BEAT - Earnings call transcript Q1 2024

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings, and welcome to the HeartBeam First Quarter 2024 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.

Before we begin the formal presentation, I would like to remind everyone that statements made on this call and webcast may include predictions, estimates or other information that might be considered forward-looking.

While these forward-looking statements represent our current judgment on what the future holds, they are subject to risks and uncertainties that could cause actual results to differ materially.

You are cautioned not to place undue reliance on these forward-looking statements, which reflect our opinions only as of the date of the presentation. of that release not revision the forward-looking in mind revise ourselves to in future statements publicly or or results light keep we obligating are to these events. Please information new of any Throughout important relating today's affect predictions. to some may factors that discussion, attempt business present will our we to our

other for complete discussion of should our recent most Risk more You under Form XX-K heading factors a and risks, also review and particularly the Form XX-Q these Factors.

results these available detailing release the Relations wires of is press A website, and afternoon crossed in section this Investor the heartbeam.com. our company's

Your host results XXXX. today, Chief Rob Executive quarter operations Branislav Brounstein, Officer, and Financial first Officer XX, of and Eno, Consulting Vajdic, March Rick Founder; for Chief present will the President; ended

the I to Vajdic. this over Branislav Officer, will HeartBeam go Executive At ahead. Please turn call Chief time,

Branislav Vajdic

different by Thank a VECG It important to on to giving understand our today. technologies the than that personal brief are ECG overview is definitely you, like our technology. operator. HeartBeam and the most is and market I'd how common more powerful start of technology

one by is at ECG many hospitals technologies performed are most be clinics. the the consumers standard XX-lead A in diagnostic tests and can that ECG patients There commonly or used and of home.

to of institution. full the cardiac a but many clinicians side. aim of heart the X-lead including synthesizes heart see or of detecting easy-to-use ECGs. quickly card-sized sufficient of is that They can key X-lead XX-lead is or conditions, technologies. attack, for couple the ECG. slide they not an right-hand this AIMIGo HeartBeam's arrhythmias, X-lead, are You is to are technology examples defects help ECG range on The the medical outside on Instead, identify and not accurately XX-lead contrast, it's a This credit detect arrhythmias. In complex adequate the HeartBeam system

believe time symptoms it to with intervention attack cardiac device, time critical by could and we to a Shortening cloud-based of reduce many room triage the evaluation to for health also in patients smartphone symptoms from facility and number software, the a care. emergency unnecessary reduce reduce physicians, would facilitates effective of the AIMIGo remote An and could costs the app and hands save of the coupled heart of The tool visits diagnostic patients. medical reduce door complications the lives.

why do transformational? patients ECG XX-lead that think easy-to-use an is So we with

they XX-lead carries diagnostic has variety the a patients potentially by First, reading take for settings of patient over frequent ability value. will ECG time huge XX-lead that be physician. a to can real-life get feeling symptoms, reviewed Whenever readings is in a

to and guide trending tracking ECGs create will XX-lead a condition. insights Secondly, cardiac allow a time insightful help symptomatic the way of ECGs, care. Frequent physicians gain cardiac over and both of XX-lead asymptomatic, trending to

deep with of predictive diagnostic combining Finally, ECGs longitudinally collected to learning algorithm. have our number a the an potential unsurpassed and large algorithms create

a $X We States, have In There the artery AFib $XX million approximately a coronary patients, patients, which there XX artery billion address coronary the is approximately the larger. market. market. market, are X also representing but only Xx is atrial to market, the fibrillation opportunity which disease billion million United are disease not

only the overall U.S. in is the $XX So about opportunity billion.

President, over now to turn the our like I'd call to Robbie.

Robert Eno

Thanks, on Branislav. to to We next an AIMIGo. update related progress wanted our give

milestone result platform the approach believe for FDA. by our run, In in the an diagnostic this for to AI it's be of capabilities. that to data on the we several expect important predictive The excellent the be the for efforts. reasons. start, company, an will it's patient-held XD is and To VECG further for clearance FDA unsurpassed be HeartBeam, will algorithms initial we be applying could Also, AIMIGo the basis cleared clearance so Our VECG system top submissions the of major a for algorithms. for the first AI and cornerstone XD device this rich longer VECG

had Our XX-lead the reading resulted in Adding a landmark ability study, technology that published comparison, of as diagnostic accuracy in crucial better our for JACC: ECG. Advances occlusions. similar ECG is in year, detecting last coronary August XX-lead a significantly a part a VECG single AIMIGo of baseline in which system showed than

XXX(k) the and XXX(k) the our for a system. wireless cornerstone the a is FDA We as submission our phase of We of from review FDA device, passed will have remains completed future with for efforts. submitted This the and have AIMIGo The regulatory patient the successfully quarter XD XXXX. second communications have a system the The with the physician application be and review among VECG substantive filing portal requests we FDA. and application under basis in questions AIMIGo the the of HeartBeam includes with elements. initial active review acceptance application,

the process are of these complete Once We to FDA official and our questions have agreed-upon open conducted submitted, the finalizing in address testing will their are review. responses. FDA's the

by XXXX Our we of remains launch and track, by line QX end time of limited of clearance followed XXXX. a the by AIMIGo on anticipate the end

which the VECG AIMIGo clearance be baseline XD system, and focused from physician XX-lead we a will the ECGs, the clearance signals. FDA XD synthesized working the the to on a second are both ability VECG offer symptomatic pair Following to of of obtain to of

pivotal second to part to VALID-ECG study. XXX(k) planned by submission a be be A this submitted of FDA QX XXXX. study, application is our will key This

with objective comparing XX-lead in in simultaneously quantitative and assessment a announced designed patients forms a wave ECG its of and of and AIMIGo's amplitudes. As XX-lead ECG to synthesized recorded have validate intervals XX-lead this primary first to study, by we enrolled ECG each qualitative demonstrate pivotal results hospital-based software ECG between the AIMIGo is is XX-lead which methodologies. FDA-cleared The the standard the those March, we ECG standard synthesis both subject using assessing by similarities in

to which of total pilot adult have approximately mirrors and an second XXXX QX the results, study these pivotal submission preparation patients. anticipate And study, XX-patient Currently, we this a study, of XX% we XXX application We the pivotal by study. of we on the enrollment based In the more for in enroll plan XXXX. than completed of of QX patients. enrolled completion VALID-ECG pilot XXX(k)

we've program discussed conference underway. previous As have active we an on AI calls,

X have million from XX-lead acquired ECGs We development sources, element various approximately a key AI fast-paced our efforts. in

initial have developed detect to deep on cardiac We learning the arrhythmias. ability focused algorithms various

conferences. its algorithm has team had at for data accepted learning Our electrophysiology prestigious on X presentation deep

in and We conditions, the including believe provide user additional experience automated enhance classification that, credit further the of number HeartBeam's XD AIMIGo and result technology, and, potential simplify our will to onboarding card-sized in and capabilities. run, process with to patients unsurpassed VECG combined when diagnostic a ways, physicians cardiac the the predictive longer of in AI value could

The first HeartBeam Results Dr. were algorithm, of presented Director scientific Cardiac Reddy, April. Sinai the by at deep of AI, was European the Services company's in Mount conference at presentation Vivek Heart the Arrhythmia Association learning Rhythm Hospital.

The ECG opportunity what and VECG, care that delivers study a in algorithm over fill greatly with and XX-lead atrial that performance obtaining challenging. is for ECG capabilities HeartBeam is showed offers health This flutter of improves equivalent AI, a a gaps to available inequality when beyond a combined detection detection XX-lead today presents an VECG-based arrhythmia VECG. to single

will held in on data the Boston learning be be Rhythm algorithm to deep presented next at our Conference week. Additional Heart Society

over our now to turn CFO, consulting Brounstein. the to Rick call like I'd

Rick Brounstein

review press a closed will results. available financial Thank regulatory is the wire filings now you, full give in market Rob. our sent across breakdown I brief today. the of our A and release after

$X.X XXXX expenses compared and were first million the for quarter of million $X.X administrative quarter General first for the of XXXX. to

first of million for the development XXXX to compared quarter $X.X quarter and XXXX. expenses for the $X.X first were million Research of

net $X.X XXXX. to for first million for The million first of quarter loss was the $X.X loss of net XXXX of quarter the compared a

Net cash Our totaled cash equivalents of to million cash operations December million as XX, ended $X.X XX was XX, $XX.X for million March used the of months in $XX.X as and X March XXXX. compared XXXX.

remain sufficient phase pace into milestones have move get the to AIMIGo. our We deliver that confident on prepared funds and commercial to HeartBeam of and we

for his closing thoughts. now will call over turn to back I the Branislav

Branislav Vajdic

Rick. Thanks,

exciting is is pivotal HeartBeam, this conclusion, and for in in year time evolution. So an our company a XXXX

be our cleared, of device When and system ECG health the be the IP-protected I It developments. robust many will patient foundation first by FDA for as want XD company. will to the for cleared be reiterate that will FDA. to clearance a be future serving foundational it AIMIGo the also

passed completed made have and successfully We significant substantive progress the clearance, the AIMIGo having filing acceptance the phase. review the initial on of have

review. the all regulatory and the raised work of are to submitted to the and FDA. FDA, FDA available tools near formal taken our have the testing complete are we by opportunities responses will their questions in the finalizing responses advantage and future, interactively these our Once We with

number end foundational clearance a anticipate QX clearance reasons. This initial to continue We this by of the of of is year. for

that the XX-lead our Currently, First, patients XX% it basis the synthesis generates study. be the than algorithm VALID-ECG second enrolled in software. we of more will on have the of submission the

submit this submission. We of XX-lead key synthesis results study to will as of a element this the FDA the pivotal

and Second, Society XD presentation algorithms HeartBeam for week. we are first Association as look the next developing VECG the in We second at Heart presented scientific signals the AI the presentation Rhythm Rhythm to European learning deep on making using conference, Boston inputs. meeting forward the Heart

our AI the With both will pipeline product robust as efforts, patch AIMIGo a from patient-friendly algorithm advances will expanding our XX-lead the advance foundation. we upon XX-lead synthesis watch. build to initial Finally, indications, on-demand clearance such to factors, as and form XX-lead to and we AI-enhanced continue the

to solution factors. in applicable has is be monitoring believe our ambulatory We and most of potential that technology a advanced the cardiac number VECG the form

we In by technology. the discussions and go-to-market encouraged with interest our early clearance, their our and partners in strategy industry refining anticipation are of our are FDA

time We and We ended cash to deliver have in equivalents. million cash confident of year sufficient this on we quarter lines. that with our remain the funds $XX.X

providing forward look the to future. updates further with near in I our shareholders

your now for We Operator? questions. like team answer attending. thank all the would to HeartBeam And you

Operator

[Operator Instructions] first from Leo Carpio The question Joseph from Gunnar. comes

Leo Carpio

slide, was And are to it some seeing was would us wondering you go-to-market base, of were the A Could you recall, if you their who a players I strategy. the of that. you specialists here industry and private practice patient your If and exactly in change strategy? leaders remind your refining with? to your question. I'm buy roll and ability quick I you're the have so product their target out said practice speaking and trying bit which on there's what to

Branislav Vajdic

Leo. Thanks, Rob?

Robert Eno

Sure. Yes.

we go-to-market is together refinement, as in far get strategy, on that. the ability that we Yes, going As aggregated product. as undertaking before, segment, these clearance, effort the are closer for after where described and the obviously, FDA pay directly the the willingness patient pay to the so working are as we're patients we're to

cases use out advantage value-based other also of market there. segments care and other within that taking We at are looking are a number of

it's Branislav a going But product, explore So for where that various get to and continue of different get potential that's at as something those. we number we're there's the things we're by meant segments. to closer. uncovering what market We're you the continuing more information a fit and looking we think on to update

also after want first the I beta we're what clearance is effort testing do the mention to to But a going that phase. calling we're

So That, do studies this product, optimizing additional the continuing on as and we're real-world is to the everything. patients work optimal getting about VALID-ECG. testing beyond experience the experience really clinical as the clinical end-to-end physicians, understanding system, for really well some with really

finalizing phase the that and So we've year. strategy see into upon of described going clearance, immediately the the while end we're launches ultimate at around fine-tuning the you'll limited the us launch

our And We're technology, applicable we're technology as is partners. industry well with of partnerships sales at technology by with form being number element, own a partners in discussions other number in ECG as going looking the AIMIGo's the that We the Branislav force potential early the encouraged we're powerful then touch to building having on direct, think of most a different has factors. really ambulatory areas. of VECG and mentioned

at a of ways. So number we're different potential industry in really partners looking

and a on building general, to wanted about to about, fit, that talk go-to-market we're details any to strategy working in little a form partners potential talking factors. our early directly underscore but there, across obviously, So just

Operator

[Operator Hamilton. Instructions] phone. on There would the are like questions Brooks to I no over to turn further it

Brooks Hamilton

First you can more question on clearance? just the timing of FDA provide detail from the webcast, the

Branislav Vajdic

the to here the already discussions much with not pleased add today. the is we there with Overall, our agency what are Well, discussed we tenor of and progress. to

year. to finalizing are of the that we progress their be they we the questions clearance we asked very QX As within timely related we we'll to and that made mentioned, light, have answers the materials enable questions. this have expect to In

Brooks Hamilton

you. Thank

Next you is mentioned the enrolling. the latest webcast that question, What that is on VALID-ECG study status?

Branislav Vajdic

go please ahead. Rob,

Robert Eno

Sure.

of mentioned, XXX X up to enrolling total we a sites. and patients as at we're we're So

are now Heart we're really Mount Atlanta the running of Specialists, enrolling the then that. sites and Network, Island Northwell The X are Piedmont Health and part pleased All of so sites Hospital, patients, up Allegheny Long Sinai and and with Heart Institute system. Jewish

So and more patients, track And we're enrollment all are up QX. running and X than finish and are that we'll XX% We're pleased really how on is in goals enrolled. to our going. to and of those enrolling with we expect enrollment continue relative

of between simultaneously. And wave this to our XX-lead synthesized designing the reiterate, then element compare to second we're submission forms an the standard just and because recorded XX-lead study ECG is important the the

enrollment quarter. and the all very well this and up with finish of progressing running So more half to expect enrollment and sites completed than

Brooks Hamilton

the you're of the flutter. on in question AI update, focusing you Can Next that? explain atrial webcast, from your significance

Branislav Vajdic

arrhythmia, is If are to flutter and it in facing existing untreated, ECG the lead important with. and can one struggling general, variables, of an patients strokes. Atrial undetected technologies

Our and AI clinical do atrial differentiating technology fibrillation sinus our flutter atrial normal the can actually the of data rhythm. HeartBeam our excellent in shows and VECG job identifying an technology that and from combination

this, synthesized data, extremely clinical is these VECG example so seen an but arrhythmia course, a further and is encouraging. of conditions, it of have far on forward can look complex We identify. Beyond we the what to XX-lead

of AI would with big the our XX-lead time ability be for an ECG, from the stems and application synthesized difference, demonstrated first with combining for will perhaps, foremost, is equipped and diagnostic ECGs of out That, VECG that offering a that like at the a tool an now and one existing the XX-lead the looking value power combined makes the but I'd I VECG powerful a who patients make And also AI. to with this more point for will to of picture, physicians algorithms. say suggestion

Brooks Hamilton

that's I'll the Vajdic like Dr. looks It for over it call questions. the webcast remarks. right. closing to his All back now turn for

Branislav Vajdic

conference. contact appreciate And this point, look have all conclude this at not your IR We continuing So very Group, for with please our MZ questions we'd to do dialogue forward investors. we if today, covered to not further to like interactions. our attendance we and much firm, hesitate

and again, a good you Thank have day.

Operator

attending The Thank today's conference has for presentation. concluded. now you

may disconnect. now You

HeartBeam (BEAT) 9 May 242024 Q1 Earnings call transcript