Q4 2024 Pulse Biosciences Inc Earnings Call
Operator: Thank you for standing by.
Thank you for standing by my name is morale and I will be your conference operator today.
Luella: My name is Luella, and I will be your conference operator today. At this time, I would like to welcome everyone to the Pulse Biosciences' 4th Quarter 2024 Earnings Conference Call. All lines have been placed on mute to prevent any background. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. We also ask that you limit your questions to one question and one follow-up.
Speaker Change: This time I would like to welcome everyone to the pulse Biosciences fourth quarter 2024 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you would like to ask a question. During this time simply press star followed by the <unk>.
Speaker Change: One on your telephone keypad, if you would like to withdraw your question Press Star. One again. He also asked if you limit your questions to one question and one follow up. Thank you. Please be advised that today's conference is being recorded I would now.
Luella: Thank you.
Luella: Please be advised that today's conference is being recorded.
Tripp Taylor: I would now like to turn the conference over to Tripp Taylor, Investor Relations. Please go ahead, sir. Thank you, Operator.
Trip Taylor: I would like to turn the conference over to trip Taylor Investor Relations. Please go ahead Sir.
Trip Taylor: Thank you operator before we begin I would like to inform you that comments and responses to your questions. During today's call reflect management's views as of today March 27, 2025, only and will include forward looking statements and opinions statements, including predictions estimates plans expectations.
Tripp Taylor: Before we begin, I'd like to inform you that comments and responses to your questions during today's call reflect management's views as of today, March 27, 2025, only, and will include forward-looking statements and opinion statements, including predictions, estimates, plans, expectations, and other similar information. Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the U.S. Securities and Exchange Commission. Our SEC filings can be found on our website or on the SEC's website.
Trip Taylor: Similar information.
Trip Taylor: Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties. These risks and uncertainties are more fully described in our press release issued earlier today and in our filings with the U S Securities and Exchange Commission RFC.
Trip Taylor: Our SEC filings can be found on our website or on the Sec's website investors are cautioned not to place undue reliance on forward looking statements. We disclaim any obligation to update or revise these forward looking statements. We will also discuss certain non-GAAP financial measures disclosures regarding these non-GAAP financial measures, including <unk>.
Tripp Taylor: Investors are cautioned not to place undue reliance on forward-looking statements. We disclaim any obligation to update or revise these forward-looking statements.
Tripp Taylor: We will also discuss certain non-GAAP financial measures. Disclosures regarding these non-GAAP financial measures, including reconciliations with the most comparable GAAP measures, can be found in the press release.
Speaker Change: Reconciliations with the most comparable GAAP measures can be found in the press release. Please note that this conference call will be available for audio replay on our website at pulse Biosciences Dot com in the news and events section on our Investor Relations page with that I would now like to turn the call over to co chair of the board and Chief Executive Officer.
Tripp Taylor: Please note that this conference call will be available for audio replay on our website at PulseBiosciences.com in the news and events section on our investor relations page.
Paul LaViolette: With that, I would now like to turn the call over to co-chair of the board and chief executive officer, Paul LaViolette. Thank you and good afternoon. Thank you all for joining.
Speaker Change: Sir Paul of Iowa.
Speaker Change: Thank you and good afternoon. Thank you all for joining and Paulo, Violet and I'm very pleased to be hosting my first earnings call as pulse Biosciences, CEO I'll start by introducing myself and providing updates on our progress with each of our market programs before introducing our new CFO.
Paul LaViolette: I'm Paul LaViolette and I'm very pleased to be hosting my first earnings call as Pulse Biosciences CEO.
Paul LaViolette: I'll start by introducing myself and providing updates on our progress with each of our market programs before introducing our new CFO, John Skinner, who will review the fourth quarter 2024 financial results.
Speaker Change: John Skinner, who will review the fourth quarter 2024 financial results. We will then be joined by Bob Duggan Co chair of the board for a question and answer session I would like to begin with my reasons for accepting the role as CEO at pulse Biosciences and in this context screening.
Paul LaViolette: We will then be joined by Bob Duggan, co-chair of the board, for a question and answer session.
Paul LaViolette: I'd like to begin with my reasons for accepting the role as CEO at Pulse Biosciences and, in this context, frame for investors the incredible opportunities ahead for the company. I have been a builder, an operator, and investor in the medtech space for the past 45 years and have had the rare opportunity to work directly on a long list of exciting technologies, new therapies, and large market opportunities. More recently, as a venture capitalist in medtech, I have led investments and participated as a director or board chairman of numerous innovative medtech portfolio. Prior to my decade-and-a-half as a venture investor, I was Chief Operating Officer of Boston Scientific and committed 15 years to helping build that market-leading company.
Speaker Change: For investors the incredible opportunities ahead for the company.
Speaker Change: It has been a builder and operator and investor in the Med Tech space for the past 45 years and it has the rare opportunity to work directly on a long list of exciting technologies, new therapies and large market opportunities more recently as the venture capital has been met.
Speaker Change: I have led investments and participated as a director of board chairman of numerous innovative med tech portfolio companies.
Speaker Change: Prior to my decade, and a half as eventual Investor I was chief operating officer of Boston Scientific and committed 15 years to helping build that market leading company.
Paul LaViolette: As I became aware of Pulse Biosciences and its unique nanosecond PFA technology, I quickly concluded that I've rarely, if ever, seen such a strong combination of proprietary technology, clinical potential, and market opportunities converging into a single focused medtech company. As a result of this assessment, my decision to join the board was natural, and when the board asked me to become CEO, I found the opportunity irresistible. I feel my decades of highly relevant experience and my passion for building great teams and important new therapies will help propel Pulse in its current mission as a clinical development stage company and its next mission as a scaling commercial growth company.
Speaker Change: I became aware of pulse biosciences, and its unique nanosecond PSA technology I quickly concluded that I rarely if ever seen such a strong combination of proprietary technology clinical potential end market opportunities converging into a single focused med Tech company as.
Speaker Change: As a result of this assessment my decision to join the board was natural and when the Board asked me to become CEO I found the opportunity irresistible I feel my decades of highly relevant experience and my passion for building great teams and important new therapies will help propel pulse.
Speaker Change: And its current mission as a clinical development stage company and its next mission as a scaling commercial growth company.
Paul LaViolette: I am now two-and-a-half months into the CEO role, and my impressions of Pulse have been reinforced as my conviction in the value proposition and business opportunity has deepened. The novelty of nanosecond PFA, the strength of our team and board, the preclinical and developing clinical data, large and growing market opportunities, and our strong balance strategy combine to create a genuine and energized excitement that I know I share with every member of the Pulse Biosciences team. More specifically, I am pleased with our progress in the early commercialization steps of our percutaneous electrode to deliver soft tissue ablation for benign thyroid diseases.
Speaker Change: I am now two five months into the CEO role and my impressions and pulse has been reinforced as my conviction in the value proposition and business opportunity has deepened the novelty of nanosecond PSA the strength of our team and board the preclinical and developing clinical data loss.
Speaker Change: <unk> and growing market opportunities and our strong balance sheet combined to create a genuine and energize the excitement that I know I share with every member of the pulse Biosciences team.
Speaker Change: More specifically I am pleased with our progress in the early commercialization steps of our percutaneous electrode to deliver soft tissue ablation for benign thyroid diseases. We are also executing on two clinical feasibility studies with the surgical plan to treat atrial fibrillation in cardiac <unk>.
Paul LaViolette: We are also executing on two clinical feasibility studies with the surgical clamp to treat atrial fibrillation in cardiac surgery and our 360 catheter to treat atrial fibrillation in the dynamic EP catheter market.
Speaker Change: And our 360 catheter to treat atrial fibrillation and the dynamic VP catheter market.
Paul LaViolette: To me, Pulse Biosciences is the next generation pulse field ablation company. Pulse Biosciences is committed to the therapeutic innovation with the intention and potential to improve the quality of life for millions of patients by developing and commercializing our novel nanosecond PFA therapies. Our clinical stage feasibility studies and initial commercialization suggest to me that nanosecond PFA will be a disruptive and transformative technology in multiple clinical applications and in large markets. Nanosecond PFA offers all the benefits of microsecond PFA, which, for example, is performing incredibly well in its initial launch in electric physiology. nanosecond PFA improves upon the stated benefits of microsecond PFA being non-thermal and delivering faster treatment times while staying within the same workflow.
Speaker Change: To me pulse Biosciences is the next generation pulse field ablation company.
Speaker Change: <unk> Biosciences is committed to the therapeutic innovation with the.
Speaker Change: The intention and potential to improve the quality of life for millions of patients by developing and commercializing our novel.
Speaker Change: Nanosecond, PFA therapies or clinical stage feasibility studies and initial commercialization suggests to me that nanosecond PFA will be a disruptive and transformative technology in multiple clinical applications and in large markets Nenets.
Speaker Change: And then the second PFA offers all the benefits of micro second PFA, which for example is performing incredibly well in its initial launch in electrophysiology.
Speaker Change: Nanosecond PSA improves upon this David benefits of Microsecond PFA.
Speaker Change: Thermal and delivering faster treatment times, while staying within the same workflow.
Paul LaViolette: At the same time, the proprietary elements that comprise NSPFA make it a totally unique form of pulse electric field. NSPFA delivers a significantly shorter pulse duration, given that nanosecond is in the range of billionths of a second. This allows delivery of high amplitude or voltage pulses that can create deeper lesions in shorter delivery times, with lower total energy delivered without the risk of thermal damage. At the cellular level, the mechanism of action of nanosecond PFA is unique and differentiated from microsecond PFA. Nanosecond PFA creates electroporation within the cell's internal engines of life, the organelles, which stimulates the cell to initiate regulated cell death.
Speaker Change: At the same time, the proprietary elements that comprise <unk> make it a totally unique form of pulse electric field.
Speaker Change: <unk> delivers a significantly shorter pulse duration given that nanosecond is in the range of billions of a second.
Speaker Change: This allows delivery of high amplitude or voltage pulses that can create deeper lesions in shorter delivery times with lower total energy delivered without the risk of thermal damage.
Speaker Change: At the cellular level the mechanism of action of Nanosecond PSA is unique and differentiated from microsecond PFA.
Speaker Change: Nanosecond PFA creates electroporation within the cells internal engines of life, the organelles, which stimulates the cell to initiate regulated cell death.
Paul LaViolette: The body then responds with its normal process to remove damaged cells. This is a special clinical benefit of nanosecond PFA. Altogether, this translates to nanosecond PFA's potential to improve patient outcomes for a diverse array of medical conditions. Our significantly shorter energy pulses also enable unique and more flexible product designs and potentially a better ablation method. We are seeing the preliminary results of unique nanosecond PFA therapy in our first use cases of atrial fibrillation and benign thyroid disease. It is extremely rare for one energy modality to concurrently achieve distinct therapy goals in electrophysiology with pulmonary vein isolation with our 360 catheter and for ablating benign thyroid nodules with our percutaneous electrode.
Speaker Change: He then responds with its normal process to remove damage cells. This is a special clinical benefit of nanosecond PFA.
Speaker Change: Altogether this translates to nanoseconds <unk> potential to improve patient outcomes for a diverse array of medical conditions.
Speaker Change: Our significantly shorter energy pulses also enable unique and more flexible product designs and potentially a better ablation methods. We are seeing the preliminary results of unique nanosecond PFA therapy, and our first use cases of atrial fibrillation and been.
Speaker Change: Thyroid disease. It is extremely rare for one energy modality to concurrently achieve distinct therapy goals in electrophysiology with pulmonary vein isolation with our 360 catheter and four blading benign thyroid nodules with our percutaneous electrode.
Paul LaViolette: This is why nanosecond PFA is so clearly a platform technology. Our single, cell-effects nanosecond generator system connects to each of our organ-specific applicators to produce unique PFA therapy for a myriad of anatomical targets and diseases. Pulse Biosciences is principally clinical and launch stage, while already having received seven FDA clearances, treated 6,000 patients, earned FDA breakthrough device designation for its cardiac surgical clamp, and is commercializing our first treatment within the soft tissue ablation clearance. This considerable list of technology-validating achievements represents a mature platform that can be leveraged across multiple clinical and regulatory initiatives. Our differentiated technology is protected by a portfolio of over 180 issued patents to date, covering an array of systems, methods, and devices to generate and deliver nanosecond pulse therapy.
Speaker Change: This is why nanosecond PFA is so clearly a platform technology.
Speaker Change: Single cell effects nano second generator system connect to each of our Oregon specific applicators to produce unique PSA therapy for a myriad of anatomical targets and diseases pulse.
Speaker Change: Pulse Biosciences is principally clinical and launch stage, while already having received seven FDA clearances treated 6000 patients.
Speaker Change: <unk> FDA breakthrough device designation for its cardiac surgical plant and is commercializing our first treatment within the soft tissue ablation clearance. This considerable list of technology validating achievements represents a mature platform that can be leveraged across multiple clinical and <unk>.
Speaker Change: Regulatory initiatives, our differentiated technology is protected by a portfolio of over 180 issued patents to date.
Speaker Change: Covering an array of systems methods and devices to generate and deliver nanosecond pulse therapies pulse.
Paul LaViolette: Pulse Biosciences possesses a unique therapeutic platform enabling multiple clinical programs. So let's turn our attention to our recent progress across the business and our fourth quarter update. We have had a productive period for Pulse Biosciences since our last quarterly update, and I'm proud of the team's accomplishments. We are set up to deliver on a number of important milestones that position the company favorably for an exciting 2025.
Speaker Change: <unk> Biosciences possesses a unique therapeutic platform, enabling multiple clinical programs. So let's turn our attention to our recent progress across the business and our fourth quarter update.
Speaker Change: We have had a productive period for pulse biosciences since our last quarterly update and I'm proud of the team's accomplishments. We are set up to deliver on a number of important milestones that position. The company favorably for an exciting 2025 here are a few highlights of our progress since the start.
Paul LaViolette: Here are a few highlights of our progress since the start of Q4. Clinical data on the catheter-based treatment of AF with our NF-PFA 360 catheter was presented at the AF Symposium along with a live telecast and demonstrated unprecedented procedure efficiency based on the treatment capacity of nanosecond PFA. Clinical data was presented at the American Thyroid Association and the North American Society of Interventional Thyroidology on benign thyroid module ablation using nanosecond PFA delivered with a percutaneous electrode.
Speaker Change: Art of Q4.
Speaker Change: Clinical data on the catheter based treatment of with our NSP FHA 60 catheter was presented at the <unk> Symposium, along with a live case telecast and demonstrated unprecedented procedure efficiency based on the treatment capacity of nanosecond PFA.
Speaker Change: Clinical data was presented at the American Thyroid Association and the North American Society of Interventional thyroid allergy on.
Speaker Change: On benign thyroid nodules ablation, using nanosecond PSA delivered with the percutaneous electrode.
Paul LaViolette: We appointed our new chief financial officer, John Skinner. We also added our first direct commercial resources to commence account development and the launch of our soft tissue ablation product in the U.S. Additionally, we added Dr. David Koenigsberg as chief medical officer for our electrophysiology program, a thought leader in the space, in addition to several new leaders in our clinical department to prepare Pulse for the execution of IDE clinical trials to be initiated later this year. Finally, we again strengthened the balance sheet through the exercise of warrants from the RITES offering last year.
Speaker Change: We appointed our new Chief Financial Officer, John Scanner. We also added our first direct commercial resources to commence account development and the launch of our soft tissue ablation product in the U S.
Speaker Change: Additionally, we added Dr. David Konigsberg as Chief Medical Officer for our Electrophysiology program a thought leader in this space. In addition to several new meters and our clinical department to prepare pulse to the execution of IV clinical trials to be initiated later this year.
Speaker Change: <unk> <unk>.
Speaker Change: Finally, we again strengthened the balance sheet through the exercise of warrants from the rights offering last year.
Paul LaViolette: These accomplishments are foundational for advancing our 2025 goals. Our top priorities for the year are to advance commercialization of our soft tissue ablation device in the thyroid market and to initiate IDE pivotal studies for our cardiac 360 catheter and cardiac surgical clamp.
Speaker Change: These accomplishments are foundational to advancing our 2025 goals are top priorities for the year are to advance the commercialization of our soft tissue ablation device and the thyroid market.
Speaker Change: And to initiate IBD pivotal.
Speaker Change: Pivotal studies for our cardiac 360 catheter and cardiac surgical plant now.
Paul LaViolette: Now, I will provide updates on each of our individual products. Starting with our soft tissue ablation device, the percutaneous electrode. We see tremendous market potential for our NSPFA percutaneous electrode system, which has a broad market clearance for the ablation of soft tissue, such as unwanted tumors and nodules in the thyroid, liver, and breast. As the first clinical use case, our product seems particularly well-suited as a possible treatment for benign thyroid disease, such as benign thyroid nodules. Patients diagnosed with benign thyroid disease have nodules growing on their thyroid gland that can cause discomfort given the location and surrounding anatomy in the throat.
Speaker Change: Now I will provide updates on each of our individual products.
Speaker Change: Starting with our soft tissue ablation device the percutaneous electrode.
Speaker Change: See tremendous market potential for our NSP.
Speaker Change: Percutaneous electrodes system, which has a broad market clearance for the ablation of soft tissue.
Speaker Change: As unwanted tumors and nodules in the thyroid liver and breast as.
Speaker Change: As the first clinical use case, our product teams, particularly well suited as a possible treatment for benign thyroid disease, such as benign thyroid nodules.
Speaker Change: Patients diagnosed with benign thyroid disease have nodules growing on their thyroid gland that can cause discomfort, given the location and surrounding anatomy in the throat.
Paul LaViolette: the nodule commonly continue to grow and become increasingly uncomfortable and symptomatic. Patients are faced with the difficult decision to either remove the thyroid in a surgical procedure called a thyroidectomy or avoid surgery and continue to experience the discomfort and risk having the nodule turn malignant. Permanent removal of this important gland, which controls blood pressure, body temperature and heart rate, would limit hormone production and lead to lifelong hormone replacement therapy along with a visible surgical scar. Each year in the United States, 250,000 patients are diagnosed with benign thyroid nodule. Out of this annual incident population, approximately 150,000 patients elect to undergo a thyroidectomy.
Speaker Change: The nodule, commonly continued to grow and become increasingly uncomfortable and symptomatic pay.
Speaker Change: Patients are faced with a difficult decision to either remove the thyroid in a surgical procedure called a thyroid SME or avoid surgery and continuing to experience the discomfort and risk having the nodule will turn malignant <unk>.
Speaker Change: Permanent removal of this important land, which controls blood pressure body temperature and heart rate would limit hormone production and lead to lifelong hormone replacement therapy, along with a visible surgical scar.
Speaker Change: Each year in the United States 250000 patients are diagnosed with benign thyroid nodules.
Speaker Change: Out of this annual incident population approximately 150000 patients elect to undergo a thyroidectomy.
Paul LaViolette: The remaining 100,000 patients choose to live with their condition and wait for an alternative treatment. At this point, we estimate the prevalence of watchful waiting patients with benign thyroid disease to be approximately 2 million patients. As such, the risks of surgical thyroidectomy leave this patient population severely underserved and with high interest in a safe, non-surgical alternative. Clinicians now have the opportunity with nanosecond PSA therapy. to treat benign thyroid nodules less invasively while preserving the thyroid gland and its function. Pulse Biosciences expects to see nanosecond PFA become a principal alternative and eventually first-line therapy for benign thyroid nodules.
Speaker Change: The remaining 100000 patients choose to live with their condition and wait for an alternative treatment at this point, we estimate the prevalence of watchful waiting patients with benign thyroid disease to be approximately 2 million patients.
Speaker Change: As such the risks of surgical thyroidectomy leave this patient population severely underserved and with high interest in a safe nonsurgical alternative.
Speaker Change: Clinicians now have the opportunity with nanosecond PFA therapy to treat benign thyroid nodules less invasive Lee while preserving the thyroid gland and its function pulse.
Speaker Change: Pulse Biosciences expects to see nanosecond PFA become a principal alternative and eventually first line therapy for benign thyroid nodules. The unique properties of nanosecond PFA enable a nonsurgical safe scarless.
Paul LaViolette: The unique properties of nanosecond PFA enable a non-surgical, safe, scarless, Thyroid Preserving Treatment for Patients. Delivering nanosecond PFA energy via the percutaneous electrode allows physicians to treat only the irregular nodule without impacting the greater thyroid or the surrounding clinical critical anatomy. The non-thermal ablation therapy delivered by NanoSec and PFA can be safely delivered within the sensitive surrounding structures of the thyroid with no risk of thermal damage. we believe NSPFA can replace thyroidectomies and attract patients from the watchful waiting pool to seek non-surgical treatment.
Speaker Change: Thyroid preserving treatment for patients delivering nanosecond PFA energy via the percutaneous electrode allows physicians to treat only the irregular nodule without impacting the greater fibroid or the surrounding clinical critical anatomy.
Speaker Change: The non thermal ablation therapy delivered by nanosecond PFA can be safely delivered within the sensitive surrounding structures of the thyroid with no risk of thermal damage. We believe NSP. It they can replace thyroidectomy and attract patients from the watchful waiting pool to seek.
Speaker Change: Non surgical treatment.
Paul LaViolette: We are very pleased by the quality of the preliminary data from our first in-human feasibility study conducted in Italy and presented at the American Thyroid Association 2024 Annual Meeting. The data, presented on 30 patients in three distinct cohorts, demonstrated our system's effectiveness in reducing nodule size. In Cohort 3, three patients received complete nodule treatment and achieved, on average, 83% volume reduction at one year and significant reductions in symptoms just one month after treatment without evidence of residual fibrosis or scarring that would routinely accompany radiofrequency ablation. Our Italian study, along with data from our ongoing U.S.
Speaker Change: We are very pleased by the quality of the preliminary data from our first in human feasibility study conducted in Italy and presented at the American Thyroid Association 2024 annual meeting the data presented on 30 patients in three distinct cohorts demonstrated our systems.
Speaker Change: Effectiveness in reducing nodule size in cohort three three patients received complete nodule treatment and achieved an average 83% volume reduction that one year and significant reductions in symptoms just one month after treatment without evidence of residual fibrosis.
Speaker Change: Or scarring that would routinely accompany radiofrequency ablation.
Speaker Change: Our Italian study along with data from our ongoing U S. Pilot program, we will inform the design of additional market expanding clinical trials to commence later this year to seek regulatory clearance for the device specifically as a treatment for benign thyroid nodules.
Paul LaViolette: pilot program, will inform the design of additional market-expanding clinical trials to commence later this year to seek regulatory clearance for the device specifically as a treatment for benign thyroid nodules.
Paul LaViolette: Looking further out into the future, we intend to explore other clinical indications for the use of our novel percutaneous electrode ablation device in soft tissues beyond the thyroid. Additionally, at the North American Society for Interventional Thyroidology Annual Meeting in January of this year, one of our KOLs presented encouraging early data from our pilot program that continued to demonstrate the safety and effectiveness of our nanosecond percutaneous electrode system in benign nodules. Our NSPFA system is currently being used in eight centers in the United States as part of a pilot program generating data that will allow us to scale our new therapy consistently.
Speaker Change: Looking further out into the future we intend to explore other clinical indications for the use of our novel Percutaneous electrode ablation device in soft tissues beyond the thyroid.
Speaker Change: Additionally, at the North American Society for Interventional Thyroidologist annual meeting in January of this year, one of our Kols presented encouraging early data from our pilot program that continue to demonstrate the safety and effectiveness of our nanosecond percutaneous electrodes.
Speaker Change: System in benign nodules.
Speaker Change: NSP <unk> system is currently being used in eight centers in the United States as part of.
Speaker Change: The pilot program generating data that will allow us to scale, our new therapy consistently these clinicians are refining procedural techniques and optimizing therapy delivery for our novel procedure.
Paul LaViolette: These clinicians are refining procedural techniques and optimizing therapy delivery for our novel procedure. We expect most of these clinical users will convert to using our nanosecond PFA percutaneous electrode on a commercial basis over the next several months.
Speaker Change: We expect most of these clinical users will convert two.
Speaker Change: Two using our nanosecond PFA percutaneous electrical on a commercial basis over the next several months.
Paul LaViolette: We are now hiring our first commercial resources, including capital equipment, system sales, and therapy adoption management. We have identified a pipeline of target sites based on thyroidectomy volume and interventional ultrasound-guided procedure capability. The sales process will consist of a capital sale of the console, training on device usage, and then treatment of an initial cohort of patients with some follow-up, and finally, regular commercial use within the practice. Given the absence of therapeutic alternatives in the category, our product launch will not face entrenched competitive resistance. Our initial interactions with qualifying accounts indicate strong interest for PULSA's NSPFA advanced therapy.
Speaker Change: We are now hiring our first commercial resources, including capital equipment system sales and therapy adoption managers, we have identified a pipeline of target sites based on thyroidectomy volume and intervention will ultrasound guided procedure capabilities the.
Speaker Change: The sales process will consist of a capital sale of the console training.
Speaker Change: <unk> device usage, and then treatment of an initial cohort of patients with some follow up and finally regular commercial use within the practice.
Speaker Change: Given the absence of therapeutic alternatives in the category or product launch will not face entrenched competitive resistance.
Speaker Change: Our initial interactions with qualifying accounts indicate strong interest for pulses NSP DFA advanced therapy.
Paul LaViolette: Given the strong clinical outcomes with nanosecond PFA, there is a pathway to favorable procedure reimbursement and economics. Other percutaneous technologies that are not commonly used have reimbursement, boosting our confidence in achieving reimbursement commensurate with the clinical value provided by NSPFA. Our goal over the next quarter is to continuously expand our pipeline of interested accounts and our installed base of users.
Speaker Change: Given the strong clinical outcomes with nanosecond PFA, there is a pathway to favorable procedure reimbursement and economics.
Speaker Change: Other percutaneous technologies that are not commonly used have reimbursement boosting our confidence in achieving reimbursement commensurate with the clinical value provided by NFS.
Speaker Change: Our goal over the next quarter is to continuously expand our pipeline of interested accounts and our installed base of users we will share details on our commercial progress in the coming quarters.
Paul LaViolette: We will share details on our commercial progress in the coming quarter.
Paul LaViolette: That leads us to our surgical ablation plan. Our first in-human feasibility study for the surgical cardiac clamp to treat atrial fibrillation is underway in Europe. During the past quarter, we opened a third study site in the Netherlands and have now treated 30 patients. We are encouraged by the acute performance of our cardiac surgical ablation device.
Speaker Change: That leaves us to our surgical ablation clan.
Speaker Change: Our first in human feasibility study for the surgical cardiac plant to treat atrial fibrillation is underway in Europe.
Speaker Change: During the past quarter, we opened a third study site in the Netherlands and have now treated 30 patients. We are encouraged by the acute performance of our cardiac surgical ablation device.
Paul LaViolette: The procedures were completed efficiently, and we expect to share preliminary results of the trial in late 2025.
Speaker Change: Procedures were completed efficiently.
Speaker Change: And we expect to share preliminary results of the trial in late 2025 in.
Paul LaViolette: In December, the Journal of Thoracic and Cardiovascular Surgery published results of our preclinical study which demonstrates the advantages of the NSPFA cardiac surgical system over radiofrequency technology for the ablation of cardiac tissue. The study was designed to demonstrate the safety and effectiveness of the new nanosecond pulse field ablation parallel clamp in ablating different cardiac tissue locations. Results validated the expected benefits of NSPFA as all lesions produced by this novel technology were durable, contiguous, and transmural, producing chronic exit block of pulmonary veins with no collateral damage to surrounding tissue.
Speaker Change: In December the journal of thoracic and cardiovascular surgery published results of our preclinical study, which demonstrates the advantages of the NSP FAA cardiac surgical system over radio frequency technology for the ablation of cardiac tissue.
Speaker Change: The study was designed to demonstrate the safety and effectiveness of the new nanosecond pulsed field ablation parallel plant and are bleeding different cardiac tissue locations results validated the expected benefits of NSP MFA as all lesions produced by this novel technology were durable.
Speaker Change: Contiguous and trans miro, producing chronic exit block of pulmonary veins with no collateral damage to surrounding tissue.
Paul LaViolette: We are very proud to have had these data published in the leading scientific journal in the field and look forward to generating human clinical data on par with our positive preclinical outcomes.
Speaker Change: We are very proud to have had these data published in the leading scientific journal in the field and look forward to generating human clinical data on par with our positive preclinical outcomes.
Paul LaViolette: As a reminder, the FDA awarded breakthrough device designation for our cardiac surgical clamp ablation device in July 2024, as well as inclusion in the FDA's Total Product Life Cycle Advisory, or TAP, program. We are actively engaged with our FDA review team regarding the design of our IDE pivotal clinical study and plan to submit a formal IDE to the FDA for this study by mid-year, followed by commencement of a pivotal clinical trial.
Speaker Change: As a reminder, the FDA awarded breakthrough device designation for our cardiac surgical clamp ablation device in July 2024, as well as inclusion in the Fda's total product lifecycle advisory or tap program.
Speaker Change: We are actively engaged with our FDA review team regarding the design of our pivotal clinical study and plan to submit a formal IND to the FDA for this study by mid year, followed by commencement of a pivotal clinical trial.
Paul LaViolette: Now, moving on to our 360 catheter system for AS ablation.
Speaker Change: Now moving onto our 360 catheter system for AF ablation.
Paul LaViolette: Our third product currently under development is also intended for the treatment of atrial fibrillation. Our 360 cardiac catheter system is designed to deliver nanosecond PFA technology in endocardial applications to treat AFib. Over 1.9 million patients are diagnosed with AF annually in the United States, creating an estimated $3 billion annual U.S. market solely for ablation caps. The benefits of PFA are impactful and are driving significant change in the AF treatment landscape. It is estimated that in 2024, the first year of commercialization in the U.S., PFA was used in 20% of global AF cases, which will expand to 40 to 50% in 2025.
Speaker Change: Our third product currently underdevelopment is also intended for the treatment of atrial fibrillation or $3 60, cardiac catheter system is designed to deliver nanosecond, PSA technology and endocardial applications to treat afib.
Speaker Change: Over $1 9 million patients are diagnosed with <unk> annually in the United States, creating an estimated $3 billion annual U S market slowly for ablation catheters.
Speaker Change: The benefits of PSA are impactful and are driving significant change in the treatment landscape.
Speaker Change: It is estimated that in 2020 for the first year of commercialization in the U S. PSA was used in 20% of global AF cases, which will expand to 40% to 50% in 2025.
Paul LaViolette: PFA effectiveness has also disrupted the linkage between ablation and mapping navigation systems. allowing them to be used separately on a routine basis and further changing the competitive dynamic. in the EP catheter space. From our observations, the benefits of nanosecond PFA represent another leap beyond current PFA. Our 360 full circumferential catheter breaks current treatment paradigms. By delivering less energy than required by conventional PFA systems, we produce a more pliable electrode array that delivers a full ring-shaped lesion in a single energy delivery of several seconds without needing to move or rotate the catheter. Other competitors create focal ablation points, not complete rings, increasing the time, complexity, burden, and the skill required to perform the procedure.
Speaker Change: PFA effectiveness has also disrupted the linkage between ablation and mapping navigation systems, allowing them to be used separately on a routine basis and further changing the competitive dynamics.
Speaker Change: In the EP catheter space.
Speaker Change: From our observations the benefits of nanosecond PFA represent another leak beyond current piece.
Speaker Change: Our 360 full circumferential catheter breaks current treatment paradigms by delivering less energy than required by conventional PFA systems, we produce a more pliable electrode array that delivers a full rainy shake lesion in a sim.
Speaker Change: <unk> energy delivery of several seconds without meeting to move or rotate the catheter.
Speaker Change: Other competitors create focal ablation points not complete range, increasing the time complexity burden and the skill required to perform the procedure.
Paul LaViolette: Because of the extremely short duration pulses, there also appears to be much less neuromuscular stimulation with NSPFA. Unlike other PFA devices, NSPFA requires no cardiac synchronization and no need to use paralyzing drugs to keep the patients from abruptly moving on the table during the procedure. Also, we produce deeper electric fields that can result in fully transmural lesions, that is, lesions that penetrate fully through the wall. Because of this much deeper electric field, our catheter is also much less sensitive to positioning requirements. For all these reasons, we believe our technology has the ability to deliver a faster, safer treatment with quicker recovery times and less anesthesia.
Speaker Change: Because of the extremely short duration pulses. There also appears to be much less neuromuscular stimulation with NSP MSA.
Speaker Change: Like other PSA devices, NSP FAA requires no cardiac synchronization and no need to use paralyzing drugs to keep the patients from abruptly moving on the table during the procedure.
Speaker Change: Also we produce deeper electric fields that can result in fully trans neuro lesions that is lesions that penetrate fully through the wall.
Speaker Change: Because of this much deeper electric field. Our catheter is also much less sensitive to positioning requirements.
Speaker Change: For all these reasons, we believe our technology has the ability to deliver a faster safer treatment with quicker recovery times and less anesthesia.
Paul LaViolette: We believe we have a significantly differentiated technology that could again disrupt the AF treatment landscape in a similar fashion to what microsecond PFA is doing now.
Speaker Change: We believe we have a significantly differentiated technology that could again disrupt the treatment landscape in a similar fashion to what microsecond PSA is doing now.
Paul LaViolette: We also understand robust clinical evidence is required to validate our observations and drive clinical adoption. Our late-breaking data from our first in-human feasibility study, presented by Dr. Vivek Reddy at the AF Symposium in January, is the first step in that direction. Early results were exceptional. Over 80 patients have been treated by 8 investigators, including Dr. Reddy and Professor Neuzil, in cases performed in Nahomolka Hospital in Prague and Dr. Johan Wiegand in Jessa Hospital in Hasselt, Belgium. The initial cohort of this first 30 patients treated have been evaluated by remapping, completed at three months following the ablation procedure, with additional data to be presented at the Heart Rhythm Society meeting in Q2 of this year.
Speaker Change: We also understand robust clinical evidence is required to validate our observations and drive clinical adoption.
Speaker Change: Our late breaking data from our first in human feasibility study presented by Dr. Vivek Reddy at the AF Symposium in January is the first step in that direction.
Speaker Change: Early results were exceptional over 80 patients have been treated by eight investigators, including Dr Reddy and professor noisily in cases performed.
Speaker Change: In non Homolka hospital in Prague, and Dr. Johann vegan and yet the hospital in Hasselt, Belgium.
Speaker Change: The initial cohort of this first 30 patients treated had been evaluated by re mapping completed at three months. Following the ablation procedure with additional data to be presented at the heart Rhythm Society meeting in Q2 of this year. The results of this study demonstrated that 100% of leisure.
Paul LaViolette: The results of this study demonstrated that 100% of lesions were acutely successful in conduction block. We are continuing enrollment in multiple centers and are excited to add new centers in 2025. We are very pleased with the progress we've made on our first three devices and therapeutic applications. We are poised to enter three large and growing markets with differentiated technologies backed by strong clinical evidence. To ensure we efficiently make the maximum impact possible on these markets for the benefit of patients, we are implementing a hybrid business model. Our evaluation of the market entry requirements in each therapeutic category will determine whether we approach each directly or with the support of a commercial partner.
Speaker Change: We're acutely successful in conduction block.
Speaker Change: We are continuing enrollment in multiple centers and are excited to add new centers in 2025.
Speaker Change: We are very pleased with the progress we've made on our first three devices and therapeutic applications. We are poised to enter three large and growing markets with differentiated technology backed by strong clinical evidence to ensure we efficiently make the maximum impact possible on these markets for the benefit of.
Speaker Change: Patients we are implementing a hybrid business model.
Our evaluation of the market entry requirements in each therapeutic category will determine whether we approach each directly.
Speaker Change: Or with the support of our commercial partner for.
Paul LaViolette: For a less competitive and less complex market, we will build our own commercial team and go direct. In others, with multiple established players and additional market complexity, we will partner with market-leading companies in mutually beneficial arrangements. We believe this approach will be the most capital efficient path to market. will accelerate the path of NSPFA to patients and will allow Pulse Biosciences to pursue multiple clinical opportunities without taking on overly challenging commercialization complexities.
Speaker Change: For a less competitive and less complex market, we will build our own commercial team and go direct in.
Speaker Change: In others with multiple established players and additional market complexity, we will partner with market leading companies in mutually beneficial arrangements. We believe this approach will be the most capital efficient path to market.
Speaker Change: We will accelerate the path of NSP assay to patients and will allow pulse biosciences to pursue multiple clinical opportunities without taking an overly challenging commercialization complexity.
Paul LaViolette: Before passing the call over to John to cover the financials, I'd like to provide a brief introduction. John is a very strong addition to our team, with experience leading the FP&A, accounting, sales operations, strategy, partnerships, and M&A functions at both growth-stage private and diversified public medtech companies. His leadership has already proven to be extremely valuable in our efforts to advance our nanosecond PFA technology platform, and John has already, in under two months, become an integral part of our team.
Speaker Change: Before passing the call over to John to cover the financials I'd like to provide a brief introduction John is a very strong addition to our team with experienced leading the SPN a accounting sales operations strategy partnerships and M&A functions at both growth stage private.
Speaker Change: And diversified public Med Tech companies. His leadership is already proven to be extremely valuable in our efforts to advance our nanosecond PSA technology platform and John has already in under two months become an integral part of our team.
John Skinner: John? Thank you, Paul. I'm extremely excited to join Pulse Biosciences and contribute to the development and commercialization of our nanosecond PFA devices to advance the treatment of several disease states. It is clear the team and the technology are world class and the opportunity set ahead is quite unique. We are establishing the foundation from which we can drive discipline growth and operational excellence as we scale this business.
Speaker Change: John.
Speaker Change: Okay.
Speaker Change: Thank you Paul I am extremely excited to join pulse biosciences and contribute to the development and commercialization of our nanoseconds PFA devices to advance the treatment of several disease states.
Speaker Change: It's clear the team and the technology are world class and the opportunity set ahead is quite unique.
We are establishing the foundation from which we can drive disciplined growth and operational excellence as we scale this business.
John Skinner: Now I will highlight our GAAP and non-GAAP financial results. I encourage listeners to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures. In the fourth quarter of 2024, total GAAP costs and expenses increased by $7.7 million to $20.3 million, compared to a $12.5 million in the prior year period. The increase in GAAP costs and expenses was primarily driven by an increase in non-cash stock-based compensation, which was $6.8 million in the fourth quarter of 2024, compared to $3.3 million in the prior year period, along with other compensation and administrative expenses to support the expanding organization and advancement of our NSPSA devices, along with severance and legal settlement.
Speaker Change: Now I will highlight our GAAP and non-GAAP financial results.
Speaker Change: I encourage listeners to review today's earnings release for a detailed reconciliation of non-GAAP measures to the most comparable GAAP measures.
Speaker Change: In the fourth quarter of 2024, total GAAP costs and expenses increased by $7 7 million to $20 3 million compared to a $12 $5 million in the prior year period.
Speaker Change: The increase in GAAP cost and expenses was primarily driven by an increase in noncash stock based compensation, which was $6 8 million in the fourth quarter of 2024.
Speaker Change: Compared to $3 3 million in the prior year period.
Speaker Change: Along with other compensation and administrative expenses to support the expanding organization and advancement of our NSP USA devices, along with severance and legal settlement expenses.
John Skinner: To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation and amortization, restructuring, severance, and legal settlement expenses. Total non-GAF costs and expenses in the fourth quarter of 2024 increased by $2.4 million to $11.3 million, compared with $8.9 million in the prior year period. Gap net loss in the fourth quarter of 2024 was $19.4 million, compared to $11.9 million in the prior year period. Non-gap net loss in the fourth quarter of 2024 was $10.4 million, compared to $8.3 million in the prior year period. In the fourth quarter, we strengthened our balance sheet considerably through the exercise of warrants related to the RITES offering that was completed in July of 2024, raising an additional $47.9 million in net proceeds.
Speaker Change: To remind everyone non-GAAP costs and expenses excludes stock based compensation depreciation and amortization restructuring severance and legal settlement expenses.
Speaker Change: Total non-GAAP costs and expenses in the fourth quarter of 2024 increased by $2 4 million to $11 3 million compared with $8 9 million in the prior year period.
Speaker Change: GAAP net loss in the fourth quarter of 2024 was $19 4 million compared to $11 9 million in the prior year period non-GAAP net loss in the fourth quarter of 2024 was $10 4 million compared to $8 3 million in the prior year period.
Speaker Change: In the fourth quarter, we strengthened our balance sheet considerably through the exercise of warrants related to the rights offering that was completed in July of 2020 for raising an additional $47 9 million in net proceeds through the end of 2024, $49 4 million of warrants have been exercised.
John Skinner: Through the end of 2024, 49.4 million of warrants have been exercised. As of December 31, 2024, cash and cash equivalents totaled $118 million, compared to $44.4 million as of December 31, 2023. Cash used in the fourth quarter of 2024, excluding net proceeds from financings, totaled $9.3 million, compared to $6.9 million used in the prior year period, and compared to $8.5 million used in the third quarter of 2024.
Speaker Change: As of December 31, 2024, cash and cash equivalents totaled $118 million.
Speaker Change: Compared to $44 4 million as of December 31, 2023.
Cash used in the fourth quarter of 2024, excluding net proceeds from financings totaled $9 3 million compared to $6 9 million used in the prior year period and compared to $8 5 million used in the third quarter of 2024.
Bob Duggan: Now, joining us for the question and answer session is Bob Duggan, Co-Chairman of the Board. Operator, please open the call for questions. At this time, I would like to remind everyone in order to ask a question, press star, then the number one on your telephone.
Speaker Change: Now joining us for the question and answer session is Bob Duggan co chairman of the board operator, Please open the call for questions.
Speaker Change: At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad. You also ask that you limit your questions to one question and one follow up.
Bob Duggan: We also ask that you limit your questions to one question and one follow-up. We will pause for just a moment to compile the Q&A. Again, in order to ask a question, press star, then the number 1 on your telephone.
Speaker Change: We'll pause for just a moment to compile the Q&A roster.
Speaker Change: Again in order to ask a question press.
Speaker Change: Star then the number one on your telephone keypad.
Paul LaViolette: Seeing as we do not have any questions at this time, I will now turn the call back over to Paul LaViolette for closing. Thank you all for joining. We're proud of our accomplishments.
Speaker Change: Yes, we do not have any questions at this time I will now turn the call back over to Paul Violet for closing remarks.
Speaker Change: Well. Thank you all for joining we're proud of our accomplishments.
Paul LaViolette: And we look forward to providing you an update on our first quarter performance at a call to be scheduled in early May. Thank you very much.
Speaker Change: And we look forward to providing you an update on our first quarter performance at a call to be scheduled in early may. Thank you very much.
Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.
Speaker Change: Ladies and gentlemen that concludes today's call. Thank you all for joining you may now disconnect.
Speaker Change: Okay.
Operator: Please wait, the conference will begin shortly.
Speaker Change: Please wait the conference will begin shortly.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Yes.