joining Good us. Thank thank for you, Tim. afternoon, you and
give a like to to team Surmodics. First, shout-out I'd our at big
some has been not dealing Even team as fazed. we've unpredictably choppy with our waters, been
their Thank you are our adapted are will you. control. results and good In overcome grit. fact, of the within down, about they now because hear that have The double challenges
toward marked ability continued key strong and our operational simultaneously by progress strategic and growth third-quarter results produce strong to initiatives. commercial make Our our demonstrated organic revenue to execution
on trends balloon quarter, our made We and made progress AVess our and drug-coated progress Sundance During important in programs thrombectomy platforms. device the of technology the third and excellent trial. radial our and enrollment we advanced
business on Our confident as Surmodics the growth we patient to progress products positioned unique improve revenue and are device I'm unit. of deliver medical growth our healthcare safety team that provider continues economics. sustainable to that consistent transformation of outcomes, we continue a into make driven by for
Turning In third of $XX.X growing we SurVeil now XXXX. generated included third quarter, $X to over Abbott. our from agreement million quarter revenue results. the the of revenue This million, X% with of our
also per We per diluted earnings share. share, reported of $X.XX of GAAP $X.XX earnings non-GAAP
and XXXX of result a continued revenue as we for guidance performance, full-year will our As discuss Tim fiscal raising earnings strong later. our are
the finish and we quarterly As final objectives fiscal XXXX, execute and on quarter will businesses generate IVD continue growth, both XXXX. we are major medical device that we for to will fiscal our three of confident strategic our top-line
continue to our invested to revenue device and flow capital provide acceleration ongoing medical our thrombectomy from drive flow offering. significant existing offerings to on first, to make these specifically to meaningful SurVeil, reminder, toward As non-drug the are, patient a success progress Mark; substantial device and our CE which IVD finally, and growth platform and enrollment TRANSCEND development; to and the our DCB cash make delivery ensure growth continue complete in second, the pipeline including to portfolio, These our and within advances fuels initiatives. the return of of cash coatings and study achieving strategic
paclitaxel-coated balloon uncertainty of paclitaxel-coated impact surrounding applications. with potential and we our of own modality, the acutely the the patients and remain the Starting therapeutic including current devices SurVeil, aware on future
to the study direct in as earnings we changes last following our the TRANSCEND response in the we March, in FDA mentioned enrollment call, in our immediately communication temporarily recommendations. an implemented FDA's As paused clinical
a long-term patient devices. make meeting consent recommendations safety of in data subsequently These circulatory hosted paclitaxel devices and review its informed and rigorous The ensuring recommendations patient improving forms, on system discuss included updating and mid-June independent FDA panel the to follow-up.
the reflect that to also certain improved The that the of mortality to in joint devices for of should paclitaxel panel but also devices emphasized The agreed inconclusive. signal. relationship the of the the findings paclitaxel-coated unanimously mortality have should efficacy market. near-term on decisions meta-analysis physicians the recommended for long-term these and and panel presence devices. need The ultimately Panelists labeling use patients of was remain dose-mortality benefits risk panel be make paclitaxel an of updated appropriate uncertain noted
to and Preclinical mechanic requiring very animal the as this any late-mortality and randomized-controlled maximize ongoing to large question has trials resolve is insights into seen and trials. testing complete data not signals, preferable to existing provided efforts new
quality panel sites and team communicating the with patient's recognized these devices job to the done trial of worldwide and The the information of effectively on of TRANSCEND a providing stakeholders relevant Finally, trial. trial large has quickly unpause a life. updated the impact to remarkable positive all
say ongoing to pleased we more of investigators, XX% trial and with commitment As I'm result these than a the efforts that enrollment. complete are of quite
have to We get XX% Recall than huge milestone. left the last in were that trial this is to call, XXX-patient level. the a completed. This back we achieve enrollment earnings enrollment enrollments XX fewer only accomplishment to on track
of do this you the you recognize If math, accomplishment. will significance the
further and of complete will of for slow trial as rate clinical August, recommendation to Europe. trial on month paclitaxel-coated August XXXX end existing well the by QX can to FDA especially enrollment use fiscal a in achieved, U.S. the of be depend ability month in this with devices. the actions enrollment respect any as the Our the the and by
to and our Southern within distance enrollment in sites the are manner TRANSCEND fiscal of complete Hemisphere, of love to year. couple striking meet a efficient the a commitment by and high-quality get the the would and we absolutely have enrollment do Australia namely to and we done and complete end New Zealand, Now this in original
with regard factors important It's related SurVeil to to to realism note They trial with the even an has prudent of steering we get and trial the given as guidance with this described, safety the head-to-head the agreement this the all its fiscal-XXXX to given risk of continue revenue follow-up. independent However, unique we Abbott. world's levels support I exercise committee go clinicians comprised leading done, passionately just independent that specific to design, assessment long-term multiple expertise in TRANSCEND area. out
is the a trial treated should As standard the on physician TRANSCEND Drug-Coated is determined considered for Medtronic the treatment, the a to with TRANSCEND candidate use be DCB has in balloon. rather the a assist does reminder, after impose treating participating patients based care that drug-coated of head-to-head thus only not IN.PACT and medical a applicable patient Admiral of Balloon the
the highly monitored one these for of is, trials DCB devices. opinion, TRANSCEND most in my
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to fiscal We Mark in to European to in regulatory our quarter. data a are filing required SurVeil make continuing for the for expect and also obtain progress submission fourth CE complete all
FDA's devices. the are by the the of on CE calendar targeting Mark regarding to European paclitaxel-coated how hard will We XXXX, end react approval is bodies guidance debate although to regulatory the recent it predict
our product drug-coated balloon to Turning pipeline.
which treat first in-human We balloon, of progress study patients. a total drug-coated to for arteriovenous up with make our XX continue can AVess, access our to
by end continue the of fiscal We XXXX. target to this in completion trial of enrollment
balloon, drug-coated our below-the-knee to also sirolimus innovative as known on Sundance. Moving
that formulation studies for preclinical required allows effect finalize events. and avoiding formulations that significant our while have again is the us multi-factorial, maximizing dosing excellent required completed announce window progress this to we for device and an know, a provides to that patients. the that As and complex you disease and therapeutic am adverse this dosing below-the-knee impact the for excellent delivering closer successfully us believe pleased these positions a We to drug Sundance. quarter has favorable I
is filing to conduct the trial. we a big This first us in-human for to clinical approval allows process that now begin a information since regulatory for the step critical have
applications While which an it complementary difficult is our have beginning highly treating by innovative early has product initiate approval trial to tight we technology vascular development of vascular potential use stage acquired time is This fiscal July, pipeline. a peripheral the end in for peripheral we technology regulatory multiple for in lesions. In disease, submission XXXX. of the to the targeted for line,
our acquire property stage our early viable platforms completes and acquisition technology commitment reflects that intellectual and ongoing to identify pipeline. This
Turning product innovations, of to next our our nondrug including delivery pipeline, the we continue and artery wave to progress thrombectomy make access radial in platforms.
and We new next are help approvals on three these over submissions expect to to of in addressable fiscal to us which our as markets. more we will XX double innovative commercialize 'XX, devices. many for end for regulatory By four of technologies as build five differentiated file and years, the track the
advances we continue efforts, As our part to of thrombectomy in major platform. make these
and use to in table date, we coming fiscal end approval end regulatory XXXX. performed and uniquely is XXXX expect designed of months. problem first activities device We this mentioned The application remain valuable submit track by of clinician capital to to our devices equipment. of of complete solve on and the to be As of for assessments the fiscal the to the on feedback by quarter the well design the the use, our newest first previously, its preclinical performance to conduct easy without continue extremely
platform Our thrombectomy stroke is treat and ultimately and from deep pulmonary this to goal thrombosis to material vein expand embolism.
Radial products length continue in and healthcare access to for costs. to of the of the progress to reduced ambulation arteries. stay, in which benefits early access, Turning radial results access complications, offers we puncture-side bleeding, many access, including now make to relative substantial hospital femoral lower peripheral radial designs
step which family including products. vascular sheet, guide sublime radial strategy forward an to Our XXX(k) our approval these another quarter, last of in is received provide entire solutions,
We is radial our diameters as approval to and below-the-knee available long vessels that the French sheet using This XXX of recently X.X-meter said PTA regulatory XXX-centimeter six five filed before, for balloons four, for are XXX-centimeter in and capable lengths. treating I've approach. U.S.
from example, way simply devices all be foot X arms to inches, an amazing. the and legs, to Tim ankle, all is As his will way track X through the long these his wrist long his able and here
in the intend fiscal begin 'XX. our therapeutic radial QX We access of to of development other devices
the will announcing they some of quarter United Telemark even quite moments the fiscal announce Now Telemark partner launch States our with support and partner, more signed identity agreement coronary multinational we've during news. medical their device product, withhold we just the to commercialize until in an I'm formally we first happy a to catheter which occur the At that for our ago, agreed XXXX. expect Europe. literally of good to leading request
This manufacturer. worldwide is a medical major top-tier device
Our medical coatings solid our benefiting offerings. device business continues performance, to from produce strengthening
business this on the tough XX% despite quarter. grew quarter, top comparison the a During top-line line
income business always improved IVD to and performance continued excellent Our of operating deliver quarter. the
the our modest in business in in coupled Going revenue, growth growth business IVD XXXX. forward, our revenue we mid-single-digit device expect double-digit with fiscal medical expected
leading a innovator detection by with enduring technology become our to track treatment assets products best-in-class on are and medical device we key strategic deliver disease. ahead, customer Looking medical for combining and our device to relationships of the
coupled by the pipeline. our our to clinical and are with use top-line regulatory performance recent further intend accomplishments We encouraged excellence, development to and our and accelerate achievements, momentum of operational this ongoing
said, this the the I'm business future. Surmodics and in forward in updates I momentum of As proud sharing our creating continued at team to for look
details I'll more our our for the provide XXXX. Tim? now turn well outlook as as fiscal-XXXX call fiscal to third-quarter results, Tim over to on
