing our investor communications over the past several months. And I know our investors, including many on this call are appreciative of your efforts. For those of you who don't yet know Mike, he holds the doctor of pharmacy from the University of Pittsburg, and 10 years ago transitioned to a career in life sciences of Investment. During this past decade he has co-managed to popular online biotech stock research and training subscription service and has built a large [indiscernible] following the biotech investments. So feel free to contact Mike at jmh@pavmed.com. Also make sure to sign up for our email newsletter and to follow us on Twitter, LinkedIn, YouTube, and at our brand new website. You will receive useful interim updates on topics of interest and other PAVmed news. As always I would also like to thank our shareholders, especially our long-term shareholders for their support, and to welcome any new shareholders to PAVmed. We are grateful for having engaged with investors who share a long-term commitment to our vision. With CarpX and EsoCheck anchoring a valuable and highly anticipated portfolio of products, which are moving towards commercialization, I'm confident that we will reward that commitment and build a high-growth commercial company. I would like to now proceed with an update on our business. After that Denis will provide an overview of our financials, and then we'll open it up for questions. So PAVmed had a strong and productive third quarter, which is continued into this quarter. Despite some delays in CarpX’s regulatory path, we broadly saw steady progress towards our strategic goals, including advancing our lead products towards regulatory and commercial milestones. And most importantly, we find ourselves than historically strong financial position with more than $9 million in cash at the end of the quarter, and the cash runway that extends well path critical 2019 milestone, which we believe will significantly enhance the value of the company. Let's now review the status of our current pipeline, which consists of lead products across the broad spectrum of physicians and target specialties, all of which are advancing toward commercialization. These include, CarpX, EsoCheck, PortIO, DisappEAR and NextFlo. CarpX, PortIO and NextFlo are internal PAVmed innovations, while EsoCheck and DisappEAR are external innovations, which we’ve licensed from economic centers are using a creative partnership model designed to streamline the transfer of innovations into the commercial spread. Let's start with CarpX. CarpX is a groundbreaking minimally invasive device to treat carpal tunnel syndrome, a very common condition where repetitive motion leads to scarring of a ligament in the wrist, which in turn compresses the nerves causing severe and debilitating symptom. The clinical and economic burden of carpal tunnel syndrome of society is massive. We believe CarpX will dramatically reduce recovery time and target and annual domestic market opportunity of over $1 billion based on estimated 600,000 invasive carpel tunnel surgeries performed each year. The total addressable market is even larger as an additional 1 to 1.5 million people suffer in silence that would likely choose a treatment option with shorter recovery time. CarpX is a single use device designed to provide the same clinical release as traditional surgery but much less invasive as uses of proprietary balloon catheter with embedded electrodes to cleanly cut the scarred ligament from the inside out and relieve the pressure on the neck. CarpX incorporates numerous features designed to maximize safety and provide confirmation that the ligament has been completely cut. Extensive animal and cadaver testing is demonstrated that CarpX is safe and effective as a precision cutting tool with no thermal spread and minimal zone of injury. Multiple surgeons have successfully performed the procedure numerous times in cadavers were consistently excellent results. As many of you know, we've been working closely with the U.S FDA during the past year to secure U.S. regulatory clearance of CarpX through the FDA's 510(k) pathways, which is based on demonstrating substantial equivalent to a previously cleared productive device. We submitted our initial 510(k) application in the end of 2017. The lead branch assigned to review the application was the general surgery branch. The orthopedic branch was asked to serve as a consultant group. We received the FDA's initial request for additional information earlier this year and spent approximately six months closely working with the lead branch to satisfy these and other requests, mostly focused on the thermal characteristics of the device. Although we often found ourselves dealing with a moving target this effort culminated and what we believe in the lead branch appeared to agree was a robust and complete final response to all of the FDA requests submitted this past summer. In August, the FDA notified us that it had not reached the consensus between the branches within the review period allotted and recommended that the company extend the review process through resubmission of the 510(k) application following an in-person pre-submission meeting. Since then, we've been working hard to ensure that we answer the FDA pre-submission meeting from the strongest possible position and with the highest probability of securing the clearance. We started by engaging the founding partner of one of the nation’s leading FDA law firms to advise us through the process. Based on her recommendations, we spent some time preparing a pre-submission package, which incorporated a large amount of testing data and other documentations generated during the review of the original application. And we took great care to assure that the package was digestible to FDA personnel who would be reviewing the application for the first time. Last month, we submitted this comprehensive package, and more recently finalize the arrangements for a pre-submission meeting with the FDA, which is scheduled for January 7, 2019. We hope for an earlier date, but the upcoming holidays made us challenging to get the doc at -- make us challenging to get other doc at this time of the year. That said, we’re excited to have secure the meeting and eagerly anticipate the opportunity to make our case that CarpX is substantial equivalent to the predicate device and should be granted by 10-K marketing clearance. We’re encouraged that the lead branch for this pre-submission remains a general surgery branch. The FDA has assigned a new and more senior a lead reviewer from this branch, which is also a positive sign. We worked closely with the lead branch reviewer participated in the review of the initial application, and will report to the same lead branch chief. We requested specific senior FDA personal and power to make executive decision to be present at the meeting, but we do not yet have a final list of the FDA attendees that have not been notified whether or not the orthopedic branch will be consulting during this run. PAVmed’s team will arrive at the meeting loaded for bear. Our senior management will be joined by a world-class team, including our FDA counsel and recognized experts in carpal tunnel surgery who strongly support CarpX as substantial equivalent target. We have strong data, strong arguments and a carefully hold strategy for the meeting and are looking forward to a positive outcome. And we are committed to providing an update as soon as possible after the meeting. I'm excited about several other important upcoming CarpX milestones. Next week we expect to secure Ethics Committee approval which should allow us to perform our first-in-human CarpX clinical series in New Zealand in December. This will be a very important step in demonstrating the clinical and commercial promise of CarpX. The ISO certification process and quality management system setup required for CE Mark submission in 2019 are both well underway. We also continue our efforts to establish a commercial infrastructure through active discussions with distributors in the U.S. and abroad. A feedback from ongoing clinician and engagements, including during this past quarter, the American Society for Surgery of the Hand meeting in Boston and The American Society of Plastic Surgeons in Chicago has been quite positive. Let me now move on to EsoCheck. EsoCheck is a revolutionary alternative to endoscopy, which our newly created subsidiary Lucid Diagnostics licensed from Case Western Reserve University earlier this year. The National Cancer Institute recently highlighted EsoCheck in its 2020 annual plan and budget proposal to Congress as one of the year’s significant advances in cancer prevention, we agreed. The technology is designed to allow patients to undergo a non-invasive office-based procedure to detect Barrett’s Esophagus, a pre-cursor to highly lethal esophageal cancer, which occurs in patients with chronic heart burn or acid reflux, also known as GERD, Gastroesophageal Reflux Disease. And started contrast to traditional endoscopy, the procedure can be performed in an office setting by a nurse or other clinical personal in less than five minutes. We believe the EsoCheck technology has the potential to save many lives to the early detection of Barrett’s, which can be carefully monitored and treated with nonsurgical approaches if protected before cancer develops. EsoCheck screening to prevent esophageal cancer has the potential, we believe, to replicate the widespread adoption and impact that routine Pap screening has had in preventing cervical cancer. We estimate an immediately addressable domestic market opportunity for EsoCheck is at least $2 billion based on over 20 million U.S. patients with gastroesophageal reflux disease who are candidates for Barrett’s screening based on existing American College of Gastroenterology guidelines. I would encourage you to consider EsoCheck as two distinct products as we are increasingly of the opinion that each has its own independent commercial potential. EsoCheck CCD, short for Cell Collection Device, is a balloon catheter designed to collect cells for diagnostic testing from a targeted region of the esophagus without the need for endoscopy. EsoCheck DX, short for Diagnostics, is a methylated DNA biomarker test of two genes by mVIM and mCCNA1, which has been shown to be highly accurate at detecting Barrett’s Esophagus in a 400-patient study published earlier this year in Science Translational Medicine. We are pursuing a two-phase regulatory and commercialization strategy for the EsoCheck technology. Simply put we’re seeking to maximize EsoCheck’s long-term commercial value, while providing near-term value inflection commercial milestone. Phase I seeks to commercially launch EsoCheck CCD as a 510(k)-cleared cell collection device and EsoCheck DX as a Laboratory Developed Test or LDT. LDTs require obtaining a clear certification of the testing processes at a central laboratory that does not currently require FDA review. Phase II seeks a specific indication for widespread Barrett’s screening using EsoCheck based on existing ACG or American College of Gastroenterology guidelines. We have made excellent progress in both phases. We expect to submit the EsoCheck CCD device for the 510(k) clearance to the FDA next week. It has an excellent predicate and a low risk profile. So I’m optimistic that it will be cleared expedition. The EsoCheck DX diagnostic test continues to undergo a battery of tests to secure CLIA certification at University Hospitals Cleveland Medical Center’s translational laboratory and is on schedule to achieve LDT designation in late Q1, 2019. We’re working with a leading reimbursement consulting firm to apply for EsoCheck DX reimbursement codes through the American Medical Association’s Proprietary Laboratory Analysis, or PLA, process. And we are encouraged by the fact that there is a strong precedent for receiving excellent reimbursement for genetic biomarker LDT. Phase II is also off to an excellent start. The ongoing multi-center NIH-funded clinical trial has enrolled well over 100 patients. This study which includes leading academic institutions across the country compares EsoCheck with endoscopy in detecting Barrett’s Esophagus. We have recently retained a leading regulatory firm with many ex-FDA partners, including the former director of the FDA’s Office of In Vitro Diagnostics, which will be reviewing their Phase II submission to help us craft our Phase II regulatory strategy. We anticipate that achieving our Phase II goal of securing a specific FDA indication for widespread EsoCheck screening for Barrett’s using current ACG guidelines will require human clinical data. But our work with the regulatory firm does just that we may be able to achieve this goal under the FDA’s less burdensome de novo pathway instead of a full-blown PMA. Our goal is to secure an FDA pre-submission meeting in the early part of 2019. An important part of – an important compound of both phases of this strategy is aggressive engaging with gastroenterologists, including the key opinion leaders, as well as the busy clinical practitioners. The America College of Gastroenterology meeting in Philadelphia last month provided us with the perfect venue for this. We held a successful launching symposium on EsoCheck and demonstrated the EsoCheck devices at a -- EsoCheck CCD device at a company booth in the industry is difficult. We engage dozens of gastroenterologists as well as industry members and successfully completed an EsoCheck market survey. The feedback was strongly positive and provided excellent data to own both phases of our clinical and regulatory spreads. The remaining lead products in our pipeline are also progressing well. And we really view these as providing additional opportunities to enhance shareholder value by mitigating risk through diversification and offering potential sources of non-dilutive capital. Now PortIO is our implantable intraosseous vascular access device, which allows clinicians to deliver medications or other substances directly into the bone marrow its better than to a vein. We are pursuing U.S. regulatory clearance of PortIO through the FDA’s de novo pathway seeking an initial indication for use over seven days in an inpatient study. The FDA requested GLP animal study will be completed this quarter and will likely be followed by a small clinical trial in 2019. We have engaged the major investment bank, which has begun a process took four potential strategic partnerships, including acquisition of PortIO. DisappEAR is our resorbable, antimicrobial pediatric ear tube that’s designed to eliminate the secondary procedures and the need for a difficult course of antibiotic ear drops in the 1 million children each year who undergo placement of ear tubes for middle-ear infections. It is made from a proprietary self technology we licensed from Tufts University and the three-month animal study to evaluate the resorption rate will also be initiated in this quarter, and if successful, we will support a planned FDA 510(k) submission in 2019. NextFlo, our fixed-rate infusion set based on a proprietary variable flow-resistor. NextFlo seeks to revolutionize routine hospital infusion of which there are 1 million per day in the U.S. by providing a fixed-rate infusion set, which can eliminate the need for expensive, unwieldy electronic infusion product. Benchtop testing of the NextFlo prototype is showing excellent results, and we look forward to finalizing the product design very soon and proceeding to FDA 510(k) submission in 2019. Finally, on the general corporate front, we continue to grow and strengthen as a company, and we expect to further strengthen our financial position by refinancing our senior secured debt this quarter, well ahead of its July 2019 maturity date. And during this past quarter and in recent weeks, we have added three employees including Mike, Investor Relations; Shaun O'Neil our Chief Commercial Officer, who joined us in the summer. He has been very busy on both CarpX and EsoCheck clinician and commercial engagements. And this week, we added a second product development engineer to assist [indiscernible] and our contracted partners in the work across all of our products. Finally, as I have already noted in these remarks, we have had several world-class consulting firms to help us with -- particularly on CarpX and EsoCheck. And now, I'll turn the call over to Dennis to review our financial results.

Thanks, Lishan, and good afternoon, everyone. I'll be brief as our financial results for the three and nine months ended September 30 were reported to the SEC on Form 10-Q yesterday. And our related press release was published this morning. The Form 10-Q is available at sec.gov and also 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 $1.2 million, up from $705,000 for the same period in 2017. However, we are about even sequentially from the second quarter of this year. Consistent with remarks we made last quarter through the end of the year, R&D has increased as we push CarpX to clearance, EsoCheck to its initial FDA 510(k) filing, and PortIO completing its GLP seven-day animal study. General and administrative expenses were $1.4 million for the third quarter of 2018 compared with $1.3 million for the same period in 2017. The increase was due to the costs related to pre-commercial activities including headcount, travel and key opinion leader events. PAVmed reported an operating loss for the three months ended September 30, 2018 of $2.6 million, and a GAAP net loss attributable to common stockholders of $3.3 million, or loss of $0.12 per common share. The different between the two principally reflects interest expense of $700,000. $500,000 of which is non-cash, related to amortizing the initial debt gap discount. Of particular note, the current quarter is largely absent the non-cash charges reflected in earlier periods of this year as well as last year related to derivative accounting of the various warrant and preferred securities outstanding during those periods. Our press release and the 10-Q provides, substantially more detail related to the non-cash charges occurring in the prior periods, as well as the various security exchanges undertaken in the first half of this year to eliminate those events. Also the press release provides a table entitled non-GAAP measures, which highlight these amounts along with interest expense and other non-cash charges, mainly depreciation and stock-based compensation to enable better understanding of the company's financial performance. You will notice from the table that after adjusting the GAAP loss by these charges company reported a non-GAAP adjusted loss for the three months ended September 30, 2018 of $2.2 million or $0.08 per common share. As Lishan has already said PAVmed had cash and cash equivalents of $9.2 million as of September 30 compared with $1.5 million at the end of year. So with that report, operator, we ask you to open up the lines for questions from our shareholders and investors.

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

So just to start with CarpX, the meeting is January 7, can you give, Lishan, maybe best case, worst case scenarios. If the meeting goes well, how should we expect the FDA to act? And then best case scenario, when do you think you will start commercializing CarpX?

Sure. So I think it’s actually good opportunity to remind everyone that this is a pre-submission meeting, right. So the purpose of this meeting is for us to meet with the lead branch and determine what their position is and make our case that we think we’ve already established substantial equivalents, but understand what remaining issues there might be and what additional information they might require to grant us the substantial equivalents and clear. So based on the meeting, we will leave that meeting with a clear plan as to what we need to do. The extremes cloud extent -- basis of various scenarios could extend from same based on new personnel being involved in the review that they just capture our case that, in fact we had and that we would have minimal additional work to do to put together the final submission. They can also ask for additional information and additional collaborative testing or other bench top testing to address any remaining concerns. Obviously the worst case scenario would be for them to say something they've never, as I have repeatedly said, they have never explicitly requested or suggested would be necessary in this case, which would be to perform human clinical study. So I'm not sure that I can give you – I’ve covered a lot of contingencies, right. I think, probably the best way to handle this, Anthony, is to sort of go through the steps of what happened. But after that meeting, we will go out and collect any information that’s necessary they requested, including, if required, additional cadaver testing to bench-top testing. It’s hard to know what that time period to be because it’s very limited or it could extend over several weeks. Cadaver testing is actually – we can actually get that done really rather quickly once we know what the requested the protocol is and what the information is. From then, we need to actually prepare to the full submission, which is really substantially similar to the package that we've already submitted for the pre-submission, but that does require some additional work on our behalf with our regulatory consultants. At that point, that 90-day clock starts ticking, and they have the 90-day period, cumulative period, to review the submission. Now given that they are well conformed with this application -- with this device based on our interactions with them over the past year. We certainly don't expect them to get there to have our first response from them over that 90-day period. We would expect a relatively early response. And as was the case in our initial submission there is a period of interactive review where we would expect as, previously to have ongoing verbal and written communications with the FDA as to how the review is proceeding. So there are really too many variables in there, Anthony. Am I trying to dodge to give you a best or worst case scenario, but certainly no more after the completion of the meeting.

No. I think that's pretty clear. I mean assuming the worst case scenario doesn't happen, most likely, as you said, you are geared up to do additional cadaver testing, and that could take a few weeks to several weeks -- a few weeks to prepare. And then you would resubmit, and the 90-day clock would start, the value wouldn’t take the full 90 days at which point hopefully whether that’s end of the first quarter or sometime in the second quarter, you will have a response back. Once you get the response, Lishan, how quickly can you start ramping up to commercialize?

Yes, it’s a great question. Glad you brought that up. I should have raised that. So, yes, we will be ready to go. So the -- one of the things, I think, I pointed out in our last call was that, although we have this delay related to the regulatory process, we did still have further steps that we would have to take from a manufacturing point of view with regard to our processes and test methodologies and so forth, to be truly ready to provide commercial product. So that process is ongoing. It’s going well. And we will be – we really will be prepared to launch commercially, very, very soon after we receive the clearance.

And then on the CE Mark submission for CarpX, I know, you said in the press release, you are going through the process and it’s well underway. Will you wait until after the FDA comes out with the decision to submit for CE Mark? Or will that happen concurrently?

No. So I think, I would -- the way to look at it is that, we consider FDA submission, CE Mark submission as well as the first-in-man clinical series in New Zealand as completely independent of each other. So as I noted, we’re hoping to get that those cases in New Zealand scheduled in December. And we will submit to the FDA as soon as we are – excuse me, we will submit CE Mark as soon as we’ve completed the ISO certification process, the completion of the quality management system, which will allow us to submit through the notified body. So the answer -- simple answer to your question is we’re pursuing all three as independent track.

Okay. And then, is it safe to say that you expect to submit the CE Mark – for CE Mark approval or at least the submission will be in early 2019 then?

Correct.

And then on EsoCheck, just to understand when do you think that CE Mark submission would occur in 2019 approximately? And then is that something you would, once getting approval, ready to go also commercially?

Yes. So it’s -- Europe is a little bit – requires little bit of more new ones as it relate to EsoCheck. But I will spend a little bit of time on it. But we probably would like to dive in a little bit deeper on that. As we said we’re submitting the FDA the device, the balloon catheter device, BCD, for FDA clearance, and we will submit that to -- for CE Mark, in the same time window. Many of the processes frankly that we’re putting forth on our quality manager system for CarpX are actually duplicative of what will need for EsoCheck. So I don’t have a specific target date yet for submission, but I certainly believe it would be in the first half of 2019. The tricky thing with the launching commercially in Europe is not the clearance of the device, but being able to provide a methodology for the samples to be tested. Right now, we’re pursuing an LDT at a central laboratory here in the U.S., which is fine for patients in the U.S. For Europe, we have to sort of explore whether we can have those shipped here to U.S. using express mail or whether to partner with a local laboratory in Europe. So that’s -- those are ongoing where we actually do have ongoing discussions with -- in one country particular, in the Netherlands to try to decide on how to pursue that. So it is little bit more complicated than a European CarpX launch.

That’s helpful. And like you said this -- working through the process with CarpX helps with the EsoCheck process correct?

Right. Yes.

A lot of the same quality management system, infrastructure and the audits associated with that are identical.

[Operator Instructions] Our next question comes from Sean D'souza, Private Investor. Please proceed with your question.

My name is Sean. I'm a private investor. And I was kind of new to investment in general. I was wondering – my investment bank when CarpX first had the resubmission issue, and the prices seems to have kept dropping every since. And I was wondering when we anticipate the pricing increase finally? Or could you give any advice or just part of that all that appreciative. Thank you.

Yes. We can't really provide you any guidance in terms of how the stock price is going to perform with the various milestones. The only thing we can do is execute on the milestones as we have outlined. And there are a bunch of milestones that are forthcoming in -- not only in the next couple weeks, but over the next year. All of them, we believe, have upside influence on the stock.

Our next question comes from Anthony Vendetti, Maxim Group. Please proceed with your question.

I’ll jump back in and ask some questions on some of the other products. So PortIO looking for FDA submission, what's the timeframe there and for CE Mark?

Yes, so with PortIO, just to kind of – just to reiterate where we are on the timeline, we are going down the development pathway, which basically means that we have a clear our marching orders from the FDA as to what they – what we agreed upon would be the next step to demonstrate safety of the device for the seven day inpatient indication. We completed that pilot study, which I have discussed previously in the spring, which went extremely well. And we’ve finalized the protocol based on that. And in the next couple of weeks, we are going to be recapturing that. We are going to be initiating the GLP or the formal animal study, based on the FDA’s guidance on this protocol. So the steps after that are as follows. So we complete those animals – they will be followed for 30 days. They will undergo implantation. They will have the device access to every day for seven days in a variety of worst-case scenarios that we’ve incorporated in the protocol in terms of the volume of fluid given and the toxicity of the drug being administered. At the end of seven days, the device will be removed, and the animals will be studied pathologically 30 days later to confirm that thing to field up well and there no infection, and that the bone marrow is unchanged. So after that we will submit that data to the FDA, and we will have likely another in-person meeting to discuss what the next steps are. As I’ve said it repeatedly, we haven’t been expletively told that as part of this de novo application that we will need to the human clinical, but it’s our suspicion that we likely won’t be asked to do a small series, 20-25 patients single-arm non-randomized to demonstrate safety for this particular application. So the final de novo, assuming we have to do that, that final process will likely take us through the mid to later part of next year. If we don't, obviously, things would move a lot quicker. You hinted out our other part of our strategy here, which is to seek a partner. We believe this is a very exciting, very differentiated product that has several natural strategic partners and potential acquirers. And based on how things will progress so far and the excellent results from the pilot study and what we anticipated will be excellent results. From the GLP study, we believe the timer come for us to have more formal engagements. And as I mentioned, we’ve engaged with an investment bank to do that.

Okay.

As you said this segment that CE Mark, we haven’t provided specific guidance as it relates to CE Mark, because that will really depend assuming we do consummate a partnership that will depend on the strategic goals of that partners. So -- but as we said previously, once we’ve established our quality system, and otherwise that we can submit for CE Mark rather quickly by the mid part of next year. But we’re holding off and doing still until we have a long-term strategy with the potential partner.

Okay. And then lastly on DisappEAR, and you talked about some of the issues, I guess with the fibers and cohorts. But just wanted to see if that was an expected FDA submission in late 2019 or could that be sooner?

I think it could be sooner. So the key findings, the key hurdle that we’ve overcome is that we’re now able to take this proprietary silk material using the processes that have to develop the test, we get a hard block of this silk material, and we’ve been able to machine ear-tubes from that. So that was our significant hurdle that took a little while working with tests to get over where we've accomplished that right now. So we're ready for this study, which is designed to show how quickly those of two -- the silk resort over a three-month period. I mean you should have extrapolated from that to determine what we think the life span of the tube will be. We want the tubes to last at least a year. And so therefore, if the data from the study shows, in fact, that others current configuration -- the current way that the silk is being prepared that it does last well past on our target period than we actually at that point will be ready to start 510(k) – start working for the 510(k) submission and doing all the design validation, all the testing required for submission. So really that will – we really will depend on the outcome of the study. But if the study goes well, we could be in a position to submit, I will say third quarter of next year. If it comes back and is resorting too quickly, then we’ll have to go back and tweak the formulation of the silk into creating this block and repeat the resource into that that.

Okay. Do you feel like you’re over that hurdle? And then lastly, this is one that would be -- as PortIO, you would seek a partner ideally for this?

I really – yes, I’m glad you mentioned that because I just sort of answer that earlier. And I think just for the investors and others, I really would look at our five lead products right now as two, CarpX and EsoCheck, as two that we’re really looking to maximize value creation internal the company, and to take as far as we can commercially. I would look at both PortIO and DisappEAR and NextFlo as three products that, we will have incredible path to stop commercialization like we always do. But that we would look to an early engagement like we’re doing with PortIO with potential strategic partners both because of the characteristics of the technology of the products, but also because they are sort of natural partners that would be presumably going to have access to this technology.

[Operator Instructions] Our next question comes from Neil St. Jean, private investor. Please proceed with your question.

I just have one quick question for you. For EsoCheck, does the 90 days start with the submission next week?

It starts technically with the acceptance of the submission. So we submit next week. We should hear, a few business days later, that they have received that in a sort of acknowledgment. And then they typically will go through a little checklist to make sure that all the components of this submission are present. And that usually takes more than few days. Once we get that acceptance, then the clock -- then the 90-days clock start ticking.

Ladies and gentlemen, we have reached the end of the question-and-answer session. And I would like to turn the call back to Dr. Aklog for closing remarks.

Great. So thank you all for joining us this afternoon and for the questions. We look forward to keeping you impressed of our progress via news releases, periodic conference call such as this one, but I really do also encourage you to contact Mike directly with any questions at jmh@pavmed.com. So everyone have a great day. Thanks again.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.