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