BioCardia (BCDA) 29 Mar 222021 Q4 Earnings call transcript

00:05 Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the BioCardia 2021 Year-End Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. the end be June of of hour approximately XX, replay the after the webcast call available will one XXXX. A call through over CORE would Jules Relations I now to the XX:XX like firm. Abraham the IR, call of company's Investor turn to ahead. Please go

XX:XX everyone thank participating Good you afternoon, call. today's conference Andrea. Thank for you, and in

management's will Joining President company's Officer; management intentions, Executive to regulatory McClung, differ Forward-looking to may the statements uncertainties making factors inherent associated and results Chief this from Such beliefs, with other statements. Officer. cause involve be and expectations leadership developing actual During performance risks approvals. or are team including address expectations. XX:XX and BioCardia’s or projections, factors obtaining analysis current today operational statements, new Chief me that materially Peter among and the results, or Ph.D, XX:XX Financial statements include references those others, Altman forward-looking BioCardia's future products from David outlook, call, that technologies for

go Ph.D, circumstances President reflect that, or disclaims to pleasure information particularly CEO. BioCardia them. With these Altman this the information publicly Form XX, my turn filed events revise factors occur recently contains refer in please call. law Form information described please statements as and any about cautionary accurate the as call obligation to risks, to to of as time most XXXX, to by company's risk reports over with SEC, Form March now filed only Peter, the XX-Q BioCardia's required except update X-K or on XX-K, The and after content Peter today, the in periodic ahead. sensitive it's any more call For of the XX:XX that this

to and diseases. to advance cell a the efforts XXXX significant XX:XX cardiovascular big year of everyone Thank BioCardia meaningful execute team. to its pulmonary its treat Jules and derived good call. therapeutics to in for BioCardia’s continues on pipeline afternoon and you, cell was

four of progressed cell We have to significantly on based candidates, in therapy in autologous core touch allogeneic I'm on these therapeutic our our XX:XX term. going platforms. of all development each of programs the and

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expanded Receptor their completed stem targeted Neurokinin-X lead excluded our the cell is program who we have completing of which program heart Our in due Chemistry allogeneic the been nature Controls failure, have from cells. and is BCDA-XX and This has mesenchymal program culture patients the Manufacturing to designated additional validation allogeneic cells to pharmacology pharmacology submitted stem the and also this Controls FDA. expand Distress year, has and Syndrome Our culture to Neurokinin-X animals. Positive March studies and XX:XX we Receptor Manufacturing an and Respiratory in program toxicology it's the validation, Acute mesenchymal toxicology Chemistry on allogeneic of in completed IND Positive study same in

we hold from additional and therapeutics call believe will David with in our proceed the We both our I will some or cell clinical for to The actively our created have expect April partners. be are summary, may financial based on XX:XX work being patients by four and therapy therapy used we treat partner and of will the our are to our therapeutic own benefit systems, product In who FDA programs we now David? platforms. programs CFO, through. provide will on patients perspectives. candidates autologous placed our allogeneic news from pass advancing the items delivery that success XX:XX McClung, this shareholders that to

Peter. you, XX:XX Thank

partners that company. disciplined was December the a to XX, clinical, cell potential and new and we device through just facility, at into primarily year cash collaborations the year designed XXXX. due net manufacturing under sufficient other laboratories cell equivalents, in reduced which both to XX:XX office We XXXX to have has in XXXX of Our Most Sunnyvale The our only activities expense XXXX. $XX to XXXX. XX:XX $XX expanding our a approximately to with entered was these Sunnyvale collaboration XXXX of million December ongoing. million therapies that increase has corporate two been are -- the new $XX.X in one end XXXX our forward, been of and XX, over a our use us which in reduce capabilities. loss XXXX our ended transition XXXX XX:XX This compared our final into look [indiscernible] as $XXX,XXX XXXX of a ended we these the completed financials systems. compared by collaborations, we $XX.X contribution advance and going and totaled of our million represents with overall derived to we lease, in our expenses year million. our XXXX. $X operating of to compared construction operating rewarded our perspective, decrease needs cash and $XX.X the for to and for and XX, forward alone. Peter December $X (ph) to accommodate net the for and in show We carry activities anticipate spending also manufacturing burn enhancing XXXX of And now this in back significant through of continue in commercial used to planned pass This strategic the their other December ended financial helps will with million the annual cash capital. of XX, deals, questions. and the delivery we Peter? The and facility call with transition compared of for before for partners. we roughly used operations million facilities of extended each million operation open have Revenue all to just while our loss is $XXX,XXX our collaborations XX:XX the the with call [indiscernible] strategies Net at I was some to $XXX,XXX for as to the thoughts significantly

our closing, In David. worked in you, Thank has XXXX. team hard XX:XX

programs. the XX%. as we We capabilities intend relationships. delivered Mesenchymal our our and and middle manufacturing with trials a in CardiAMP seven-fold to before the modest product and commercial our enormous Our clinical cash with believe in our programs by and technology, of on with Stem and our first enhance and our our autologous operating reduce We we Year-over-year, pandemic strategic revenues. and While advanced therapies clinical burn speed allogeneic their Receptor goals are there Neurokinin-X complete all cost. invested revenues We Therapy increased of Cell patients to patients for by initiatives these decreased to families. safety, we partnering includes significantly Cells scientific accelerating can rigor, both as our our Positive treating prioritizing growing Therapy benefit XX:XX patient bring XXXX team,

readout. have enrollment are XXXX reach trial to targeting now are myocardial support to failure to take the ischemia adaptive questions. chronic We planned to ready and trial complete heart to We enrollment the XX:XX Operator? in

will open we question Kumar ahead. Instructions] XX:XX At [Operator time, our Capital this Markets. questions. of call first Raja from to comes Please the Brookline And go

Device all XX:XX Thanks my the also for progress Breakthrough include and congratulations taking Designation. questions on the

how will you Canada, the soon four do So of which first, enrollment, had you to sites patients before do there? are with in we think pandemic terms think the start U.S., COVID of be to impact the And what get seeing in the will in to the regard able soon we terms started? in you you pace, how recruiting

question. XX:XX Kumar. you joining Thank the the Appreciate appreciate you, and I call

on them expect working device So within entire The four throughout Canada, sites to first, been forth with in soon be them we're Canada Canadian team Health have side. working we have Canada the biologics the enrolling? sites on and different we activated with both [indiscernible] Health how do and back and we at the side Canada

four bring don't us I for it'll think be in on all to So very long sites Canada.

on is on in talking as the have lined weeks a -- Breakthrough you data time how to the would having some therapies, breakthrough therapy of of from our yes, X enrollment of it They the doing the approval we're our I clinical we X, in to -- the through With for and is well Designation cell the everything because up will the that FDA addresses, respect through the is doing almost Monitoring think really through that the reduce you have United therapy, and handful on we're before in our went it. administratively, a that reports about were and data roll and with three data I Data cell impact a some these go say, try that it is this for programs other phase X criticism there think enrollment, of concerns trials. barriers and -- you noted of as way and but XX:XX gone have Board. Safety States, phase the all matter to we after it the phase the take

my FDA BioCardia data of enrollment. guess is so says So good. the perspective concurred And management I a when that's XX:XX The to has degree. on

today. to it consent with initially with more expect consented the a begins they for being much patient had be that's and a where enrollment after rapidly really series go And coming that share acceleration. can online We We of starts, through some it process I tests.

respond inclusion of XX% we eliminated know, enrolled us assay the therapy. the patients have likely potential results that Unfortunately in assay in the potency As we we the all this trial. who be the essentially that that performed, identifies cell from criteria are patients most having to to those

can so COVID have be through that process these nation, to for And all of share regulatory the and call comfort. the enrollment time this waning easier takes from with us enhanced the move enroll, further easier perform, comfort physician Health appear to the inclusion-exclusion, does to (ph)across Canada enhance DSMB the but reviews patient I make FDA, comfort, come all in to CMS to that elements and trial enhance physician and

together coming are pieces really these forward. of all to these push So trials

review you. DSMB about XX:XX back next line. the the I'll Thank in its maybe a you And talk can Thank and and bit get little you. expectations

you, Kumar. XX:XX Thank

well. I we DSMB next -- the August-September, date it. the exactly the I but of data scheduled, of of think the review, I update folks have the the is the think will review of when all follow-up mind, treatment, DSMB yet, when in And all at So as not know looks keep only cusp don't data we but for

we're now. working as hopefully And working on crossover some towards, have review just we're increase will follow-up XX:XX so towards And these we throw have significant I well also, patients. that it the think patients I'll enrollment as

are We open treatment. Those crossover have label seven patients.

patients you our their will. the subsequent as to share we're with endpoints reach they if So folks able going trial, on crossover in data be to

question. next So,

Your & question from H.C. XX:XX Emanuela Co. go of Branchetti Please Wainwright comes ahead. next

patients guys you XX:XX a give on you and insurance for the I Good you did questions. wondering, afternoon, taking thank lack many of not because sense trial mentioning? my was the coverage access us can of were Peter, how

XX:XX Yeah.

get at, are these numbers hard -- I mean our to So, Emanuela.

expectation Medicare are demographic of patients. Our approximately this patient in patients XX% the is,

United United put in reimbursement lives is us the and for typically cover XXX Medicare million States. addition, they that about has and followed In forth Aetna by

significant them We're frustrating that to patient and it United that's pre-qualify So pretty the a that and denies for go therapy you're a it if so not insurer first. or they're a also, at putting center have that becomes you pointing Canada. when group, and out a will elements Aetna, is together hey, and the is this we're enhance that, available but in

it cover an of previously. then in sponsor blessed we're the with cost putting CMS Second, Those the to questions a yeah, making of that the three the to treatment are clear CMS it’s -- arm us decline to we're insurers both from And is lastly, able control at has. and reimbursement go approach pretty reimbursement, that's the enables all and all pieces much site together arm any XX:XX up that the the that a we code, address place recovered.

So heavily contribute other where hopeful as and that this see bring since and Medicare breakthrough still -- we in we're will going because to it’s well who see patients the insurers patients are of enrollment, to but we'll Aetna these United as follow will the hopefully part. this in

to getting from elements the staying it. investigators XX:XX there Yeah. site. like any other subjects, just Are on than mentioned? the getting feedback seems you from Got you. these optimize you're -- Maybe one you're the you're it working Thank enrollment on other

policy -- our health patients. Inspector ability to just came the place services is are of there at related XX:XX cover that that to of oof have office opinion There we out in General a co-pays the the an human and

Got it. XX:XX

so… And

single as all to think every And barrier those think address COVID. including esoteric I have trial. XX:XX been addressed, if a court that not the of of acts we've enrollment with significant of barriers hit in more one element, a the waning this most issue but press full That's this we

XX:XX can sense and us color COVID give us centers these more what and you question situation a waning? my around Yeah. geographies, and situation No. Absolutely, the give if other in could with of how seeing you COVID in was, different fact, on if geography the and you're is

XX:XX Sure.

is COVID for go And related the our can for perspective. to want potential clinical do certain our Remember, around the procedures So periods. electric know COVID. folks is, first impacts we trials trials. the only all there It's two don't [indiscernible] centers. pieces interactions to Patients to only to from

The second though is related to staffing.

So used has staffing across centers been problematic from working a different to of country. the lot home, coordinator at got folks

And change, very so leading very they how just a we appeared long get trial now quiet screen are seeing It's been very one They queue. that was and for trial. and they quiet they three internally and to want the XX:XX said, the approve into in center yes, Another there's on for center. patients time. the the us just have radar

well. so we're bringing that there's centers on And other as board still

think I who as take favor happening is has as know, well. on can it's that evolving piece staffing the anybody time, our So in call process think but hired the people I

sense. always much you. sense your assay? as center for taken and potency of if with therapies regarding had how the important be assay I stage give XX:XX you recently. you recently wondering, FDA question, the my was I it's as have wondering Thank was And potency can of dialog last center taken a the recent relevance Makes us obviously, but stage cell

data we in of that high that is number -- a would the benefiting. of all are this a assay before our of cell on So which biomarkers probability support the patients selection have XX:XX a identifying based

it's really, inclusion-exclusion trial. so criteria And our in an

it, terms potency at. the does potency called and the look the We from cell it's of would a under cell agency to that a it it have assay but relate different assay state

cell And cell respect stage many agency so are know with of advanced assays other for the center potency there. therapies out think I to that I the

diagnostic things the a that studies their potency total, and what forming each a used we cell our of in is looking also well. think the been that assay the potency looking I assess past potency procedure, in things assay aspect as in to fundamentally, but and but colony only we're has as cell doing, form this not ability support assay that I as device and units doing are other that cells the perspective we're at. we're do system. have efforts [indiscernible] every We from in a selection for, the XX:XXSo regulated think viability

not we're that's generate been we probably can't it's cell patient a so doing treated laboratories. same something to patient potency because And going that treated. the our for in It's have is already after criteria, the core

much. very you Thank Understood. XX:XX

XX:XX some However to and Neurokinin-X a our programs and on Emanuela, lead step, what absolutely derived all but the forming will programs assay allogenic of of these units with -- the the programs, one colony on it feed we knowledge be have our cell cells have mononuclear cells on X. in will more respect expanded we from the X they potency work into for just allogenic we've also and we're done program, doing in lead

Thanks. Understood. XX:XX

XX:XX Appreciate the question.

XX:XX The Maxim of next question comes Group. from Michael ahead. go Please Okunewitch

for question. XX:XX my taking Hey. Thanks

but their like therapy discussions of analysis. moving the first, for targeting a ischemia in right this ischemic heart the as the cell I regulators patients to with of of product? heart Can your validating benefit therapy saw failure with with greatest viewed BCDA-XXrepresenting cell guess they add be just diabetic context and patients, regarding into subgroup patient specifically So I'd failure something in in Mesoblast

dataset that we've they've I XX:XX patients follow-up data. the shared at Class first, so that in and the good Heart Well, Michael, data publicly. II looked to want Mesoblast three-year at -- New York the cardiology It's Association it's acknowledge as ischemia

it that Now than of that's from therapies a any are out latest trials delivery is failure That uses seen therapy it said, we've there. platform. a the advancing the signal, pivotal are different than and different exciting. That's the other stronger we heart the

greater we're our targeting that patients trials. does with their line responded trials However, say patients substantially they in up in the the

doing patients of from II and our they've York large six hospitalization So is they're of forward. which required doing XX:XX II, what what to the Heart status Heart either the New between prior from how Class the I the don't we of they high we're but portion level, I believe New as those. a don't on failure going required know that In Association numbers, of the to Association they a Class require months heart in York treatment and are delta they focusing NT-proBNP said the and measure a trial, -- say

that so patients we're signal sick, So for going sickest less is noise. said not patients reason York and I what the trial are art we CardiAMP is, MACE these that all events because are design Class NT-proBNP leaning the recently along have sick in the And of which not a trial. go had these II as clinical hospitalization optimizing is to high who to forward. patients the they into threes think Therapy to in Association an that right such and think they've big And significantly Cell a Heart they're believed are they driven believers going the sickest New we've after. we're event the is patients do the looking We're not of

ours their patients are is delivering going what derived It's but those And an is. delivering to go therapy, us rely bone though with because a myocardial too for cell so yes, again they different on it delivery are it therapy, saying, to which forward. the different going they're a is much system, data, they're interim cell they're after marrow

there is saying also you're kind trying point support significant. limitations -- would to are which of to So what the I'm

also cell mechanistic are I'd and color. assay the additional biomarkers if what you're to the us level? selection potency see appreciate for you I you. selecting Thank remind on could of like a No. Yeah. XX:XX

only in been counts. So in of other have detailed number is so marker one -- as at. The a looking that's And past. XX:XX this we've we a used CDXX biomarkers publicly trials cell clinical we the we're the

perspective. XXXX, cell past, than data platform trial a efficiency CDXX combination pivotal cell that dosage actually efficiency Ischemia, of it's disease selecting trial on the current XXCC And presented processing the this an be delineation ischemic dosage actively we that promising in the shown patients patients only Ischemia major be heart may based high Ischemic. we say, and failure elements is The their folks only is cardiology signs on is not we first look mean, caused mechanisms Ischemic them are I every and actively failure by androgenesis it's we're the able is treating that with the because need CDXX the efficacy of failure CDXX, XX:XX often achieve patients, therapy in treating on. higher not I important potency cell were to of with microvascular its cells. has going one enhanced to heart and and marrow of again, but achieving Ischemia. that element and means our we on focus. assay delivery we we're on heart to Just the want So to the don't in from for that's the aspirate group we're think and

probably this action as of other into there So well. woven is mechanisms

than with about Thank equally you. easier they is? be with And you coming could developments sites of should it think given that environment the right. then Do trial last make that these the the one All the CNS, different XX:XX Canadian reimbursement or just enroll U.S. one, as addition online. to

also We is leaders, a involved We started in having XX:XX -- there element that's an this becomes know, the that process it without great the in we issues. great That's who've case in in But test space Canada, historically done and reimbursement work was enormous question. don't KOLs a trials. know other been answer. a opinion part the there, some key because great

agencies as pay Canada, Canada. approval two will in do we in clinical for through trials going the to process for not And It's was although, everything to have daunting. so of expensive separate the paperwork

sacrificing belt a we've necessarily what to to worked that on the and without question working Our expectation reimbursement States. of we both our test the addition suspenders trials and of causing Health through difficulties. in approach enables nuances is that in And taking Canada XX:XX us were value the Canada, proposition United some for was sites

think we that's to going have efforts -- done some friends the at of issues made roll system get to help going and through so good forward. well And that those we our think us CMS resolved to

different see the it be enhanced day, At interesting but the able be BioCardia a support the have to we these listening So make trial them? reimbursement. optimize tease sites sign of value understand perspective, in what is easier, scientific it's site, provide from of for to this that for element end Medicare we is impact of exactly to we How the while enrollment we at which trying the are out resulting will to elements. won't which we a the the more problem also propositions, it our clinical can reimbursement constantly and

right. Thank you very answer question. the you All I to time appreciate XX:XX much. my taking

it. XX:XX Thank appreciate you, I Michael.

The next Global Please James ahead. question comes Molloy go Partners. XX:XX of from Alliance

XX:XX you -- you DSMB or here COVID for given for thoughts quarter. waning? the a way for idea Any the trial. is for can ramps with expectation -- my you I taking the to On better think the you guys getting when for guidance there questions. look very insight expectations a on get gave and of fourth an enrollment trial thank is XX how all to Thank the another much And

XX:XX Yes.

of Ischemia that in we're Cell in same the Jim, I targeting also the think BCDA-XX targeting the we're for for indication Myocardial therapy DSMB We're program CardiAMP completing So year. heart Chronic of the lead completion third for in for readout the ischemic in which of enrollment XXXX. failure. targeting Therapy And same review is quarter adaptive the enrollment

out very out, -- year a in the And it for success find will budgeting we big can't more things, here. go for and report us. budget provide specificity enrollment as we going on as So XXXX to we but that, I is any be we're we will

the subsequent are are on based pushing only and soon enrollment the the So activities as these going There's trial and the in this completed we're things have that XXXX. not happened to things XXXX efforts in XXXX on to today a doing be possible. we as lot make hard on

getting across some environment maybe a biotech or low environment partnerships been board. half the us given XX:XX does more the dramatically or Excellent. how less of first the really Then changed challenging environment the obviously for gotten potential given been been of levels. has going on year active with what's the Has stock's acquisitions

that XX:XX development to All I the Jim, right. business have we activities only can underway. speak

although, are those on into couple a not there And of so, tied is licensing really and M&A, elements.

recap briefly. I'll just them So

In a of one specifically PMDA acquisition, that Japan. a our XX-K, I've In That CardiAMP for United we light things can be near there meeting is outside involved interest. and we is with detailed have of identifying that would not the future. shared in partnership I ongoing we the are been efforts that in that the place. and share partner an States have So all taking just the

I of and we're the and I approved that's also Terumo, it that it aware is note has having conversations that a therapy is parallel cardiac great in HeartSheet and reimbursement having cell with be in in advance Cell million And so them CardiAMP need a there is to $XXX,XXX equivalent. partners reimbursement It's this to patients failure. conversations Japan Therapy with will where with help unmet heart only again a potential has the the a think by we there Japan,

support a we’re Japan So medicine also the some advancing. hopefully behind for that put will therapies wind there in is regenerative

partnering we're our that’s around level is in of The So second involved that biotherapeutic delivery XX:XX one. platform.

today, that's safest the we for we appropriate use delivery actually to easiest and cell the feel So protein and delivered heart. to system delivery efficient gene at have most

of And we've we can so available things partners. are -- all solved the for

assets We our the an it we're that can And move enable market So delivery year. them and dollars more potentially don't and can having the and partnerships. AVANCE existing will product we our, that the significant benefit XXXX. product. And that all great. partner is competitive we're if our of these perspective We that like would product, will more did transseptal that And at patients that that of initiatives a shareholders is delivery therapies, some to to same two so actually procedures use the with reflects those from us our and we technology an corporate trying significant cannibalistic, deals part at own compete have here other technology towards we've conversations around core identifying which time, great in their that BioCardia. therapies the benefit very is to in we're enable a XXX,XXX in idea monetize extremely would our to our that If system, in but even have both monetizing ultimately of is today around delivery, and compete we feed that to active entities systems, the initiatives. that area AVANCE developed It's the come XX:XX in elegant. one assets the on the fit technology States, of other is that's with learned what is sheet, be call we've area an in from And based which DNA last will addresses biotherapeutic in though on United it's it FDA-cleared our

so is can activities very really we our delivery with the of number the treat note, have. past partner, we the partner those confidential, And the only three international our of be relationship types and but with the amongst strictly done have information AVANCE reputation activities, partnering one And think Of partners. and those efforts can are work partners. and biotherapeutic we a good current we monetization I

ahead. And year be often partnering other we're don't for the therapy delivery. we'll funding with the to still therapy this programs do nice some but has or And It's sometimes go the programs nothing optimistic wait or to is to in ongoing. last It elements, that related forward. year doing

the XX:XX Great. taking questions. you Thank for

Jim. XX:XX Appreciate

Jason James. Kolbert comes question ahead. Dawson from next The Please XX:XX go of

me can I'd to are understand critical my of Peter. a Most little trial. associated. talk the measures about Thank answered, Hi, like you XX:XX help questions endpoint been have kind of what you. bit the And of but the

what there, What the have I Finkelstein-Schoenfeld analysis. using think and it's hierarchical been critical other key approved that drugs significant aspects endpoint? are

it and Finkelstein-Schoenfeld endpoint. have a other to have failure And identifying is because approved, shared but use X-minute FDA clinicians for it's past, to then us recommended difficult Jason I cardiac a understand, There that up hierarchical of a more nudging a moving was question statistics because been that endpoint in heart a it programs number endpoint. in probably great The endpoint, specific X-tier events, So of endpoint us this measured by And even that’s it this that major accepts, is adverse is the important trial capacity one. the though the substantially XX:XX mortality, more sophisticated been and good using specifically advanced that a the the is, other would think been and endpoint Finkelstein-Schoenfeld an I I Finkelstein-Schoenfeld by the walk. but us something something as guided us includes was endpoints may and say, understands in appreciate was and we're that to with functional way drug than was that composite describe we the the therapy perspective, better what had sophisticated X-tier have with something it and wind an towards agency from the had this equivalent everybody that to works little service patient. the we a we bit more did as that

rolling We results good. how coordinator do is is in whether It so there the far as know no X-minute the X-minute can foremost. subject patient is – measured we're that no, it dies, questions, another a leadership functional live day worst manipulation if is if patient by week patients that event, is they're is you related can first next to and of and FDA rank. endpoint and that’s walk. to MACE sense NHLBI If walk clinical And but walk disciplined the the so X-tier XX:XX element two this Lung, the Blood our a they're do want X-minute trial from cheering is combined, X-minute out? related capacity that's the have because very to there no Heart, patient, there the MACE walk and And be So in And your We've a modification. doing answer recommending who Institute death that's I'd cheering is be rigorously in how with as is in better by blessed plays this day. or it And, if rank. one not? by a are a at on a all we been us the endpoint. may it does that patient an there to on non-trivial has we a And it's to next out, XX:XX effectively the working

expand you on said, XX:XX pretty up so is that? Right. far I'd like you to the which just Can upon is something pick data good.

our our we blinded worse I years note at the very look three data all under I drug XX% at Phase of look any three II, if years, data at you Mesoblast that don't of are don't we so But a where results trial. had -- in so at And mortality if XX% that's for in I are XX% trials. mortality Well, they XX:XX X I The roughly out actually at three think Phase if are at XX%. the far their rate published the data years. the coming mortality data look know in three you see a -- rates large years. at of you

York in -- Association the Heart is there class New that's So II.

as only published, but in had was Phase Phase X that the one-year cohort one-year rolling in that X, I the share lost trial. we in lost And So no our have up. Phase the patients data no patients can we data of that III follow

sense, that's XX:XX That Okay. makes it's encouraging, so you're what saying. Sure.

Yeah. XX:XX

So improvement exercise well improvement saw we but tolerance. again, see in is function. in in Phase saw X, elements X, of improvement that life. holds in tolerance. metrics It Heart in we exercise doing We We function. in We these fact and We improvement look quality those the are improvement very see sick datasets. heart see heart in improvement saw together. those function. X, in Phase all of other patients great, we at you The the saw improvement if tolerance. Phase exercise they're

have it's data these not we those benefits as element doesn't a it of complicated. and are if dataset, sets So one include

at XX:XX And the we patient's heart. damaged compartmentalization a if trials toxicity we is at other have There tissue can day. if for they localize hopeful, where have the normal of you and of from drugs concentrating X, feel become the we the therapy a can check it's that so it's we're of new have Implants therapies one-time look you adipose a advancing, get with potentially events end in drug can the around good these very repeat cells tissue you procedure, the at results, implant. Phase treatment we safety and safety the therapies of the downstream erode procedure, perspective, device at the had own end in end the these So we're patients. with in And infected. the no, the an

don't haven't profile are the Therapy programs. there again have safety that think in ramifications been also in as for Cell risks we But and an risks of therapy. we're This we safety procedural about is are cells we doing compelling. fully There those the CardiAMP that is long-term it, pretty any the So what adjudicated. not think approved

XX:XX Thanks, Peter.

XX:XX you Thank on Appreciate Jason. you, call. being the

Peter XX:XX Altman for This to any turn would like closing to back over concludes our I question-and-answer remarks. session. conference the

have today's healthy, wonderful participating Stay to a want I our XX:XX and progress. Thank look sharing of in you, Andrea. continued be kind all you day. We for Thanks. forward to BioCardia. call thank interest on your and

concluded. for presentation is and conference disconnect. The Thank you you may now attending now XX:XX today's