Pulse Biosciences at Stifel 2025: Strategic Expansion and Innovations

On Thursday, 13 November 2025, Pulse Biosciences (NASDAQ:PLSE) presented at the Stifel 2025 Healthcare Conference, highlighting their innovative nanosecond pulsed field ablation (nsPFA) technology. The company is pursuing a dual market strategy, directly targeting the thyroid market while seeking partnerships in larger sectors. Despite a recent dip in stock value, the firm maintains a strong financial position, supporting its ambitious plans through 2026.

Key Takeaways

• Pulse Biosciences is focusing on nsPFA technology, offering faster, deeper, and non-thermal ablations.
• The company reported $86,000 in revenue from their M-Pulse Vibrance system in Q3 2024.
• A robust cash reserve of $95.2 million supports their strategic initiatives.
• Clinical trials are underway for thyroid nodules and cardiac ablation, with positive early results in Europe.
• The company is actively seeking partnerships in the electrophysiology market.

Financial Results

• Q3 2024 revenue from the M-Pulse Vibrance system reached $86,000.
• Pulse Biosciences concluded Q3 with $95.2 million in cash.
• Approximately $400 million has been invested in developing M-Pulse technology.

Operational Updates

• Thyroid Market:

- Initiated the Precise BTN clinical study, with completion expected by Q1 2026.

- Focused on expanding operations in large metropolitan areas.

• Surgical Cardiac Ablation:

- FDA approved the IDE pivotal study; first patient treated in the NanoClamp AF study.

- Positive clinical results presented at a European cardiothoracic surgery meeting.

• AFib Ablation (Electrophysiology):

- Engaged with the FDA on IDE study protocol, aiming to start pivotal trials in Q1 2026.

- European feasibility study has enrolled 150 patients across various sites.

Future Outlook

• Thyroid Market:

- Transition thyroidectomy procedures to minimally invasive M-Pulse Vibrance techniques.

• Surgical Cardiac Ablation:

- Expand treatment to more eligible patients, focusing on post-operative AFib prevention.

• AFib Ablation (Electrophysiology):

- Actively seeking industry partnerships for the M-Pulse Cardiac Catheter commercialization.

Q&A Highlights

• Pulse Biosciences is exploring partnerships for M-Pulse Cardiac Catheter commercialization.
• Clinical data shows nsPFA technology reduces ablation times to about 12 minutes, compared to 30 minutes for competitors.
• The M-Pulse Vibrance system targets 200 ultrasound-trained physicians, leveraging skills from previous RF procedures.

For further details, readers are encouraged to refer to the full transcript below.

Full transcript - Stifel 2025 Healthcare Conference:

Ricky, Conference Host: Ready? Okay. It is my distinct pleasure to welcome the Chief Financial Officer of Pulse Biosciences, Jon Skinner, sitting in the audience, the Chief Technical Officer, Darrin Uecker. Thank you, welcome. Glad you could be here. We were just discussing Pulse Biosciences is a bioelectric medicine company. There’s a phrase I have not often used: commercializing its proprietary nanopulse stimulation technology, referred to as nanosecond pulsed field ablation, which is used for tissue ablation in many clinical settings. And we may see this slide. I don’t know if we’re going to see this.

Jon Skinner, Chief Financial Officer, Pulse Biosciences: Yes, we will.

Ricky, Conference Host: I pointed it to my favorite slide. But when we met and spoke a few months ago, just the headline of this slide, which we’ll come to, nanosecond PFA delivers higher amplitude, shorter duration pulses that provide significant advantages versus other PFA forms, microsecond PFA, non-thermal, faster, deeper ablations. I mean, I think this is important. This is the next generation, second generation PFA. So with that introduction, please tell us more.

Jon Skinner, Chief Financial Officer, Pulse Biosciences: Thank you, Ricky. I really appreciate it. Great introduction. We’ll walk through that part that Rick highlighted as part of our story. Most importantly, thank you for having us. It’s a great conference, and we’re really appreciative of the opportunity to be here and tell you about Pulse Biosciences. Please note that today’s discussion includes forward-looking statements, which reflect management’s views as of today. These statements are subject to risks and uncertainties that may cause actual results to differ materially. Full details can be found in our SEC filings available on our website. At Pulse Biosciences, our mission is to build a thriving, viable company by providing revolutionary and life-changing therapy for a variety of diseases and disorders with next generation nanosecond pulse field technology. Innovation drives everything we do.

We are pioneering a new class of medical technology platforms powered by our proprietary M-Pulse technology, which delivers ultra-precise nanosecond pulsed electric fields to targeted tissues across various anatomical sites. This breakthrough science enables novel, minimally invasive procedures designed to improve patient outcomes and redefine standards of care. By developing a diversified portfolio of specialized medical devices for multiple clinical applications, Pulse Biosciences is not only advancing therapeutic possibilities, but also creating new markets and long-term value in the rapidly evolving healthcare landscape. The company has been around for about a decade, having about $400 million of capital invested in the development of M-Pulse technology and our clinical applications. We have a large volume of preclinical data, multiple FDA clearances, and have breakthrough device designation on one of our market programs.

In the overall wave of delivery of PFA for clinical indications, we believe Pulse Biosciences owns differentiated energy with a growing body of preclinical, clinical, and commercial experience, showing us that nanosecond pulsing is likely a safer and more effective treatment option than products already in the market today. We have a very impressive array of intellectual property claiming the creation and delivery of very short duration pulses at high energies to treat patients. We continue to develop additional intellectual property across systems, applications, and methods with more than 215 issued patents and more than 100 pending patent applications from dozens of patent families. We have a very strong leadership team in place with significant operational and market experience, plus considerable experience with new technology development, including energy delivery in the ablation market.

We are supported by a fantastic team of engineers and clinicians and have three really influential chief medical officers across our clinical opportunities. Lastly, we have a very strong board led by Bob Duggan. Bob is, of course, a serial entrepreneur. He’s a legendary investor, and he’s a great asset to our company. We have a very strong balance sheet with $95.2 million in cash at the end of Q3 to execute our plan. This plan is focused on running two IDE studies as well as growing commercial activities. In Q3, we initiated our limited market release of the M-Pulse Vibrance percutaneous electrode system, which is FDA cleared for soft tissue ablation. We generated $86,000 in revenue during the quarter from this first step in our commercialization activities. Now getting into some of the points that Rick was highlighting earlier, our mechanism of action.

What’s truly unique about Pulse Biosciences is the proprietary creation of the delivery of pulse durations into the nanosecond range, which is another way of saying we measure our pulse duration in billions of a second. Other PFA technologies in the market today measure their pulses in millions of a second. Both of those obviously sound really fast, but bear in mind there is a 1,000-fold difference between millions and billions of a second. By reducing that duration, we drive our amplitude of energy significantly higher, and that creates remarkable clinical benefits. nsPFA has a unique ability to permeabilize intracellular organelle membranes because of the short duration and high amplitude of the fields applied. The much shorter delivery time avoids heating and allows a non-thermal energy delivery that generates pores in both plasma and organelle membranes while leaving these membranes intact.

This disrupts mitochondrial function and initiates regulated cell death, the process used by all cells at the end of their useful life, whereas other energy modalities like microsecond PFA create an inflammatory response. PFA is a very popular and dynamic technology today, and that’s a very good thing for us at Pulse Biosciences. The important distinction here is that nsPFA energy is not the same as what we hear about from other companies with microsecond PFA. It’s important to not only understand these differences, but to understand that it is a differentiated platform. It makes deeper lesions, which is critical if you want transmural ablation or through the full thickness of the cardiac structure, for example. Given the speed of delivery, our proprietary technology delivers less energy overall, and this substantially improves our ability to create non-thermal lesions.

Patients treated with nsPFA energy can undergo procedures with lower sedation requirements and non-paralyzing anesthesia, which can enable procedures to be done in less intensive sites of care. Overall, we think we’re in position of a very novel form of PFA that fundamentally changes our position competitively in various markets. As a result of our novel energy, we have the ability to go after multiple markets and have targeted three initially. First is the creation of a thyroid intervention market. Thyroid is not a clinical target for many companies, but it does represent an organ prone to very significant diseases. We believe it is a wonderful greenfield opportunity for Pulse Biosciences and our M-Pulse technology. The second target market is cardiac surgery, where there is an existing AFib ablation opportunity that is significantly underpenetrated today. Finally, our largest potential market is AFib ablation within the electrophysiology market.

This market alone currently represents a $3 billion opportunity and is growing. When all three market opportunities are combined, we see a $6 billion opportunity for Pulse today. These market values increase to more than double over time based on market expansion and operating with a global footprint. Because we are a platform company, it will be very difficult for us to go after many of these markets simultaneously, and we’ve created a hybrid approach to these markets focused on capital-efficient entry. We will take on markets in a direct fashion where we believe they are addressable and we can enter and scale in an efficient manner. In markets with very large established competitors, we will likely partner. EP is an example of an obvious partnering opportunity for us. Thyroid is an obvious direct opportunity.

There will be other markets that are in between and could be attractive both on a partnership basis and on a direct basis. Now I’ll go into more detail on our three market programs, starting first with the thyroid market. Thyroid is a remarkable category for us and one that we think has enormous potential. The thyroid is a gland and produces hormones that perform critical functions in our body, like controlling body temperature, heart rate, and metabolism. Yet, with benign growth today, patients end up having their thyroid surgically removed because it is so difficult to treat given the critical structures around the thyroid. Our mission with our first indication in benign thyroid nodules is to convert a surgical removal of an organ into a less invasive alternative. Approximately 250,000 patients are diagnosed annually in the United States with symptomatic benign thyroid nodules.

Of those 250,000, 100,000 go into watchful waiting. This produces over a $1 billion annual market opportunity in the thyroid space. Ablation of benign thyroid 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 the 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 M-Pulse Vibrance procedures, as removal of this vital gland should not be the primary option for benign growth. We also believe interventional volumes for benign thyroid nodule treatment will expand by offering nsPFA as a treatment option to a large portion of watchful waiting patients.

These patients have chosen not to undergo an intervention because of undesirable consequences of either losing their thyroid or accepting the risks of thermal ablation modalities. The M-Pulse Vibrance percutaneous electrode system is cleared under 510(k) for soft tissue ablation. We are early in our launch and focused on quality therapy development and are proud to have recognized initial revenues during the third quarter of this year. As we progress through the rest of the year, we will maintain consistent commercial headcount in Q4 as we concentrate on expanding accounts in the existing large metropolitan areas covered by our current commercial team. Once these initial accounts achieve the desired utilization levels, we will expand headcount and launch into new geographies. We also initiated the Precise BTN clinical study with the first successful procedures of the study completed at multiple sites.

This prospective single-arm multi-center study aims to generate robust clinical evidence to demonstrate the safety and effectiveness of this less invasive thyroid-preserving procedure. Benign thyroid nodule soft tissue ablation procedures will be performed on up to 50 patients at up to four sites. Study endpoints evaluated during the follow-up time points will include safety, symptoms reduction, improvements in quality of life, targeted nodule volume reduction, and cosmesis over various follow-up periods. The study is progressing with more than 40% enrollment to date with multiple sites up and running. We expect to complete enrollment in Q1 of 2026. Next, moving to our second market program, surgical cardiac ablation. This is an area that already exists, but it’s significantly underpenetrated. It’s a market that is treated today with radiofrequency, so it should be highly amenable to the clinical benefits offered by M-Pulse technology.

Patients undergo open-heart surgery for bypass or valve replacement about 300,000 times each year. Nearly one-third of those patients have pre-operative AFib. Clinical guidelines for most relevant societies suggest surgical ablation should be performed concomitantly with any first-time non-emergent cardiac surgery for patients with AFib. Unfortunately, and likely due to technology limitations, this concomitant procedure is underutilized and underpenetrated today in practice, as it’s only done approximately 30% of the time. What we are trying to do is offer an improved therapy that will not only replace current RF treatments but expand the market to more of those patients who are on label but not currently receiving treatment. This is a significant market today with opportunity for immediate expansion. Additionally, there is a subsequent market expansion that could be made available with additional clinical studies to treat patients prophylactically because there is a very high incidence of post-operative AFib.

The M-Pulse Cardiac Clamp is engineered to deliver precise, continuous, and transmural linear ablations during concomitant cardiac surgeries. Due to its non-thermal mechanism, nsPFA significantly reduces the risk of unintentional damage to surrounding tissues such as nerves. This bipolar system utilizes Pulse Biosciences’ proprietary nanosecond pulsed field ablation energy to achieve full-thickness durable lesions with reduced ablation times compared to traditional thermal ablation methods like radiofrequency. The FDA has granted approval for our IDE pivotal study, allowing us to proceed with initiation of the M-Pulse surgical ablation clamp study, NanoClamp AF, for the treatment of atrial fibrillation. This is the first PFA study approved by the FDA for a surgical cardiac ablation device in concomitant surgical procedures. This prospective single-arm multi-center study is designed to assess the primary effectiveness of the M-Pulse Cardiac Surgery System in treating AF during concomitant cardiac surgeries.

Up to 136 patients will be enrolled across approximately 20 sites, including two international sites. We treated our first patient in the study last month. Late-breaking clinical results from our European feasibility study were recently presented at the European Association for Cardiothoracic Surgery meeting. As the first clinical use of an nsPFA cardiac surgical technology, the study demonstrated that the M-Pulse Cardiac Clamp enables fast, safe, and efficient workflow, highlighting its potential to significantly broaden the adoption of surgical ablation in the treatment of atrial fibrillation. Lastly, our third market program is the M-Pulse Cardiac Catheter for AFib in electrophysiology. It is the largest market of those that we are pursuing and has been transformed in the past few years with the introduction of microsecond PFA. PFA has added a speed and safety factor, making it one of the most attractive areas for our technology.

We believe nsPFA can add significant value on top of first-generation PFAs that are available today. The M-Pulse Cardiac Catheter is designed to deliver a complete circumferential lesion in a single brief energy application, a five-second ablation cycle. This eliminates the need to stop, rotate, and reposition the catheter several times in each pulmonary vein. This provides the ability to have total ablation times under 10 minutes with moderate experience compared to 30 minutes for devices on the market today. We believe the system offers key advantages, including lower cumulative energy delivery, potentially reduced neuromuscular stimulation, as well as a valuable ability to create deeper, more uniform lesions. The system’s flexible design also enhances maneuverability within the left atrium, making it intuitive and user-friendly for physicians.

Encouraging initial clinical outcomes from Europe confirm our belief that the benefits of nanosecond PFA delivered by the M-Pulse Cardiac Catheter will significantly advance the treatment of AFib for patients worldwide. We are engaged with the FDA on our proposed IDE study protocol and expect to resolve remaining open items over the next couple of months and in position to commence our pivotal trial in Q1 of 2026. In Europe, our ongoing feasibility study with the Cardiac Catheter has now enrolled 150 patients across multiple sites. We are anticipating sharing new safety and efficacy data, including one-year follow-up data from the initial cohort of patients at an upcoming scientific meeting in Q1. In summary, Pulse Biosciences is a very novel platform company. We have proprietary ownership over next-generation PFA energy with multiple target indications.

We are producing impressive clinical evidence across an array of indications, and we are adding to that with multiple IDEs. We have very large target market opportunities, some of which we will pursue on a direct basis and some of which we will pursue through partnerships. We are in position of a strong balance sheet that enables us to execute on our plan through 2026. We are very excited about Pulse Biosciences’ opportunities and prospects ahead. With that, I’ll conclude my comments and open it up to Q&A. That’s great, Jon, and a wonderful overview. I might come at it from reverse order. You’ll be shocked. Absolutely. Yeah. You’ll be astonished to hear that. I’m sort of fascinated, of course, with the M-Pulse Cardiac Catheter, and it’s exciting to hear the trial gets underway in the first quarter.

You talked about throughout your presentation, you alluded to direct versus partnership. Can I guess that this is going to be an area that you’d be thinking about a partnership? Are you in conversation? I mean, I don’t know. I always use the Rick Wise rule about everything, narcissistically speaking. If I can understand that this is a powerfully disruptive platform technology that could be really, really, really transformative to current leaders or have-nots, are you engaged in talking to everybody at this point? Yeah, yeah. Just as you highlighted, this definitely falls into our approach on our hybrid strategy that this makes sense to be in the form of a partnership. That’s the avenue that we’re pursuing. Right now, we haven’t affected a partnership, and today we’re running the trial on a standalone basis, and we’re fully equipped and ready to do that.

At some point between now and that ultimate commercialization, we plan to partner. As you’d expect, we’re engaged with folks across the industry to try to find that right partnership, what the right home is, what the right structure is. We’re still evaluating that today. It’s still to be determined on where it lands, but fully intend to partner in that market to ultimately commercialize our platform. Yes, we agree. We expect it to do great things in the market. We’re really proud of our technology and looking forward to giving out additional clinical data in the future to demonstrate what we’ve been able to put together. Are all the players aware and conscious that this exists? I think I would be frightened again to miss the proverbial ring. Yeah, yeah. They’re aware that it’s out there.

We’ve done live cases at the Boston AFib Symposium earlier this year in 2025, where we actually did a case on the Insight system. During HRS, again, we did a live case where we were mapped on the CARDO system as well. We have done work across those different platforms. Ultimately, which ends up being the home for this device is still to be determined, but we’re obviously fully engaged with folks across the industry. All right. I mean, go ahead, Jon. You mentioned beneficial or incremental safety and efficacy benefits of nsPFA compared to microsecond PFA. Can you just talk a little more about what that actually means in terms of procedure times or in terms of freedom from HF just in your clinical data or clinical experience so far? What does that actually translate to? Yeah, yeah.

So far, we’ve seen the data that we released earlier this year. Total ablation times were about 12 minutes, and most of the devices on the market today, you’d see about 30 minutes or higher for where they are. A significant step forward with that. That was in our early feasibility data for the first cohort of patients that we released. Over time, as you’d expect with most devices, as you get more comfortable, get more use of the system, those ultimately could go down. We do see the opportunity for significant time savings versus what is out there today. This is really driven by our 360 development of the catheter, where we get a fully circumferential lesion within the pulmonary vein. Our application, we put two pulse applications of five seconds each in each vein.

We usually average about 12 ablations for a total pulmonary vein isolation versus others. If you look at some of the other competition, it could be about 40 applications or so because they go into the vein, they pulse, they ablate, they rotate, they rotate, they rotate. We can do it with much fewer applications and also do that much faster. Efficacy. Yep, efficacy. We have had, again, just early data from our feasibility study has done really well with great efficacy. We are working on putting the larger data volume together where we will report out early in Q1 on some additional data from our feasibility study and ultimately getting into our IDE to prove that out.

We feel strongly about it that we’ll get good efficacy, but again, we got to go out there and get the data to report it out to you. I’m sort of jumping away from the other two opportunities just for a second. It just seems like this is a foundational technology that could be used in many areas. For example, I have no idea if I’m just jumping off in some bizarre direction, but like renal denervation, for example. Are there other big markets where you think this technology has applications? Yeah, yeah. Have you talked about that publicly as well? Yeah, we haven’t talked about it publicly. We do see a lot of utility in the device across the spectrum. As we highlighted, it is truly a platform technology where there’s a lot of great indications.

You can see that just in the fact that we’re going after soft tissue ablation and also cardiac. Very different markets, but a lot of utility for the technology in both of those. There’ll definitely be more to come in the future from us, but we’re laser-focused on these three opportunities right now. Ultimately, we’ll build those out where it could be some that are like line extensions or improvements in the call points that we have or other ones kind of where you’re headed as true new platforms, new technologies that we’ll go after as well. Talk to us more about Darrin. Obviously, you’re early in the launch. How many centers are there? I mean, I don’t know anything about this market after 40 years as a med tech analyst.

I mean, are there 100 doctors or 100 centers or tens of thousands? Give us some sense of the dynamics. And do they have the skills to do that? Are they trained in sort of catheter-based techniques that would make argue for a rapid uptake? Yeah, yeah. The initial target for us within the market, again, it’s a broad market. 150,000 thyroidectomies are performed. That in and of itself is a large market. We also have the watchful waiting pool, which ultimately could become candidates for our procedure. As far as the initial cohort of doctors that we’re going after, it’s around 200 physicians that are ultrasound needle-guided and trained.

Those are the ones that have either performed RF or have the skills to do the RF procedures that were done before but did not really take off because of all the negative impacts of thermal energy. That initial cohort of doctors is our focus right now in our limited market release where we are going after getting those surgeons, getting them up, getting them trained, proving good outcomes, getting good market access, and showing that utilization is really taking off in those accounts and also expanding with insights to go to a second doctor, a third doctor, a fourth doctor. That is where we are focused right now. We are in a small number of accounts. We did a pilot study where we went through initial accounts.

We had nine sites in our pilot program earlier this year, and we started adding some commercial accounts in Q3 as we highlighted. Still in a small number of centers, but we have a small team, and we’re very laser-focused on specific geographies right now where we’re building depth in those accounts, building the foundation for what will be a successful business in the future where we’re focused on utilization, outcomes, market access, and proving that these accounts can become viable in the future. Just at a high level, what’s training like? Is this a day of training or a weekend of training to get with the program and have enough sufficient skills? How many proctored procedures are there? Said differently, how long does it take a doctor to sort of incorporate this? Is it five procedures, 10?

Yeah, doctors right now become proficient very quickly because, again, the initial ones we’re going after have that ultrasound needle-guided technique. So they have those skills already resident. We are going after those doctors saying they become efficient very fast. At this point in our launch, we’re still in every single case because we’re very early days. We want to make sure everything’s going great. Over time, we do view it as a device where we won’t have to be in every single procedure to ultimately grow and scale this opportunity in the future. We’ve got a minute, 16 seconds to not neglect surgical cardiac ablation. The nano clamp, I assume this is for cardiac surgeons who are doing it. Correct. I would think they’re, I know they’re doing sort of similar techniques with different technologies.

I would think this is potentially a rapid uptake opportunity. Yeah, exactly. Yeah, same exact technique. You could even just liken it akin to the step from RF to PFA that occurred in the EP market where we would be coming in. RF is the resident technology. We’d be coming with our next-generation PFA, nanosecond PFA to come in and do the ablations where you’d see a lot of the same factors where it’s just a couple-second ablation, and that line is done on that second common ablation procedure. We see a lot of the same benefits and potential for quick uptake for all those same reasons that PFA was so successful in EP. Yeah, that makes sense. I think we’re basically out of time. Jon, thank you for an illuminating discussion. Yeah, it’s great to hear. Congratulations on everything you’ve accomplished. Yeah, we appreciate it.

Thanks a lot, everyone. Thank you for being.

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