PAVM - Earnings call transcript Q2 2018

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Operator

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.

Bruce Voss

Thank you .This is Bruce Voss with LHA. participating PAVmed for update all you in business today’s call. Thank

Lishan from Financial Executive PAVmed me Aklog, Officer. are Chief Joining McGrath, Dr. Chief Dennis Officer, and

ability in actual Before encourage statements materially Commission, regarding products comments are operations and caution, commercialized; to Securities products identify in clearance call, competitive not we of authorities; specific management review PAVmed not and and time has the results the cleared or like PAVmed. described the once regulatory of raise cause FDA the and from results company's development, to may to, cleared this the market whether filings I acceptance and including by differ forward-looking during to to its advance and conference additional that products. Exchange regulatory when contain environment. will company’s future and any by of which begin, forward-looking that results uncertainties the I’d the are Factors, you submission; other made to limited events with regulatory received capital; that or products the statements. may yet to the inherent those factors, affect from but research market cost to include bodies the company’s required

and uncertainties difficult are risks New predict. may arise and from to time-to-time

or difficult control. and accurately predict factors many are to these company's impossible beyond them of the are All of

subsequent conditions likelihood said, XX-Q. like over annual actual on in Part Dr. that as Form that update maybe Factors differ or Item results affect and filed statements filed Risk description report the reports from affect the those XA disclaims which law, further circumstances list or any in changes and to recent expectations the publicly to Except that see PAVmed forward-looking in quarterly to Form may or expectations I'd and the based important SEC that turn XX-K PAVmed's forward-looking any and or With Aklog. For reflect intention required these contained or X Aklog? in most revise on events in by any with may Lishan on to a updates other obligation risks those will future operations statements. of call uncertainties entitled

Lishan Aklog

products you, in have results this on our thank Thank as everybody, to Bruce. afternoon and this I interest for you company in you the business. a is its us Good with of update number on as recent record our surge participants consistent that and joining from for call, the me strong shareholders commitment our to we to Investor financial well their our shareholders see on discuss questions and past call which with by the shareholders, past words our PAVmed. especially you expressed your like few community thank our vision. have to welcome I our and long-term the and email of over over support, encouraging contacted new Many months. to long-term

fact New of offices to have taken our time in the you York. in visit Some

press overview of provide to release up are sure which of drive head then detailed products all this our We those financials, fully is differently CarpX, the the of provide and a or release I'll provided previous quarterly remain investors shareholders calls. have a just truncated on to are make updates press focus transparency we topic we eight interest, in along ago an full of to frequent and more are announcing to you grateful results, see a and going review engaged than as systematic bit initially but enhance update date. our to not then to for PAVmed who days new Since value. structure I'm the our Dennis of committed did greatest last having business call

and injury was on a millimeters for numerous I've to update end detailed general of with the extensive assist branch, a that We additional animal FDA's provide less orthopedic conversations procedure. the branch. target first before than XXXX were documented request and to information, zone well our of the protocol and of surgery on noted us lead much lead to of a protected at in well submission. millimeter submitted this clearly the FDA's zone of and FDA less our assure as maximum resubmissions. we've with. the the FDA target several reviewer branch provided briefly the times the had assigned the CarpX's during branch as assigned additional other The status with performed and testing application we us presented XXX(k) structures and for thermal time the X.X recap, us of review for responses specimens was application The a earlier to year. consultant that like purpose by application under than the The with approved requested this a FDA received injury had most To for that below I'd So that X this information

raised establishing the the beyond interactive and complete the consultant was also standstill CarpX experience that zone to element time. The month the the that request received branch quality great and other We total not they branch, than surgeons cadaver the documented times have the to we lead results. we formally our device’s clearance the of carpal We've we that the CarpX with FDA resistance. the patients was response. with was protection groundbreaking, the of and the conversations branch, multiple all provided branch their up sharing that the the lead call’s for multiple case data of predicate. tunnel showed resubmitted they was surgeries, thousands turning anatomic encouragement balloon surgeons better showed procedure that review perform consulting the cutting agreed, it to puzzlement vast are that original outstanding equally less-invasive lead CarpX and been separation believe, As branch us in at branch then, or had this which branch clinical basis by excellent solely the To a presented record response of clamoring. lead They narrower, XXX(k) the branch had of for FDA notified branch's provided the above that testing bench-top multiple to great be the successfully cadavers month. Thoroughly the data commended the with lead had strong If variance. for These written believe substantial even including frustration unequivocally advisors persisted in lead around that moving new us with additional testing the really and of of and consultant participating our over in are each over that and the safer with data, surgical the acknowledged last CARPX we requested, form equivalence. the of last confident with was sum what the data in and to we issues branch helpful in multiple month and address today would would and that orthopedic gone necessary acknowledged our, with enthusiasm FDA's Instead, frustration, that both a the which today. performance part profile with of with safety structures and anatomic since requests from even robust lead were the information, We injury the not the past safe was procedure rare target, additional and reviewer.

closely today. XX take the the resubmission meeting to the and recommended So under to next is Today, rules request face challenge the where and review that the lead branch preparation steps lead do that secure engaged to we we go and which allotted we plan from in pre-submission its regulation. we is initiated reviewer the XX FDA we through used lead days. for process with XX to has here? hopefully a continue the the The days a branch which will in that We up appropriate submission now remain this

plan to with engage process DC-based also potential any to FDA assist appeals. us We this counsel and

the in "We the we as ground have – In and education series month meantime, you, New We’re pre-commercial continuing later the activities, in first-in-human Boston. the Society hybrid for our clinician and Mark American relentlessly said, the commercialization in happen." fact work the line, on that next lead including and proceeding include, the and accelerated remains this lay CE quote for this Hand supportive channel participating greatly all to fall, of and European in described make pushing and be for year, with submission Surgery engagement to meeting Zealand strongly are with These by we’ll work I manufacturing want CarpX. encouraged our other before, branch of for fronts qualifications the

in So the hands treatments, ever that for alternative tunnel patients recovery which into care an committed times as to of demanding this of believe condition such of really revolutionized spectrum patients unfair patients I technologic CarpX circa invasive while with are as approaches approaches, clinical the of carpel we treatment device are as a traditional of advanced surgeons modern syndrome, I’ll modern, have decades. conditions. that quite with with the millions XXXXs reiterate not the are who debilitating less-invasive safer, it's stuck with benefit this shorter across as ground-breaking get to have

review the our on I’ll we you done. results. now, sense call the So to where financial of of I’ll the early to and XXXX he to a provide product half be Dennis over development second is update McGrath of each when XXXX turn and give an over expect

Dennis McGrath

and on and June press Form results and reported following good the months Lishan published afternoon our for XX, brief XX-Q as the the ended was were related morning. on to August SEC three six Thanks everyone, release I’ll XX, our financial

sec.gov W to million, with second financial be release. which we development million license the to $X.X are XX-Q for and press to difference Reserve increased the $X.X professional the and over loss XX, compared available period a of June paid due Form of fair expenses warrants, $XXX,XXX the of of expenses warrants in $X.XX several to $X.X GAAP an the Series XXXX. With administrative or agreement, million, a University, with incurred attributable EsoCheck related expense Case million, connection in services. approximately same interest higher for reflects PAVmed our for with of quarters. all and issued million were and at expenses and principally $X.X of accounting Series second of period XXXX. common for ended share. license two same on XXXX The XXXX R&D we primarily Z up will by headcount for quarter exchange $XXX,XXX regard upon agreement; XXXX $X.X excess the per research months have Western from were to in the between General simply warrant Higher website, the $X.X the outside loss over results, of charges modification and convention of Z operating quarter the fee also is stockholders posted $XXX,XXX the charges. reported where loss and in of Increases about the common in three Series non-cash due million value net non-cash transaction

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

of these adjusting after XXXX cash for charges, $X.XX notice XX, compared equivalents $X.X had cash adjusted will and that ended as You XXXX million PAVmed table, share. the the of of June of by XX, company June three-months non-GAAP $XX.X GAAP loss per had or million the common the loss XXXX. XX, as a $X.X with million from December

back and in recall of our over public stock of extended that, runway offering the net proceeds has company January of to completed turn recently completion offer for Lishan. common company of XXXX With proceeds the also I'll completed million in a the rights June for The rights more offering You'll of its considerably. $X.X a net cash it a XXXX $X.X million.

Lishan Aklog

Dennis. Thanks

innovative pipeline. take I'll those bit our with provide opportunity now of new corporate highly broad is you backtrack and limited PAVmed So updates a that's in differentiated pipeline device a the and overview rapidly business with an and device advance commercialization, of multi-product the more to a medical capital than devices typical less company expanding significantly on to designed much model medical company. on the other to a PAVmed to products medical built

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

which We have five lead commercialization. towards products, moving are

each and CarpX separately. NextFlo, include EsoCheck, addition talk about DisappEAR PortIO, one and I'll these In to

cancer with newest in pap Esophagus be detected before self-sampling heart This licensed non-surgical believe as the to reflux, prevent million disease addressable Together, cancer adoption clinical impact EsoCheck device risk short, detection at domestic endoscopy screening Reserve replicate subsidiary, cancers. of the in Americans, billion. cancer widespread is market is a with We has biomarker to for that Let's screening will EsoCheck Diagnostics accurate strategy lead representing many preventing a believe licensed and chronic that two alternative esophageal detecting develops. DNA Western commercialization has shown lives Such the combines had known burn occurs test, the Esophagus carefully for Esophagus. screening office if been -- then a cervical an and also a study precursor treated office-based monitored in was to swallowed Barrett’s heart with recently Case gastro-esophageal without more estimated with routine highly early opportunity a with to can widespread to five-minute we've is our save a eventually has that's start development be potential burn based targeted product. revolutionary from $X to which EcoCheck non-invasive of the crafted University. Barrett’s or our We these immediately EsoCheck acid or G-E-R-D. GERD, potential patients approaches target that We've than have esophageal landmark and reflux which EsoCheck. XX and pronged Barrett’s of recently in test. Lucid by with the the

of shorter is U.S. the a the The quarter in which year. launch XXXX late strategy, is first the product next first term first in EsoCheck to commercial

of EsoCheck FDA along And XXX clearance test. really developed of for FDA submission processes good FDA anticipate laboratory making we're these are of also or with DNA device require LDT clearance self-sampling which We the not seeking designation, EsoCheck test does high-risk on progress biomarker and in device we the is LDT device are process December cleared to with for will commercialize as endoscopic assessments self-sampling GERD EsoCheck, mean the selecting gastro-neurologist of year. of the candidates and complete, which initially to Once patients is the Barrett’s. this moderate

a target ongoing enrolled help definitive for current comprehensive screening has already clinical longer widespread to Esophagus. medical over X strategy on CEO subsequent a to His of and strategy. de veteran This device, that Lucid That The the study at future The access. regards pathway. assure consultant to the the Barrett’s XX support along us help the for second with leading intraosseous multi-center ensure to FDA's and progress overview products prong and With biopharma access being regulatory collected patients novo regulatory submission. a patients that establish clinical with implantable data term lead accelerate a centers. regulatory which continues is Lucid all is PortIO, some enrollment is of study the providing underway NIH overall EsoCheck in NIH other is evidence of recently will funded our vascular of us retained process our as necessary highest vascular to quality trial poor the schedule.

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

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

collections. tube challenge well. the ear to remove product procedure pediatric the operation for ear most U.S. to ear patients a to ear the the general progress on for a the major second eliminates retained anesthesia, antimicrobial Each for their undergo tubes. which placement continues million for need DisappEAR under about resorbable, DisappEAR persistent need drop year also in called fluid parents X and our surgical is post-operative middle and of is infections children our Next, tubes, kids eliminates regimen treat This common ear

We machined three-month the rates to or resorption next FDA an us study have impregnated for towards will advance animal to protocol from tubes allow a year. finalized the coated rods, silk assess development submission antimicrobial which of

We in NextFlo, infusion design advanced testing This ready for will this hospital and recently fixed-rate in day. every hospitals finalized over have our had the quarter. a flow-resistor, believe million the the have States infusions We hope and product fourth to set, of troublesome technology and pumps electronic expensive to vast on to status. return lead is a X United based eliminate and proprietary the infusions gravity-driven majority technology for performed variable permit we to we

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

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

of or additional value opportunities We also payout vigilant continue ground or to technologies breaking EsoCheck. to restructure activity remain explore through M&A some licensing debt, shareholder of enhance and whether like opportunities to our for the

to now we operator any can call that, open the with So questions.

Operator

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

Lishan Aklog

Anthony. afternoon Good

Anthony Vendetti

afternoon good Good afternoon good guys, Lishan. afternoon Dennis,

to, guess, CarpX. up follow just on I So

information. know you orthopedic wants person one like branch, seems testing it that further this is additional or So particular there there

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

Lishan Aklog

clear let be me that. just about No,

the are they lead what that -- first it's requesting. is clear rating not the actually for part branch So, for both

And creates testing So really additional it just that for. we the to to us clear and frankly looking the the some lead more protection I request have process. they to back made everything the temperature they of provided, snapped to We of the is addressed haven't did that issues in the and that during we not balloon -- reviewer, provided testing you allotment believe data definitively frustration part really to some we know, anatomic this that, review profile. so document carpal of and interactive was bench-top which us, cadaver have to original equivalent a overwhelming not this and asked XX and -- -- and to lead to they it's but is did request XX-day submission. predicate, successful various some that have separation additional we better That’s that's And just do, are a variance has, branch been that the days as temperature on through information, of challenge determine some We cumulative the review. superior for today, to assess what additional as better did the the nerves tunnel. around they going

ends days So -- tomorrow. that ended XX

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

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

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

address that So, the we that this that actually really in is we we outside of is have would lead and concurs is concerns, will And out cuts safer. human and there branch The documented view. add cadaver mentioned I ligament information, just the established any the that just don't any cutting because perform. it point predicate an not would to have of has be data reiterate and element that a which predicate, one any simply difficult that that completely to of it clinical a believe we've a study

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

Anthony Vendetti

Okay.

see if correct. it let have So me I all

XX tomorrow days So, is the up.

PAVmed else with date lead tomorrow, -- you're going to You request hopefully is to and a be what is as reviewer to expect speaking get required. to clarification the to going

Lishan Aklog

pre-submission a meeting, that's basically right. Yeah,

have XX-day So, at anything And in additional that what of again. over resubmitting plus meeting. comes start we either we anticipation clock XX It or up that we have just then doesn't will what that what allotment, the haven't all that days. have that They'll they reset. that won't allotment will from will hear mean clock get -- in that -- them restart, the much

Anthony Vendetti

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

Lishan Aklog

variants. specifically are a the around anatomic surgeries the concrete at anatomy. documented at nerve as [ph] bit of in we CarpX can that this that of all we least wait the requested, variant address that tunnel careful is get protecting they specifically to rare have that little assessment certain of lab the by into very things anatomic likely We cadaver because the bit carpal Yeah, and dark safer in the safe,

they've for, that we've addressed. asked us specific everything So,

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

Anthony Vendetti

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

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

Unidentified Company Representative

what in we the branch, world September of they’ve as if were it's conclusions done based through to our as hear conclusion steps and sort them and on before. get, well able get the depends interesting believe should from then it take time that because we the XXXX, need be at be them can lead really should what it to of we because that we they around a what way But face hands want remaining that's our is to if Well, a launch, of what actually deliver we until sort actually can can down have information ideal us get we in that right. -- every get That so QX that on us [multiple are speakers] yeah, we for moving -- time launch and the there still to but asked it that's in we additional that I to nail commercial for them as forward, we know face is. QX information it to no mentioned a

Anthony Vendetti

even this still extensive launch as So launch delay, -- it's a CarpX. possible request, could that still an for with still not XQ, 'XX it's it's long as QX possible have you

Lishan Aklog

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

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

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

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

Anthony Vendetti

Understood, totally makes sense.

to if track, anything plan? gears maybe changed Or everything shift there Has for a to half according launch, is there? second everything PortIO. Let’s is on XXXX goes

Lishan Aklog

Yes, let’s a plan. just timeline. is I I according reasonably Everything – going that’s think think, to

and -- So much novo with is this the more protocol it's process. formal the de

So we the the animal protocol formally approved actually formally had written to submit for study. that. They

in up weeks started. gearing We’re get to that coming

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

a either they’ll clinical on quick. for -- fairly expect moving should that that study us be We small be and ask can

including lined up that for advisors day up centers already are go, have XX We follow don't and really we several to and a of our anticipate that. ready

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

Anthony Vendetti

good. Okay then… And

Lishan Aklog

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

Anthony Vendetti

commercial that XQ hopefully launch? Understood. then And lastly submission then DisappEAR, on for XXXX and track on also is

Lishan Aklog

elements is de-risk still the resorption it think have some to that we Yes, There rates. to relates as fair. that’s I

into for can rods -- little machine which to the in these a of tubes. main is the one struggling we So, which processing of while, these, the from been main frankly that we’ve the the silk rigid challenges silk with

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

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

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

Anthony Vendetti

I And you, lastly more Dennis, then for guess.

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

Dennis McGrath

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

So payments second quarter. was expense term long but are in the recognized

However, increasing of R&D items lead a the over NextFlo in of and in of other X terms expanding Lishan the we with initiatives, or product will next months. identified X some our to be some that the all cost of

Anthony Vendetti

Okay.

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

Dennis McGrath

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

Anthony Vendetti

Okay, good.

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

Dennis McGrath

Anthony. Thanks Okay.

Operator

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

John Levin

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

Lishan Aklog

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

said the relative will to study really lead that John. point can dodging it's provide that we I'm examiners for and talked hard not as to that because me to question, your clinical are. is So where we we to answer information no I additional there

have you mimic do to for better a grasp and anatomically cadaver same -- the that have that's at very suspect come narrow what And we'll budget. I if they various in we a the couldn't in would current So did short procedure meeting absorb could that. the within something something have sample for just think to and you study. so really can our human we with human to you than is within size. it more and can would that Because a specific manipulations see something as small they be cadaver but can I But and this say scenarios

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

John Levin

May up I a have question? follow

Lishan Aklog

obviously. Yes

John Levin

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

Lishan Aklog

a great and Yeah, that's question.

I think by to all starting I'll and on in continue PortIO discussions even EcoCheck, answer we had off that that by at we CarpX and products DisappEAR. way saying the on have

if we're we plan out had that we interest of have this window have to conversations that's explore. with that we in that path FDA the that not kind CarpX. larger so of to are, I companies most But some a would expect that really and expressed uncommon the come And And some the a that conducive with next some in partnership, with I it's would going don't. have and something to industry really that's hope don't take be

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

John Levin

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

Lishan Aklog

John. thanks Yeah,

Operator

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

Unidentified Analyst

Lishan. my Hey, for Thanks good question. taking afternoon

use support of beyond screening be also be the would and I Barrett’s for date completion the have multicenter data of has requires initial recently think data review you the EsoCheck like you now an when FDA the guys clinicaltrials.gov might EsoCheck estimated for would as base plans. in another Do as process, that you had this of of widespread study XXXX. to initial April put estimated some some consolidated and timeline, test that in

Lishan Aklog

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

Unidentified Analyst

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

Lishan Aklog

Hi, are don’t want Mike, how I to was you. to you, Nice presumptuous. it be you, talking sure. I I wasn’t but thought

is So let little a -- clinical I prepared because some some our include on expand trial. looking did bit, we’re about in how at that information me there the remarks

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

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

So a able the not the an Grail of that second get Holy have indication prong to [ph] defined What get Barrett’s which in clearance XX this of cleared FDA to an some the of to balloon is right. us subset sub test. and EsoCheck designation in detection and next is really which beyond be million LET really we with first is for – are is what order seeking Esophagus trying indicated is patients, the we’ll for require quarter does for be the year,

And a so that require PMA.

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

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

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

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

Unidentified Analyst

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

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

Lishan Aklog

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

Unidentified Analyst

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

that something possibly about? is So hear could we

Lishan Aklog

with DC obviously Yes, this mean we’ll all avenues in and a pursue folks deal are I some who there lot. are -- get

get But had that. to forth, in we I want we’ll go hope meeting. in -- advance those haven’t down appeals of to in so We experience ducks and routes row, it with doesn’t the to and come our

Unidentified Analyst

lot. a thanks right, All

Lishan Aklog

Thanks Mike.

Operator

at no are further questions There Instructions] [Operator this time.

to free any closing remarks. You're make

Lishan Aklog

that forward abreast and of mention all James the the of we are our CarpX. via directly questions afternoon such Hey website our releases plan progress Smallcap the portion us I of through to to October. to you at I for encourage will thank with also plan and great or questions. significantly us the as of end pediatric Dawson based joining not for to attending have this one. on presentation keeping by at the emailing Group that right. us hopefully status on IR any All who that, we that so you Jupiter, calls info@pavmed.com. at this contact Florida for in And present Conference do conference to We webcast those on timing more of information look want news

have again. So great Thanks day. everybody a

Operator

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

PAVmed (PAVM) 22 Aug 182018 Q2 Earnings call transcript