are hope your and We joining and thank appreciate healthy time. greatly those Good that are interest you you around Debbie. I in for Thanks navigating of challenging successfully you all this and today. afternoon us everyone Shockwave.
on the to would COVID-XX begin comments a our pandemic. results, offer discussion few of Before I the like we
We’ve not may impact business, only the are who And the community the patients front-line situation, many to for thank how to the have our us. we and acknowledge it monitoring physician affect global our customers, consider workers, whom - for us of for friends some around the want fighting I been closely been employees, potential on but all. healthcare and
team The to minimal months into well flexibility with the past dedication far couple moving of the been continue normal. has customers enable will creativity, Shockwave the serve from future. patients which their But to demonstrated forward have us us and our and safely disruption
to open your call update, will I the call in close and discuss then my turn to the results we over more questions. Following for will I Dan our detail. financial will
We To the indication up which highlights. U.S. the revenue the million for reported coronary start, III, over CAD March. will completed million in first and ended in $XX.X we quarter I XXX% recent $XXX reported we the a pivotal was in quarter in We review our quarter cash. enrollment the for in trial million first with revenue in XXXX our $X.X of
CAD our are the in XX. annually. in is up which field, in study We progress India in received XX coronary CX interventions coronary team good given India X.X response enrollment made U.S. from on IV, in India encouraging We we In in December expanding and individuals the over early a the our ended completed positive at launched there April, very Live XX February with million and pivotal Meeting that quarter field Japan.
geography after gross pre-COVID was precipitously in procedure both perspectives and dynamics. would some every on margin. provide the March volumes revenue XX. impact on street landed beginning quarter a slowed COVID to market like March We would at and they started have first that very above early encouraging we Now pace in us to almost consensus
for While for the our encouraging at cases and Limb still continue, reduced cases being performed, some rate have by procedure the he been out ideal cancelled. albeit Access that peak peak. U.S. in The a U.S. were February, Shockwave in volume were of of coronary and to at the XX% or delayed TAVR late appears below volume in t second majority the The April, did roughly the critical internationally. February Ischemia cases bottomed week
extremely geographies earliest. of May return seeming to localized quite half early into busy but becoming intention restarting of a until and the has no volume April with late second witnessed and have modest at the it PAD have some May, cases, we others In been to
from elective up ramping noticeable of seeing are the a May, gone is for improvement. which scheduled when conversation and procedures universally of to second has the if Fortunately, cases we now half
pipeline our return to a call few months and Ultimately, before treatment patients of receive needed, planned what of pre-COVID majority patients to still had to work rebuild vast be ultimately anticipate the backlog, they will they new we believe customers treat that can one it the normal. but the will would the methodically they
good The still centers beginning Critical standard of knee that restart return device, for more chronification The fact be cases. Ischemia CLI access our in that the CLI large-bore or followed below Limb early early rollout. mind most and its will to which is that by evidence cases customers quickly for top in are our in suggest the SX is U.S.,
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similar disparities what U.S. Internationally, U.S. the country-to-country, significantly we the between the impact some procedures seeing states in to what we look saw not very we was with on as in unlike are
increase week to procedure of with appears lowest have week-over-week been the a week second U.S., the in thereafter. the As modest April
of are then But the U.S. the through will the for it We for is busier, months will slow and summer procedures become first out. and return the of resemble couple sorted what also managing leading ordinarily slow believe into as mechanisms be months. patients
PAD application coronary recover. our approach a percutaneous to of surgery our complex, of often the business, patients outpatient cardiologists and enables instead Like to undergoing treat calcified U.S. in hospitals remaining
advantage we stepping the grew So and the return. effective in Safe, in starting auger XXX% just despite us era. the March great is even we that COVID stronger bit, combination IVL simple, winds globally see and the we a back the well so eight them in present headwinds to are first ago quarter subside as a April, benefits patients in and our myriad positioned still somewhat to while that considerable weeks and are grew of any will feel
long have better hire we to how sense until our we meaningfully of procedure hold be had would since deep Operationally, how reductions selectively mid-March very COVID and continued on extension, would and business. a hires the put we’ve new and impact many by
As a be. we the we the U.S. professionals had end March, is of end of expect the at ahead XXXX, at mentioned XX which where it versus of the bit to previously, in XX field in
U.S. planning meet our are hiring more XXX personnel with additional in still in than the candidates very high the identify field continue and people standards in year we We who when the we field
strength and the implemented. is it is critical the from polite team great support albeit as hospitals the relationships distance our has access This new will to Our continuing to of policies see be team facilitate clinicians. to customers, our with to are
dozens applications, their our conduct eager us downtime training team also resting, our enabled growing to various Type of professionals and having been our on thoroughly get across customers. homes publications. prepared, sales extensive for to Trapping and in and train two day and of programs not A plan train more back to months The to has but pretty, better them our is every library serving
things and the impressive on commitment One dedication home R&D of from most is operations, was while of teams. do by recently country groups can’t the hunkered shown witnessed their these didn’t and the work skip beat. and a Zoom, have I quality our They down most
and at pipeline gives manufacturing r we returns build demand clean helpful our rapidly a if them April. the should The expecting. and ate or we advanced permit on our time are built in extra team and able us we output increased new R&D were Our over cushion to the inventory pre-COVID side, to have cut room projects longer the actually takes
our U.S. Turning coronary the to this patients regulatory. IDE, make we key protocol. now our statistical and evaluable of to be with had We XXX needed to clinical were fortunate XXX able very as our considerable the plan satisfy with we III, enrolled pre-specified and CAD only patients Starting quarter, the of end year. in to progress trials
are current we lead U.S. plan, our we could The continue which on third anticipate review with prepare Based the FDA approval of that last work would data, sites the now with PMA. to six submission the follow-up monitor XXXX. we a XXX FDA, in quarter quarter and and on to to submit handful by final months of the least first working at module of the patients, patients, and agreed a
were in the enroll COVID CAD our investigators, completed able trial IV, escalation. Japan, the to through to credit also of our and they enrollment
stay a We Japan. approval and and working with mid-XXXX which suggest with in will on be approval continues PMDA track to to our submission sites timelines, our
of initiated has patients randomized in trial, treated knee cohort to and above III of MX help XXXX order On develop registry the market the IVL PAD a now We study the both arms device. over the the have to for III peripheral device. enrolled demonstrate this PAD study of our utility arm side, The with in patients. and considerable were the registry
the disrupted So but treated was elected following SX randomized now patients going back online of we’ll starting the then again. come narrow to arm COVID X DCB be The PAD only forward. and we focus arrived the the was trial just debacle, and have with including to
considerable determine to advantage to pursue warranted of study the resources whether as challenges of different taken studies COVID. have a the We strategy the requires given this managing and reassess and opportunity during it how
prescheduled be so investigators delivers and was in trial study collectively with need the validate and from to week. reduces principal that minimal so final what are of the with we The the the goal after clinic dissections completed PAD lumen to of to the stents. helpful gain team, statistically this will this outcomes the our our stopping day We we idea for every commercial see III do believe cases decided IVL discussed excellent
be and map of out will data will the next the trial results when year. begin of those We then process presented likely early lock
and We are effort controlled XXX randomized in study pleased to have the appreciate of patients enrolled a the over investigators. rigorous,
our customers on optimally to challenging of these clinical further serve will months, enhanced note innovations by through priorities to next we unique provide growth patients, is productive to it to our advance for for our that and IVL; to held wave maintain capabilities; and capacity employees our near prepare look continue to data and the focus and environment to to we their our markets phase As to to next a have continue to benefits customers their long-term generate and organizational we treat IVL. the return the move to steadfast investing to for addressable expanded safe, in a of expand and thoughtfully the patients demonstrate important
With that, turn the to I Dan. will call
