Lynn, sorry, difficulties earlier. everyone the first technical Thank TransMedics quarter Good everyone, and for call. earnings XXXX very to welcome you much, and afternoon the
today our Chief Gordon, is me Joining Stephen Officer. Financial
year. stated we catalysts last The we our XXXX, looking As strong for first the this will covering X the to to expecting was long-term we call, be call. growth several set in be catalyst believe Today I positive in we're on vote and are topics our FDA many foundation year Heart indication TransMedics. PMA this following major approve for panel throughout DBD which forward achieved will important a to more our
the a summary of results quarter. our First, financial for
the achieved progress strategic across initiatives. Second, our key
on a was update the I discuss Third, results. for Heart catalysts commentary impact their meeting business. first XXXX expectations panel OCS Fourth, remainder status the and $X.X the on upcoming Net revenue the XXXX. then topic. Starting potential finally, will of million. with for our first in quarter on our And
recognize that to U.S. despite Liver, revenue OCS contribution X% our minimal CAP important completion the the from year-over-year, overall to it grew our While business roughly of is enrollment. declined XX% due
the hospitals. impact activities. the business the overall due encouraged O-U.S. continued U.S. in European by are our U.S. transplant the continued on and numbers COVID the the in to throughout recovery We growth disruptions struggle transplant to revenues and
and topic second operational TransMedics. strategic the progress XXXX we drive laser our for initiatives me to across first outlined quarter, business, to initiatives made to focused all the for key major our are which we In discuss. on leads meaningful help growth We for strategic
of status Program. by describing National start OCS the me Let the
benefits and among awareness North regions activities in bringing to our are U.S. in reach Carolina we States, increasing the transplant and throughout new clinical In national the expand about while we We as in key United regions financial stakeholders. X Arizona, continuing initiated this initiated program total leverage expanded the X its build QX, and and clinical to
with stated engaged regions OPOs goal new actively active are in XX meet being our to of several by We year-end.
X transplant market U.S., We webinars programs also targeting held the Program. OCS lung National across this to
of of program. these We and continuing broader any Meanwhile the will necessary infrastructure hurdles build long-term webinars awareness continue potential to we're resources year ensure hold to the for to maximize throughout and the address this approach. success important adoption to this
clinical this as add expect and XXXX and throughout capabilities continue additional to we indications. new into XXXX, We early service and organs new
the OCS utilization believe States. previously, an in long-term we be the growth revenue important As that strongly mid- stated and and National will program OCS for we driver United
Liver Moving our panel this OCS to FDA the PMA. second on to our forward been with engaged OCS we initiative, important look advisory We've in PMA actively holding and mid-July. Liver now
Liver panel the of of of Given OCS the the FDA is approving CAP. date, the tranche proximity the now the second questioning timing
to discussing panel FDA a resolution soon. is hope one really where We set bitter-sweet thrilled are date with This have reach issue to QX. are the this and we a in actively situation, in hand
seems in in current before QX. and increases year-end. impacting said, associated benefit will and it focus the its approval timing to be That which confidence on the revenue our success, panel However, been potential negatively from the approval long-term remains has CAP always that
DCD the Our third indication. was OCS Heart strategic advancing initiative
As randomized enrolled XXX track additional system on heart on protocol. access heart of line OCS important XXXX. end transplant XXX-patient the DCD we top heart those new on We program OCS. using specifically we've cases completed readout the Heart were QX using with for continued in in this of patients At in DCD have QX, DCD trial DCD for X, the OCS April XXXX, remain you of XX our transplanted know, XX
important of panel was Heart DBD We with approval Finally, our for the a strong indication. this OCS initiative fourth favorable milestone strategic Heart PMA. finally vote the completed DBD OCS
few me from this XXXX. panel the to opportunity the clarify topic allow meeting. are turning third approval Please and Now focused decision on we success major an into this cover observations discuss in and
theme a the discussions key surprise and expected panel were were a fully not of for TransMedics. First,
FDA. were topic we address Importantly, by to prepared raised major every
panelists comments controversial seems with or the experience. from heart came transplant that of no many Second, limited
as So the ultimate may not be one relevant as would impact think.
to that believe label, label support an clinical the Heart we from CAP the approved related and appropriate the DBD data, for the FDA. OCS evidence expand Third, if by indication,
in remember of must language we in nature the that OCS multiple and PMAs organ the given static label concurrent never same Importantly, the they typically transplant fluid are market. evolved are our indications our
study to XXXX Heart For post-approval order and real our our updated evidence with have position. I'm continue the sorry be enable the approval Heart which language example, with for XXXX world the DBD will indication label results in of in proposed post-approval -- in study, to of a to DCD Fourth, we expansion and indication. build market our indications, setting to potential leading in support the the the
a by academic that to to and cardiologists post-approval design robust leading U.S. practical We failure is and easy surgeons heart supported are study implement.
Finally, I'd an conducted System. the program like animal studies safety of reiterate to pre-clinical of XXs TransMedics extensive supporting and that with the clarify testing OCS Heart
have human globe, DBD results. we hearts Importantly, clinical transplanted to with we DCD donors need across remember the more than excellent and both from human X,XXX that
on I would Now to for catalysts major topic update XXXX. our to like X provide move status let me fourth major that and cover the
overall want trajectory growth on future. I potential impact highlight for Importantly, of the the to these our foreseeable catalysts
FDA DBD is The of we Heart approval catalyst expect the indication. first OCS
FDA the engaged course. Heart, drive we FDA In preparation a of actively next commercial the approval the to months. hopefully are are OCS launch with the few regulatory of We pending parallel, to decision continuing over for the
XX clinical the our with engaged heart that currently given are program. with Heart we the their DCD experience OCS the are active in in Specifically, transplant program, CAP centers DCD
robust We we and are FDA program national the add approval is active infrastructure practical to the enhanced. finally, post approval that implement KOLs design registry regions to working preparing Heart are to to with in to once scale. planning our in and is And our leverage our we're OCS to OCS the a
The is and meeting OCS second panel potential FDA catalyst the approval. subsequent Liver
forward and we're to position this well mid-July, approval to Heart, in XXXX. XXXX. the OCS engaged Liver which in potential the conducting QX Similar prepare later in We the OCS in early meeting Liver our actively as a presented national centers our to once another for are approval enhanced. program OCS to launch On U.S. panel would a presentation OCS with FDA us for is Congress potential will regions also session June. PROTECT OCS our Trial in full results upcoming add the be Liver up Transplant to We're plenary with note, approval planning at follow X-year looking American
exact the and the is announce date program We finalized. once time will
milestone. approval OCS This that The National it third filed coverage potential FDA of we been fourth to the XXXX. and in are U.S. in is The is we indication its Heart for and OCS under catalyst will be has of track will optimistic DCD breakthrough PMA potential and we data This and line the of and XX designation on from heart the least the expanding that supplement. expansion support XXXX targeted believe the this QX liver. major at filing regions cover achieve read-out Program are to the for the top clinical catalyst
is of track The the and on year-end. impact potential journals. in data and clinical OCS on the are OCS and OCS the publications Again, We a adoption of Liver meet achieve to driver will fifth broader clinical track These standard DBD are to high a care publication trial by globally. and the medical DCD critical milestone. final be this this we for the transformation catalyst technology milestone of
remain a near pronounced volumes. expectations and we XXXX. COVID term. variants new Europe, the finish transplant in impact terms remainder a see of and normalization specifically this and me the transplant summary with activities internationally in its threat to let of of our for Now more in thoughts Today,
lung activities being volume recover final So continue to to far, from U.S. perspective. recover with organ transplant the
at last to still, anywhere QX, X% in are We below between year's X% least volumes.
any in United revenue OCS hope the major emerging these our Liver FDA and and on decision as to view barring Heart leverage our from programs timelines OCS new would this continue the expect in We peak to ability regulatory grow States. limiting for that near We programs. potentially CAP recovery the term
be U.S. to expect late in in XXXX major catalyst the a we However, drive growth and revenue approvals beyond. to
indications the a to Specifically, all Liver panel approved goal impact our with fundamental growth CAP will revenue trajectory QX. FDA, driver on hesitation due second the approval XXXX remain to transplant from major be our Liver on huge ending We CAP by tranche imminent revenue our and however, in X the streamline for which generate future. may date revenue laser-focused, FDAs ability of the for negatively
Chief guidance the financial quarter turn Stephen Given issue Gordon, to for the and to key XXXX. for that, call detailed current Officer, the imminent financial our not results With uncertainties year. timelines, the we review FDA will Financial I and will our full