PLSE - Earnings call transcript Q3 2024

specialties, nano-PFA treat benign of use the delivery to initial potential has to parallel, disposables, and end-effectors platform the called novel skin. In include of and medical the cardiology, and profound the for experience in commercialized the focus XXXX potential our on and studies. in of the and nano-PFA in markets, growing preclinical patients to significantly use its energy efforts on outcomes improve preclinical large Based select to providers. throat. platform and ears, open a These patients positive company decided developed explore and such primary invasive gynecology health of application treatment procedures used been for other tissue ablation, catheters, the a endoscopic it could surgical designed as and variety or company in sometimes the of lesions as other and the where soft as such disorders AF, minimally gastroenterology, medical variety Uecker, less its Danahy, cells or Pulse the delivers the of Good review non-thermally background, X by treat system, third afternoon. revolutionary question-and-answer I targeted of proprietary quarter the for to using Mike of to destroy remains Darrin than Chief a Nano-Pulse modality way each a tissue The adjacent million Co-Chair then while all Chief its used financial our of when for to pulses nano-PFA, us. innovation business and and cellular optimal is ablate sparing Officer solution Officer, to session. By Duggan, will will Bob noncellular that structures joining Biosciences committed potential Board; CellFX which by XXXX a joined electrical a providing novel Commercial and Technology and of Then be long Today, an technology Thank you Director; energy, Kevin patented company for of start progress, on a endoluminal impact treat has nose few a material. President both will indications to as we atrial a has unfulfilled. devices updates Koffler, Finance, results. medical second each health nanosecond in developed or duration Nano-PFA markets for energy procedures, Stimulation and have well technology company conditions Vice fibrillation, on care

million billion to a PFA commonly that much in X Our is destroy better for method unwanted is of designs the benefits remove at a and pulse to is of goal which and and X,XXXx the so which X shorter the allowing is different width than pulse This for micro shorter from used different up level, the the of product in range PFA microsecond has the technology second most both to ablation shorter. or of of potential cellular width, cells. the unique

progress of Breakthrough than for system start The TAP FDA short few also in Device nano-PFA productive was is here Pulse surgery the Designation cardiac for The are Product our U.S. even of for received in was highlights the quarter provides more and AF a Program. using Advisory Cycle with Total Europe. cardiac extremely surgery accelerated of Life treatment And the system which first program, QX. enrolled our FDA's patients since Biosciences. AF third pathways TAP Breakthrough. We treated

price right patients warrants stock and its offering, per rights $XX $XX trading warrants an $XX the if redeemed significant with Each proceeds our or potential the which for of completed is the of these $XX.XX other they progress gross redeemable XX exceeds company's also half accomplishments exercisable Each warrants the days the are in of million to are deliver warrant to company redeemable trading the days. by are mission time at with them additional units. support represent to million for the of around the exercisable share, the Warrants the exceeds the providers nano-PFA exercise expired. XX consecutive stock world. will the warrants. raising company that any subscription have are the raise and by equals We of Holders for through XXX% immediately. business technology Half our until to for $XX of exercise our if consecutive

radiation nano-PFA currently than The action with the technology multiple of PFA. and of differentiated heat, in standard body. the potential cells treatment applications micro disease or unique our demonstrated for across the has better to care destroy available states mechanism work human potential confirms even cold, of advance X a way that the different has Our of the clinical the belief indications strong to clinical the early

maintaining great property know-how, in assist competitive surgery believe continued for tissue, ablation and for which we AF across will soft ablation with to AF. Our products our with cardiac The QX endocardial are team in strides advantage. technology Pulse this protected intellectual and advancing applications our make catheter

indication. now and our to or path developing with strategy Compelling data to competitive regulatory for these centered lead each effectiveness propositions and each market payers clinical awareness commercialization stronger unique demonstrate and the to is as for applications profile compelling perspective and X the from on these to producing to benefits indications level, focused the precise products a hold regulatory currently safety of application, and We high follow devices. marketing, labels marketing a will and of selling endeavors significant the by benefit time a subsequently process and disposable seek on are technology. use attendant for of over data nano-PFA training of well indications. At perspective, also raise and specific well value involve are a our potential types differentiate the lead our of to data us as occurring each of specific clinical a single-use applications our will nano-PFA-based but across U.S. we clinical treatments, evaluated ultimately Robust These enable for the enhance plan can as differentiated for patients. devices. to hundreds understanding and advantages of X reimbursement. From occur articulate progressing clearly for clinical permitting users treatment These

approved. specific expect and help adoption We once will indications drive clinician market faster penetration

need treatments. our so-called the to Now, procedures. tissues. the thyroid, FDA claim utilize Today, as system array year, soft FDA, surgical launch use clearance soft better in tool body. Under ablation tissue number tissue into parts with intraoperative the and as our the significant products. promising deeper XXX(k) ablation current clearance can Physicians soft in such broad in provide Starting system of I breast, of percutaneous as opportunity solutions tissue the unique those a will application. for soft I Earlier patients of well tissue individual on provide procedures, received ablation obtained CellFX the will our involving this in a of this the in use other for for of each in dive ablation U.S. we from percutaneous our and soft of liver, many we updates electrode

using When it least butterfly body. A at thyroid system using gland testing noncancerous neck. that properly, patients surrounding clinicians our nodule of small benign to to thyroid, thyroid's treat a by can of thyroid to gland device tissue main front shaped producing the located hormones. nodules The metabolism. from be benign thyroid visualized ablation the isn't typically important controls within thyroid. the job ultrasound. The thyroid is and a of tumor far, control XX% impact entire soft working the the the thyroid an part of at are over debilitating is is the functions lifetime. nodule releasing develop of endocrine and can the It's uncomfortable of many the with So speed Up and body's may their the X it the distinctly adults benign

are frequency. benign Many thyroid happens remain it great undiagnosed asymptomatic. So with and nodules

nodules. benign, The are diagnosed in per about palpable with nodules benign are this for X are of of portion waiting the in eliminates the the thyroid, XXX,XXX We estimate However, women. nodules. performed worldwide palpable thyroid benign about per year. is XX% more monitor XXX,XXX remove vast the nodules thyroidectomies and main of the age incidence of and X% which year incidence of estimated nodules, in of growing the incidence each There which called thyroid entire that U.S. management these in to options a thyroidectomy. increases or about watchful majority, the year. each X.X% XXX,XXX XX% is is which prevalent performed reliably thyroid surgically fourfold is U.S., patients are U.S. to an year XX% about about the Today, palpable with to the for or is either with these about to called benign sometimes disease. Thyroidectomy nodules translating

risks with surgical organ this significant comes procedure. However, and removal associated critical of the with morbidities any

the for chronic health hormone care require replacement Importantly, with in removal therapy. of the may system, treatment patients thyroid

microwave control population the risk adoption. damage the laryngeal from market, have thermal speaking specific spread or and risky. this paresis recurrent these like makes high to ablation horned vocal We potential creates and changes cords this believe thyroid benign these the inability risk this treatment associated not critical devices nerves the to ]. The the heat-based from these called gained laryngeal in thermal devices in indications [ is ablation for of nerve the Pulse. result the cord market available spread From devices. per for hoarseness with not larynx to This have damage potential in clinicians, RF esophagus are a vocal widespread in excess cause represents ablation sensation $X to of damage of supply thermal The use billion devices nodules below believe skilled a year can with nerve these to because to voice While structures thermal like the thermal-based we nearby structures. to potentially recurrent procedure nerve the some mainly patient and inability there of of and important of spread control on thermal they U.S. do needle precisely a and

As cost program with U.S. agreements. point this date, our a have to into our under placed we as evaluation in part no market, the entry sites pilot system X of

of first months. removal deliveries are As relatively of the majority their during to needle fast part in thyroid, nodules with the month techniques patients device the no the ablation program, delivery typically the our of require clinicians not subsequent benign be the nano-PFA clinical the neck. into covering of a benign novel nodule, of and scarring positive. By have of therapy energy nano-PFA refining there needle thyroid initial from permanent procedure and relief continuing procedure. in size nano-PFA The the the is this nodule experienced surgical the benign the placing of reduction and does for experiences multiple procedural continues and electrode optimizing symptomatic thyroid The thyroid nodule delivering

potentially we another is cosmesis And the positive see of very procedure so, factor. the

XXXX. We expect to the into program expand pilot

submission primarily electrode unique leading compelling benign properties nonthermal nodule uncomfortable, of use clinical to is patient very live resection intend study intend plan bodies surgical a we percutaneous to to visible in invasive on pivotal their the research continue sites pivotal market We the today have and debilitating to to or for system excited other a and study support clinical opportunity specific FDA for well nodules. a for to in nano-PFA. nano-PFA thyroid treatment conduct modality We this to specialize nonthermal own this protocols work with these our and thyroid pioneer in is The to device to an suited develop need a We're a and a pioneering of with use benign also organ. organ-sparing choice expect the face summary, alternative. for novel We using for work to patients minimally physician-friendly of treatment with often patients. area select and device clinical ablation is benign clinicians that mid-XXXX. In the thyroid initiate the nodules. the that There to our for clinicians regulatory indication of this

We using convert majority device expect the percutaneous clinical a will that conducting quarters, our users coming also from nano-PFA needle these commercial during basis. of the clinical on assessments to

for Looking ablation ablation into future, we surgical application. further indications intend the of tissues device in to us the the soft needle clinical leads use out explore our other novel our beyond to thyroid. That

in Here, our first-in-human is Netherlands. study the underway feasibility

During we past quarter, a now patients site Netherlands. the in study opened at sites. X X second We've study treated clinical the

We are has performance demonstrated. were our efficiently. procedures encouraged acute device completed by cardiac ablation the The surgical

the agency the FDA's and in devices with to for importance. future early, communications PMA. congress differentiation and As Breakthrough we by to XX will device program. were health believe ablation study patients. its share U.S., We engagement late our able providing enroll to premarket increased the innovative a in study a results with the are FDA by status or enroll the this to by strategic This provide Designation medical in feasibility up reminder, application, Also, FDA frequent TAP's of XXXX. In Device is preliminary of the engagement approval will multicenter public to in cardiac devices of for primary facilitating prioritize this to validated parties position of key a planned patient TAP surgical review nano-PFA designed medical we access be other goal of expedite was award device. with that is and the unique at

to We pivotal actively clinical and This study. formal the for of to us with in study pivotal FDA regarding engaged have clinical plan trial IDE FDA to our design submit commence been the a IDE mid-XXXX. the should a this enable

on moving our Now, AF ablation to catheter-based endocardial application.

under currently fibrillation. is the product development of for also atrial third Our treatment

heart designed treat is and catheter nano-PFA AF. applications to inside cardiac endocardial the XXX deliver Our technology to of

catheter's pleased well feasibility to pleased case XX have safety clinical EU over and require of scheduled engaged first-in-human treated efficacy patients Our also to and procedures the quick are the that treated We're studies is and conduct device, truly our performance study with pulmonary the after the and ability observing study. catheter's clinical by Prague, usability, view We're cases users, efficiency, fully we potential clinical its where several a a chronic promise device highly The is my acutely demonstrating veins we report to of that XXX isolate successfully in underway performance show study to more year-end. will will efficacy sites XXX decades of including unparalleled. are impressed PFA ablation, in is pivotal isolate using of is are I device that investigating performance. that, AF. AF establish catheter's understand high-quality AF to including clinical to firsthand patients. the continue of now a catheter ability quickly pulmonary the having We that its additional electrophysiologists in spent the ablation development The X third-generation perform unique my to of our more working add veins past, Its times great with X the Prague efficiently ablation in device. performance. And with for of acutely the be clinical

current Additional are understanding of catheter's device, during the AF and designing Leveraging its users XXX pivotal on ease clinical in of and use performance the clinical ablation study. performance, provide procedures. will learning valuable sites different the we workflows information curve, a

electrophysiologist practice. David for he significant has years, our Medical as development confident XXX will recently catheters. strategy, us and We the a thriving announced continue FDA an our and Dr. Electrophysiology. PMA pivotal study product pivotal of pleased many ablation Chief submission David for have study year. middle Officer accomplished is joined to with we for support an David Kenigsberg AF begin will are ablation private I of to the contributions known to clinical product further the support IDE have make clinical AF to expect clinical am the catheter. To next U.S. Successful results in I

thankful catheter. They technology Additionally, a of the XXX both advance as a positive be invaluable have of join these input Natale in and providers. Jacob Their adviser. as maximize and have Austin, is will EP the patients join strong who catheter. believe Koruth, we our impact joining Drs. this insightful this to of advisers, the We're the guidance thought-leading key and is of world-renowned and to evaluations for also efforts medical nano-PFA potential electrophysiologist, testament instrumental existing Andrea our XXX and to Reddy our Texas, Dr. our Vivek team EPs transformative been

third financial pass the some Now, results provide to XXXX. Koffler Mike the for call to quarter I'll over

Burke Barrett	executive
Michael Koffler	executive

Pulse Biosciences (PLSE) 30 Oct 242024 Q3 Earnings call transcript