recent you thank at to this opportunity afternoon, update looking you, our call everyone, to on Thank for results. here and you to exciting quarterly our on forward joining Good developments PAVmed. Mike. financial discuss We're us many and discuss this business
thank and for commitment of and all our especially to new support timely thanking their just our our long-term reiterate shareholders robust transparency and I'll by communications. shareholders
transactions regard, so that to event. logistical through before I'd matters in the it post those we'll few specific releases communications. like to for of as We press In hoc our the a other discuss ad releases and milestones, to announcing or market press do just continue morning open relates typically achievement
align investors response in of our our feedback However, to and to quarterly from better update. communications business related
forward market Moving close business quarterly we to did our our today. post call the after press update update releases as prior just we will
We will note our this of update future our quarterly announcements call. in
started. get let's So
over call, our and past up series with been in upcoming few we weeks I last of days, As extraordinary fronts setting progress months solid previewed the milestones a active the have coming over across months. important multiple
the CLIA/CAP starting test milestones by of our complete a important product. at major In EsoGuard partner launch certification me expect we process ResearchDx our into as Hartland, Let gastroenterology December, laboratory for before us lead laboratory individual California, to upcoming excellence. diving the centers developed commercial start highlighting allowing most commercial to deeper
we Barrett’s well multicenter to trials market with Diagnostic for Esophagus EsoGuard two of In FDA screening their the clearance opportunity. commercially detection in a expand IVD to significantly risk in be as without Barrett’s Esophagus January esophageal indication regulatory specific registered device test an with will high or cancer. to expect the as as support DNA secured EsoCheck of long-term and In-Vitro launch patient It to first facilitate and and only available dysplasia, clinical
us allow in CarpX CarpX first-in-human January. days resubmit XX FDA the for XXX follow-up which day to to we clinical expect this coming successful the will from expect incorporate our to will study, early application which resubmit data complete to safety the we In study
There our provide sign-off in from acquirer non-dilutive during strategic launch light some New after which January Infusion the additional us clinical and which upcoming in-person we a a FDA Zealand. milestones for NextFlo securing protocol M&A study for the a to PortIO meaningful scheduled seek the where safety capital System from the coming small in green X give meeting pre-submission to partner include study months completing or will the process
inflammatory clinical called the XX-day prevalent Launching partner free to a partnership Columbia, South demonstrate and our produce trial to silk with up of human EsoCheck in commercial-scale tube. implant maintenance clinical DisappEAR aqueous pediatric study ear PortIO Esophagitis, Launching esophagus small agreement for Eosinophillic large America pilot a to duration. securing disease in strategic long-term the finally;
need larger products with even to EsoGuard Start we longer now proceed hopefully extent our dive those limited and into the as for well our PortIO. launch on to of and calls time by however, to I'll allocate as of clearance commercial sort portion we'll that communications deeper as product. and these approach in commercial not noting after, of launch other CarpX
While of other focusing our on the the technologies – with portfolio. just a immerging critical highlights
time opportunity. condition CarpX. billion start immediately we in the repetitive to open carpal involving surgery from motion. scaring CarpX will a targeting tunnel is an device, minimally believe syndrome, with to recovering market very reduce Let traditional estimated CarpX which compared a wrist of automatically addressable domestic design invasive treat We common ligament $X
inside a catheter ligament, inserted tensioning and under out the it bipolar the This electrodes activated, nerve scarred of away. When pushing while in from cut matter tendons is the precisely radiofrequency seconds. balloon device ligament the
We minimally market are invasive CarpX commercially clearance release. FDA for tunnel to carpal XXX(k) seeking
extensive resubmission. positive safety our clinical to FDA pre-clinical the the small study of support data, XXX(k) review recommended Following
The very the study at endpoint primary function with in primary includes develop and consultation We narrow and study for this safety assessing effectiveness protocol motor straightforward days. a endpoint intraoperative a clinical specific the protocol XX nerve FDA.
carpal patients New complete. is in met tunnel the using XX and two performed study’s primary release by device surgeons the nearly CarpX invasive first-in-human clinical Zealand, All CarpX effectiveness endpoint. The minimally successful safety study, underwent
that believe CarpX's the the potential. device commercial strongly and We performance of support clinical
time curve problematic These surgeons short with base with surgery. to was were learning traditional crossing the shorter For than area pain is tunnel no of or incisions, the palm, procedures keyhole healing, for final the incision procedure traditional small after example, performed and the release. through carpal comparable recovery persistent
also appears the received positive. that balloon been the CarpX's tunnel, study we'll in carpal finally, has outcome. the And will more improve feedback we've very to create long-term from space believe patient which
final XX met safety the effectiveness of completed – endpoint. has All follow-up study's follow-up primary patients Our as of nearly those XX-day XX have mentioned primary endpoint; patients who the have their study’s complete. met I patients
The remaining the a which will their coming complete get schedule are three to XX-days to follow-up. in us XXX% follow-up days
the the data CarpX's XXX(k) clinical resubmit application safety study incorporate cycle. FDA We and early January in review the FDA will then XX-day initiating from a
move EsoGuard on to EsoCheck. Let's and now
the short note proud clearly progress period. made of these already I'm have we As advancing to that such technologies remarkable revolutionary to in a commercialization
Western cancer that dysplasia, to to will University cancer EsoCheck them EsoGuard ago. from without as Briefly, months Barrett’s esophageal itself. conditions lethal XX diagnosis with are case we I just esophageal and as Reserve note Esophagus of which design facilitate precursor licensed and highly the well are
and or subset as These conditions but recommended the these of burn small treat known before also it's millions a disease only occur reflux chronic cancer, to progresses in Screening Barrett's gastroesophageal high-risk in in GERD. performed is with detect it heart of patients patients patients.
careful Over of through The to esophageal are have these that aware prevented that have monitoring if could Barrett's been and will had most of is that diagnosed within XX% cancer patients diagnosis years patients of progression cancer. these earlier. underlying with five of die treatment their the tragedy conditions cancer esophageal not been diagnosed Barrett's they the and
least billion of market EsoCheck U.S. currently based on is domestic screening EsoGuard according patients recommended at to addressable for immediately GERD $X penetration very for estimated society The published Barrett's already and opportunity modest guidelines.
to EsoCheck individually; a products available cells The can for any cells a a from two the is without of diagnostic then sample to procedure designed test be the endoscopy. office-based about sample need commercially talk five EsoGuard. in including non-invasive region esophagus minute subjected targeted the device, And
program clearance FDA our launched earlier successful has meetings at been especially gastroenterology in for positive. the this very this and secured education to EsoCheck gastroenterology recall year and efforts The increase of may digital You and major to meeting. EsoCheck a print response marketing XXX(k) we've awareness
an Translational Medicine specificity. is Science published has which without be test to dysplasia, DNA esophageal than esophageal shown sensitivity EsoGuard been accurate and detecting in XX% human study in Barrett's as as at cancer XXX-patient with highly a and with greater well again Esophagus
saw NGS this test along genes. two on were methylation because uses very or path. to attracted these technologies two to at market XX next the abnormal parallel to detect generation opportunity of bisulfite-converted sequence The sites We address large we DNA
commercialization of early LDT. culminating We laboratory saw first tests as path the developed for in the as EsoGuard a
a EsoCheck clearance Barrett's culminating The as screening in-Vitro Device an FDA IVD GERD and second FDA registered path, high-risk with indication esophagus Diagnostic specific patients. in in for EsoGuard of or
The to commercial California. EsoGuard I LDT expect our centers as imminent. Irvine, at complete allow major IVD LDT will certification we as commercially and noted provides December, is an at or developed the gastroenterology LDT process path an of partner laboratory And laboratory begin while significantly opportunity to CLIA/CAP path the generate path grow revenue, opportunity. to market early The In we expands the excellence. launch and in this some test will ResearchDx us located
to the it facilitate only commercially detection reiterate of as to as Barrett's DNA this just first well the So esophageal available test make esophagus, and cancer. will
process. CMS a EsoGuard to We contractors or Laboratory payers. and CLF gap-fill the the advanced private Medicare LDT CMS designated has a We discussions and Fee for designation have with successfully the to code granted permitting coverage were by Clinical us secured through initiate CBT reimbursement Schedule it
The by studies along we IVD take in PMA support multi-center clinical to of in the an path a EsoGuard, following two major FDA January step expect launching submission. EsoCheck IVD month
protocols branch We Xth director which included through regulatory pre-submission meeting the vetted. diagnostics us have a were October studies to positive process FDA in-Vitro has retained shepherd of for the FDA these where former the the
-- satisfy study, prior a without screening diagnosis guidelines. cancer. or second a or The will previous Barrett's GERD diagnosis with with study patients a will enroll American of who College screening dysplastic esophageal esophageal diagnosis case of Barrett's patients Gastroenterology non-dysplastic Barrett's study or with Barrett's, control The enroll prior of cancer
University lead In of to lead the gastroenterologist and ACG recent standard compared Shaheen endoscopy serve most be will guidelines of Nicholas both the EsoCheck and gold both with will for Internationally biopsy. author North investigator EsoGuard renowned the study. of of Carolina Dr. the as studies;
which threatening EsoGuard of active condition. device treatment promising Finally, with diagnosis or designate program deliver to EsoCheck we're the breakthrough a discussions program FDA – as effective medical recognizes more life in a FDA an through and that devices through
some on review accelerated as other and focus FDA boost the and achieved, our highlights can as I'll products the coverage FDA If also from well path breakthrough portfolio. in provides accelerate assessment now reimbursement. designation an CMS briefly
very progress device, we believe with I'm PortIO, delivery to groundbreaking have the of the made for route vascular the which allows market access fluids our access other opportunity. bone an with substances. and million medication, the pleased $XXX well-established intraosseous marrow addresses estimated We implantable PortIO to direct
the Office and Patent that very us important with and device excited claims the U.S. methods. broad patents independent Trademark technology We're granted PortIO covering recently two
and This testing secured Xth. cadaver quarter, completed successfully for past January meeting FDA we an extensive pre-submission animal and preclinical has
single in this During study a novo de duration post-explant protocol for small seven-day patients follow-up implant the indication. XX-day PortIOs in will with center for XX a of up we to clinical clinical meeting application safety vet support a
on Zealand in feedback soon We the protocol will after during our receiving and clinical launch New FDA this meeting. after study submission safety
development, we completed duration. which have implant completed of has a six-month long-term long-term animal PortIO exciting we study free maintenance Another -- have demonstrated
which prevent stark other require to stand These all failure. access in device regular to occlusion contrast devices available commercially flushes unprecedented results and vascular
this by Next intend in Columbia, long free South in to long-term we duration maintenance America. clinical implant quarter launching a demonstrate term study humans
PortIO poor for venous undergo implantation XX and use Dialysis patients up to patients with days. and will access
day pumps Our the complex height NextFlo independent electronic estimated highly delivers infusion of States. the the the for which in gravity and system, infusion most one for million IV each eliminate of driven delivered United expensive need infusions the infusion bag of accurate to things
strategic run professional global firm large the active is NextFlo M&A entities. with is and Alvarez and a the process process of both by being financial promising subject several formal opportunities Marsal. services The including
the revolutionize Our pediatric bilateral year. silk tube tube ear each one manufactured to a aqueous placement undergo estimated care from seeks ear children DisappEAR million of proprietary who technology the resorbable
anti-microbial ear property. the silk in animal possess been of eight-month including plastic intrinsic of DisappEAR potentially study tubes with The provide An which properties fluids has out several benefits completed and tube of would unique results. over unexpected to appear traditional enhanced and excellent surfactant flow tubes
A animal to XXX(k) completed GLP six-month next study support will division be month. FDA future
a scale produce strategic XXX(k) future partner also silk to with and commercial mission support We large a aqueous commercialization. to discussions are in active
Finally, entered newly addition Wong. infrared Airware technology were new Jacob and agreements Solys commercialize and a excited subsidiary a into by diagnostic technology develop through Dr. announce we formed non-invasive nondispersive Sensing definitive with Liquid our its to subsidiary to pioneer recently portfolio NDIR Inc developed Inc. or Diagnostics. We laser products using to
The blood patent need promise and space, glucose, other maneuvers. invasive important in for in core international the multiple substances patents and holy and the shows a needle been other biochemical U.S. technology covered without by or in great electrolytes has sticks U.S. seven achieving applications measuring diagnostics what long grail namely non-invasively draws, issued patients
and a partner, commercialization opportunity for no the develop Sensing Wong we saw major massive Dr. as investment and of inpatient upside sought unique by a interest been applications dollar technology equity Valley the to while team development high quickly significant the additional investment market that it Silicon and reward immediately technology to a and has wearable meaningfully as an out area in non-dilutive efficiently glucose and company. When multibillion his commercialize capital keen participate of and technology, seeks low-risk of develop us a through opportunity stake Liquid monitors,
the full budget. which started than our product Neither several six work take I monitoring this schedule and commercial the expect schedule the subsequent completion, a materially exciting which less and partnering acquiring commercialization in months the work, is has of to our us development or create will first such strong regulatory to initial joint critical would our overall -- have impact On for I recent press partnership. a development care space the nor to on active product. details in to companies interest large you with of refer release
results. Dennis a financial I'll summary now it on pass for to of our