Pulse Biosciences Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 12, 2025

Key Takeaways

  • Positive Sentiment: Pulse’s FDA-cleared Percutaneous Electrode pilot for benign thyroid nodules has treated over 140 patients with consistent positive outcomes, transitioned procedures to ASCs and ORs, and is set to generate initial revenue in H2 2025.
  • Positive Sentiment: The Cardiac Surgical Clamp holds Breakthrough Device designation, is in the FDA’s TAP program, has a 150-patient IDE under review for PMA with enrollment expected soon, and shows outstanding results in a 40-patient European feasibility study.
  • Positive Sentiment: Over 140 patients have been treated in the European feasibility study of the NSPFA 360° catheter for AF, reporting procedure times as low as 5–8 minutes, and the company is in interactive FDA review to commence an IDE study.
  • Neutral Sentiment: GAAP net loss widened to $19.2 M from $11.4 M year-over-year, non-GAAP net loss increased to $13.7 M, while cash and equivalents rose to $106.3 M, and quarterly cash use is expected to increase as R&D and clinical trials ramp up.
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Earnings Conference Call
Pulse Biosciences Q2 2025
00:00 / 00:00

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Operator

Thank you for standing by. Hello, and welcome to the Pulse Biosciences Second Quarter twenty twenty five Earnings Conference Call. Please note that this call is being recorded. I would now like to hand the call over to Trip Taylor. Sir, please go ahead.

Philip Taylor
Principal at Gilmartin Group

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, 08/12/2025 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 US Securities and Exchange Commission. Our SEC filings can be found on our website or the SEC's website.

Philip Taylor
Principal at Gilmartin Group

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.

Philip Taylor
Principal at Gilmartin Group

With that, I would now like to turn the call over to co chair of the board and chief executive officer Paul Le Violette.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Good afternoon and thank you for joining. Today I'm excited to share updates on the progress Pulse Biosciences has made in each of our three market development programs. I will then turn the call over to our CFO, John Skinner, who will review the second quarter twenty twenty five financial results. And we will then be joined by Bob Duggan, Co Chair of the Board for a question and answer session.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Pulse Biosciences has developed a next generation energy modality, nanosecond pulse field ablation technology or nano or nSPFA technology that delivers therapeutic ablations applicable to numerous clinical targets by generating much shorter pulse durations measured in the billions of seconds. NSPFA produces a fundamentally differentiated mechanism of action that delivers deep ablations in short delivery times, all while delivering low energy levels to tissue, which reduces the risk of thermal damage and other complicating factors reported in conventional or microsecond PFA, as well as with thermal energies. We are progressing as expected on the priorities we established at the beginning of the year. We have expanded pilot utilization of the percutaneous electrode for soft tissue ablation initially in benign thyroid disease. We have also submitted our NSPFA three sixty catheter IDE to treat atrial fibrillation.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

So in addition to our previously submitted IDE for the pivotal trial of our cardiac surgical clamp, we are advancing toward our regulatory goals with two IDEs under review. In parallel, we continue to treat additional patients with our cardiac devices in their respective feasibility studies in Europe, which continue to generate outstanding clinical results. These achievements further reinforce the advantages we've seen of NSPFA and by continuing to generate these early clinical results, we are increasing awareness of the technology among clinicians who may choose to support Pulse as clinical investigators or commercial customers. I will now provide more detailed updates on each of our individual market programs, starting with our soft tissue ablation device, the Percutaneous Electrode. Our NSPFA Percutaneous Electrode System is FDA cleared for the ablation of soft tissue.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Surgeons are currently using the device in a pilot launch mode for the ablation of symptomatic benign thyroid nodules. We see tremendous market potential for our device in this market as NSPFA addresses unmet clinical needs by offering a safe, minimally invasive, nonsurgical and thyroid sparing treatment that could be appropriate for several hundred thousand patients per year in The US alone. Ablation of these nodules with NSPFA energy has demonstrated significant nodule size reduction and meaningful reductions in patient symptoms just one month after treatment without evidence of residual fibrosis or scarring that would routinely accompany radiofrequency ablation and without risk of thermal damage to nerves and other critical structures surrounding the thyroid gland. We believe these compelling aspects of the procedure create an opportunity to convert thyroidectomy operations to minimally invasive NSPFA procedures as removal of this vital gland should option for a benign growth. We also believe overall interventional volume for benign thyroid nodule treatment will expand by offering NSPFA as a treatment option to a large portion of watchful waiting patients.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

These patients had chosen not to undergo an intervention because of undesirable consequences of losing their thyroid surgery or accepting the risks of thermal ablation modalities. The percutaneous electrode system from Pulse is currently being used at multiple centers in The United States as part of our pilot launch program. Over 100 40 patients have been treated in the pilot program to date. With procedure volumes and the number of treatment centers continuing to grow as positive and consistent outcomes are reported across providers. This experience is helping refine our commercial use model.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Based on surgeon and patient experience feedback, we have determined the ambulatory surgery center or the Operating Room to be the preferred sites of care rather than the office setting. All procedures are now being transitioned into the ASC or OR. In addition to the optimal patient and surgeon experience, the reimbursement guidelines in this setting also support improved patient access. We are pleased to see insurance claims are being processed that appropriately reflect the clinical value provided by the procedures. Our therapy development managers are focused on working with these initial users to support their NSPFA procedures and to integrate the procedure into their practices.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Our capital equipment system sales professionals are engaged with our first potential customers to purchase the systems and are building a pipeline of potential future adopters targeting high volume Thyroidectomy Centers and those with ultrasound guided procedure capabilities. Throughout the 2025, we expect to achieve a blend of non revenue evaluation procedures and revenue generating procedures from our first commercial customers. As is normal with capital equipment and therapies, system sales cycles will span months and acquisition purchasing structures may vary. Generating high quality clinical data is a central component of our sales and marketing efforts to drive awareness and adoption of NSPFA for the ablation of soft tissues such as benign thyroid nodules. A multicenter prospective clinical study will be performed to generate additional clinical data.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

We have identified and are contracting with five sites for this post market study and expect to commence enrollment in Q3 upon receipt of IRB approvals. We will also be sharing positive clinical data for the treatment of benign thyroid nodules using MS PIFF PFA at the American Thyroid Association Annual Meeting in early September to be presented by Doctor. Ralph Tufano. This year we plan to demonstrate the strong product market fit for the NSPFA percutaneous electrode system as a treatment for ablation of soft tissue such as benign thyroid nodules and to develop clinical evidence demonstrating NSPFA may be a better treatment than surgery for many patients suffering with benign thyroid disease. Let's now discuss our surgical ablation plan.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Clinical guidelines from most relevant societies suggest surgical ablation should be performed concomitantly with any first time non emergent cardiac surgery for patients with atrial fibrillation. Unfortunately, and likely due to technology limitations, this concomitant procedure is underutilized and under penetrated in practice today. Based on our initial clinical experience including three month post procedure electrophysiology mapping to demonstrate ablation durability, we believe that our NSPFA surgical ablation plan will address surgeon concerns and clinical barriers to enable more widespread adoption of concomitant ablation by delivering rapid, consistent, full thickness ablations. As a reminder, the FDA awarded Breakthrough Device Designation for our Cardiac Surgical Clamp Ablation Device in July 2024. And the device was accepted for inclusion in the FDA's Total Product Lifecycle Advisory Program, the TAP program, which quickens regulatory submission review times.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

As mentioned earlier, our IDE submission is under review by the FDA. As planned, the clinical trial will enroll up to approximately 150 patients in up to 20 sites. The trial is designed to evaluate the safety and efficacy of the CLAMP as measured by freedom from any atrial fibrillation, atrial flutter, or atrial tachycardia and freedom from use of new or increased antiarrhythmic drug dosing. We anticipate this trial will take approximately one year to enroll and we will report on protocol and other timeline details once we have IDE approval. We've received significant site interest to participate in the trial and expect to enroll our first patients in the next few months with rapid site expansion thereafter.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

We will provide an update on enrollment next quarter. Our confidence in the device is informed by the feasibility study underway in Europe and the outstanding clinical outcomes observed to date. We have three centers enrolling patients and have already treated 40 patients. Feedback from surgeons has been positive reporting the device consistently produces fast, contiguous and transmural ablations. We remain very pleased with the clinical value proposition offered by NSPFA and the surgical clamp device, including very rapid five second ablation times, limited total numbers of ablations and total ablation times, and deep and fully transmural lesion formation.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

We are looking forward to treating our first patients in The US upon IDE approval while we continue to generate and publish positive patient outcomes with our feasibility study in Europe. Now moving on to our three sixty catheter system for AF ablation. Our second feasibility study is ongoing in Europe for the three sixty cardiac catheter system, an endocardial ablation catheter specifically designed to deliver our proprietary NSPFA energy. Over 140 patients have been treated to date by multiple investigators with very positive outcomes. We will continue to prioritize the generation of high quality clinical data to validate our technology and support future regulatory filings and market adoption.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Our early clinical results suggest that NSPFA energy could represent a large step forward from microsecond PFA, the current market standards. For example, our procedure times have decreased compared to what we presented at the HRS twenty twenty five annual meeting in April with physicians now reporting ablation times of as little as five to eight minutes compared to averages from our feasibility study of eleven minutes and of about thirty minutes for ablation catheters already on the market. The procedure is streamlined due to the benefits of NSPFA which allow Pulse to deploy fundamentally different catheter designs. The three sixty catheter delivers a full circumferential lesion in a single short energy application without the need for catheter rotations. We believe our system uses less energy, causes less neuromuscular stimulation, and enables deeper, more consistent lesions with a more flexible catheter that physicians find easy to manipulate in the less atrium.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

On the regulatory front, we are making solid progress with our catheter IDE. We are engaged with the FDA in interactive review of our proposed study protocol and remain on track to commence an IDE study in the next few months. Looking ahead, we view the EP ablation market opportunity as one in which a strategic partnership would be beneficial to Pulse. We are focused on the possibilities of collaborating with a market leader in the electrophysiology space to create value for all stakeholders and will provide updates on partnership progress when appropriate. With that, I will turn the call over to John to speak about our second quarter financial updates. John?

Jon Skinner
Jon Skinner
CFO at Pulse Biosciences

Thank you, Paul. Now I will highlight our GAAP and non GAAP financial results before providing commentary on future cash use and revenue recognition. 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 2025, total GAAP costs and expenses increased by $8,500,000 to $20,300,000 compared to $11,700,000 in the prior year period. The increase in GAAP costs and expenses was primarily driven by an increase in administrative expenses related to the expanding organization to support advancement of our NSPSA device clinical trials and commercialization, along with other compensation and non cash stock based compensation, which was $5,200,000 in the 2025 compared to $2,100,000 in the prior year period.

Jon Skinner
Jon Skinner
CFO at Pulse Biosciences

To remind everyone, non GAAP costs and expenses exclude stock based compensation and depreciation and amortization. Total non GAAP costs and expenses in the 2025 increased by 5,400,000 to $14,800,000 compared to $9,400,000 in the prior year period. GAAP net loss in the 2025 was $19,200,000 compared to $11,400,000 in the prior year period. Non GAAP net loss in the 2025 was $13,700,000 compared to $9,000,000 in the prior year period. As of 06/30/2025, cash and cash equivalents totaled $106,300,000 compared to $26,200,000 as of 06/30/2024.

Jon Skinner
Jon Skinner
CFO at Pulse Biosciences

Cash used in operating activities during the 2025 was $12,800,000 compared to $8,400,000 used in the prior year period and $13,500,000 in 2025. We ended the quarter with $106,300,000 in cash, which was a decrease of $12,900,000 versus 2025. Cash used this quarter was a result of disciplined expense management and aligned with the planned cash usage. Looking ahead, as previously stated, we expect quarterly cash use to increase as we invest further in our commercial infrastructure and in our IDE clinical studies for our cardiac devices. These investments are directly aligned with our 2025 priorities and will support development and adoption of our NSPSA technology.

Jon Skinner
Jon Skinner
CFO at Pulse Biosciences

On track with prior expectations, we also expect to generate our initial revenue from the percutaneous electrode in the second half of the year. This initial revenue recognition will vary based on the individual contracts with commercial pilot program participants and new customers. At this early stage, we are accommodating various purchase and placement models to best suit the needs of potential customers. For revenue recognition purposes, accounting rules will dictate the cadence of how revenue could be recognized. For example, it could be recognized at a point in time when the system and electrodes are delivered to the customer or over the evaluation period, which could require the deferral of a portion of revenue depending on the specific agreement.

Jon Skinner
Jon Skinner
CFO at Pulse Biosciences

This is a very exciting time for Pulse Biosciences as we drive adoption of our transformational technology in soft tissue ablation and advanced development of our cardiac devices. Now joining us for the question and answer session is Bob Duggan, Co Chairman of the Board. Operator, please open the call for questions.

Operator

Thank you. Our first question comes from the line of Suraj Kalia from Oppenheimer. Your line is open.

Suraj Kalia
MD & Senior Analyst at Oppenheimer & Co. Inc.

Hey, Paul, John, can you hear me all right?

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Yay, Suraj. Yes, we can. Thank you.

Suraj Kalia
MD & Senior Analyst at Oppenheimer & Co. Inc.

Gentlemen, congrats on all the progress. Paul, on thyroid ablation, and maybe I'm jumping the gun here, could you share some patient baseline characteristics in the field that are driving or causing a pull through for an SPFA?

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Sure, thanks, Suraj. So first thing to think about is these patients are symptomatic. So if you think about the base case for thyroid disease, and the growth of benign nodules, actually the prevalence of nodules across the population is probably fifty percent or greater. That increases with age. But a lot of patients have very small nodule growth.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

And so for those patients for whom nodules become problematic, these are growing and that growth can be stimulated by changes in hormonal levels post pregnancy or immune disease. And those patients undergo a growth that becomes symptomatic. And so it is driving pressure in the neck area that could affect and literally encroach upon the trachea, the esophagus, and alter thyroid function. And it also just becomes unsightly as a growth on the neck, And it can become uncomfortable with compressive symptoms, if you will pressuring inward, and disruption of sleep as an example, based on the fact that a patient would have a growth on their neck. So patients seek therapy.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

And today, if you think about the, I'd say the expensive real estate of the thyroid gland, it is surrounded by critical structures, it is difficult to operate on. It is surrounded by nerves such as the recurrent laryngeal nerve that controls the vocal cords. So it's a very delicate space within which to try to manage growth. And despite the fact that this growth is benign, the most common outcome for these patients is to have their thyroid removed. This is not a late stage disease for aged population.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

This is commonly a younger patient, sixty percent female. And so the option of having thyroid removal, losing the gland that produces vital hormones that control blood pressure, body temperature, metabolism, it's generally a very unacceptable outcome. One alternative emerged over time in the form of radiofrequency ablation, which is conceptually appropriate because it's a less invasive alternative. But as you know, it ablates tissue by introducing extreme heat. And you can imagine in that small organ in that tight and sensitive location, the introduction of uncontrolled ablative thermal energy is undesirable.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

So this large patient population has no choice but to undergo thyroidectomy. And just to give you a sense, of the two hundred and fifty thousand patients that might be diagnosed per year, one hundred and fifty thousand will undergo thyroidectomy, and another one hundred thousand will go onto a watchful waiting list, because those patients are choosing not to have surgery because of the undesirable downstream effects of losing their thyroid function. So if you then introduce to them an alternative that is a non thermal ablation energy, that offers a percutaneous needle treatment done by a physician using ultrasound guidance under conscious sedation in a procedure that probably lasts forty five minutes total. That leaves no scar, that is pure intervention, that preserves all thyroid function, that delivers symptomatic relief within thirty days. And since that thyroid function is preserved, the patient essentially goes back to a normal life without symptoms, and with base case, if you will, hormone production.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

So it really is a fantastic alternative in a market today where the alternative is quite undesirable. So I think that is the fundamental driver of the market dynamic. It is the introduction of a less invasive, a classic med tech less invasive alternative, avoiding surgery. And in this case, not just avoiding surgery, but avoiding loss of a vital organ.

Suraj Kalia
MD & Senior Analyst at Oppenheimer & Co. Inc.

Fair enough. Paul, just I'll quickly have my other questions, and I'll let others hop in queue. Paul, catheter ablation, is the expectation still for a single arm study? And in the surgical AF ablation IDE, would the label SOT be cardiac ablation or soft tissue ablation? Gentlemen, thank you for taking my questions.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Yeah, thank you, Suraj. It would be a single arm study in EP. And yes, in the CLAMP, because we are endeavoring to not only perform an IDE, but also submit that IDE with a class III designation for PMA, we would end up with a cardiac indication, not soft tissue. So that's the goal, to take soft tissue as a base case, which in many cases, let's say for an interventional radiologist could provide them an opportunity to deploy, let's say the percutaneous electrode in multiple organ targets. But in the case of the cardiac surgical indication, we are pursuing a direct cardiac indication with a PMA.

Suraj Kalia
MD & Senior Analyst at Oppenheimer & Co. Inc.

Thank you.

Operator

Thank you. Our next question comes from the line of Josh Jennings from TD Cowen. Your line is open.

Joshua Jennings
Managing Director at TD Cowen

Thanks. Appreciate you taking the questions and congratulations on the continued progress. I was hoping Paul to just follow-up, make sure I heard you correctly that Pulse is collaborating with the market leader in cardiac ablation and you report on some partnership progress later in the year. I want to make sure I heard that correctly and maybe see if there's any other details you can share today.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Thank you, Josh. No additional details to share today other than reinforcing our strategy. With a number of clinical indications and markets to pursue, we're being very selective about those with which we can pursue with capital efficiency, a direct business model, and those where the market dynamics may be competitive enough and costly enough that it makes more sense for us to pursue with a partnership. We have determined as it relates to catheter based EP that a partnership is most appropriate. We're in partnership discussions.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

We believe we'll have a partnership available for our certainly for our commercial timeline, and possibly in advance of that during our clinical stage.

Joshua Jennings
Managing Director at TD Cowen

Excellent. Thanks for clarifying that for me. And know we've talked about this earlier in 2Q, but just about the compatibility with mapping systems, Dinosaurs and Cardo three. There is compatibility with the NS PFA platform. But how does that evolve from here?

Joshua Jennings
Managing Director at TD Cowen

And are you any details you can share on the collaborations with both Abbott and Johnson and Johnson?

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Yes, Josh. And as you know, we have done cases and shown live cases. In fact, throughout the course earlier this year, at the Boston AFib Conference and more recently at HRS, in which we demonstrated that full compatibility in live cases with each of those two market leading systems. I think it's safe to say that each of those systems has different levels of integration. And the more one works with each of those partners, tighter the integration can become.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

And so there are, I'll call it simply off the shelf or out of the box software integration capabilities. And then there are those that are more elaborate, more customized based on the specific rendering of an individual device on the mapping system. So are both compatible and they're both suitable. And over time they could each one could become more tightly integrated depending on the interests of each party in potential collaboration.

Joshua Jennings
Managing Director at TD Cowen

Appreciate that. And maybe just lastly, you know, we've talked historically about the NSPFA and cardiac ablation potentially being a great solution. If AFib ablation moved into ASCs and it looks like the potential could be sooner than later. Maybe just talk about the ASC opportunity and how your platform is positioned today and better positioned after you have the ID trial under your back.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Yeah, it's a great question and we agree with that premise. So a couple of things. Number one, ASCs, if you just think about the benefit of being there, but also the limitations, you may have less desire or capability of using general anesthesia. And so a therapy that can both enable very rapid procedures and low neuromuscular stimulation from the pulse electric field. Both of those factors would create a lot of benefit in the ASC.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

That would be I think a critical factor. When you think about overall procedure speed, if you will, patient throughput, the ability to ablate effectively, quickly, and have high patient turnover, lab turnover. We are seeing in our most recent cases in Europe, as low as forty five minute skin to skin times, ablation times consistently below ten minutes with operators that have just a little bit of case experience. So we think our system, both on procedure workflow, based on ablation effectiveness, and based on anesthesia requirements could be very well suited for the ASC.

Joshua Jennings
Managing Director at TD Cowen

Appreciate it, thanks.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Thank you Josh.

Operator

Thank you. Our next question comes from the line of Anthony Petrone from Mizuho. Your line is open.

Anthony Petrone
Anthony Petrone
MD - Equity Research at Mizuho Financial Group

Good afternoon. Thanks for taking questions. We'll begin with one on cardiac clamp and then follow-up with three sixty cardiac catheter. And this is really about data that's being collected overseas for both product initiatives. And so, you have the multi site study for the first in human clinical trial for cardiac clamp, it's out of The Netherlands.

Anthony Petrone
Anthony Petrone
MD - Equity Research at Mizuho Financial Group

But you're enrolling here the pivotal starting mid-twenty five. So just wondering, The Netherlands data be published? And how will that kind of play in the PMA application for the clamp? And a similar question would be on cardiac catheter. You have a multi site study, I believe in Prague, and half of the patients have been remapped and the data based on the filings is promising.

Anthony Petrone
Anthony Petrone
MD - Equity Research at Mizuho Financial Group

How will that data play into the IDE pivotal trial? And then I'll have a couple of P and L follow-up questions.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Hey Anthony, yes, thank you. Good question and great to hear from you. Yes, in both cases, having human data and in clamp, as you know, N of about 40, obviously with the catheter over 100 now. So the more volume of human data, I think the more helpful that is with FDA. And so that is both those data sets are included in their respective IDE submissions.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

And of course, when you think about the threshold for IDE approval, you're really getting FDA to a point of determining that this device is safe to enter a clinical trial in The US. And so having dozens and dozens of well tolerated, safe, properly documented, and in some cases durably followed patients. That really does provide FDA I think with a very important checked box for the IDE. Of course you can get an IDE without human data. And of course you need other layers of data, bench top testing, pre clinical histology, things like that, that you cannot extract from human data.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

But that human data is collected, it is submitted in each of those two, and I think it will be incrementally just positive for FDA as they move us toward IDE approval on both of those. In the case of CLAMP for data publication, there is a meeting in October in Copenhagen, which is called the EACS meeting. It is actually the European Society of Cardiothoracic Surgery. And we do expect to have additional data publications and case demonstrations at that meeting for the cardiac surgery clamp. So we are flowing data, if you will, in that direction.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

And we're continuing to advance our catheter data similarly. I don't have any near term conferences to announce for data issue, but we are working on publishing our European feasibility data. And that will I think look very good. So more to follow exactly on timing of publication, but we're certainly advancing the feasibility data to transparency, if you will, for both studies.

Anthony Petrone
Anthony Petrone
MD - Equity Research at Mizuho Financial Group

No, very helpful. And then just looking ahead, both PMA devices on the CLAM side, obviously you have breakthrough designation and you're now enrolled in this TAP program. So just high level on both studies, will they be modular PMA submissions? That would be the first question. Being that you have breakthrough designation and now enrolled in TAP, how much quicker can a can clamp kind of get to market ahead of PFA? And then just quickly on P and L, just in the second half with both studies launching here, just directionally the uptake in R and D, how should we be thinking about that? Thanks again.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Yeah, thanks Anthony. Yeah, breakthrough designation I think is very helpful in a number of ways. And the TAP program, I would say, has been an excellent experience between our company and FDA. Transparency, a lot of interactivity. There's no wasted time in sending questions and answers back and forth without clarity of intent.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

And I don't think there's any doubt if you just look at the data that the TAP program in particular is helpful on regulatory timing. So that's been very helpful. And then I'll just spill over into the modular question. Modularity in your submission really is independent of breakthrough designation. It's really the sponsor's choice, the company's choice as to how you submit.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

I personally, having been associated with a couple of dozen PMA approvals, I would say modular makes sense basically every time. It allows the FDA to review components and spread them out over time, and I just think it's a much more work flow friendly process. And I'll just comment in particular because as an example, our console is basically shared, right between the clamp and the catheter. And so if you think about a manufacturing submission, and both reviews taking place within the cardiovascular group of FDA, there will be real synergies in not only taking advantage of the basic benefits of modularity in submission, but then having FDA see module, the manufacturing module as an example for one submission, and then also for the other. You can imagine that the overall review time would be lower, and questions that we might have received on the first review of a module, of course would be answered prospectively on the second submission.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

So I think there are a lot of benefits to that. And with that, I'll maybe turn the call over to John to answer the P and L question.

Jon Skinner
Jon Skinner
CFO at Pulse Biosciences

Sure, yeah, thanks for the question Anthony. To highlight and address your point for R and D spend, we do expect that to increase throughout the back half of the year as you highlighted with the two clinical trials commencing for the IDs of the classic catheter that'll cause an uptick in our spend along with the associated headcount that'll go along to support those trials. So we do expect an uptick on the back half of the year, and this goes hand in hand with the operating cash burn commentary that we provided, where we're at a $13,500,000 operating cash flow burn in Q1 and 12,800,000.0 in Q2. We do expect that to tick up in the back half of the year as we again hire more heads to support those two IDs and also the initial commercialization activities that we'll be working towards on the perfect electrode in the second half of the year as well.

Anthony Petrone
Anthony Petrone
MD - Equity Research at Mizuho Financial Group

Very helpful. Thanks again.

Operator

Thank you. There are no further questions. I will now turn the call back over to Paul Le Violet for closing remarks.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

Thank you, operator. I just want to thank everyone for your attention today. I appreciate the commentary about the progress that the Pulse Biosciences team has made over the second quarter. We're very pleased with that progress. We're very focused on a lot of activity for Q3, including expansion of our pilot activity with the PERC electrode and our two IDEs.

Paul LaViolette
Paul LaViolette
CEO & Co-Chairman of the Board of Directors at Pulse Biosciences

And we look forward to keeping you apprised of our progress, including at the Q3 call that we'll gather together for in October. So thank you very much all. We appreciate it. Have a great day.

Operator

The meeting is now concluded. Thank you all for joining. You may now disconnect.

Executives
    • Paul LaViolette
      Paul LaViolette
      CEO & Co-Chairman of the Board of Directors
    • Jon Skinner
      Jon Skinner
      CFO
Analysts
    • Philip Taylor
      Principal at Gilmartin Group
    • Suraj Kalia
      MD & Senior Analyst at Oppenheimer & Co. Inc.
    • Joshua Jennings
      Managing Director at TD Cowen
    • Anthony Petrone
      MD - Equity Research at Mizuho Financial Group
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