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PAVM PAVmed

Participants
Mike Havrilla Director of IR
Lishan Aklog CEO
Dennis McGrath CFO
Anthony Vendetti Maxim Group
Call transcript
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Operator

Greetings, and welcome to the PAVmed Inc. Business Update Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note, this conference is being recorded. to PAVmed's conference Director like host, to now Havrilla, Mike of would turn over the your I Investor Relations. you. Thank

begin. may You

Mike Havrilla

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

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

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

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

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

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

Lishan Aklog

to LinkedIn, January, investors value to and business past all to over our have and the hoc channels. our PAVmed community, committed on you, also through Mike. and portfolio clinical innovative continents really investor our FDA this since device. Earlier with now products, is in few anchored the interval valuable sign consensus ago productive recent of we press human our which our directly stretches at and year. maturity, coming quarterly have a includes a does Mike invasive news. mature investor also million removing YouTube, by active sheet with of commercial confidence as overhang share us communications time CarpX, for for which line breakthroughs our spread for recent time quarterly receive team so our to well but was our will And proceed vision of done under NextFlo and you relations shareholders then the to that other new this everyone. know open did lead study. lead who thanking We portfolio. his [warrants]. he terms pertinent in any other to provide transaction We our major discuss update the abiding results. strong a like notably newsletter very Several fortunate to a as have strong safety company, shareholders, on our call forward a remain with employees, and so, afternoon, our EsoGuard, free our this year-end believe study always blockbuster the and of business. financial numerous thank our lower meeting I'd including other nine, like regular to their we transparency by look our team, on questions November. to many $X by had corporate be to And carpal a during and like as strengthened tunnel have this who previously in on you to consists on potential community between support, we term first senior feel of months. efforts, encourage hard for July. which let increasing key Thank world shareholders this debt great of and no Good updates you, product update and balance our topics We'd financial CarpX in to commercially call. are on Dennis has during our Twitter, we to first consultants call debt interest agreed an and begin rate other We're and run. which in through refinanced attached com to then updating commercial PortIO. the working website of you our with interim our at financial joining product minimally with In we coupon by and the for email for and will welcome efforts been our upcoming to two time to investor especially be dive favorable our jmh@pavmed.com, Also engaged Mike in My overview requests, January communications capital appreciative of the the soon I'll our questions. the I full most ten This and a not products. to The a outsource on experts up I'd activity always, scheduled agency, the on contact and family. of calendar long we updates have with human and But amend worked reiterate and me the of and his demonstrated jmh@pavmed.com or weeks, job. process secured on releases across six an parameters weeks needs. do robust company, I and to last to of deeply follow deeper due enhance and start responsive full reached ad class us This highlight. will

in and New have members are completed logistics. team the complex currently -- Our ground Zealand on

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of CarpX shorter society tunnel economic a would many times in carpal proprietary to embedded compared or clinical is The and CarpX very traditional our market dollar. causes electrodes syndrome provide catheter is recovery reduce with dramatically silence, an larger, use of review, is suffer motion, with device surgery and carpal syndrome but relief treatment burden compression groundbreaking of invasive as uses immediately people debilitating carpal risk $X option tunnel addressable CarpX time. likely common likely pathway. tunnel causes total clinical surgery opportunity and in on for severe testing FDA which a as tool repetitive device, under Just nerve, is less recovery tunnel scarring target treat We will safe to a U.S. traditional of which regulatory condition precision market same massive. and secure domestic the cadaver the CarpX balloon but single and from syndrome. chose ligament much The a demonstrated a syndrome. of minimally open a working animal treating over billion believe cutting has Carpal experience is effective the estimated symptoms. a We've with addressable through XXX(k) the syndrome CarpX been Extensive of turn that to carpal designed to invasive. closely tunnel to is even

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name Week, independent where technology formally presentations. applications the will the be or diagnosis major and including was Diseases DDW esophageal at introduced a gastroenterology exhibits other. promising the change times each strong of pathology meeting, that This So in of are at Digestive will Lucid presence upcoming have

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with focused and this recently on Wurtman, Dr. studies. effort, time for to planning of the consisting clinical filed submission. consultants, be Address class a former requirements finalized a a a biostatistician a consultants, package, premarket Lucid Chief necessary has to of protocols a world part two along operations be Medical synopsis which and central clinical sponsored who meeting or including pathway PMA novo other request approval multiple now data FDA addition In discuss pre-submission full and with official. for Lucid's Officer with de the secured also is will soon been a regulatory have of clinical team FDA Lucid will the executing resources

in progressing DisappEAR in provide of products opportunities and and lead remaining highlights earlier years mitigating over breakthroughs month. and got on the others. are products be. like technology on and activities development couple intravenous the next offering value need potential we might and for open pipeline pumps our set really a while provided milestone and bullish believe medications like door additional resources the this growth for our we've Reaching sources however shareholder capital. the of on enhance or settings couple US. So month, in out-patient the next focus CarpX non-dilutive commercial infusion delivered infusions I've disposable I electronic eliminate of risk free would other expensive IV a X key have remaining and most Last always its prospect to day our well comments our estimated and to diversification PortIO infusions complex my very the hospitals of of its and been in to past what the substances million to for fluids, and opportunity clinical quest limited the limit and NextFlo of each achieved to

of element episodes central care, nearly in and are infusions of inpatient So our increasing patient all play an role care.

the at plagued examples Class infusion overkill are been complications today. X a physicians possible reasonable deaths much require most however do were a lower complexity training, despite driven all these of infusions using recently, Any century, the an the as peri-operative, electronic a the of simple, specialist and bag and Engelman, to becoming malfunction boluses by at bag adjust [indiscernible] and infusions recently described in flow software infusion healthcare fact ubiquitous, in not during rate most a critical The delivered the pumps the Electronic fixed For in hang are recalls glitches, and the gravity. nurse and infusion height lead would rate last this complications. care IV inadvertent of simple with of poor flow Dr. chart. that problems. complex thus one even another change and technological have clamp nearly incorrect associated would More height the pumps drip and and pumps. of the by expensive rate, or

the infusions infusion drip no these bag, the NextFlo is for of highly to height. delivering and designed gravity-driven expensive to electronic adjust so health costs of flows, complex care accurate pump, need charts the infusions constant by independent the at bag or IV keep no reduce a height simplify need

passive rate IV testing NextFlo easy pump. of manufacturer one incorporating IV inexpensive, connected pressure demonstration constant entirely NextFlo intravenous the following. variable a of heights models set sets our top flow of shared parts. across infusion. range maintains attached consisting electronic accuracy a with wide channel. infusion Two bench specified rough bag flow flow-resistor forearm to Bench-top to a vein on by establish physiologic disposable comparable of saline dependent demonstrated has proprietary mechanical to bag infusion our a each NextFlo YouTube recently a fluid NextFlo video It infusion an containing showed We in were the identical and to constant with

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safety testing piece also NextFlo -- several has demonstrated clinically bench-top key features. significant several

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in a formal process to we've M&A result, NextFlo weeks. decided for coming a As the initiate

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

Dennis McGrath

XXXX I'll reported release our financial Lishan. brief this as related available the the our website, and we December The sec.gov at for were week, earlier XX-K as also SEC posted this on afternoon, where well our Form Good results XX, release. published ended morning. on as is press the everyone. Form was year XX-K to Thanks, be press

stock-based for to headcount, research expenses So in results, quarter $XXX,XXX principally of development higher of per by and million, $XXX,XXX as towards large initial PAVmed from period $X.XX $XXX,XXX. clearance, $X.X trade difference and XXXX third XXXX GAAP the last principally XX, with expense to a were administrative share. its and and increased million and the quarter seven as Consistent with an costs, increased year CarpX increased was to of leader were towards in expense, last pushed activities, shareholders $X.X pre-commercial to regard opinion The PortIO months for quarter XXXX $X.X in costs common related EsoCheck of this -- three also the a same or as earlier higher sequentially. with XXX as for the animal launch day to activities, well December shows, (k) headcount sequentially. loss in cash. and Compensation financing due FDA XXXX, for largely one, G&A and compared $XXX,XXX year, compensation including operating period it's we higher fourth of related it ended XXXX the reflects operating net the attributable all common quarter. last the well the remarks million and R&D and approximately including general loss through travel million two a filing million Not expenses other are of $X.X costs including as for the $X.X compensation financial of same the related up complete GLP key made about study. year reported increases about the end The of the expense interest we event. between or loss were

in to million digging of was well our these the lion's those for And Rather in charges related related the the refinanced non-cash $X.X In the fact, as provides it press of as the and measures, half with other exchanges some those of non-cash charges, of the amounts depreciation release a along various highlight to undertaken detail press the and company's understanding performance. non-GAAP security our the the the of these to financial mitigate provides periods, non-cash. occurring more of better compensation, interest all end share current, to which first events. a this the year. kind XX-K financing prior give debt than of substantially and as you release details, of expense debt year charges mainly Also, non-cash table approximately we a stock-based at

of notice or XXXX, per common million. from in change the loss GAAP addressing from was by $X million as for non-GAAP a that had a mentioned company which year-end ended the September XX the that the $X.XX $X.X loss You'll after PAVmed -- during prior reported the XX, cash is three the December earlier, table of months adjusted charges, million year these of December share. $X.X quarter Cash of XX, approximately XXXX as $X.X million now.

our to mention for is thing annual XX other year. this June one scheduled Just meeting

in mail You'll the in the sometime be May. proxies getting early

it for questions that up with audience. let's operator, from So our Operator? open

Operator

be a from Anthony question. At of comes this session. time Our Group. we will Instructions] your Maxim line first Vendetti with a Please proceed with conducting question-and-answer [Operator question

Lishan Aklog

Antony. afternoon, Good

Dennis McGrath

Anthony. Hi,

Anthony Vendetti

I Good follow-up afternoon. Dennis, CarpX. on hi just Hi Lishan. to wanted

be by was the XX end understand on the will delay say think at call. elaborated of treated there you bit little you you So of Did patients, week. which I next a a

Lishan Aklog

the at coming of week. end Yeah, the

Anthony Vendetti

thought was I that a little quick, okay

Lishan Aklog

In the week. coming

long -- we little had surgery elaborate previous announced So, some bit on these as release, press that the in just date a to procedures. just to are our not

five So, relatively. the approximate surgeons a day able are to

through We have mapped out that days the we week. have days and are four scheduled four in today that coming extended

have be period -- the should and completed -- patients their those really then should So procedure follow should up the all been of be in near future.

Anthony Vendetti

XXX( so would the Okay, k) in and would third an the studies that delay, still after in mark getting quarter an expectation is as FDA and that you the doing data, submit with there a even quarter third well. then back submit the CE it for

Lishan Aklog

days completed so submission period FDA some it days will if we have yeah, XX review will So XX to and the the procedures We'll for are out and been package short together the completed. map from time have the put have to that. of when follow-up period

So you QX, QX. I sort guess I into map late that of goes think out, the could early

So but hopefully have we this delay to have timeline before. much mapped have related -- impact, not out the we some will too

Anthony Vendetti

FDA takes the full days And that assumes XX thereabout or [ph].

Lishan Aklog

Yeah. true. is That

is this to re-submitted, So to is resubmission. recall on elaborate a this just a this just is that

they've extensive testing, all of So manufacturing, the all that to have all -- had done. has we review opportunities been of already the preclinical

certainly the -- they signed and also that we as protocol, on So well. have off

hope hinted, as would review take it day period. So that them XX full Dennis not our the is

Anthony Vendetti

it that's XQ, sounds possible saying scenario late that case it case… submitted that it's early you have into the worst it like XQ by if you're pushes and is But but then still

Lishan Aklog

days, I think push submit what it it referring XX submitted it full to then would if I take -- they the we into that should was is QX. QX. have within And

Anthony Vendetti

it. Got

possible XQ in still if well, goes as is everything ’XX. it So sometime FDA clearance,

Lishan Aklog

same you’ve submission definitely hope time. a mentioned that's our mark CE so around yeah, and expectation, Oh the and current

really we're to line with as our like time, concurrent the study So going up we've the that we'd because submit Mark. clinical with study, last to mentioned CE clinical

Anthony Vendetti

Okay, good.

about know then, you try understand I so And the EsoGuard. talked and -- and EsoCheck Okay. I

still pre way, we me tell two? And track more FDA like our that that in Is have Can the seems XQ the you impact submission also the a it any have in difference accurate? pre that does little on which Phase ‘XX. have submission, on bit timeline submission. about X between for Just, I any there. everything's

Lishan Aklog

The the nomenclature go the -- the before do let's actually question, bit. for well submission back for – I sorry and answer a

So to the of Barrett’s nomenclature Esophagus, eosinophilic any some processes. I for in confusion or a were there decided on esophagitis has was no What we than EsoCheck EsoCheck. other others. Candidiasis interest using for do, was of the -- diseases we're in said with and getting both impact we And because under to frankly, gastroenterologists conversations to lot as referring

as and EsoGuard, test sampling. as for to keep do decided was call the EsoCheck we name what So the the diagnostic cell to

or anything That So regard strategy change clear. that. or of any is with timelines to that our the doesn't

Anthony Vendetti

Okay, FDA with to the submission (k) by Cleveland should for working know I clarify, so just but the be Clinic, been to XXX just when? you've EsoCheck

Lishan Aklog

already we've submitted device, the For that.

that is at of was last a year. submitted selection cell end EsoCheck the back device, So

are we the back. small additional in process. results do from some got an asked animal letter that. study to where came The good completed. provided That We study. FDA GLP they We We animal us were response

GLP our clear we they XX submit response have days. animal XX So to clock we're clear it will their within will study, from the Once expect -- and data just on another ready response. to days that the that about submit our we they

Anthony Vendetti

here be when? is that XX response going Okay, soon to pretty is submitted so the and after days then

Lishan Aklog

Yes.

we'll it think really We've So asked I quarter. do cleared they've get this done to. us everything

Anthony Vendetti

then And on be should Mark this CE in second Okay. in here quarter, just moving submission the quarter. to PortIO,

Lishan Aklog

the European of the -- challenging. strapped. a if bodies, been because I verified really little MDR have That's don't bit you

to a will be looks on them their there's getting we a so audits touch with for today But like done, quarter. in and submissions our we target and so forth. And bit this got challenge initiate

Anthony Vendetti

Okay. on real me And then that update in FDA an the for give just quick? PortIO, terms of

Lishan Aklog

Sorry. Could please? you repeat Anthony

Anthony Vendetti

for for PortIO? FDA Sure, the

Lishan Aklog

Yes.

study parallel FDA last a do study just an year, -- reiterate, And pilot we a we're So FDA to animal along animal to X-day us say, back part our that animal for gave asked we're work. through study in and here's the up FDA package, novo as we to and we've of the the go will That us expectation. expect so GLP cadaver a is pre-submission come pursuing results, pre-submission that some data GLP indication completed. put together pursuing. did animal where our we The it. being with study And was with excellent additional the that do screening

we're do doing CarpX. PortIO, we person New formally that with is we haven't have in they a us like this so anticipate of going they showed In doing with Zealand where we study, parallel requested XX that pilot asked Although or it, that, applications, just trying which did to value particularly this get to study patients pursuing a at long-term think evidence longer is indication though term the even for sort develop is where to we're of is do base to point weeks here, what -- antibiotics. where intravenous which we're an we X X-day X would is

the to excited heparin perfectly all as the XX at long-term end data tunnel and was for maintenance, flushes about functional that open. flushing we're on of without require XX-day regular it We as it keep it, said, And where them unlike, implanted without one our [ph] regular of know in really of touching XX-day. devices, implantable So it. I basis you days works left catheters on a

thesis So that's this. the the been from always underlying for previse

breakthrough opportunity that's we profound think the think on a is I really it's that. and where market

non-FDA So this get started Well, I based do we're we Columbia. actually to on as mentioned, to a that study quarter. going in hope that,

have as We days veins for target vascular and implant that's variety there -- of their patients ready We're work with to in PortIOs surgeon. poor dialysis as going and FDR a a well with a for to XX for us use applications. patients, intravenous

Anthony Vendetti

in submission, then quarter de by Okay. the 'XX timeline still? third And have my novo so I

Lishan Aklog

It depends comes do. it the -- well, FDA what when we with, back on depends

So show clinical say come will we'd -- will we'll them like okay, back certainly study. the like pre-submission, do you and data, they back almost and we do say small a you will safety the come to we'd in to do

OUS, Assuming CarpX together something it they did they us do actually with quickly. can that's pull let like rather we

we New could could that do in the infrastructure do have quickly. We place and we rather Zealand, in

because sort on So that, of really you depends it how to ability I they have month respond. per based the don't on give

Anthony Vendetti

Okay. And then…

Lishan Aklog

I the in that's that certainly don't out range. -- think completely of that's

Anthony Vendetti

three study range, you to you're study? And okay. you DisappEAR, said, full completed start and the going then month It's the in now

Lishan Aklog

three the we'll actually the let we And based some can study, on we get process we guys a as get soon we the some report -- of have and the to manufacturing But are we the that the the out and we we'll have of we of believe establishing final begin we let as soon as month work. it so and months. So which application don't X that, data on X XX -- X know, validation some begin you as final have months results. X continuing study, animals forth. we'll the But world X month believe the we submit, months, the

for as a early out release, way. XXX in (k) hinted submission year. end we're still this adverse So press are regard But cases. three intriguing clinical events are routine month I'm expectations of And that relates data the it study, sort the certain with along of I towards looking these collecting as events, to in reports kind clinical the the to like longer term of really the in

I and that So will the think data together pull coming week. on that report all in

Anthony Vendetti

Perfect. All helpful. That Appreciate so much. was right. Lisan. Thank you it,

Lishan Aklog

Anthony. Thanks, great. Okay,

Operator

questions Instructions] no [Operator call like remarks. turn queue, Dr. are would further to there Aklog closing the for I Since, in to the back is over

Lishan Aklog

So, thanks afternoon joining and your for everyone for us Anthony. questions, this

jmh@pavmed.com. Mike We periodic day. abreast forward look encourage are of Thank progress any again also Everyone a Again, questions one. directly releases I -- much. as with at to via such conference news you to this we keeping contact will you our great and very calls you have

Operator

This concludes today's teleconference.

disconnect lines. your now Thank may participation. your you You for