BioCardia (BCDA) 11 May 222022 Q1 Earnings call transcript

Ladies and gentlemen, thank you for standing by. Good day and welcome to the BioCardia 2022 First Quarter 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 August of of hour approximately XX, replay the after the webcast call available will one XXXX. A call through to IR, now Abraham firm. would like turn call I to of company's the over CORE Investor Relations the Jules ahead sir. Please go

And everyone. Thank Roco. today's participating you afternoon, call. good you, for in Thank conference

President company's today Officer; and Executive from the Chief Joining Chief Officer. today me leadership team McClung, the and is BioCardia Peter Financial Altman Ph.D, David

statements will to others, be expectations. BioCardia's making regulatory projections, During that this developing including or references address include the for statements, results, outlook, call, with obtaining associated management's approvals. new performance future among management uncertainties Such factors current expectations or forward-looking products and beliefs, inherent analysis operational or intentions, technologies

factors involve may differ risks results to statements. other from statements actual and materially cause those that Forward-looking

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

cell-derived since year-end execute advance to disease. its and treat cardiovascular has to pulmonary call. afternoon BioCardia continues with and pipeline the to significant therapeutics good XXXX the and results, It Jules, call been efforts meaningful cell weeks only six last on and of our its to in Thanks, everyone

BioCardia allogeneic was therapy quarter significant for autologous and the with cell both platforms. of in our first progress The development

our from States in continuing health be is clinical United a programs, the which the research effort Our recovers enrollment as COVID-XX. the primary focus care across will systems

autologous trials milestones pivotal ischemia BCDA-XX clinical to efforts quarter. have the nice some and complete of the CardiAMP failure Our indications cell or had chronic this myocardial or heart therapy BCDA-XX for

heart a our received Canada. pivotal of code Inspector supporting our throughout have to a shared data failure in favorable clinical human in We both failure review validation it date efforts but CardiAMP reimbursement co-payments board heart in bears and is support conference Therapy had realized of We lead to General new services failure compelling. successful the lead that health trials cover and was Canada’s quarter. quarter trial in breakthrough our last this that to truly received We designation, our in first XXXX providing XXXX, these Cell the opinion to already heart first of CMS trial. a trial. data and the from safety call, independent granted ability expand heart received in repeating These were We program FDA our the the Objection patient Letter Health our no Office failure we of result in monitoring

the For at the day the three same sites cardiac have on scheduled heart States the United first failure trial time, procedures we in across ahead. three month

as We the possible. in world-class are trials complete our CardiAMP working diligently enrollment to and partners clinical support soon as

myopia We to its ischemia enrollment cardiac XXX-patient the of and enrollment are a trial trial readout. patient heart in the full XXXX cardiac in with completion chronic enable the the failure XXXth of interim working of goal

CardiAMP the and consultation have States Union. Therapy regarding Cell the that the the all our had the Medical around is went Cell system This We approvals elements of consultation CardiAMP United Agency with Cardiac our Japan's on The European exist with in the well. meeting based and clinical PMDA of regulatory of just first Device of Pharmaceutical and quality Japan's data registration Therapy. Japan,

still are information on and and consultation, for on approval for where the our Device we planning pathway that and based aiming will current requested We second system Japan’s of data have this our data Cell Medical been in Agency. Japan Pharmaceutical Therapy provide by

declining, Japanese Although, well awarded been CardiAMP Japan's pluripotent Cell CardiAMP population the appreciated field benefit. induced with have scientists that have development many led which that heart Japan has Therapy is is we to central Medicine. they cells Prize in of development were there this patients Nobel are as central that is been not scientists Therapy, can the of Cell Japanese believe in to failure just to stem What the for

Now I'd based on two Positive our product has stem allogeneic our progressed like the since candidates call. six to cell Receptor Neurokinin-X platform, our weeks cell therapy in allogeneic which last move mesenchymal to

to acceptance as in the designated targeted have autologous due we have program Our failure, we heart what for pharmacology the enable by toxicology been completing is their of submission patients believe studies XXXX. the FDA our in nature IND BCDA-XX, which cells program and to excluded from is targeted last the who to

Our patients Distress program patients next Syndrome, quarter, approved we enrolling targeting to BCDA-XX in early been April patients are XXXX. FDA by recovering have as and designated has treat QX first which from we this Acute Respiratory as

we in and active development therapeutic Distress based companies are at cardiac initiatives. Development have product these We autologous in we therapy Respiratory being that our the development Respiratory our Syndrome diseases unmet candidates on summary, Distress address important four and second business Acute invited therapeutic cell advancing leaders MSCs three From alongside Symposium present allogeneic pulmonary Syndrome. developing Drug efforts, platforms. efforts In to annual from for have been Boston, July held our Acute peer

CardiAMP Therapy platform internationally. our partnering is Cell First

AVANCE David? biotherapeutic perspectives. the heart. Second David I delivery our will introducer who for now Catheter therapy protein sheath in our candidates systems Based CFO, to pass some is transseptal cell, And gene our licensing and third, provide call monetizing McClung, the will financial product.

the cash provide April the $X.X runway with totaling in $X.X quarter the million, ATM which ended proceeds in the with into of company The XXXX. first Peter. you, together Thank quarter from million

The increased and to and increased $X million for of development by now spending And questions. take to million from $X.X trial. to $X.X in first XXXX of million is net expenses of expenses was quarter compared prior unchanged year. support XXXX, first quarter first the in XX% expenses in year's prior increased failure during the XXXX The due coupled payments research XXXX. Operator? Our to during the net company's cardiac to from to $X.X SG&A used loss heart collaboration in compared the in of the was million QX the development quarter $X.X research in operations timing quarter. cash ready of the QX the first due with $X.X We're million million increase the quarter. partners, was

you. Thank

We session. Instructions] ahead. first will go [Operator from now the question-and-answer comes Raja Kumaraguru Today's Please Markets. question with Capital begin Brookline

taking questions. my for Thanks

to to So little that can trial target are clinical in sites in enroll much are talk first, Canada, of about these regard there bit you're potential these where with you four in areas? population the going a located? How these

for you you question. thank on call. the being Kumar, appreciate really the I

Canada. sites specific were yet identified in the We clinical active haven't

there have on-boarding ago. approval, Canada are actually experienced approvals four at have site done investigator and once in will actually likely But principal are forward They the before first others Health well. sites efforts or sites. securing first all national you the can patient. the are the a call at time we We activities on as dose for some quite began If get Canada Health you moving on-boarding the with past, announce IRB to clinical we've The site approval. the

in so the And yeah, is process. expect it's sites an some future, on not-too-distant and there four interactive involved. great all folks come But board we to

As far primary challenges. our for potential of as one enrollment, the that's

States they the is they I that associated major don't they're I that not the we areas. with that have the the think, major they're have in advantage the with in all reimbursement. have – Medicare billings burden And think United –

that's will the not them Canada. free competitive as other many So thing in that is there's up activities one –

And able world-class folks with to we'll very those sites. delighted all ahead. have sites them and work both and they're we're enrollment them honored will But from so advantage another be to with that's experienced and identify that

challenges patients And more in there? share you You Whatever can that? you stand are seeing from of where US, here. what to in the terms screened see regard COVID-XX, guys being with the do you

this hoping tamped And keep be down. is something will that we Absolutely.

I think -- I'll give example. folks an

are relative the anyone's this. of Even We this who outside hospital, have patients know people said site, to in have close don't want offered everybody But the where actually few that's Florida, has participate everywhere. you hospital very element been the said quarters to at the particular trials and hospital. there's to outside one it are they and is come yet is one one the diseases in participate hospital, that it's infectious where element. And safer they if any that's the than the masked in of with hospital. And though hospital that that literally Florida COVID-XX biosafety to in have to masked, investigator

research The second through the the from There major working are clinical began Kumar, at folks element, difficulties period. of is evolution institutions with COVID staffing. Many home.

were currently research eliminated positions stopped. because folks is Some restaffing. was everybody And

example. an So give I'll have -- we you

because higher that We any space And board. actively stalled folks that their that a this on our person, to I'm seeking to enrolling site sites not for need a coordinator on coordinators for can't other trials. effectively recruit, currently And have is clinical get their they patients person of that's address team. so to they're to aware issue center pay are in they recruiting without one until key

issue, is seen number a and in but there So that's resolved. issue progress is that longer a potentially of being a recently. And centers bigger it we've

So really ones. the big -- are those

in we're are contribute. is, enroll, we've to first strategies have other things done quarter these we all as this to The looking of going at

In delivery being hurdle in to already also classic been up. having is of implementing marketing and so what device we're tamped going in is as areas, addition, many not seen the interventional staffing after are tied into another daunting. patients is that which down the fears But efforts cell certain therapy, procedure, going a that the our medical addition exposed requires have is strategy COVID there's

and own these fact, left The a trivial for some of only have this their thing cells. their is seen own onetime that's cells who permanent procedure folks may board their they're In are on because it's we cells. behind where devices deliver catheterization as

we're be one as going pathway. that's a the well. as to So And working think ahead of that on enrollment compelling initiatives I

Japan, consultations do And and And the line. with before able need are time the to the maybe more move regard many you think there? forward you to move PMDA also finally, with filing in you how forward

Yes.

least well, couple a there's I So of that consultations, have think The we're that actively. interesting. at of two elements there's will other more pretty we this -- that's And on number -- working are consultations. to

the what time for predict So the only consultation line, line the time quite actually it's next soon. we can and

only cells I that work. the in our two the physician lean have Cardiovascular CDXX the physicians mind this, neovascularization same into platform in Japan ischemic in think in was but delivery bone work isolate we is indications. Journal we he as are for systems not we've revascularization keep approved Dr. disease. that's strategy, And He heart our this And Asahara. approved marrow could particular that cell named of in transplantation. to in And systems. in other it had space. conversations Europe, with and Japan the doing provide in two preclinical it on partners and and Japanese actually Takayuki shared There's And ischemic the those autologous that a at disease was really with who hind-limb delivery Japan. published have related blood interest as earliest was began There collaborations in that therapeutic thought first I processing to that the from time, surgery

are So excited, some breakthrough Dr. and pretty by follow-on work we're there other

Asahara.

systems with in us working also Europe. the These an group who the the day, these of things So, -- things support, designation other originate investigators sophisticated in Japan, partners and wonderful series identified the will helpful a also this. up these is systems have are that is of can chance publicly, to end system the PMDA be think being provides there's I principal there, not we very Medicare reimbursement there's enable part the we provides in approved that we of many context, mean, is best elements, initiative. all quite valuable. of think that up, we be us basic and But conversations. I line and these that that that effort the approved as go a may this using breakthrough the fact successful whole the think of this discoveries of co-national so Japan, part effectively delivery fact of this Japan. in forward we in The in in interested at is give clinic the But line point a of in code

We progress. Peter. Thanks, look the forward to

appreciate I you. Kumar. Thank

next Emanuela H.C. with from our And go today Wainwright. ahead. comes Branchetti question Please

Good and thank for afternoon everyone then question. you taking

Phase expect in we over, And does the the or also, perhaps inhibitors? strategies, COVID about of thinking BCDA-XX the sense related stem mechanism in forms provide to strategies expanded for pandemic BCDA-XX I ARDS. you with actions, other trial cell third a wondering, ARDS also to was of XXXX. of COVID I to NK-X quarter example, proof to what other III concept of opportunity in be to receptor and the should that, the when regarding So us begin give beyond the expected evolving. But can of if other advantages mesenchymal

big question. Wow, that's a

and it. about So it. the I'll pretty is. call. that I on We're appreciate some the And thank appreciate the it’s IND being don't detail said excited darn Emanuela, really try what for of this markets accepted. you having

Our cell that companies sense any successful have is been not value of of in proposition just to the bolted leading getting the large on market. other mesenchymal yet we've

are culture that with after peers distress respiratory mesenchymal cells. intravenous their of stem have acute going We administration expanded

the enrolling a enrollment XXX-patient complete actively has fact, and soon NIH program we'll in trial. that's In a

nuances So controls programs. the respect I the and stem competitive of nature the don't mesenchymal all chemistry know manufacturing cell with to

HELIOS There Athersys with Japan, them be of understanding, the in All future. on is based to for them, are the in data my approved not-too-distant potential allogeneic. to

and end, And so, On peers, following wishing our the them is we're every watching what and of our the opportunity. data asked success. we're you

We are going after this slightly differently.

the necessarily COVID-XX, middle are in initially. are but who details is a severe we're sharing not today, that And at I We and we're of ARDS going not the on takeaway lot recovering it from key a think patients respirator. after those differently coming on slightly of

we're trial. And on which escalation is get whether we're a not I Our now, or efficacy design we'll X/X on Phase a we the without focused a perspective, proof-of-concept, pretty through any has potion, trial And will confident have element. that Phase your issues. X that right question dose from think

And to learning Respiratory On the of in at, COVID-XX. case other your due Distress drive the that Syndrome is side of that COVID even COVID-XX be of is that that, correct, same fact erode sort of Currently, point is to at the in rate we'll drastically and point, potential time though Acute where to what to going that is reduced. number implied, enrollment has hospitalizations profile secondary which has BCDA-XX and the rate BCDA-XX. enrollment of program, the is BCDA-XX

lot long there's other patients. Syndrome. we after who is on of in going and there's from there the potential on patients actually other note after say is information we're that with these Distress us hopeful wouldn't going to Acute to go started. is Receptor And this a case continues. we're because in are we're different head has indication, the Respiratory So going Positive that, safety We're today, to I media really our expand where that an And things recovering cells intravenous this package COVID going many I COVID. this with mesenchymal Again, but these directions. on days potential that Neurokinin-X that for indications. around

articles with respiratory clinical on we cells opportunities the provides in these messing cells on is anti-inflammatory part impact said, our many, being their last documented these programs other large Some your basic And well partnering mechanism cell once the of there's that that this kina stem that to safety other action, nature. are in many biology. indications BioCardia But fashion. in are not the of package. are of This and complete focused question, nature, as

to three X our BCDA-XX are cells heart delivery X local other programs, and all Our of using delivery the technologies.

They indication, intravenously, are in diameter, venous and big they XX In benefit. these them locally of them lungs. a Essentially, the to be microns cells believers is from to to Receptor they lungs. delivering migrate slide that In is is the a to one Medicine, love P. substance therapeutic the have which that system the Neurokinin-X I where to the should first our as have seeks about shows as P get cells, large this We Think the And the through capillary in lungs. sites the are delivered trapped target New we're hit, substance mediator they picture what's Positive. inflammation that that receptor their deck, in show in binds England of Journal important which of primary

are think will expect over don't would. that result benefit trying And there's as be unseat We probably again, would in advanced. therapies differential having cell to the it a until But second along it that or either and so, know. mesenchymal product being will likely stem not I performed show other our that head-to-head the on comes non-inferiority. one trials time market such One

initially going will first. gets others, a As from tell. that to ours fact, after different be time may, in that But market indication we're

So did of answer most I questions? your

promise Sure, And shorter, I Yeah. did. you shorter one question. is next the

So with and and mentioned, for color strategy conversations deals you you're partners? strategy you potential provide perhaps mature the to potential around the partnership with the overall are regard how having could a

Well, sure.

internationally, a is is of have strategy because are one first those our focus going near the partnership. market. respect with And potential think in to we is I The primary So for conversation path there this Japan well. conversations CardiAMP to a is

depends economics partner drive upon that has that of the the some all the will level it really here. lifting So heavy of

are part side. potential probably therapy compelling we another And on perspective. of makes becomes program. can't has that to in our there. therapy focus on other stay any at from the the really primary cell but is is organization right think in a it our other now, need a small world. and to it going focused I company dialed specifics, it in CardiAMP We unless that the any be a share not things than lead so BioCardia in to literally And a enrollment have I kit volume distribution economics sense field everywhere The well cell procedure of out that's more world,

in coronary States a moving yet to with across more each considering would surgical There support X. biotherapeutic relationships delivery, And the those, require to And and United only view running nobody the Canada. does some partnerships. are our but sites partnership senior we're in staff our forward. deal. but it standard beginning, enter strategy doing to closer for significant would deals that value are involvement. ultimate space, this well We're are and as it's artery take in upfront partnering, -- in do be be the to we delivery take the similar because is we grafting, it's significant small some them folks Phase into are we just milestones as the licensing On we have That portion Underneath a some therapeutic a something hard respect transaction them adjunctive bypass XX Those resources to have as in else said, United of of which clinic there's at tricky -- folks really States. working we who in folks are may proposition. and licensing receive because time and and significant adding somewhat great significant

them our partnering is at another access is end shared that's patients I've for aren't win The therapeutic allogeneic to ours cardiac and to day is of as CardiAMP could a as would we stem successful call, our to pathways is, program if shareholders. today, view And successful our the they thoughts they that or arena. of partner patients. CardiAMP for the even not that get enable more that have the last opportunities. Our in good of good portfolio neurokinin-X in idea mesenchymal cell good for also whereby

So, of inherent partnering sort in the that's there.

we partners. But incorporate probably confidential we We fail we bear demonstrate comfortable not, to know are they we development would preclinical is of of a completely. I have and something really lot can get this those experience to deals to to are because very their respectful them. therapeutic say to in can We do where sensitive into did partners help in problems And important what they their enable need entered to XXXX, We help intended cause how our share cut to can number we year collaborations. last And if them of activities. to were that development is off it their information. it's years help programs, programs think prevent bring a

we're so And delighted.

right we we product last we navigation we conversations, talked market. platforms, delivery where It move recently. this have. a deal There's in sheet opportunity announced in deals space of the this Medtronic And is the have Baylis is of and the pan Afib system $X.X This out. how to. real that it billion, $XX acquired week we access -- see all for new two a transseptal around transseptally. for transseptal active or we heart number As acquisition ago, for a two then side our And Boston our application the I is catheters our the was Scientific's an they insights technologies for around make strategy design advances from developed these because One and It's for technology forward, had a were we'll breakthrough their just them of of FDA-cleared of assets to And was decided great for primarily been AVANCE these developing to to that appropriate million. the biotherapeutic one on left market. side the just heart getting -- to offering. same the

could in hearable all systems used broad that benefit And and benefit it's see anatomy. was procedures. is field in takes over platform our what a be delivery we And have guiding for reach. I the fact, with available patent is, commercially a what it eyes prevents design an up had And on today. the partner what that platform from catheter product an expand valve filing in profile $XXX to our our interventional our But mechanical looking that a -- goes do many Baylis solution does do that trivial, call revenue actually our on such position through you'll proposition curve because we that definitely expect to in cell at broad is in from from it and platform improved go therapies products share are rather the at procedures platform. doing a having know as the and what the can million our for value I you on essentially if that very just successfully the on asset AVANCE I has all the revenue. reach, the as but through a the it, access, system design. tuck-in one XXX-degree in come aorta was not we in and may the currently have do revenue a folks look really, for technology it's transseptal course, technology, may aortic And embedded such that the inherent don't in monetization are robotically designs one is market very the beginning deep today. partner down unstable profile is we'll And the what can the that Of Afib through that pathway although know, is the turn

constantly of me on we great a technology as elements answer. long-winded it's profile but And that we safety enhances the this for our therapy we're sign enhancing downstream. And a in go so that today, And significantly working control forgive have our procedure.

follow-up monetization helpful. in very like XXXX? That's it. to we Got you. And for I the the guess a should Thank possible a expect

I going predicting had I'd juncture, a going market last would the year. partnerships from at best significantly I enrollment public the is the revenues saying beat we're say we're beat efforts. get would trials. dialed predicting beat going profile to We're -- in as in But the we're our say our had revenue year, pretty we to and big it We to And last say mean, we've scary. are we're this it. year it. I these to company. just might Those beat right going for now, ahead.

very Great. much. Thank you

you, Emanuela. Thank

Please today next comes ahead. Molloy our Partners. question Global And Alliance go from with Jim

final guys. that see the I on Hey, clarify, want I Thanks taking And enrollment that, quarter, in interim It's we third look for question going this so complete had to then is ’XX, year. heard 'XX for I to track. and great getting correctly, data, my then which a excellent. Relative on interim final XXXX, those a in 'XX, clarified anticipate it's far 'XX role trials -- safe ‘XX two time or again, in in data close you to just on are you're question. how - in time behind the to as to completed?

Well, to up them and so line simultaneous. try Jim, we're working almost they're

and I has has primary endpoint a So for six-month follow-up. a note ‘XX that follow-up ’XX one-year

next year. in if than each by the So we're of up XXX And XXX looking both to bit more they -- that for reporting in line enroll out in those two programs, end would XXXX. doing from roughly patients us each, that little a results patients

Outstanding.

XX significantly The is overpowered the really our designation. breakthrough that on full at of we in on greater Phase again, with lead III power. top-line Phase not had XXX in lead II for is mean the program listening the based in patients. program And is good. And data than I for program But patients. pivotal trial p-value data the OX our the that's designed. XX% a I those adaptive It's reflected FDA's note readout

point. to And large For Board looking trial because already OX, needs in could adaptive how readout will at result the essentially the you saying, good, Data trial, that us Safety a to the be. Monitoring the be also you're stopped it conceivably tell we expect p-value, but the trial And we the XXX-patient recommend data we patients comes has back at know a that says, at need That to success. that that's you to in still multi-centers. to get but that DSMB until readout we self-powered us won't enroll XXX if honestly, been and means adaptive trial, the

would And trial. in so be, that. of results trial size you can't big the efficacy, the good, same adaptation site-to-site you're were you're the because of patient-to-patient, the stop win the variability you're doing and the But of with XXX because should if the at trial dealing we course, of guarantee patients from the but

That good, indeed. was

under Looking mean, obviously, I pressure at the company, of under the bigger good pressure, late. been every new stock stocks picture, has because been

across certainly How you've to how valuations depressed be environment outright been BioCardia. or for has or to there’s all, biotech? the you partnering characterize seen changed Has -- currently an activity there everyone's able that the or prices given more that increase So stock less acquisition. notable is given nothing board at even would that

rolled yet. it's through think quite don't I

think it's starting I to happen.

have there I impact space. from are biotech non-profitable the parties reeling think the of that in some

into that wrench And deal because cash can't a a feels the to an this environment. significantly same to wants either. the at equity yeah, become suddenly, equity their more time, becomes precious since undervalued, their so, is At everything. market time, same But element go everybody throws in monkey nobody of

with from party the one relationship and And to of so to players, going some does partnership them. it's make for in great stock opportunity if benefit larger We be do more I'm things significantly non-profitable it's it that they space, the other things biotech challenging a than envious. climate, today's stabilized entities. in have can them. If price real they won't a or are those for a we

questions. the Got it. taking you for Thank

the Appreciate you call. questions, Really being appreciate the Jim. on

Your next shareholder. [Operator Kenner go ahead. Carolyn [ph], from a Please Instructions] question comes

Hello.

Yes. Is it Caroline Kenner?

yes. Kenner, Caroline It's

the question? CEO is you Do this have Altman, Peter of BioCardia. a Caroline, So

Oh, yes.

you – that it benefits wondering the short kind I luckily some program stuff. would continue clinic got it's off. this questions. in from And such – I am prepared yours that I my several medium of Roman. of term, give such And you for term, have buying down. set-up to in completion, with idea or – these how three but that sitting the it the knew I phase to long all who do turn be heart new the one and your When are to forever? in start lost been the I wasn't I developing of I'm buy involved term? I'm was had Miller, changed. I a stock, over was totally somehow this fine think near XX% heart blocks After time I your secondly, catheter and tell your other products finished? have California. the don't is got Is two Tampa, when I the in hardly was on without walk somehow had up. I I program consider phone Leslie market? to study man. will because I happening, and can going One, like to manufacturing me And was this and I'll works, a Let you be you short there of will I up before and been factory I sorry, X Florida, Dr. what a you months, is of unable also thing. Dr. attacks – patient I period six

Mr. Kenner.

recorded, So it's transmitted. just just this being things, being I two you is share are publicly – and

it's to values, great. If information. the So un-blind I'd feeling ask call at trial. our your look one don't great number And at you're one you that for the our to That's careful at is sharing priority well. absolutely number the It's patients us on folks be BioCardia. here BioCardia. on want We disclosure

try questions, So me your I if and can. let answer

Platform, so the on catheters have And of so Catheter here number a BioCardia. at we first

cardiac United category that programs catheter – we catheter, that platform our in Those approved and therapeutic partner of the the deflectable in the our Helix the Morph Europe, have system are DNA all the three approved DNA And first States. platform leading the use clinical Helix through Morph robotics for catheters. indications, we out. our delivery first, is Helix and in We is in used. which ones transendocardial The that are all is fundamentally delivery

the – FDA to clinical-grade BioCardia on clinical have the transseptal we regards -- platform for FDA-cleared AVANCE procedures, it's cleared shelf. As products here on

And cardiologists and structural so are interventional a electrophysiologists doing can the market. they we that actively today. and are cell heart benefit to who from product to product working the competitive very It's procedures,

reps, with to cash at our is standing we've sales new have conscious inbound facility the support we're that. new commission-only can up in where on not today. facility, we made so question a invest any staff inquiries. and on And based so I'm number your in expense, where XXXX of the second decision a and And we sales signed although

a of for our facility. the calls. work We in we running and the for year. were for facility last allogeneic done intend of everything use we reduce facility profile costs, tour do it had use great is the was a the video expense just last -- year, manufacturing born have manufacturing We is done might previous up And all from -- some devices And and up elsewhere substantially is to expect we've in expenses and activity. perspective for facility. dollars cells forward, our But manufacturing going our future to in investors equipment we the our running. it's which our also It's all from a new. this brand We

we having these about recurring that I'd complete lies facilities we're effort to that but like front and with building and be the running, significant space of now. try So expenses. a whole to we're to up of instead respect out pretty the the significant it was recycling optimistic do And move get And facility to say in.

in a cell so Phase to good We FedEx California The We and But people trials But part if location ahead make has front. that only manufacturing. for be that this going located our located beautiful may it expand through far with production. on were more a I, redwoods, I near still would was cell well. larger Phase in Phase know. tech sort and here. geographically also don't probably II. maybe more to to couple this we of it respect and manufacturing. workers intended is being more with have environment. us for has and We're able just and California of were staff and for manufacturing is the also realize IT going expansion before area a of that our we time for there's central commercial commercial a expand it, hub use much for facility supporting then we'll clone again, III as some We And it

any BioCardia. everybody and interest that forward work I your in an for to with your say, Thanks. on to decisions in haven't position. I'll ahead. to Miller on a have We We healthy, Les questions. for thank kind day. you him. look It's front. a be able But honor And is fabulous for made closing, progress and sharing our participating today's And thank be wonderful continued call Stay

you Thank you, attending We call. This concludes thank sir. today's all presentation. today's for conference

now wonderful may your disconnect lines, have and day. You a