C. Mills
I share am with Thank you, today Elutia. to you Matt. super of story be excited to the and
we're in CanGarooRM. can to that But both. compromise that word Our where away to humanizing options take actually X those we're when instances between forced what are choose could product care patients really we're today particularly talk going trying patient with and trying process in to launch, means, physicians to getting of patients thrive fact, our them the is give in we medicine mission, ready to flagship about and compromise. We're so that what that without do
stage So company. Elutia is commercial a
We think in the have and call to some use which breast we solve reconstruction. the and we more of that. to and X where moving We're on about that SimpliDerm, we're be to and I'm going is Biomatrix do people excited update the proprietary excited going pioneering be super which it most product importantly, our internal defibrillator really this of giving this, exist. We're problems regulatory progress an really for are today, I our product. a space platforms, drug-eluting But about pacemaker we've on lot CanGaroo, talking what I'm and that launching complex in made. excited to are about
it. into right jump just let's -- that's So
we year, be an team. Elutia. more We the proud of And I a -- this year. had couldn't year transformational I had exceptional am at For
eye ball, kept growth and were Our the everybody significant all strategic but on CanGaroo really their making in the SimpliDerm, ball kept their while job beautiful, delivered these commercial shifts on XX% beautiful and X.X% commercially rather the within we teams the and operationally. growth kept did company, a a in focused eye stunning and
know, much way application, on a From expected. many XXX(k) people and we accepted progressing that The that standpoint, premarket pretty notification our as review development FDA exactly call this the we December. in is submitted really
not new We've expected And actually squarely a had going half a have decision looking timeframe. our is May-June request is, But XXXX. we on this in we But some are from clearance the right for had first standpoint, us, believe everything really We to believe, are data. any at we of from any requests where be for clarification. track. we
is launch, established company, us CanGarooRM In help is a event. this think value transformational committee get to product prepare most preparation can just most that to strategic for product, not value a advisory for but way that for the CanGarooRM out value and of we company. make most have very transformational to in a we realize, sure We the such launch. and the the that able need a the it we're we the position for
the sophisticated from significant strategic leading as as space. and done People of defibrillator pacemaker committee We're space. Obviously, executives development a reimbursement established launches there, have minds is and we've the end, biologic that there, marketing the been products. implantable in and that well penetration. that has business commercial advisory hospital best on from that about talking So really led
right. we get a advisers launch make first-class group So really us to help sure this
things to our last orthobiologics that continue then we that in year closed gross divestiture, do proceeds And one execution. Elutia bringing -- execute proud is of we $XX.X business, divested million. ball And very cash and that the we of group the the our at that eye that handling we on actually announced but lastly, I'm kept
year. you So around for thank to team all the exceptional an
we do. what overview quick Just on a
remove really device-host developing is at drug-eluting the the and the Elutia that So interface. to exist reduce biologic complications
into complications predictively, the quite surgeon device that's long a fibrosis things a of patients, capsular contracture. pathologic when device there like implants through time, device a to arise going and number were like thin things erosion particularly period can which that of migration, a there infection for lead skinned obviously, patient so to And be of
at when markets And look seeing in, XX%. breast the that reconstruction, stunning a we're X% you XX%; X here, to pacemakers, rates we're at complication
patients. really value we and So we think for significant where go is this improve can an area and our outcomes add
and compromise. how a have go pharmaceutical drug that at patient biologic lower So is answer. with look remodel able I should the be and response? and we natural offers I a we own we say, should think don't biologics, with efficacy fibrotic that have problems that drug-eluting decide, Well, the payload will which hey, patients do device that? and solve these we both. the should do do We a without should to physician again, or the go the that natural tissue Both into with to
benefits regenerate the healthy provides enables on own payload, regenerative And of drug-eluting active why in those that tissue. biologic an of so but pharmaceutical the it that's developed that all to patient's we've a scaffold
CanGarooRM. So let's CanGaroo and get into
commercial that only CIEDs. pacemakers Boston Medtronic, look of this market XX% that's approximately States defibrillators, the Scientific landscape So XX% then and that a placed of distant about one obviously standpoint. of for alone. sets dynamics XX%. really When the Medtronic and because really have space. has this a all about Biotronic, are at But really but in these antibiotic-eluting use pacemaker them some internal Abbott have of term up This -- really, of business. a significant little XXX,XXX United year, here that fourth at and a a Each another market space, are a is actually and an you from players overview patients has interesting there pouch that of bit is in
TYRX. so started bit And and product, their a Medtronic little we about
this was able have in for Again, to Company, is out synthetic acquire but of in took after develop, $XXX back it's about by So clearance in polymer it the eventually -- as the And product envelope releases just shortly TYRX this XXXX. park. this it FDA they in actually got was while and antibiotic. numbers, XXXXs. early clearance, developed And it dissolves from a knocked It a a its product the XXXX got since Medtronic it the is million. that, body, Tyrex
grown done a they've really and $XXX about job. to great product this to So million they've our estimates, $XXX by million,
They really got things here. X
First, they have there this they to when in create a were able foresight, $XXX XXXX paid for was market market. the to have million no technology,
did they and really this they Medtronic But local that that they exist the idea proved and was did with of here. their actually electrophysiologists thing to second resin job physicians a having liked great to a value postoperative the physicians worked. local out worry delivery antibiotic proposition have about infection. about that don't that's market particularly so These a The antibiotic surgery could
developed why of benefits couple TYRX But a -- it's and that have body. it biologic a it isn't there's forms we doesn't of in great that's changes like physician really using there's easier a great less any patient for own and CanGarooRM. in and biologics all scaffold But fits into less of polymer patients a [indiscernible] of the dissolves that's a fit -- remodeling, the job biologics. inflammation, eluting really the perfect reasons. the minocycline. glove. around We long pathological and antibiotics, I remodels the said TYRX for the a pacemaker And tissue. product. Like run. therefore, because And the One It information scaffold gives does is the feel, out like the idea better
once compromise, said, So physician us and and went penetration. again, and that good compromise. of great XX% to without opportunity concept. job and XX%. that $XXX there really we've help where are with stunning. thrive users, this this market We can to having and CanGarooRM. about that TYRX the we can It was a done electrophysiologists really great out we an the used was these start really, have would XX% talked actually compromise patient a CanGaroo make to that think We opportunity remove and patients TYRX became example available, pretty electrophysiologist looked is some are we and And of electrophysiologists, where an gives move million a using a we product a of into
of our to slide favorable market sort payoff here, our back of So dynamics the this. market,
on envelope you So top drug-eluting the of when overlay now, look this. you
You couch to and have right? sitting Alet have there a with million Biotronic, And then TYRX, $XXX And they about don't and do TYRX. million them. they have in between Medtronic Boston, you $XXX
was used is what on more XX% here's non-Medtronic to TYRX started of to like our -- found and XX% we Now really XX% research. own actually XX% doing internal market We it's pacemakers. [indiscernible]. probably
Abbott to of on Boston or So Scientific going a is TYRX a lot an pacemaker.
One things. great And you sort go it when you us we -- creates launch for of at X a this think and to altogether, out this does is look product. when this opportunity
are We simple. going doesn't here. a Elutia's would or don't envelope viewed Biotronic, going time. kind you're Elutia or them whose your pacemaker like or matter It's to say Why? ask and single whether Medtronic you're Switzerland drug-eluting It case, to they're rather of in does. you Medtronic's, have Abbott every make if Boston We
And $XX so million, $XX out this sale. that's and to take of a real really opportunity for us go million TYRX great low-hanging fruit
in of because could But a these really company's $XXX right, But in talking margins from in selling Gross the one uncontested million players about There's no right additional space. of play It cases already XX% XX%. here. also and $XXX plug that's do market we're look view, million, of you these are at anyway. costs, point estimating. if the essentially it this every now the product you're
value companies. do PDE, so their Look math sort earnings. the something of XX, you're product like dropping to then that, somewhere talking And add million the these $XX $X.X billion about to year in $X between a that to could XX at billion a on you you're to
that thing patience value and we product really, coming methodically really the discipline to are really the this excited greatest take get -- about we'll we and are we really, to also market and out and for both roll so we to understand it value the market, the but CanGarooRM launch it and So its company. the have
Okay.
Now clearance strategy move to and let's and our activities. on clearance our
XX, have December thought. the we So since that very positive that The we've this they're We meeting having at after as with -- exactly that, we you FDA presubmission know, did the been as with interactions meeting. been XXX(k) filed guys going actually and we filed FDA a XXXX.
As we've were number be a times, stated expected on we haven't this of questions, to asked we call going asked and we questions.
no all been variety. they've actually of Fortunately, FDA in the for this. asked really clarification has new And the data importantly,
really, in clearance home. second good a you're if are favorable in shape will timeframe decision lining of quarter scoring really believe think we for what said, here, up May-June the So we as be I we at
the we therefore, up on of the And with We're Advisory half are, Strategic work to manufacturing why other launch this for the Committee. get doing preparing in all have of of accordingly those That's second product and internally reimbursement, ready value-added we a year. committees, things. pulling getting also
as just and pacemaker get space. expect in with the reminder, actually sleep neurostim, not indications then to done Parkinson's apnea the And approval and like. a we're like We
And so market. triple going line just future to sure best bigger make we to is But than do there to don't our a the pacemaker we're for do CanGarooRM going here, here goal the that. we're
Okay.
SimpliDerm. to I not just going bore will now again. breast Turning you guys over XXX construction quickly
unmet need. huge with a States variety year each that about is this That's that There's a where are United big medical require reconstruction. the come our in really out, we in point of SimpliDerm with to really breast the products. Just mastectomies XXX,XXX market
that require is terminally a and is been soaking to And it is up, is a going It's to it And surgeons, that's doesn't handling fibrotic prehydrated. so It how and response. just therefore, simply product. This already look product open at go. to ready lower What it is means characteristics. we invokes here. been also It's anything has comes SimpliDerm, actually think, that. sterilized, It demonstrate better like moist. this they sterile. it It that inflammatory able a the great or we it's we've
that love this surgeons and product, use product using this them. keep the they So
quarter So we've this no product being why after of this that's year growth. XX% quarter growth quarter. after seen And exception,
proprietary of we X own So ways. network distribute different product is our this distributors. One through
which Sientra, with place. X, is XX% crushing reconstruction it. of they other these the And The are owns breast between
SimpliDerm see really, things we ahead for good forward. So really going
those base with go postoperative and experience breast after end obviously this reconstruction. technology infections following combine is to goal women of to scaffold and here SimpliDermRM Our our SimpliDerm create RM help to able be who
With that, Matt Chief Financial the and to turn Ferguson. I breath our will inhale, a take over call Officer,
