管理層發言
Ladies and gentlemen, thank you for being here. My name is Colby, and I will be your conference operator today. I would like to welcome you to the Pulse Biosciences Q4 and Full Year 2025 Earnings Call. I will now turn the call over to Trip Taylor. You may begin.
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, February 19, 2026, 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. 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 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 pulsebiosciences.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, Paul LaViolette.
Thank you, Trip. Good afternoon. Thank you, everyone, for joining us today. At Pulse Biosciences, we aren't just making a better medical device; we are creating a pulsed field ablation platform to completely shift how physicians treat disease. We intend to transition the entire medical field away from using energies that apply extreme heat or cold to destroy tissue and toward our much more precise method, nanosecond pulsed field ablation or nsPFA. Our technology has the potential to completely disrupt multiple soft tissue ablation markets. And here are the reasons why. First, it offers incredible precision. Our system directs ultra-short duration bursts of energy, lasting only a few billionths of a second, to only the precise locations where therapy is needed. Second, nsPFA creates a human body compatible healing advantage by initiating regulated cell death. Third, it operates with blistering fast speeds measured in billionths of a second. Precisely because of the speed and efficiency in ablating cells, we deliver less cumulative energy due to significantly shorter treatment cycles delivered in record fast procedure times. And finally, we have built an imposing legal fortress of intellectual property. We added 67 issued and 77 pending patents in 2025 alone, equivalent to adding a new piece of intellectual property every 2.5 days throughout the year to protect our novel developments. In total, 250 patents have been granted to Pulse Biosciences, and an additional 180 patents are pending approval. Overall, we made progress in calendar year 2025. Today, I will walk through those updates and our plans for 2026. After that, I'll turn the call over to our CFO, Jon Skinner, to review the financial results, and we will conclude with a question-and-answer session joined by Bob Duggan, Co-Chair of the Board. At the start of 2025, we defined a focused set of objectives for the year. Our highest objective was and remains to advance our nanosecond PFA platform into late-stage clinical development to treat atrial fibrillation in both electrophysiology and cardiac surgery. In addition, we plan to explore launch feasibility of our soft tissue ablation system prior to gaining a specific therapeutic claim using Category II reimbursement. We are pleased to report we made progress across each of those goals in 2025, and that noteworthy progress continues into early 2026. On the clinical front, we secured IDE approvals for both our electrophysiology catheter and our cardiac surgical clamp programs, positioning both to move into pivotal trial enrollment. In parallel, we significantly expanded treatment of patients in our European feasibility studies across both cardiac platforms, generating increasingly robust data sets to show superior workflow and procedural consistency. We also started publishing those data sets and through today have produced clinical performance of interest in each of our three clinical programs. On the commercial front, we continued the highly controlled launch of the Vybrance platform for soft tissue ablation in a targeted disciplined manner. We did so by focusing on supporting a few select institutions dedicated to procedural excellence in order to validate the clinical and economic model. We fully appreciate the essential value of FDA indication clearance as well as reimbursement certainty. We anticipate this to be a worthwhile work in progress over the next four to eight quarters. Operationally and financially, we executed well and maintained disciplined expense management, exiting the year with a strong balance sheet that will enable us to execute on our clinical priorities in 2026. As we look ahead to 2026, our focus is clinical and market development execution. In electrophysiology, we intend to commence and complete enrollment in the nPulse cardiac catheter IDE study while continuing to treat patients in Europe in support of expansive clinical data essential to our successful CE Mark submission. In cardiac surgery, we intend to expand and accelerate IDE site activation and complete patient enrollment in 2026, while continuing European feasibility activity and preparing for an additional CE Mark submission by the end of the year. In soft tissue ablation, we are completing enrollment of the PRECISE benign thyroid nodule study, deepening commercial utilization in key accounts, driving the business model to our goal of financial viability and continuing to demonstrate the clinical advantages of the Vybrance nsPFA treatment. Each of these milestones advances our position as the disruptor in PFA therapies and first mover in nanosecond pulsed field ablation, a position that is reinforced by our significant intellectual property estate. Pulse Biosciences is advancing a platform that integrates advanced biophysics and precision engineering that will be changing for the better the standard of care for multiple disease states affecting patients worldwide. I will now start with our nPulse cardiac catheter system for AF ablation. While our nsPFA technology is a versatile platform designed for multiple clinical applications across the body, our primary focus is transforming heart care for AFib patients. We have developed the world's first one-shot ablation solution for atrial fibrillation. Our nPulse cardiac catheter can treat a targeted area of the heart with a 5-second single-shot burst, delivering circumferential pulmonary vein isolation or PVI. The nPulse cardiac catheter minimizes the need for the physician to reposition the catheter or overlap lesions. The nPulse cardiac catheter incorporates several differentiated design and performance features that set it apart from existing ablation technologies. We have previously presented data on acute procedural measures that validate workflow advantages and our recently presented outcomes data provide the first long-term clinical evidence of procedural success and are available on our website at pulsebiosciences.com. Because nanosecond pulsed energy is delivered so rapidly, the system delivers minimal cumulative energy to tissue. This results in no measurable tissue temperature elevation and low neuromuscular stimulation, which contributes to shorter procedure times and may reduce required anesthesia levels. In addition, the catheter incorporates a patented proprietary flexible electrode design that enhances maneuverability and conformability within the left atrium, allowing physicians to deliberately move the catheter within the left atrium and rapidly achieve stable positioning, enabling seamless procedural efficiency. In comparison to the current standard of care, the clinical benefits we reported in February 2026 have been nothing short of outstanding. In our European studies presented at the AF Symposium on February 5, the lead investigator of our feasibility study provided comprehensive as well as compelling data on procedural speed, workflow, safety and outcomes durability. Key study findings were outstanding and highlighted 100% procedural success or freedom from AFib at 6 months and 96% procedural success at 1 year for evaluable patients. Overall, freedom from atrial arrhythmia was 90% at 12 months as shown on a Kaplan-Meier curve and the data are available on our website. All three of these endpoints represent new standards of therapy effectiveness for nsPFA treatment of paroxysmal AF. Procedural efficiency remains remarkable. While still early on, we are routinely seeing physicians finish these ablations in just 6 to 8 minutes or faster, which could cut total procedure times by over 50%. These results reflect the underlying advantages of nanosecond PFA: deeper lesion formation with fewer applications and lower cumulative energy to deliver durable isolation. Physicians continue to highlight the simplicity of a single-shot approach and the reduction in catheter manipulation and lesion stacking compared with legacy technologies. The nonthermal nature of nsPFA continues to show a favorable profile, allowing physicians to treat efficiently and proceed to additional targets without delays between dose deliveries, unlike microsecond PFA, which requires prolonged recharging times. The Pulse Biosciences system directly addresses limitations of current generation catheters, microsecond PFA or thermal modalities by enabling complete durable isolation in a single energy delivery with the potential to cut procedure times in half. We expect to use the data from our European feasibility study to finalize our CE submission in the second half of 2026 with the potential for CE Mark approval in 2027. We are focused on accelerating our market entry strategy through strategic mapping partnerships. To bring this revolutionary nsPFA technology to the global market as swiftly as possible, we are actively pursuing strategic partnerships with world-class mapping providers and EP market leaders. Such a partnership should produce a tremendous win-win. By integrating our best-in-class nanosecond PFA solution with an existing best-in-class mapping ecosystem, our potential partner or partners can capture and solidify their market share with the most advanced energy solution available, while Pulse would benefit from nanosecond PFA worldwide commercial launch acceleration. These synergies should ensure that physicians and patients gain rapid access to the fastest, most precise and durable nanosecond PFA solution in present time. Let's now discuss our surgical ablation clamp. Our nPulse cardiac clamp is the first in the world FDA-approved IDE pivotal study, NANOCLAMP AF for a surgical device that delivers PFA. This represents a significant landmark in cardiac surgical innovation. Our system is designed to deliver fast, contiguous transmural ablation lines during open heart procedures for patients with atrial fibrillation. We believe the current treatment of preoperative AF with concomitant ablation is significantly underutilized, and the speed and effectiveness of ablation delivered with nsPFA can transform this therapy and market. Our IDE program is progressing and enrollment activity is underway and expected to conclude during 2026. As a reminder, NANOCLAMP AF is a prospective single-arm multicenter study designed to assess the primary safety and effectiveness of the nPulse cardiac surgical system in treating AF during concomitant cardiac surgeries. We intend to enroll 136 patients in approximately 20 sites, including two international locations. In Europe, we continue to generate excellent results. Data presented previously at EX highlighted what we consistently see with this system: very fast total ablation times, clean lesion sets, and reproducible workflow in the surgical environment. Surgeons continue to emphasize the importance of speed and predictability in this setting, which aligns well with the intuitive workflow and short energy delivery times observed with our system. These initial treatments keep us on track to file for CE Mark by the end of 2026. Beyond the significant clinical progress of our cardiac programs, the nPulse Vybrance percutaneous electrode system is validating in real-world use our technology in non-cardiac soft tissue applications. The nPulse Vybrance system is initially being used by physicians to treat symptomatic benign thyroid nodules, eliminating the need for traditional surgery. This is a very common and disabling condition associated with 250,000 new annual U.S. diagnoses. This annual incidence converts into 150,000 total or partial thyroid removal surgeries each year. And this is precisely the clinical practice opportunity we are exploring with our minimally invasive application of nsPFA to reduce nodule size and eliminate patient symptoms. Our current nPulse Vybrance technology has the potential to shrink nodules while sparing vital nerves, blood vessels, and sensitive structures in the neck. In the fourth quarter, the team generated $264,000 in revenue from Vybrance systems and electrodes, an increase in revenue versus the third quarter. We are taking an extremely disciplined approach as we closely monitor individual account procedural volumes, site-by-site patient outcomes, all local procedure reimbursement results, procedural efficiency, and overall clinical and business success factors routinely considered by each hospital when adopting a new procedure. Our approach remains deliberate, evidence-based, and focused, operating at an intentionally limited scale to demonstrate how meaningful this opportunity can be within key accounts at large hospital systems in selected geographies. From a clinical perspective, the PRECISE benign thyroid nodule study remains on track to complete enrollment of 50 patients in the next few months. We plan to further expand the study to 100 patients over the ensuing two quarters. Broad adoption and viable long-term market expansion is our goal. It is important to note that scientific recognition of this work is on the rise. Data from Dr. Stefano Spiezia in Naples, Italy, have been accepted for a podium presentation at NAFID, the North American Society for Interventional Thyroidology in March. In parallel with the PRECISE-BTN study, we are expanding the clinical scope of the Vybrance platform. In the fourth quarter, we announced a research collaboration with the University of Texas MD Anderson Cancer Center, one of the world's leading oncology institutions, to evaluate the use of nanosecond PFA for the treatment of both benign and malignant thyroid tumors. Under this collaboration, we are conducting an FDA-approved IDE study evaluating nsPFA for the treatment of papillary thyroid microarcinoma and expect to complete enrollment by year-end 2026. In addition, preclinical work is underway exploring the potential application of nsPFA in anaplastic thyroid carcinoma, a highly aggressive cancer with limited treatment options. We view this collaboration as strategically important for several reasons. First, it meaningfully expands the potential indication set for the percutaneous electrode beyond benign disease and into cancer, while remaining within the same core workflow of endocrine surgeons targeting thyroid disease. Second, it reflects external validation of the nonthermal mechanism of action of nanosecond PFA, particularly its ability to ablate cellular tissue and initiate regulated cell death while sparing surrounding critical structures, an attribute that is especially relevant in the neck because of the high density of critical nerves such as the recurrent laryngeal nerve, which controls the vocal cords, major blood vessels, the trachea, and esophagus. And third, partnering with a world-class institution such as MD Anderson reinforces institutional and physician belief that the Vybrance nsPFA platform has broad applicability and will expand over time beyond its initial commercial use case in benign thyroid nodules. While this work remains in the research and feasibility stage, it underscores the platform nature of nsPFA and its multi-decade potential to address a wide range of soft tissue applications as clinical evidence develops. Economically, the Vybrance system is driven by recurring disposable electrode utilization and minimal facility overhead. The opportunity and model align with the growing trend toward minimally invasive procedures performed in lower overhead settings. We look forward to continued adoption of the Vybrance system and additional data publication in the second half of 2026. It is clear to us that multiple therapeutic FDA clearances beyond the soft tissue ablation clearance, while not yet achieved, will be essential to building a significant revenue growth business. Our commitment to generating clinical evidence, which will be highlighted later this quarter, will be the next critical step toward achieving FDA therapeutic clearances.
Thank you, Paul. Now I will highlight our GAAP and non-GAAP financial results before providing commentary on future cash use. 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, we generated nominal revenues comprised of both nPulse Capital and Vybrance disposable sales. Total revenue was $264,000, up from $86,000 in Q3. This sequential growth was driven by both capital and disposable devices. Cost of product revenue was $260,000 for the quarter, slightly lower on a sequential basis compared to Q3 2025. Total GAAP costs and expenses decreased by $1.7 million to $18.5 million compared to $20.3 million in the prior year period. The decrease in GAAP costs and expenses was primarily driven by a decrease in nonrecurring expenses. To remind everyone, non-GAAP costs and expenses exclude stock-based compensation, depreciation and amortization as well as nonrecurring costs. Total non-GAAP costs and expenses in the fourth quarter of 2025 increased by $2 million to $13.3 million compared to $11.3 million in the prior year period. The expected increase was driven by increasing clinical trial and early commercial launch activity. GAAP net loss in the fourth quarter of 2025 was $17.4 million compared to $19.4 million in the prior year period. Non-GAAP net loss in the fourth quarter of 2025 was $12.2 million compared to $10.4 million in the prior year period. As of December 31, 2025, cash and cash equivalents totaled $80.7 million compared to $118 million as of December 31, 2024, representing a decrease of $14.5 million versus Q3 of 2025. Cash used in operating activities during the fourth quarter of 2025 was $14.8 million compared to $9.1 million used in the prior year period and $13 million in Q3 of 2025. We have also recently completed important corporate housekeeping filing a $200 million shelf registration. This provides the company with flexibility to support the balance sheet in an expeditious manner to ensure we have the resources required to achieve upcoming clinical milestones. Cash usage aligns with investment expenditures in pivotal trials, device scaling, and initial commercialization. Expense growth remains deliberate and focused on long-term value creation. We continue to maintain ample liquidity to fund operations and clinical programs through major inflection points during 2026. With that, I will now turn it back to Paul for closing remarks.
Thank you, Jon. We are standing at the forefront of a medical transformation, leveraging nanosecond PFA energy. Our Nanosecond PFA platform is no longer just a concept. It is scientifically validated, clinically proven in early use, and its vast potential is slowly but certainly emerging across the fields of electrophysiology. We are moving forward with speed and purpose to establish nanosecond PFA as the new global therapeutic standard. Our mission is steadfast, delivering significantly better outcomes for patients and creating robust long-term value via an emerging new era of patient and physician-friendly therapy for our shareholders. We are enthusiastic about the promising journey ahead, and thank you for your continued support. Now joining us for the question-and-answer session is Bob Duggan, Co-Chairman of the Board. Operator, please open the call for questions.
分析師問答
Your first question comes from Anthony Petrone with Mizuho Group.
Congrats to a strong start to the year in 2026 to the team. Maybe Paul, I'll start with Vybrance and then jump into nPulse for pulsed field ablation. Maybe looking at Vybrance here, we're two quarters into the launch. The team is expanding in a limited launch release phase here. Maybe just as we think about the next couple of quarters, when do we transition from limited release to a broader release for Vybrance? And then maybe just a recap on the enrollment time lines for the post-market surveillance study for thyroid, and then I'll have a follow-up on nPulse.
Thank you, Anthony. I appreciate your comments. Vybrance is currently in a market development phase, and we are evaluating how it works at a limited number of centers. That phase is progressing well. The team is stable, and our focus is on quality rather than quantity. We are concentrating on collecting data, particularly regarding the BTN study, as this will drive our efforts. We aim to ensure high-quality outcomes for patients across multiple centers and are working on speeding up the reimbursement process. The data we gather will be crucial for future therapeutic indications from the FDA. We believe it's essential to establish a strong foundation before we significantly expand commercialization. I have extensive experience in market development in med tech, and getting things right from the start is critical. We're pleased to see rising revenues, but our main focus is on the qualitative aspects of market development that will support future revenue growth. We are committed to building a solid foundation for the long term, given the market size, the limited alternatives available for patients, and the positive treatment outcomes we're achieving. We believe nsPFA's unique capability to treat benign thyroid nodules compared to other minimally invasive options and surgery provides us with the right approach. We expect that growth in patient treatments and in transitioning patients from surgery to less invasive nsPFA will occur once we establish these fundamentals. Regarding enrollment, we expect to complete it in the next few months and are currently on track, having enrolled most of our target patients in the early quarters. We feel confident about finishing enrollment on schedule. Furthermore, we plan to broaden the study, as we anticipate very positive clinical results focused on patients' quality of life and symptom relief measured by the ThyPRO-39 score. The data we present at the NAST conference, which will showcase long-term outcomes from our European feasibility study, combined with our current findings, will support our case for additional regulatory approval. Therefore, our goal is to complete the current enrollment and expand it to strengthen our data set.
Very helpful. And then I'll just squeeze one in on nPulse. So obviously, good showing at AF Symposium '26. 96 procedural success rate at one year, 22-minute dwell time in the left atrial wall, and 90% freedom for arrhythmia. So a quick two-part question. One is we move away from that medical meeting a few weeks ago. What has been the reception from the community? There seems to be quite a bit of buzz at the conference. And then what are the updated timelines for the IDE study in terms of enrollment? Can it actually be accelerated just coming off a strong feasibility study?
Thank you, Anthony. The reception to the data has been remarkably positive. I appreciate your observation about the buzz during the meeting; you captured it accurately. The excitement around AFib stems from its significant impact as it addresses the most prevalent arrhythmia in our population, representing a vast market. Historically, retreatment rates for ablation tend to hover around 20% to 25% in real-world scenarios. We've observed the evolution from RF to PFA technologies, yet most physicians agree that the recurrence rate requiring retreatment remains at about one-quarter of patients, regardless of the system. When we highlight a 96% one-year procedural success rate or a 90% rate for freedom from arrhythmia in the left atrium, it stands out as a notably positive outcome. This does need validation through a pivotal study, but it has certainly caught a lot of attention. We're optimistic about the response from various stakeholders, including physicians, patients, and corporate entities in the cardiovascular sector, which has been very encouraging. As for our timelines, we expect to begin enrolling participants in our study within the next one to two months, and we aim to complete enrollment by 2026. Regarding acceleration, we are prioritizing this program and are exploring all feasible options to speed things up. In my experience with pivotal studies, enrollment velocity hinges significantly on physicians embracing the technology. It's crucial to have a straightforward protocol that supports high patient flow through the screening process, fits well within clinical workflows, and is embraced by physicians because it benefits their patients and enhances efficiency. This combination is quite compelling. Previously, we demonstrated that our workflow is superior, and with the data we presented at the AF symposium suggesting an outcomes benefit, we believe interest in the study will grow. Given the protocol's requirement of 155 patients and the enthusiasm from various centers willing to participate, we anticipate that the process can progress quickly.
Your next question comes from the line of Suraj Kalia with Oppenheimer.
Gentlemen, I'd like to echo congrats on the exceptional data for nPULSE at the AF Symposium. Paul, if I could, just piggybacking on Anthony's question, right? So we do expect or at least hope pace of enrollment would pick up. But one of the things that Dr. Reddy had said at the presentation, Paul, was the nPulse wasn't really integrated effectively with mapping. I'm paraphrasing, but you get the point. For the IDE Pulse, are any steps being made to make the nPulse more effectively integrated with, let's say, CARTO or EnSite? Just trying to analyze or assess if there could be some incremental benefit in the IDE from mapping integration. Paul, next question, if you could give us any update on the next-gen nPulse. And are you seeing any spillover on the NANOCLAMP side of the equation, just given the EFS with nPulse? I know I threw in a lot in there, Paul. Hopefully, you got all my questions.
Thank you, Suraj. I’ll address your questions. The first question is about the benefits of an integrated catheter and mapping system. For context, at the AF Symposium, we demonstrated a live case from Prague showcasing a more integrated system between the catheter and mapping software. This represents a significant advancement in how catheter rendering appears on the system, a feature that wasn't available in the initial 150 cases. To answer your question, yes, we anticipate enhanced software integration in the IDE. It's difficult to predict how much better the results will be; Dr. Reddy humorously suggested that the current results are already impressive. However, he noted that during his feasibility study, he sometimes couldn't determine the precise location of the catheter, but with the new integrated system, he could, which he believes will enhance the accuracy of lesion creation and potentially decrease the number of lesions he has to create. His current approach to nPulse already results in a low number of lesions, but with greater confidence, he could use even fewer. So, we expect to see both immediate procedural advantages and improved outcomes from better integration, which we plan to have in the IDE. The next-generation nPulse system is still under development, so we aren't offering specific timelines. It aims to combine a regional footprint ablation system — like our current 360 — with a focal or large footprint device integrated into the same product. This would facilitate pulmonary vein isolation and left atrial ablation points or lines without needing to switch devices, representing a significant advancement with procedural benefits, although it remains in development. Regarding your question about potential benefits from nCLAMP, the answer is yes. These advantages are derived from nsPFA, where we are applying similar energy to cardiac tissue using different methods and ablation line patterns for the same indication. As we’ve reported, we’ve conducted thorough remapping of our open surgical cases, which strengthens our confidence in the effectiveness of our ablation energy. We've achieved a 96% procedural success rate, which underlines the potency of our ablation energy. Our data showcase excellent safety from the information presented at ESC for surgery and at AFS for electrophysiology. These data sets will be submitted to the FDA. We believe we have a solid process for IDE approval, and the TAP program status along with the breakthrough designation of the clamp device likely contributed positively toward our IDE approval for the EP catheter. Both sets of data are currently being collected and will undergo submission processes around the same time. This approach provides the FDA with more safety data and reassures them that we can deliver effective lesions in both interventional and surgical settings. While it's hard to pinpoint the exact benefits, we know there are genuine synergies as we compile positive data in each application, with both data sets being reviewed by comparable FDA teams on similar timelines.
Your next question comes from the line of Josh Jennings with TD Cowen.
It was great to see the stellar feasibility results for nPulse at AFib Symposium. During the data presentation, Dr. Reddy and others discussed the clinical success rate that 90% freedom from atrial arrhythmia at 12 months, exceeding expectations and maybe even higher than what we expected just based on procedural success or lesion durability alone, suggesting the possibility of some other biologic impact or modulation beyond just the conduction block. You reviewed some of the hypotheses behind that at the Pulse event at the symposium. But maybe if you could just review those? And is there any way to confirm any of these hypotheses with either an animal model or anything on the preclinical side?
Yes. Thank you, Josh, and very good question, and thank you for paying such close attention to everything that was reported at AFS. It's great to see. I would echo exactly what you said. These are hypotheses. We don't know that any incremental mechanism is actually required in order to achieve the results that we've seen. I think the first thing I would say is that the reason a hypothesis for incremental benefit might be pursued is because the original data that we presented were so strong in comparison to a history of delivering lesions with PFA that clearly maxed out at lower levels. It leaves one to question how it is that such a significant leap can be made. We have less wonder about why that leap can be made. We've been making lesions in preclinical models for years. We have tremendous understanding about the power of nsPFA and that it is a differentiated energy. Yes, it's a form of pulse electric field delivery, but we really do believe it is a different type of energy. It has a different mechanism of action already as we've defined than microsecond PFA and the consistency and depth and the transmurality of our lesion generation we think is on its face, the explanation for superior results. That being said, we certainly can conduct preclinical experiments to assess whether other nerve targets that might be extra atrial could be effective. But while we will work with our clinical advisers to do that, I would say we are less inclined to search for a novel mechanism because we believe we understand the clinical results and why they are a direct result of the energy that we are delivering. What's unique about nsPFA, and we see this in multiple indications, is that it is hard to imagine how effective it can be while being so fast, while being so nonthermal and fitting into workflow as exists already in existing clinical practice. But that is what we're seeing essentially time after time. So we believe the most important thing to replicate is not a novel mechanism that is the result of speculation, if you will, but rather to replicate these clinical trial results. They've been derived on a large n. We're continuing to follow those patients. So I think the most important clinical discovery will be how does the next tranche of patients as you build up the full 150 now going to beyond that and follow those patients 6 and 12 months and continue to just reinforce the fantastic clinical results. To us, that's more important than looking at preclinical models for atrial ganglia ablation.
Understood. And then just to follow up on the tail end of your answer, just how should we be thinking about the timing of future updates to the feasibility study results and particularly the final results that will be submitted, it sounds like for CE Mark approval?
Thank you so much, Josh. Timing, really the next event will be at HRS. We plan to submit data for review at HRS. And that, of course, will be, I'll call it, on a rolling time line. So as many patients as meet the endpoints by the various presentation cutoff deadlines, that's what we'll present. We think that will provide us a very nice increment in total number of patients over time. And so that will be the next event in addition to an update when we commence enrollment in the study, which we expect, as mentioned, in the next few months. So very nice updates coming between the announcement of first patient enrollment as well as HRS by just a few months down the road.
Your next question comes from Jesse Crawford with Luxury Lifestyle Design and Development.
Thank you guys. Thanks for putting on these calls. These are actually really, really beneficial to everybody, especially all of the people who really believe in the technology. I'm one of those people. I evangelize for Pulse all the time. And when people ask me what it is, I kind of have to give them the dumbed down version of it, but I kind of equate it to the tricorder in Star Trek. People laugh at that analogy, but I really think this is the future of kind of the two holy grails of treatment for cancer and heart disease. So as an avid investor, I like to participate in the calls, but I also have AFib. So I would be very interested in participating in one of the clinical trials. I'm that big of a believer in it.
Well, thank you, Jesse. And I appreciate your transparency about AFib. The fact of the matter is it is so common. We can't go very far without finding a patient right in our midst. And AFib is so common. It's growing in incidence. And what we're faced with right now is, as you well know, a progression through early diagnosis and then most commonly drug therapy, which is often undesirable for the patient, some combination of anticoagulation therapy and antiarrhythmic medication. And I think the ultimate vision for a therapy is to pull forward the option that can be offered to a patient to allow for a very safe and highly effective intervention as first-line therapy so that a patient that is tolerating atrial fibrillation, which is obviously associated with higher risk factors that, that you would not have to tolerate AFib because the balancing act between first-time effectiveness and safety is so favorable that you can be offered the option of going straight to an intervention. We know that with AFib, the earlier one intervenes, the likelihood is that the AFib is not advanced in its complexity. And if it resides still in the pulmonary veins, one is more likely to treat it definitively, which is to say an ablation can be a cure. And that's not really the way patients are provided therapy opportunities today. That requires more data, more changes in guidelines. But I think the trend as supported by the kind of early results that we've seen so far could be supported by this kind of a breakthrough technology. So we really appreciate your support and your evangelizing. And I would say from what I've seen, if I had AFib, I would want the therapy, too. So we are like-minded. So thank you, Jesse.
Jesse, it's great to hear your question. Your perspective on the product and our technological efforts aligns closely with my own. I'll address the key issue you raised. The challenges we've faced stem from the fact that this is a novel technology. Unlike MicroPulse, we're dealing with nanoPulse, which is distinct from traditional laparoscopic methods where robotic procedures are often viewed as an extension of laparoscopy. This technology is considerably different and significant, which needed to be demonstrated. Fortunately, we've collaborated with some of the world's leading surgeons, and we feel confident as we approach this final study on the CA side. While this won't be the last study, it's one we expect will lead to approval, and we're quite optimistic about it. In terms of reimbursement in this industry, where I've spent a couple of decades, having a label is a top priority. However, to obtain that label, we need the best professionals to use our product and endorse its ease of use and the outcomes they achieve. These experts can make nearly any product work, so we need to ensure broader accessibility. We're making good progress on that front. Importantly, we currently don't have a label beyond soft tissue ablation, which restricts us from offering specific guidance or training based on that. Given the limited patient pool available for trials, reimbursement has not yet been established. Paul mentioned during the call that we expect that to materialize in the next four to eight quarters, so those who may be feeling frustrated with Vybrance will need to be patient. I've seen many companies rush into things without proper approval, which can stall their progress and lead to revenues that fall short of expenses. We will avoid that pitfall with Vybrance, even if it takes longer. We're still working to secure a label for the CAF and clamp, which we anticipate will be ready by 2027, and we have a high level of confidence in that timeline. We're pleased with the outcomes so far. On the Vybrance front, we look forward to trial readouts around mid-year, and that news looks promising. As for funding, we will need additional resources, which could come from partnerships or distribution agreements among other options. We previously conducted a substantial rights offering about a year ago, and we have around $80 million in the bank as we close out the year, plus an additional $2 million in warrants as our stock trades above $22 a share for a few more weeks. We're very mindful of our financial situation, knowing that we always have access to funding without needing to resort to extensive equity dilution to maintain liquidity. We're satisfied with our current position and leadership. While there is some frustration over the lengthy process to obtain a label for Vybrance, we are narrowing that gap and are on the right path. Although I wish I could promise a turnaround in a couple of months, it will realistically be about four to eight quarters before we have everything aligned. Once we reach that point, we expect substantial momentum. I appreciate your enthusiasm and your accurate assessment. I also have AFib, and I plan to get this therapy as soon as it’s available, if not sooner. I've seen the procedures firsthand, some even done without full anesthesia, and it's truly gratifying to know that I've been involved in this and the benefits it will bring. I hope this answers your questions, Jesse.
And with no further questions in queue, I'd like to turn the conference back over to Paul for any closing remarks.
Well, first of all, thank you, Bob, for those comments and really for the great questions we received. On behalf of the team here at Pulse Biosciences, thank you all for your interest. We look forward to providing you with updates throughout the very busy 2026 we have ahead. So thank you all for joining, and good afternoon.
This concludes today's conference call. You may now disconnect.