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PAVM PAVmed

Participants
Mike Havrilla Director, IR
Lishan Aklog Chairman & CEO
Dennis McGrath President & 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] As a reminder, this conference is being recorded. to Director conference PAVmed. of like host, to now Havrilla, Mike Investor would turn over the your I Relations for go ahead, Please sir.

Mike Havrilla

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

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

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

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

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

Lishan Aklog

everyone update this and joining discuss quarterly our -- financial on results. discuss business to our you, Mike. for thanks Good recent us afternoon, call to Thank you on and

and who shareholders I'd engaged providing on PAVmed. you so with are long-term communications shareholders like our vision to progress. shareholders, for new our remain of and committed ongoing their share timely especially our shareholders fortunate We support. We our here to long-term commitment robust have all thank firmly at a to

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

some [ph] PortIO, important the from with of GI and regulatory the studies reimbursement allowances EsoCheck, solid breakthroughs for include fruition X.X most the press enormous a represent Conference, year company's EsoCheck successful of during enthusiasm history exciting DisappEAR, I milestone patent period to major in of our important months progress and months clinical Exelon multiple release, with PortIO morning's and and on this X.X palpable fronts. -- this and critical the and hardwork As EsoGuard the USPTO. EsoGuard for first the exciting technological perhaps animal coming the perseverance stated in Annual for for for CarpX, completion even of amount These

to like Before collectively valuable target of the that lead central millions dollar products EsoGuard Dennis provides These bulk mission I'd build and opportunities to products EsoCheck. and addressable growth unmet multi-billion patients spend quarter our results, in CarpX, our today's are an and including high commercial overview a of to portfolio, on needs company. our the market update of first worldwide

some are PLA Zealand, related in Director Operating at of we safety strong we multi-national the of of process the laboratory in of are products; EsoGuard Clinical to the the Meeting, we medical nine to through assay. successfully proprietary these to Here organization key Chief and contract the treated Lucid's human Officer, serve Annual advanced that clinical diagnostic highlights key reimbursement first first in patients study company specifically CarpX New of key positive substantial Lucid a Operations we and our subsidiary, secure the kits the EsoCheck analysis results and two we steps, we opinion established a major received animal products EsoCheck the on EsoGuard Diagnostics, Gastroenterology from the recruited it's large leading the a FDA parts study, presence EsoGuard as GLP to specimen the equivalence and build for engaged perform custom of device

now a Let's deeper CarpX. into dive do

our device know, open reduce is burden a is will Carpal As designed to dramatically clinical carpal severe very extend repetitive massive. and syndrome motion nerve condition several common a compared a longer. many treat typically tunnel ligament and which of society tunnel carpal invasive syndrome times of is ground-breaking The We months causing tunnel recovery debilitating scarring traditional where in is carpal CarpX believe can from compresses minimally but wrist surgery syndrome. to symptoms. the you of CarpX on economic tunnel

that to brings XXX,XXX of suffer in chose innovation. exposure revolutions a dollar limited over a that a carpal are with option which surgical the many immediately billion opportunity tunnel based recovery condition syndrome likely an primarily many decades has more who estimated other the of have percutaneous treatment conditions We doesn't silence, a but time. CarpX minimally year shorter and invasive targeting taken the tools for market remained with over surgery established addressable include to and for would domestic on treatment each patients undergoing of $X

invasively. a designed provides the mimic So device but uses CarpX anatomic radio electrodes do invasive catheter device scarred under electrodes results balloon which less pushing of the with inside-out a effective catheter physicians The surgery the XXX closely procedure. safety that and dividing We've away. a the of for cadavers much FDA the and while bipolar the through closely in has RF over precisely safe precision from be to in proprietary embedded been to XXX(k) to inserted ligament single-use nerve in which the the fashion When testing carpal ligament is minimally carpal demonstrated so ligament. and tunnel the ongoing tendons working is balloon invasive a to frequency activated, preclinical transverse cutting is energy animal is to clearance designed the secure seconds. tool CarpX pathway. with regulatory is optimize a cutting device in feedback The CarpX and it's cut designed complete the matter Extensive of a with U.S.

During the a pre-submission resubmission it's and process to meeting outside requested performing in by indicated in study IDE clinical U.S. document the time consuming XXX(k) studies FDA that safety January, procedural for humans a with definitively we of U.S. the testing could avoid

carpal deGuzman all the successive even performed CarpX time led Officer, study. clinical we in of protocols endoscopic minutes carpal it's nine clinical using first was patients protocol normal tunnel cases curve, Certain in limited on plastic procedure Christchurch, the for this New short post Zealand procedure. human effectiveness on traditional the carpal should in of FDA the the than was to reconstructive were parameters of syndrome cadavers endpoint New division consensus and the carpal was a design primary device and tissue device. well a and procedures St. patients the previously CarpX with the the room As ligament, in of enhanced the very CarpX a steps Chief tunnel that with confirmed the planned precision was shorter living that carpal deGuzman. similar patients visualization, short first released as there the and living we carpal and anatomic be each XX of result, CarpX successfully was with a human XX part or Complete study two and veteran underwent team minimally Medical saw surgeons events. procedural with on were preclinical This the device with it transverse procedure multiple Zealand, testing. were cutting syndrome. Dr. present the tunnel a The closure safety The discussions operating trained technically no ground at CarpX amended Zealand consistent and a syndrome, successful during the as with used following safety surgeons; CarpX three in patients performed cadavers announced underwent Hospital adverse days first enhanced to of procedures. in release at extensive PAVmed property the differences was Brian as invasive Yesterday, group syndrome including by between device-related Nine study diagnosis possibly by incision address tool and with tunnel were first procedure of successful rapidly to tunnel an George's and endpoint from times with New straightforward learning procedures members surgery. safety by

finding procedure. in cut the and with For CarpX less wanted the and at to to prices example, patients that it endpoint. the testing these XX-days device According to unexpected than positive follow-up the found cadavers. the go which further the safety two was visit enhanced had required an power clinical This balloon repeat surgeons follow-up weeks electro-diagnostic lower at ligament the protocols protocol, XX-day to post-procedural during document

this to this patients data well Once CarpX the group with time from clinically as are and are in weeks. hoping their in of a we are procedures XXX(k) procedures from now it for complete finalize incorporated Another application completed, the and calendar New time resubmit Zealand, and coming follow-up will in delays year. the and the protocol the commercial XX-day CarpX of FDA, to [indiscernible] undergo study. the to safety regulatory we CarpX effectiveness process Despite during scheduled these launch few are administrative took logistical as

to EsoCheck. Now let's EsoGuard on move and

technology Just recent subsidiary Esophageal to EsoGuard from screening month University; in DNA ago XXXX the Western PAVmed called one the most of Test technology year owned the a created [indiscernible]. Diagnostics majority Cell this EsoCheck highlighted National Cancer was Case The revolutionary the and only-cancer Device. license we Institute Collection technology Lucid

tens trif a without BE of is next-generation converted office-based DNA is CCNAX. EsoCheck or human when on been to of domestic addressable based the detecting at XX of BE, collection and esophagus test shown which highly according screening to EsoGuard unaware market bisulfide Barrett's cancer are millions for to with GERD. test, DNA they is procedure two guidelines. for available on the EsoGuard San VIM is potential genes, related as that team candidates an EsoGuard year diagnostic A risk morning. a EsoCheck unaware educational a on which Esophagus already who be many -- sponsored to EsoCheck, Amitabh where traffic on the was this excellent has the Week, developing minute published animation known and very author both and highly of strong [ph] $X billion, gastroenterology a is two, and subjected available which endoscopy. Shak estimated EsoGuard We was [ph]. BE the esophageal cell by Esophagus EsoGuard also American Meeting YouTube presentation of by of engaged cancer. lead partly commercially then that and any both, oil reflux, lives meeting samples peg-methylation regional can array GERD quality the from materials sites five excitement and had of early and from and EsoCheck acid the gastroenterologist, Barrett's study thus Annual and to had with uses collected EsoCheck in on So by gave a at now in at driven Lucid EsoCheck overall and precursor The this esophageal are device detection and that XRTFFX in U.S. EsoGuard is a factor Booth believe that excitement -- Most EsoGuard it's of or non-invasive the be through in at week's cells space, sample over patients was lethal community. immediate advantages including and performed the booth high esophageal DDW, targeted prevention EsoCheck main includes their cells the presence on cell Digestive are least precision sampling to designed need an current is Gastroenterology the major sequencing CytoSponge including sample Association. diagnostic heartburn issued This in Dr. their patients opportunity this which accurate at has our EsoGuard competitors individuals which chronic BE the the link with and feedback physicians very abstracts. The is of an this to save EsoGuard. published cancer. press release esophageal test have our strong well-attended Diseases leading fantastic acknowledged Gastroenterological We namely site, on new e-detections esophageal our introduced Diego

lower Unlike modern inverted who Board cells. must it The share has umbrella-pad-like EsoGuard results For by EsoGuard sponge which dilutes can Nick a data in Barrett advantages throat marketed example, expert lower which Shaheen a to BE is perform esophageal the used results test it pathologist. cells, allows happens Lucid's EsoCheck translational the Medical presented test, from were and is many sample which a whose automatable, the inferior the and high-end showed immunohistochemistry a [ph], standard which esophagus, year contaminates CytoSponge markedly is EsoCheck's digested requires Dr. CytoSponge Medtronic. DNA last cells technology which published mouth using capsule biomarker protect be over study sample CytoSponge TFFX to EsoCheck leading Advisory device entire to from medicine. of and a esophagus, TFFX targeted before spherical stomach CytoSponge and sample be [ph] in and a unlike to which

we subsequently or So then, test end EsoGuard laboratory having pair review reimbursement for the Medical completed PLA and panel. it's as and LDT, is the the billing private [ph]. submitted spring. and validation in Cleveland this the EsoGuard cleared analysis now test the laboratory a full EsoGuard review secure process The American March, laboratory-developed proprietary in technical officially LDT secure on-schedule. the Association is At clear the the to Since step progressing in editorial to of CPT to advisory LDT steadily has first two hurdles, additional diagnostics process or a CPT CMS EsoGuard

clinical next participate EsoGuard the step is build Lucid proposed and a process fee to laboratory or engaged meeting also to methodology month, will CLSF Next schedule contract portions leading the amounts scheduled organization marketing custom in public where CMS actual in annual payment the and kits the of EsoGuard key the LDT. we month specimen This diagnostic assay to support presented. be perform the of

of EsoCheck work. to of we're really hurdle also XXX(k) the GLP weeks, regulatory submit on Our and the support do provided are to final process accelerated And safety GLP document clock, the endoscopic preserve pre-submission EsoCheck clear been while some completed couple used review in XXX(k) major the these FDA that brush. from remaining reviewer clearance. FDA choose the is FDA the we study step the for we safety and allow to on opinion of and we time substantial were the to approximately through to thrilled XX-days clearance. her expedite requested review has expect fact review that clearance an efforts final completed to for to and clearing quarter effectiveness, secure matters review outstanding to EsoCheck validation validation data the process we FDA's process in [indiscernible] we commonly completion. a the finalize sterilization and Last GLP The equivalence that study effectiveness nearing quick animal pre-submission the relative completed a study Once results through pathway animal the the

to DNA indications it's cells collect for for other pursuing to EsoGuard use Barrett's Esophagus. test EsoCheck the are also detect beyond We

a medical the is advisors yeast utilizing inflammatory a the EsoCheck Esophageal systems, have leading compromised a patients key and of Candidiasis, other in the begin to common as at couple We engaged esophageal of esophagitis, which centers such infection Eosinophilic academic common which immune occurs esophagus condition conditions of with and esophagus. is which

as studies former progressing FDA medical long-term patients collaboration using million is requires advisors, recently Lucid This to support BE discuss collected will data XX secure these for Operating clinical a Our or samples pre-market denovo of our medical this EsoCheck a recommended. device. on FDA Director meeting requirements widespread be system will to operations trials, in whom an with published to the device operations the to Lucid's well sponsored FDA's process regulatory a with pace pathway Chief a most EsoGuard having screening of approval, the based specific of is LDT. of it's currently EsoGuard begin with as at by In the guidelines performed including to in to IVD the FDA upcoming company submitted weeks is director Operations Clinical EsoGuard indication in is submission. who screening request course, an oversee served office. for on multi-national outlining new An This or be close Officer, coming and world-class complete in-vitro in clinical cleared indication along and BE the package the accelerated June, large as diagnostic PMA, of the sponsored clinical clinical IVD of strategy, as of pre-submission Lucid now planning

in brief pipeline in updates submitted at product lead in press as going update So this as as be well morning's I'll our are recent the well, releases products are with the remaining release, the press these dedicated covered weeks. they

vascular maintenance pre-submission FDA denovo study completed data these to device pathway, FDA will submitted the a intraosseous the for been been also advance requested continues access to a study be and animal to six FDA's designed GLP of pilot an over to incorporating the XX duration in animal study free PortIO implant months has package has document animal Our free from through implantable initiated. unprecedented data the by up another the maintenance implant durations Ground-breaking coming weeks. days, in demonstrated

are in mark America, human and submission CE finally long-term We South of Columbia, in planning first a coming months. series the

to strategic partnerships continue outright explore potential PortIO. acquisition We including of

Our substances milestone complex need for achieved one in day medications the patient States. estimated million and each pumps quest other fluids, in infusions and of of infusion most our the NextFlo in the key United intravenous hospitals a set electronic it's recently eliminate to across disposable infusion settings expensive delivered for

infusion X rates NextFlo clearance. testing will across of IV has will with FDA introduction demonstrated whose market device be accuracy heights Class NextFlo not electronic constant require a rates wide-range flow We a to anticipate comparable bag pumps. XXX(k)

We are finalizing before expressing device demonstrating acquirers market ready-packaged the commercial including a our in the to who of technology. in interest version it recently contacted leader potential space the us

month of demonstrated the antimicrobial silk the study fluids pediatric been technology properties from study three with tubes resorbable blocks several enhanced including intrinsic plastic surface a results. and Finally, animal The which and ear DisappEAR, over tube machine of completed appear a properties. excellent animal antimicrobial ear out in unexpected traditional of benefits proprietary potential has flow provide to unique tubes of tube resorbable

longer determine properties difficult and a the properties ear autoria are being antibiotic confirm incidence for antimicrobial to manage middle to testing [ph] also [ph], for is need to whether durations stability fluid the being of canal. the followed surface performed low animals collaborate have strains without the and antimicrobial coating. pus Additional of device is In-vitro condition out where

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

Dennis McGrath

financial the Form where release to be the everyone. XX, afternoon, sec.gov press The published on brief morning. quarter-ended as our the our for and posted available SEC week, have I'll we at reported XX-Q and results good this is website press this Form past related on XXXX release. also XX-Q were and was our Lishan Thanks, March

milestone the than with quarter, our XXXX research So as were the explained. of PortIO development million, and $XX,XXX their through R&D made completing remarks as current Lishan we for the Consistent and end as pushed to quarter. with CarpX expense well we quarter for the towards the DisappEAR quarter breakthroughs regard of NextFlo about last FDA animal fourth clearance, results, this as first $X.XX increased studies, EsoCheck and financial

administrative our the year-over-year pre-commercial are expenses for key sequentially. activities Third-party XXXX, operating accounted for related $XXX,XXX opinion a $X.X the March common compared for related or was and $XXX,XXX. the loss expense, $X.X largely costs, as net XX% leader events. a by detail first two the $X.X look were and lower $X.X fair in manufacturing for of ended the quarter and increase GAAP contract for development around to share. stockholders nearly tradeshows, and including the non-cash XXXX million loss XX, increases value million and of compensation of which to XXXX per The three General same PAVmed between were reported principally and you well lot affecting GAAP XX-Q attributable to accounting have expenses launch with period costs headcount of other travel other principally charges related due $X.XX for increased including in an as stock-based million, about of compensation debt and common in can whole changes million a and loss regards that. months to The reflects difference operating convertible the more to

events. million Note, and release cash along XXXX XXXX, non-GAAP during or release year exchanges provides are change which XX, had We'll where a as from first of reader these share. by charges current amounts per charges, approximately after that company to these of common of related the $X.X performance. million With increased offsets Also, from $X.X loss million questions notice of provides ended, PAVmed cash namely the other March entirely. ended charges, is the almost might we the liabilities. depreciation of non-cash of periods, the Due substantially XX, the $X.XX predominantly in $X.X a well of that million prior table press compensation, more quarter. measures, used, mitigate security in understanding interest as of detail those to months as accrued the have the non-cash occurring quarter the us and which Our million the company's with the for financial after the some and quarter highlight $X a part last which that $X.X press first GAAP that various burn and stock-based entitled three undertaken let the the table so which the expense of better addressing reflected it cash a by reduction for audience. loss adjusted and open non-GAAP operator, reported the of million, a $X first that quarter March up payables significant the our XX-Q

Operator

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

Anthony Vendetti

Just is wanted to follow-up trials, in I XX? extremely and we the fourth on doing From get the CarpX first, the and we next group discussed first is Is that when to -- next talked so adverse smaller it patients nine first I the the patients events. quarter -- it the think no a we sounds like went the about human or up. next know group doing XX XX group before well,

Lishan Aklog

in we about us finding. round are submission fairly We're results those to through are that according it confident more get through the complete next Bottom-line schedule actual XX, preoperative we'll patients may those sort of and but be that going of is outlined. patients the the are informed follow-up -- approximately talked is process to but to we're had enough day then being number call. XX patients they and of our what through those testing last and we're on -- confident The during timelines XX-day we've recruited this consent to close really, we

Anthony Vendetti

Okay.

is is start possible it end next you and this that to then still well of the by call, Lishan, assuming group goes on as mentioned to So get it the commercializing XXXX? expectation clearance

Lishan Aklog

Yes, that's correct.

Anthony Vendetti

changed there on or timeframe other have products you gave update you And still else with as the all the good on-track? in a quarter fairly fourth then, the I products; know the anything on has that that everything is other CarpX, from

Lishan Aklog

I would on-track. are say really things

that with worth I them the the process fact of think animal mentioned that sign-off data that of used I study. of all the the probably out things the FDA and we substantial to highlighting get the the the is key on to equivalents -- came probably pre-submission

time clock that did and So that get them which preserve very always that up did in us to think quickly. allowed we a it the we'll some I helpful we and to is way on wrapped

good consistent all a discussed who lot also, was use obviously as it's lot that's of this of to of news the to new -- the excitement this So time gastroenterologists good at last opportunity DDW what around there the it mentioned, booth came and Barrett's there a first with week and both, we by a well that for for condition I having as [ph]. another really as is is works because

Anthony Vendetti

terms there then, through the year, be to going of could these products the going of the the the thinking ahead of in of with you're is this focus we but additional in And obviously, Lishan, forward as look always know about remainder all By what's we'll year pipeline? any on products be I end other products. that start hearing

Lishan Aklog

and were licensing will DNA because highlight that technology is that we look in on always to model month, company on, be today, creation a radar, hadn't think within sort exactly opportunity I use -- in QX that of this even this I'll been the that which to thing be within your that this we this innovations it's say sort -- just it's the founded value and I'll fit of question of what company, mean to I were year believe and additive our the EsoCheck we and business presented January Well, seeking of talking the offered if it the a XXXX, had consummated we story these sort EsoGuard at in agreement. of this technology, we it were of ago of even been XXXX, not to we

can really no that is good and opportunities pretty to that. stronger a for this company identify think evidence more be always of story no opportunistic, always should we're So looking EsoGuard, EsoCheck value there [indiscernible] example the add -- to we're I attractive that

Anthony Vendetti

the something of for lighter was up. forward expense as to are and little of R&D modeling little we than XXXX of was Are came in the terms looking going look in numbers just down those were then overall Dennis, Dennis, a a those G&A for. line; different we G&A in little better cadence on for for -- And up then or R&D? expenses a the bit, the rest you terms should and

Dennis McGrath

see is It's the beauty because slow opportunity expenses as right; and up of speed based a almost pretty or you our them great can down DisappEAR to the we the variable, model than in them through the to sense advances to we ability behind largest something -- upon go anticipated. the and resources were so technology this made and question portion and NextFlo, have initially of that and like you faster PortIO can continue it accelerating what Lishan's remarks, significant made is invest EsoGuard

second like second of well the expenditures through lot on first the these all the heavy for advance very some to Zealand So quarter then upon modulate we depending for duty the the non-lead outright things these get commercialization going R&D for is step technologies New look as and the of instance, technology what in or the these start may next will quarter, a some the trial strategic exit quarter of to products.

Operator

the end time. for to there turn CEO, gentlemen, the next Our Lishan session. would questions reached line remarks. back the Dr. are further no the And [Operator I [ph]. apologise, Ladies from of and Aklog, of call question Tom Instructions] to comes I we question-and-answer at closing have this like

Lishan Aklog

and this Anthony. you. various news this We great frequent thank to keeping abreast jmh@pavmed.com one. any with us our conference you Everyone encourage us as contact social So, had look also questions of to afternoon question, day. listed Mike periodic media and contact directly at Thank progress always earlier. to I sites that a you have your on the for I forward you releases calls as for joining such via all and

Operator

This concludes today's teleconference.

now participation. this you Thank may lines at your for time. You disconnect your