PAVM - Earnings call transcript Q2 2019

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Operator

Greetings and welcome to the PAVmed Business Update Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] 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 for PAVmed. you. Thank

begin. may You

Mike Havrilla

This you Havrilla, today's all conference everyone. Investor business Director Relations. call. Thank for is afternoon, PAVmed's Mike of update Good participating in

and are today and President Officer. Lishan the me Financial Officer; call Joining Aklog, Dennis on Chief Chairman Chief McGrath, Executive and Dr.

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

and are beyond time from are accurately. time difficult control. of predict arise are to these company's to impossible Many may uncertainties the to and risks or predict. difficult New All factors them

statement Exchange affect IA, most Form and quarterly annual Risk any to law, any Form be expectations the expectations contained in updates may risks reflect forward-looking update Part reports or in to differ other Item or disclaims based or intention Factors in conditions and any from on and in with those forward-looking affect description on subsequent obligation any that publicly as Except which Commission required and list results future For statements. the or entitled events a further XX-Q. in and these changes actual report filed or PAVmed Securities by revise I, important uncertainties see on may will filed the those circumstances operations that XX-K PAVmed's recent that likelihood of may

Aklog. I said, that turn With like call Dr. Lishan the to over would Aklog?

Lishan Aklog

Mike. for who recent discuss you and you, update and have thank us read for you call. this business on I to everyone, Good afternoon, press those you financial of joining release lot today's our on call quarterly on our clear be we results. Thank should this to cover a

First, believe like especially our will thank external however, our unique by new efforts story support shareholders public shareholders our partnership we're I assist in new reiterate actually relations new long-term these outstanding to for commitment to work within this investor tell firm far our audiences community. to enhanced robust KCSA excited an and profile The existing the their the has to with timely our PAVmed's communication. I'd so to job done and the with further we community. recently be investment Communications, and to within transparency and us and team them raising and engaged Strategic

to and LinkedIn, and keep our sign up to our our Twitter, the on YouTube, follow to is and reminder, a -- newsletter to is updates, way website. As on best up for with us news e-mail

study CarpX receiving progress completion We've made EsoCheck. of release, morning's for solid procedures our for months in on As extraordinarily FDA product the been and across being I stated have clearance our this lead safety clinical important fronts multiple the successful team. past the most portfolio five active XXX(k) with press

some I'd important lead of milestones. The of deeper be by highlighting ones some packed products. doing to before like actually our promises the of the major most with year dive start remainder a to into

in remaining clinical expect safety follow-up the clinical study the CarpX of in postoperative complete to the We patients New Zealand.

thereafter, resubmit XXX(k) FDA data we will the from CarpX's application. Soon study use to the

expect plan California. one complete Hospitals, of designed begin first which DNA developed a launch translational commercial Barrett's Center's assay to located Cleveland to full EsoGuard then it or targeted in detect diagnostic to commercial nation's the as from the University of the test available laboratory LDT, to of make the Medical organizations contract Esophagus. transfer test commercially laboratory We leading EsoGuard ResearchDx, We Irvine, will

plan launch device. we to of formally commercialization Concurrently, esophageal cell collection the EsoCheck our

secure participate IVD. code get in FDA and On elevate required sign-off EsoGuard an diagnostic complete are for protocol process in-person an X, clinical the the in to vitro CMS reimbursement expect LDT. pre-submission we for to present that's October trial to or on the also Lucid meeting the to FDA-registered EsoGuard to to We scheduled with

complete begin recruiting what's to infrastructure in clinical patient first enroll now an to trial. required that's to expect the and We sites effort build operations trial clinical intense our ongoing a

provide to infectious viral M&A source esophagitis with EsoCheck an and hope We a ongoing including to secure or process initiate a pilot acquirer us We set infusion non-dilutive one prevalent and fungal human eosinophilic esophagitis. NextFlo expect clinical using least diseases, formal of for capital. potential our other trial strategic at complete partner in to to

will one maintenance-free we and South And second long-term in use for study, a resorbable in of to in-person human one secure device ear is We novo our study FDA. PortIO to unprecedented a sign-off de pre-submission completed infusion lead and submission. clinical In application. to PortIO DisappEAR this will PortIO concurrent a in support those its small a of support we This dialysis our weeks, future X-month meeting FDA America protocol of its study, tube GLP second of on with intraosseous clinical FDA Colombia, safety This a couple PortIO have participate in document expect X-month their which the animal study venous the poor a patients demonstrate will to access. to complete animal patency with XXX(k) will functionality. finally,

So, as months. to said, have a we lot to in look the forward I coming

two others, at submission; and large; hopefully and Just code; small CMS one closing M&A human the two a do reimbursement FDA four a study, to FDA That's transaction. out animal one tally: in-person successful clinical studies; meetings; closing least initiating

of on So on little and EsoGuard now products then bit most our lead CarpX, time deeper let's I’ll do dive and the a a really spend of EsoCheck.

traditional times ligament catheter we When invasive dramatically designed reduce fashion. billion. CarpX is compared CarpX addressable a we Just a inserted approach, recovery review seconds. to minimally bipolar is the its tendons syndrome it's invasive CarpX the when to domestic that to condition less our Carpal cut surgery. immediately out nerves scarred market of with radiofrequency estimate replicate much a is the CarpX, ligament to of balloon tunnel The opportunity carpal and which tunnel the very treat a We least designed from inflated which invasive syndrome. the device, the away. minimally will matter and electrodes under in precisely tensions $X a common ligament, in for at activated traditional pushing balloon open be surgery inside believe to while device, the results

technology the to excited FDA closely to underlying a of families. clearance now to us that across XX are now We the a broad recently XX granted covering intellectual secure portfolio CarpX. patent very and very We've growing expands been with the for patent over property working our patents CarpX, while USPTO which XXX(k) incidentally applications announce for

they tiny this established Just very FDA consultation a the CarpX human FDA, with work sliver energy completed preclinical minimal it a safety -- substantial both requires. XXX(k) the its to work FDA of as cadavers, to thermal which we year, us that believed small early ligament, study. this animals cutting summarize, our asked We in delivers extensive spread. the predicate Nonetheless, precisely to with and to in equivalence time at the process requested the documented

to to were during the extremely minimally excited using sign-off and with overcome XX the XX-patient last successful We but to final We underwent scheduling safety really release, -- a we and spent patients endpoint, at administrative to assessing very had we time function device. and tunnel is certain All their some set a motor spring for procedures had on XX overcome hard nerve a invasive primary the days. worked some challenges month. study and narrow of complete protocol CarpX summer, carpal specific which get

met visualize the primary to small of effectiveness completely edges All cut cut. the no using surgeon study's endpoint, the and endoscope them a which confirm also There ligament device-related involves has of the been adverse events. were it that

He present all for for Dr. Chief procedures. important the several the clinical of bode which Medical I'll well observations Our summarize. surgeons success, and and commercial which CarpX's made deGuzman, future Brian was Officer,

fell. suggests steadily comfort and and and Two procedure were surgeons device important same minutes will time as "skin-to-skin" One, to less the carpal study release. or procedures than test final short the experience things progressed XX the completed traditional in the strongly happened with the relatively CarpX tunnel set have that of procedure. a the learning gained curve. The XX procedure is which This

smaller incisions addition final the more XX-millimeter efficiently, of and incisions. the just perform enough and set that procedure surgeons introducer able large faster to through were smaller able sheath. performed In pass being X-millimeter and to to procedures were keyhole use The to the were

XX% the surgeons the avoid the This time to of the appear causes relieving of and the of of to these from pain, problems within after for of results space traditional by completely called compression the were think should more the incisions improve also that away the pillar carpal is CarpX nerve stayed compared most importantly create patients developed to preventing scarring. the This this surgery. healing regard that this and the more Up condition area at traditional we pain with traditional tunnel problem. surgery. and base balloon completion surgery Most recovery return after CarpX should to the procedure The palm. impressed patients troublesome swelling,

his on been the positive needed have patient importantly, research that release. most stood a his much one the CarpX conventional that his recovery and underwent coordinators particular out, second initial because who insisted gentleman of anecdote CarpX the friend than One a but was still Finally performed carpal feedback. -- He hand. other treatment in who be with very tunnel underwent procedure mini-open on hand, procedure faster receiving

nerve As doing complete clinical They XX-day function. the protocol, passed well assessment to all point of will Once resubmit the follow-up expect as patients their this and fully the first safety effectiveness application of the electromyographic who we prescribed involved follow-up are incorporating we complete, endpoint motor follow-ups primary study's in which well. XX-day patients primary important of of their XXX(k) study The the clinically, safety fall. all completed them will data. of pass CarpX are XX-day so the remaining the group safety all

FDA that provide U.S. the allowing us us commercially an clearance with hopeful and in are launch review We will expeditious to the

EsoCheck. and EsoGuard to on move let's now So

technology. review Case can these to of from to then performed EsoCheck It last and Any year a procedure need subsidiary we cells noninvasive targeted without majority-owned through protect licensed again lower revolutionary the Lucid we Reserve region Just a including commercially device the collect a test available EsoGuard cell esophagus technologies from X-minute for collection of diagnostic sample refer University Diagnostic. office-based Western a is as an endoscopy. sample. invasive the be on in what

of it The to and within began actually G.I. campaign and accelerate summer those in device received availability summer marketing efforts program use. conjunction in and generate an this the We EsoGuard. for formally are fall commercially slow designing implementing we to community it FDA the now fall. training with a available XXX(k) this ramp clearance we'll awareness the is launch expect commercial And and a this

EsoGuard. DNA so-called heartburn highly test, chronic lethal esophageal a or highly esophageal designed EsoGuard to the detect patients is cancer reflux is GERD. -- lethal Esophagus Barrett's in with the to which to acid onto Now precursor

at to for U.S. tens of published estimated Our that immediately Science human the published society of Case a with GERD currently the XX%. really of sensitivity billion. specificity who guideline. addressable screening The This EsoGuard of Barrett's market in modest at $X Translational recommended patients domestic Reserve University detecting Medicine year for is partners is EsoGuard which highly grade very at accurate penetration was of Western opportunity study and last results a according are millions Barrett's on least XXX-patient based showed

of sites a patient on returns Barrett's. EsoGuard next-generation XX no result sequencing That quantify the to at genes. then percentage or and to of DNA or methylation the uses bisulfite-converted bioinformatic with incorporates a used or suspected not to to site complex NGS DNA which whether yes as two is algorithm, detect is methylation have

commercial will the strategy screening this our term work to enter in market strategy we paths maximize and have we and required down allow long-term the refer really two the a believe product We performing EsoGuard as to advance So as value to EsoGuard generate of IVD. EsoGuard near to which falls the test. us LDT while the parallel revenue widespread

the through its as EsoGuard completed back to process. -- certification laboratory University LDT CMS what's Cleveland CLIA/CAP by is referred controlled EsoGuard translational certification laboratory process to controlled spring launch. begin do before in and Center's marketing test, and a the to Hospitals, certain became developed laboratory this an LDT us things at LDT CMS initiating through however, Medical codes. full seeking We allowed which EsoGuard reimbursement to commercial commercial transfer decided, high-capacity including

near-perfect laboratories an their be that LDT required we commercial point, from team We over they've to establish EsoGuard replicated academic validation the a the process of organizations. They've And this in testing of commercial launch the a LDT. quickly correlation. a with Irvine, CLIA/CAP relatively had a partners the end the in full-service work the based under EsoGuard leading expect ResearchDx ResearchDx to year. full one will results engage our decided initiate begun completed contract which assay period short as time. before is previously that of we the to nation's The And effort, At diagnostic this fantastic of is certificate. has really California. performed done as

Barrett's. FDA or to patients The EsoGuard allow Esophagus together a IVD to be as and diagnostic or by PMA PMA vitro EsoGuard requires an specific in the path screening submission seeks our broadly IVD for our strong in FDA EsoGuard completed to diagnostic as advisers, regulatory a by secure team, EsoCheck FDA-cleared and novo designing will single tool This X-arm data. support device. Barrett's clinical marketed for excited study clinical submission. Really supported screen to an medical It indication progress or consultants de the robust our de a have world-class novo a to

scheduled a who of There esophageal which biopsies. College compared to arm patients will EsoGuard will screening I the screening seek patients be and Barrett's and of cancer. meeting with dysplastic diagnosis will enroll arms, diagnosis trial standard without both this endoscopy the enroll will or the esophageal on or Barrett's arm of have case Esophagus October pre-submission FDA filed the GERD satisfy also will Gastroenterology package EsoGuard secure goal We a to broad mentioned, The a American of indication. prior be guidelines. In screening EsoCheck protocol, X, IVD with clinical ACG previous a control sign-off as pre-submission non-dysplastic, adenocarcinoma which

CLFS successful -- technical CPT Meeting we Review we Clinical Public Annual reimbursement subsequently The process. AMA secure code. cleared additional progressing. and also a process the to steadily advisory payer Laboratory a Schedule CMS or CMS PLA is under at CPT hurdles Panel, the the actually interim in the and a some proposed and had private reimbursement CMS, review, coverage from Editorial meeting the yesterday reimbursement this Panel, for EsoGuard Fee reviewed where secured its LDT code We including We've the

endoscopy. FDA Esophagus. endoscopy whether in in conditions known replace collection other patients pilot diagnosed We've with we're cell of it prevalent as eosinophilic instead a a infectious the these surveillance suspected of conditions initiating also The patients is a is EsoCheck Pennsylvania device, whether as physicians determine than common pursuing EsoCheck EsoCheck with immuno-compromised who aggressively can esophagitis opportunities Lucid-sponsored also condition are cleared Barrett's for Since to study of with to caring engaged be for esophageal determine esophagitis. University can generic

on keep brief. going the I'm other products to my fairly comments

$XXX for medications a estimated PortIO we substances product the -- access million. which access market and fluids the of vascular -- which bone implantable to of a targets market direct delivery an estimate device, marrow Our allows other

advance small study we do to pathway protocol The the continues these on this de as in animal PortIO meeting as safety well application. pre-submission a acute seek an sign-off excellent New form which clinical we X-day the to to animal for in the requested FDA upcoming studies will basis cadaver a through with a FDA a GLP Zealand FDA's studies. plan supplementary for from data along support preclinical of duration. secure completed novo in-person study, The FDA PortIO implant we've and So which

of six also right animal fluid that well. require will forms the and other in be study documented weeks any expect we close doesn't which as point maintenance. And of at the We're functional. the or four any there weeks study X-month the has about -- now We're months, and a separate excited very case patent an at now to flushes remains couple unprecedented fully in it PortIO

anticoagulants other with to patency also This is and is how on substances We're this maintain other access flushes highly overemphasize planning regular vascular -- differentiating functionality. all or can't require devices because a venous data and their in animal result as of poor first data South patients a Colombia up America in-human days. doing with to this clinical for patients access XX study positive dialysis for long-term really

disposable which product hospital that eliminate every most electronic U.S. for delivered the the seeks exciting year infusion infusions another for and need NextFlo are in of intravenous infusion set million which we to settings. pumps is -- outpatient the

Deloitte We comprehensive and long-term addressable large be with -- to that NextFlo. strategic out to an very recently we Consulting market impressively acquisition NextFlo. perform demonstrated recommended or and seek partnership strategic They a research a analysis market a turned what engaged of

right is these professional now we Marsal, a strategic Alvarez potential or XX us over on targeting space services actually who interest. market firm engaged M&A already & a the process with a formal recommendations partners have in armed report leader and including based who And global expressing acquirers contacting this are initiated

The functional The and results very resorbable performed brief future DisappEAR from anatomic We GLP of of point our support which view. a study X-month that a well pediatric submission. a animal ear tubes about excellent. tubes. were completed comment FDA Finally, a will

corroborate doing antimicrobial vitro longer plastic We're with eliminate findings. device stability ear durations tubes. of testing we're followed may that comparison and also might confirm -- silk, and coating. indication a being are have some antimicrobial for comparison And the properties for need intrinsic doing to the these we because animals direct Additional effects have in surface antibiotic

your So cover. Appreciate I lot a to patience. know that's

I'll results. Now over to turn financial to the Dennis call review our

Dennis McGrath

I'll our on afternoon reported is release. available on the and available this the aware Lishan. morning. also matters our was I'm financial posted can Thanks on results press earlier published quarter we've June Form as brief XX-Q Good SEC XX these the you're XX-Q and everyone. ended release were sec.gov as website be sure -- press for Form at where The be our to

we the and clearance, we this results So completing and regard FDA financial the remarks for development R&D well $X.X in were for million, CarpX their EsoCheck the DisappEAR about same XXXX $X.X during to the with lower towards quarter sequentially. studies research of year, period second milestone for as and about half first NextFlo. $XX,XXX and made pushed last million with expenses breakthroughs Consistent PortIO up XXXX quarter increased as animal as from

accounted with increase and EsoCheck development focused balance of compensation contract nearly largely due the increase for Third-party the and the headcount related increased EsoGuard. of on and manufacturing expenditures XX% to costs to year-over-year

about and including events. opinion increased compensation launch expense as are increases trade regard due they $X.X headcount costs With principally $X.X other million XXXX by in compared same period XXXX to operating compensation-related the general of or leader and the higher administrative with $XXX,XXX for sequentially. costs as activities expenses, our in key The largely quarter travel million were well pre-commercial to related to for shows, second stock-based including

$X.X of related share. attributable PAVmed GAAP XX, charges net affecting reported convertible shareholders for operating million of and loss XXXX difference for and value three the other months $X.XX principally between fair an common in accounting a two common changes GAAP non-cash million ended The per reflects loss to or debt. the the June the $X.X

which and to entitled, release the with namely release current along compensation. and provide charges table Our the charges stock-based also other amounts related the depreciation a and XX-Q substantially press interest the more the highlight provides in these non-cash detail non-GAAP Also non-cash in occurring expense and year. prior measures, period press

presented a It way. gives the when that you financial it's company's of performance better understanding

loss notice adjusted a reported for non-GAAP by these XXXX the the charges per ended from share. $X.X three common company that the XX, $X.XX or table after June the million You'll GAAP months adjusting loss of

as also million you'll an from had release as cash second the million the from $X.X press the And is Q, increase note PAVmed of June of $X.X which quarter. from of XX and approximately

it So up or Lishan it turn back operator have with either to for the open questions. that

Lishan Aklog

Open it up for questions.

Dennis McGrath

Operator, it up please for questions. open

Operator

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

Dennis McGrath

Anthony. Good afternoon

Lishan Aklog

Hi Anthony.

Anthony Vendetti

Good afternoon How you? Afternoon Dennis. are Lishan.

Lishan Aklog

Great.

Anthony Vendetti

make It talk thing is you're I other if moving CarpX well like if done the wondering, hurdles. anything you seems primary needs at the safety else and days see or XX the that see is Is can any like they've about could for electrodiagnostic to -- was testing this you along seems just waiting that just sure at there met to you last point? that now. endpoint. study's very anticipate be It

Lishan Aklog

not. frankly Really,

were during So, as testing. undergo of I you will really -- the to get the XX-day primary of scope that endpoint. constitutes XX-day mentioned the highlighted safety test will their remaining We as this follow-up careful diagnostic electronic patients portion the the there, their narrow very they

motor of So function panel of broader of it's a tests. a subset a of test sort

any of frankly, it the normal. certain motor clinically nerve likely extremely, don't that injury fact patients evidence will fine almost motor have doing that they – come -- those extremely the really back that nerve makes almost And tests are now

sure track all them gone anecdotes Zealand woods done off on our you we or they biggest follow-ups. have their couple and were Australia their I -- show do just safari, down well is get know chase they've they've in what New There of challenge where Frankly, have out on but up they're -- and to we the don't make patients so down follow-up. the making and for sure a patients

be with and the was in filing forth so and certainly we frankly scheduling some I our never control submit really which you you the of that but we the know between things -- relatively mean one I operating the -- expect once of challenges FDA, and and our now straightforward resubmission, So to looked obviously to up. -- really we getting

Anthony Vendetti

Okay.

and getting the file of So the Correct? back results expect year. the you'll to end be those resubmission by

Lishan Aklog

Yes.

I about that's think right.

So fill follow-ups there's the holiday collate -- in resubmission in a It documents. file the you're possible will should weeks Xth of the off, holidays that something. wrap data with often situation if XX-day sort you're the a January us and to to the few mid-November. where will X, on up take better of or It's instead December approaching

it up -- So it with really the first doing we end of week targets. may any see may those January, but I problem don't reaching

Anthony Vendetti

Okay. commercial in get then specific terms Great. little when of will launch of more can think you on a And happen? you that EsoGuard,

Lishan Aklog

Right.

So of item transfer assay. as is the now for that -- so really this right gating the I've

So any process. this as doesn't working and is internal commercial the of through mentioned that's an of schedule. laboratory That's now. the We're ahead transfer validation. in available require ResearchDx LDT in actually the -- It And and right really California. Cleveland of kind to all well. assay active external I It's going

CLIA all it test. performing of certification steps available as an be as developed and laboratory simply a CAP it's So LDT have the officially to internally

October, fourth for we'll in goal early will sometime and to range. our that -- So market it And be it. we'll done, be that once so able be is quarter, that's late available mid-November

October. really that awareness have wings We'll Officer, The right on implemented. of our distributors we a are a fairly us waiting gastroenterologists strong We program now to current has and Shaun be call backlog presence Gastroenterology have will we a we O'Neil Commercial for actually -- the this. who in have who -- of And American and in will on Chief turn a switch launch active -- there. College the be were

and are there if that If -- forward successful have to our market through then. them reimbursement out and is to will us. know on be our under clarity it we'll have by There using to representatives. to So some able get be in will longer as able bit we're you and we list excited then seek code, currently reimbursement achieving submit of independent contacted move And not model that. under little requires a code are They plenty where have codes. of it we reimbursement -- that

So full November, ahead come we so. really expect steam to be things

Anthony Vendetti

Lishan. Okay

question Just last on that.

In as already them think terms have independent EsoGuard? independent market of up do up. sales of sales it will reps have by lined these some -- you have you how of to many like you mid-November, reps, sounds some you them recruiting But signed do

Lishan Aklog

prepared guidance these Yeah. I'm on rep really not week specific mean demand from this. are the that sure expected a country. give just the of Shaun a value amongst They to call straightforward, the I understand we're of say gastroenterologists margins. to that, the understand entire gets the They every covering engagements relatively given

in is But many a patients will this premature know really ramp what a that. know hard to I are be We be. predicting bit to out launch trajectory from position little there. how what it's But we're the to think is. point. ramp don't a going opportunity do We at know the market

Dennis McGrath

key leader And the opinion robust. pretty group is

there network That a will number also be active. podium of coming events of will up. are independent reps. whole So The the spur

give said a up. as to that and just it's guidance Lishan of So there'll positive numbers. on to be to give momentum the And speed that premature lot

Lishan Aklog

out Again just the out we're screening Barrett's test meetings nothing there's literature Barrett's this to at and one is competing reiterate in test, there. we that see the -- but hunger the everything there is a the only detection There for with. there and publications real a else

start. to know able to So get be this great will really people a we'll off and we're confident we embrace that --

Dennis McGrath

they podium. Advisory how on Coming to frequent and Board the Medical our get

Lishan Aklog

Yes.

He's Shaheen of of We -- Gastroenterology, really wrote this in and authors an well. So talked he active guidelines before. is head, the this College the other as for most American and Esophagus MAB Barrett's we've area. like the the about to brag the the about but clinical researcher editorial Nick member also our

with are to is in really already out about the great the -- are coming they frankly again screening. we get and hungry word know regard the know to word this. And for do So this really to ability people shape the is out. People

Anthony Vendetti

great. Sounds

Thank queue. the you. in back hop I’ll Okay,

Lishan Aklog

Anthony. Thanks,

Operator

question. Our [ph]. go next question ahead your from comes with Please Tahase Dave

Lishan Aklog

Good afternoon Dave.

Unidentified Analyst

Good afternoon.

little I at the a my on question process, about acquisition NextFlo process? where what partnership first as was you a and time looking but more know for official insight on NextFlo. we're as little update far you mentioned give us and that So bit frame we're for can

Lishan Aklog

process. Well, of fill the this. the as that is out details. starting we -- formal a Dennis But mentioned we engaged have have Yeah. firm we some I'll outreach have a on We've

ammunition present fortunate us to really are We list this have already mentioned strongly with have There interested already list. a suspects this And be obvious some which one they fantastic, opportunity long report, was -- Deloitte strategic. as that they contacted armed -- I the are which There for to us. we'd ton that on some a of they're is gave in.

We have use that demonstration. ready in can we packaged commercial devices a

So we're get started. forward looking to

sure… Dennis not let add I'll anything. I'm

Dennis McGrath

much But Not very to add. competitive process. to it's structured a have

process. our a analysis that folks study and from So the the personal that adviser The in we has I both some have past. than market and were was globally. robust better in reach that the results with selected developed transactions the clearly going and Its into opportunity both financial nationally with the anticipation models some that Deloitte very doing what the experience were even

developing in intentional aware with an hard into down the components to the you're incur how intel that it process agreement. time a fast now a in degree to elongated to we're right comment sure the start also products' that going equipped field There be I'm then But the to take are process. costs maturity long specificity. many narrowing it's an as LOI, weeks months hard at where companies. way very encouraged It to market a this It to process. could down lead. so the then could It's and that from pin optimistic of line on you to the and about It we're and we're could for be some we're on where that with definitive with is other

Lishan Aklog

arms technology. this as are I talking I impact content really the a here. about little We the I Yeah. interested XX good a a good in been going very process should Deloitte groundbreaking definitely really report, disruptive potential. in. or there process had model mean, I But be would say in feel about the for field XX this boy while But a it. with the And It we complex sense players real of really think has initiating preparing. well though. knew who of it to really, pages we we've are for us it's

Unidentified Analyst

partner potentially question Great. these? solely of about marketing you was as strategy something sense the you're lead device around it a is with EsoCheck of company And well as this give for talked looking to for I that to next Can you these? Thank know my you're is something EsoCheck, another this CarpX. us market approaching but Or that both from… you. products

Lishan Aklog

I you're right? to make not to and sure just sales want referring still marketing

Unidentified Analyst

actually. Both

Lishan Aklog

an that and products Both I and fit of as a they're we CarpX the sales have hybrid will sales Yeah, told slowly expands and specialties mean for do slightly which sales country this because those natural up is ordering Anthony a we ago, using a call they model reps and have -- of technologies. on management. different. Okay. the are be because did so is well We'll list build sales it realize minute on these as who span we time model. first our independent what over ecosystem

We have Officer. a Commercial Chief

regional would have that implement grew. managers as We we some volume candidates for

said I go model I we to Anthony, mentioned as to independent that ready have upon launch. reps So

anticipate We been the really and partnership-type it EsoGuard we it I And that more I hinting at really the -- certainly really short-term. to if reps same point ability and true of think consider later EsoCheck. is thought agreement, have natural but needing if as a a in a don't short-term. as you model might our revenue have enhanced distribution said we the at in which ecosystem with will They ramp well. our the would work value of

much more Marketing actually straightforward. is

EsoCheck. of have gastroenterology together Shaun we Gastroenterology, back and highlighting EsoCheck. have remarkable an it, amazing the EsoGuard called of in marketing already. We has a Last ad primary journals team for put both full-page a O'Neil month's cover plan

which think with clearly too. increasing see attempt superior the from other start same few devices, but physicians will to a EsoCheck marketing to differentiate the I it's materials in thing reports -- EsoCheck do an our

to plan So aggressive. be we

the Dennis products. encouraging obviously, expect are field We And on very look in within and much these podium to to very the leadership, this have up mentioned, close we and as market the KOLs physicians. on focused at awareness have them to the ties people

So that's really how we be to aggressive intend look at it and we really that. on

Unidentified Analyst

Great. plans capital long-term that you're And Are my there last short-term question and looking just around funding. at?

Dennis McGrath

milestones. It's a I'm general level XXth and give hard And nearly specificity million One, many of And initial fuel $X June to plenty of know specificity. It's a milestones coming at that's but those you we get comments. question. that through to to a few Yeah. up. of want had sure sufficient great

Our with have the of our company. evolved over financing strategies maturity time escalating

be will Board conversation of sense. that a the the terms this we when just non-dilutive it between timing three around here think themselves in there's NextFlo opportunistic all NextFlo, thing products one. being and things I for had makes There's we've about talked all So provide possibility all capital

pike little some Shortly process the talked then the the patents bit behind pathway We DisappEAR. PortIO and the FDA, issued that that of the will is A allowed. probably it claims will for upcoming further be regulatory down that cleared. the PortIO is to meeting have move with surrounding after been is about PortIO.

So the of one sufficient there of future. those number finance foreseeable for to are Any could things. them be our needs a

and finance very from Board's a interested institutions before PAVmed. But are -- sense along, said, that EsoGuard we financing to in of now But make that don't continue that there available. to With play that's have button be to we'll in to things, some for sense press the opportunities we XXXX. if of at out need makes of IVD need the makes push us we these look today. longer-term to that We'll sure entities are fuel And lot perspective. it will some

were the out with in that's So thinking about things the exactly looking to it that us. trying front to answer but balance I in not you for, sets of are we're question the of kind know the that opportunities

Unidentified Analyst

Thank so time That I makes much actually have sense. response. And here. of appreciate question. I lot last one you the for your a

QX. revenues mentioned to see we Can EsoCheck in expect QX early launch in You about XXXX?

Dennis McGrath

that. didn't I hear

Lishan Aklog

not revenues, seeing start Second really We probably look to is XXXX need much. to to there is early revenues. part

Unidentified Analyst

Early XXXX, okay.

Lishan Aklog

brings quite a I think meaningfully. this this perhaps does --

Unidentified Analyst

time. for Thank much Perfect. you so your

Lishan Aklog

It’s great a you. question. Thank

Operator

Please Our with next question [ph]. from David go your ahead comes McCarty question.

Lishan Aklog

David, how are you?

Dennis McGrath

Hi, David.

Unidentified Analyst

Yeah. I just to of patent and Health Do regarding their use? be you Technology. is had seems similar and think It to going your a Meerkat question your technology. very to CarpX be that Sonex quick

Dennis McGrath

said… I didn't you --

Mike Havrilla

Sonex.

Dennis McGrath

you Sonex? said? that what said You Is

Unidentified Analyst

Sonex MicroKnife. and the Meerkat, their SX-One

Dennis McGrath

Yeah.

Unidentified Analyst

Do that It to a very be what aside, very, you cetera. -- is patent the RF provide to rather push your it the to seems than enough similar nerves going uses et except you think technology knife and protection? the

Lishan Aklog

final to I confident that very, elaborate an about answer very IP So So yes, the any our could that. to to it, it feature a to can feel feel all about a device -- simple okay? and in that confident the absolute but your is as probably we very relates balloon bit, question position -- has I other we

you lot this might asked question as get imagine. We a

appear to just things I'll to out others bullet So I'll similar the but are I two cover us extent superficial. point similarity points. to to couple is extent, a noting. think out rather just the that couple pointed really to give be which I that a that of it large somewhat technologies of have you a can't worth

II into once for leave I'll other be and putting cleared a that tunnel -- it that is it will a by just the -- time Class device, will we a structures the because device. that. gets resources the be getting FDA at into and We it the we're mentioned are the you capital this is inserted device and carpal will of that device effort pursuing classification. vicinity II And cuts nerves CarpX believe the amongst in products and Class XXX(k) and only clearance unequivocally and

issue other some The ability how think other device it features that has other for to outpatient significant which ultrasound their setting, requires will they're mentioned is an forward. of limit in marketing move and we you in the visualization terms

happy perform trying perfectly are in other a invasive tunnel are way. carpal that products are to that there there We out minimally release

but space, the confident terms in technology I and highly we'll we advancing in of for this, think good entire that are that's that the a we marketplace. have thing that the prove best

Unidentified Analyst

Okay. Thank you.

Lishan Aklog

you. Thank Great question. Great.

Operator

question next Masood your Please [ph]. with Ahmed go comes ahead question. Our from

Dennis McGrath

afternoon. Good

Lishan Aklog

Masood. Hi,

Unidentified Analyst

of capital Hi, for you. stuff, what ask, want recent just these Lishan. make to I investor Dennis I'm mean, Dennis, understand all this plans went are if to but a in just is I I This sure mean, you ask of we we soon the for actually your And company. something how we to over raise sell And are or, to fund don't might a year? -- so maybe can the one you close down I have to raises? any do more or get need how raise do and deals

Dennis McGrath

my we milestones those the or not any of that. for financing achievements add upcoming the to with further prior of one I'm one can makes the that financing two financings surround down of any NextFlo that products more of other I Yeah. sure to outlined not of answer. have any line the the specificity non-dilutive sense It is some

I the in We're So of in confident highly of can that give more business, the much will funds one you. you of stay I terms terms available outlined need not financing be from tuned. the timing. that presented sources There's multiple when for the the is

of to sale be us A position one Obviously, could a of products. to of And of is I non-dilutive previously these significance do one the as any financing indefinitely. by mentioned, fund them

inside of ownership. institutional opportunistic of in together all is with parallel other We're well majority-owned about There our shareholders Diagnostics it. as PAVmed interest the with be Lucid Board, as plenty -- the subsidiary. the with as surrounding our significant And we'll

are as well shareholders team aligned. the highly So, as management at large the

financing and best So, we do is for required provides want to value highest that whatever shareholders. the the

Lishan Aklog

this because is Dennis long-term mentioned together. just I'll targeted comment, in add as the investors, really to one are all we which

hopefully, one on of one it my of comments, from air are press release those in the a the opening we really of have any think, which be going terms clear lot lot and multiple -- should I a there our upside in balls value. are significant of -- there has in and here from any

clear that we keep create will more company we're saying, hope, that long-term just confident so enough I'm than -- and as very these much the valuable a today. I over this -- making along that really just I move be will And create are it's we'll that it a value

Unidentified Analyst

are Okay much. how really what taking I from of mean, companies. compared low point to my bottom and amazing company, an guys this many you Lishan And very guys other hosting Dennis. rate. are you think doing stuff the you view the -- All Thank so job, I are

this gentlemen. forward far. looking So thank very taking and hopefully your much so time. you all you, Really Thank appreciate

Dennis McGrath

you. Thank

Lishan Aklog

you for question. your Thank

Operator

Our comes ahead. from Peter go Kelly question Please next [ph].

Dennis McGrath

Peter. Hey,

Lishan Aklog

Peter. Good afternoon,

Unidentified Analyst

gentlemen. quick questions. afternoon relatively two I Good have

going you've investor EsoCheck the there potentially is, plan second similar see -- plans commercialization as attractive first one as potential the CarpX is them my presentation there. NextFlo. acquisition mentioned that products is and my on to CarpX question the the you've approval of to much out products. and seems from that XXX(k) the you potential those Is would make to is both the more regarding EsoGuard targets. have commercialization plan differences? And perspective submit And that Or that are far for put The DisappEAR two for acquisition is for the mentioned And then guys both I both a question there it any that are XXX(k) I that? to

Lishan Aklog

both are questions. good Those really

early surgeons happen to and different question, a Let -- really is, let's jump are as because as through there which independent the have can representatives, we centers obviously simple me but cohort, a -- hand clearance ready I procedure, model. we will soon It's see surgery year. get who basically ecosystem the of sort -- and in commercialization typically same a on we are It's who would of do this the of yes. pocket, on our network CarpX answer quickly who different move independent in if hope next willing reps call ambulatory really

really model is same. the the So

good The other one. is question actually a

be products be So EsoGuard, products, which significant and create when EsoCheck we you products you three these to positioning our that to push and really Even internally sort at potential waiting with with a that matter that to commercialization, this a pushing not as validation other ahead -- needs processes we are Phase Phase and II, verification to clear, part Phase III with be done steps with strategic I, of NextFlo, that and work are you to a that But if to are CarpX that, portfolio, someone and up all that. process intend we steam around to when the we're to all value that the forth the regard sitting when of general of done M&A show for do full as we're with and get look full need look for or at mentioned started development as acquisition. partnership a XXX(k). we required to we are the ones through

be I think us frankly we to that an to understand -- be more make acquirer's opportunity your intending were to make will not forward we're derisks it that step an larger point important we're I clear So a acquisition company. process I of FDA view. self-commercialize gives we to can as towards the clearance want to obviously, we it moving target if it or path because that every point an a close And have question from makes pausing attractive a it if of -- think anything

I a pathway difference the And would clear really a I makes So XXX(k) that's looking where that's that it. them. between slight quite to clearance of and the way -- NextFlo. hope is sense we're one there's The fairly has straightforward in terms at say

if the you you're of can that document you point terms on testing to that and a acquirer's basic blocking be clearly and clearance. towards tackling see you get and at from in view look the engineering path would and required prototypes -- a a of functioning XXX(k) strategic -- the So see to through

answers hopefully, your that So question.

Unidentified Analyst

believe I so. Yes.

you device minimally saying the be has anticipate from Just and implanted process? is in which contrast two it's of to that an to the I two mentioned is in the between XXX(k) difference products because those to perspective those be between FDA what a DisappEAR NextFlo, type you're NextFlo clear, actually that DisappEAR difference invasive so body. The on

Lishan Aklog

Yes.

Unidentified Analyst

NextFlo. The for much easier

Lishan Aklog

XXX(k). characterize for I low infusion right? are some way is testing all are -- higher, equal NextFlo that's quite though a -- the are intravenous the some -- is that is Not really our Some them it even right? required One it -- tests a of XXX(k)s is And an would a clearly have lower straightforward XXX(k).

Unidentified Analyst

you much. Thank Understood. so

Lishan Aklog

lot. a Thanks Great.

Operator

[Operator question. [ph]. Please Instructions] Rabbi next Our your Gellman from comes question state

Lishan Aklog

afternoon. Good

Unidentified Analyst

the few an Thank you afternoon. I've been taking globally about I've time. sell is mark. years plan I've European a hearing for related CE My and CarpX. the and good been to about hearing question for been this to Hey investor

we that European the And is the XXXX, do hands for plan that? submission coming for QX markets? the in see what in end when revenue CarpX CarpX assuming CarpX approved of do approval see of and question get second CarpX in So for you is and patients when And you on my getting some side?

Lishan Aklog

of endeavor. Europe, lead Great. every our products into I'm companies intention able we be really of nightmare called actually against glad commercial perfectly have because what up device expectation actually become have a regulatory ones you MDR every have up of way medical get the the bit against, that we're is working an part regulations their What device brought a and are up market any It's important every we that all new cleared sort will blunt products. be in to which already we Europe. medical company which these Europe to medical even is -- that through has device for is is

moving submission works. system of entities audit means our what these point practical CE to really with of notified The bottleneck these which that your is from for system. point are CE required was we that we do They our an a can these view how place what which mark several of getting forward products applications. is that is from bodies, So view, quality come ready regard and with audit a and are quality for is which problem called process in mark there to with

get now clearance new everybody's to right frustrating there's which across is Europe. So efforts the within backlog a industry huge

go. to ready we're So

to has regulations. very kind notified but a new right in as slowed to We the down have of our do these now everything figure bodies slow they audits, try handle they position how pace to out

So that's Europe.

be have do plan will be we in and And can there our will allowed submissions process frankly. as to we if place streamlined, there. the as So we soon are be

was Your clearance question second the launch. timing to from

to the similar with we think are what I analogies very described EsoCheck.

now between manufacturing We site -- have ready. is the

We available will this commercially have year. products actually

cohort limiting already So are We that a ready be have go. of the factor. independent won't reps that to

that I'm we So from the be the not to to really commercial weeks -- time weeks specific months window number on clearance of a of and to of we're achieving give of sort before -- and no sure would say than but you on more before the I launch market. can expect we're short. a a that order I revenue fully couple

after mean I there that have terms I is starting holds. hospitals. a in the clinical to that Now long that sites, get that very how ramp going. sales ambulatory into receive. work We that same be ramps the will anticipate get process, needs surgery of be But again done ramp still the caveat we centers, to the to that don't --

Unidentified Analyst

Right. Right. Thank you.

the we'll and like a sounds getting year it revenue as in XXXX be So will good start some company. growing

Lishan Aklog

I so. believe

Unidentified Analyst

you. you [indiscernible]. we doing for and you team trust and everything that Thank Aklog your Thank is Dr. really

Lishan Aklog

much. so you Thank

Operator

Thank back are turn time. closing questions this management to for I'll at remarks. further it no you. There

Lishan Aklog

a the by knowledgeable investors how set of We're Really, our today. Great. Thank I excited you how great everybody and always questions very are. appreciate time. much. taking engaged and shareholders

these conversations. really So enjoy having we

sign update So of remainder said I newsletter year. have as continuing posts. again, forward busy you with a up and up-to-date social sure we make to keep our please to for very look our And very, you we the media as

So thank much. you very

Operator

conference. today's day. parties concludes This you. may Thank a great All disconnect. Have

PAVmed (PAVM) 5 Sep 192019 Q2 Earnings call transcript