Pulse Biosciences at TD Cowen Conference: nsPFA Technology Focus

On Wednesday, March 5, 2025, Pulse Biosciences (NASDAQ: PLSE) presented at the TD Cowen 45th Annual Healthcare Conference, highlighting its cutting-edge nanosecond Pulsed Field Ablation (nsPFA) technology. CEO Paul LeViolette outlined the company’s strategic plans, emphasizing both its strong financial position and the promising clinical applications of its technology. Despite a current stock price drop, the company remains optimistic about its future market potential and commercialization efforts.

Key Takeaways

• Pulse Biosciences aims to commercialize its thyroid application by mid-2025.
• The company holds $130 million in cash, supporting its clinical and commercial activities.
• nsPFA technology is seen as a safer, more effective alternative to existing ablation methods.
• The company is targeting a $6 billion market, potentially growing to $15-$16 billion by 2030.
• FDA breakthrough designation was received for the cardiac surgery application.

Financial Results

• Cash Position:

- $118 million in cash as of December 2024.

- Pro forma cash of $130 million following a rights offering in Q1 2025.

• Burn Rate:

- Approximately $36 million in 2024.

- Expected increase in 2025 due to expanded clinical trials.

Operational Updates

• Thyroid Nodule Ablation:

- Commercial launch planned for mid-2025.

- Post-market study in 10 centers to be completed by mid-Q2 2025.

• Cardiac Surgery Ablation:

- OUS feasibility study ongoing, U.S. commercialization anticipated in 24 months.

- FDA breakthrough designation received.

• EP Catheter Ablation:

- Feasibility data being collected, with clinical trials planned for 2025.

Future Outlook

• Market Potential:

- Current market value of $6 billion, expected to grow to $15-$16 billion by 2030.

• Pipeline Expansion:

- Plans to add additional indications to their market strategy.

• Commercialization Strategy:

- Direct approach for thyroid application.

- Partnerships for the EP catheter market.

Q&A Highlights

• Positive feedback on nsPFA’s safety and efficacy.
• Promising early data from approximately 100 cases.
• Efficient procedure times with high isolation rates in AFib treatments.

Readers are encouraged to refer to the full transcript for more detailed information.

Full transcript - TD Cowen 45th Annual Healthcare Conference:

Josh Jennings, TD Cowen Medical Devices Research Team, TD Cowen: Good morning. I’m Josh Jennings from the TD Cowen Medical Devices Research Team. We are excited to have executives from Pulse Biosciences participate in the conference for the first time. I’m gonna introduce a veteran in the medical device space whose career we have admired from afar, and we’re excited that he has joined the Pulse Biosciences as the Co Chairman and CEO, Paul LeViolette and the Chief Financial Officer, John Skinner is joining us in Boston as well. And I’m gonna hand it over to Paul to, to present.

And it’s a pleasure to have you, Paul. Great to see you.

Paul LeViolette, CEO and Co-Chairman, Pulse Biosciences: Josh. Thank you, doctor Jennings, I should say. So as Josh mentioned, I’m Paul LeViolet. I’m the CEO and co chairman of Pulse Biosciences. It’s a pleasure to be here, today.

I’ve been in the medical device industry for forty five years. I’ve run a number of things, been associated with many new technologies, many, exciting marketplaces. And, it is with that in mind that I found the technology of nanosecond PFA and, the core value of Pulse Biosciences to be irresistible. As Josh mentioned, I, chairman of the board, I’ve been on the board, for about a year. I stepped in as chief executive officer at the start of, 2025, and it’s one of the most exciting technologies I’ve ever had the privilege to be associated with.

And I’m looking forward to sharing that with you today. And, to advance the slides, So, I will be making forward looking statements today. This is our disclaimer. And then, I just wanna spend one second on our mission. We do intend to build a very thriving viable company.

A lot of early stage companies focus on, let’s say, building value and quick exit, becoming a tuck in story for strategic. We think we have a tremendous platform value here to share with multiple clinical specialties. Therapeutic value of nanosecond PFA is vast and will go after multiple, clinical conditions and chronic diseases. And, we think nanosecond PFA is a very unique energy and has remarkable therapeutic value. So our focus is on building this company, initiating commercialization with our first platform in the next year, concurrently initiating multiple clinical studies in, in other fields, which are equally exciting and in in some cases substantially larger and building this platform out to be a really unique story in the medical device industry.

I’d like to start my talk off with this quote from doctor Niv Ad. Niv is one of the most prominent cardiothoracic surgeons in the world, certainly among the most published. He described NSPFA as an energy that can replace all other energy modalities in medicine. And obviously, he’s focused on cardiac ablation. I’ll give you more insights into the cardiac surgery field, specifically.

But, his thought is that this is disruptive. It’s transformative for the patients he serves, and we’ll describe that in more detail. But not only is it potentially capable of changing the way patients are currently treated, but substantially expanding the number of patients that can be treated. And that is because you end up with improved safety, improved efficacy, substantially improved procedure flow, speed of intervention, overall efficiency in delivering therapy, and that that brings into, therapeutic, targeting, far greater patient populations than we see treated today in in our in many of the markets that we’re targeting. So we’ll describe that in more detail, but we we really think this nicely characterizes the potential that that Pulse offers.

Pulse is a very strong company today. We have multiple programs in the clinic. We have, achieved multiple FDA clearances. We have a very strong financial outlook. We have a balance sheet as of, the December, that showed a hundred and $18,000,000 in cash on hand.

Pro form a earlier in q one, that was a hundred and $30,000,000 following, final receipts from a rights offering that was conducted last year. So that provides us with a multiyear cash runway. Our burn in 2024 was approximately 36,000,000 That burn will increase in 2025 based on our embarking in multiple, clinical trial activities that I’ll describe in more detail. But, we have ample cash resources to conduct our clinical work and our commercialization activity over the next several years. We have very strong inside ownership, which is indicative of fantastic commitment and conviction, for our technology and for the clinical mission that Pulse Biosciences is pursuing with nanosecond PFA.

Speaking of that conviction, we have a management team that has just been recently expanded with the addition of John Skinner. John is our chief financial officer, has excellent EdTech credentials with, fast growth companies like Imperative Care and strategics, like, Teleflex. We have a very strong senior leadership team, chief commercial officer, chief technology officer, chief strategy officer, Kevin, Darren, and Mitch are deeply experienced decades of senior management and even chief executive officer experience across multiple companies, deep in our space of energy delivery. And I will say as I joined the the company, certainly, in addition to the technology and the number of markets we could pursue, the quality of the leadership team was a major draw for me. I started in med tech leadership in 1980.

I led the first interventional cardiology business in The United States. I’ve been associated with growth platforms, for decades having started at Boston Scientific, when it was a relatively small company and staying there for fifteen years and helping to lead its growth up to $8,000,000,000 when I retired. I’ve been a EdTech venture capital investor for the last fifteen years. I’ve been on, a couple of dozen medical device industry board of directors. And, as I mentioned at the beginning, my excitement about Pulse is based on, frankly, a very high expectation for therapeutic value.

I’ve seen some of and been associated with leading some of the largest, market creating strategies in in medtech history, and I think Pulse has the potential, to be a very exciting addition to those, chapters. I think it’s extremely important to emphasize that in addition to a very strong management team, we have, an array of prominent chief medical officers that have, joined our company on a part time basis, leaving portions of their practice time behind to help us work on applications of this disruptive therapeutic energy into their fields of of practice. And so we’re really blessed to have great clinical minds, but it also shows the commitment the company has developing great clinical science to go along with our, energy applications. We have a a fantastic board of director, board of directors. That board is anchored by Bob Duggan and McKee Zanganeh.

Bob and McKee are legendary serial entrepreneurs. They’ve built fantastic companies. They’ve created tremendous amounts of value. I would say they are, legendary investors as well. So we have a very active and engaged board supporting a very strong management.

I just wanna spend a few minutes giving you a perspective on, nanosecond PFA. It’s it’s a it’s an energy that has been under development for probably about twenty years, starting perhaps for the first decade or so in academic research as, energy pulses of electricity were, tailored and reduced in duration from milliseconds, thousands of a second to microseconds, billionths of a second, then into this entirely new space on spectrum of nanoseconds. So measuring pulse durations in the billionths of a second, time duration. And I’ll go into more detail as to why that’s important. But by in very short form, by reducing the duration of the pulse, you you are reducing how much energy is delivered, and therefore, how much heat is delivered.

And if you can reduce the total amount of heat associated with that pulse, you can drive its amplitude up and improve its therapeutic potential while not leaving any thermal footprint. And that creates, both novel clinical mechanisms, but also significant technology differentiation, from other companies practicing pulse field energy delivery. This is a field that has developed and been substantiated by over a thousand publications. The company our company itself has invested $400,000,000 to date developing this technology and its clinical, evidence. That has led to seven FDA clearances, our most recent having earned breakthrough designation at the FDA, and a proprietary position for this energy, which I think really sets this company apart.

We have over a 80 issued patents. We have another hundred plus pending, and that really allows us to, stake claim that this energy is proprietary. Unlike many energy forms that have preceded us, which become open market and commonly practiced, and generic, we believe we will own the ability to generate and deliver nanosecond pulses of of PFA for, for years to come. So let’s talk about market potential and and where we’re focusing our management energy and resource. We have multiple large markets, to aim at now, and we are developing a list of additional indications beyond this list of the first three that will keep us busy for years to come.

That target, list of markets today creates upwards of $6,000,000,000 of real time potential. And those markets, as we look out to 2030 and expand globally, will produce target value for Pulse Biosciences exceeding 15 to $16,000,000,000. So we are not short of target market, potential. The first indication for commercial use will be the thyroid application, which falls under our soft tissue ablation approval. That is a an an existing addressable market over a billion dollars, and we feel that can double in the in the relatively near term.

The second one we’ll go after will be cardiac surgery. That’s for preoperative atrial fibrillation. Patients undergoing surgery already have existing AFib for whom that AFib could be addressed concomitantly with their, cardiac surgery to correct other, issues, whether it’s coronary bypass or mitral surgery as an example. That’s another 1 to $2,000,000,000 market, which also based on growth and penetration, and expansion, believe we believe could reach 5 to $6,000,000,000 in the next several years. And then lastly, but the largest of all is the EP catheter market.

That is the AFib endocardial ablation market. Multiple billions today for ablation, more than doubling in size based on organic growth accelerating, beyond 1520%. So very large markets, some of which we believe we can enter directly, some which we will partner. But when you look at pulse and nanosecond, PFA, we think we can create new indications in markets like thyroid. We can substantially expand markets such as incontinence surgery, and then we can enter existing large dynamic markets and become a disruptive therapeutic innovation, such as the catheter market.

So an array of opportunities for this business and this energy. So a little bit more about PFA. You’re familiar with PFA now in ways that we never would have been two or three years ago based on, the launch of Therapulse in the EP market. It’s revolutionizing that category. And and if you step back and look at why, it is because existing ablation markets, EP or other, have historically used extreme temperatures, either extreme heat as delivered by, let’s say, radio frequency energy or extreme cold for the purpose of destroying tissue.

You can destroy tissue, with minimally invasive approaches. You can avoid surgical intervention and take advantage of the energy’s ability to disrupt unwanted tissue. That that has created substantial market potential based on less invasive benefits, based on faster procedures, based on increased throughput in hospitals, lower recovery time. All of those are benefits, of minimally invasive procedures with energy, and they’ve been improved upon by first generation PFA applications. And so what’s important to understand about pulse is that we will bring to the market those same benefits of PFA while substantially adding, to that list of benefits by shortening our pulse duration into the nanosecond zone.

And so if we look at the specifics of nanosecond PFA and how that might, alter tissue and alter clinical applications compared to conventional PFA, there are there’s a list of reasons why, our select nanosecond PFA will be substantially advantageous. Perhaps the the most important is that by shortening that pulse duration, we can increase the total amount of voltage we deliver, into the tissue. That change allows us to deliver substantially larger and deeper lesions. It eliminates nerve capture of the energy, which eliminates unwanted patient movement during, intervention. Despite having more voltage delivered, we leave no thermal footprint behind.

So this is an entirely non thermal, method of ablating tissue. And because our energy is, or our voltage is higher than regular PFA, we don’t specifically create electroporation at the cell membrane level, but rather inside the cell at the engines of cell vitality, and such as the mitochondria. And we actually stimulate the formation of of natural cell death or regulated cell death, which is a natural healing process that avoids, immune response, and avoids a fibrotic response. So this tissue is left as if it had not been treated at all. No history of heat or of thermal damage, and it really is a fundamentally different way of treating tissue while using lower total energy delivery into the body.

It’s a result of that combination that we think NSPFA will be disruptive in multiple clinical applications. Now the company cannot go after every market, by itself. Some markets are more, attuned, if you will, to direct entry, and other markets are more attuned to partnering. And we start with a business model that will be a combination of direct and partner. Markets such as thyroid that are not deeply competitive, and can be addressed with a capital efficient commercial team, we will address directly markets that are larger, that are more entangled with different therapeutic, support systems such as EP, are likely to be approached by us via partnership.

So let’s look at our three markets and spend a few minutes on each. First and foremost is thyroid. Now the thyroid is a gland that produces hormones, and those hormones control vital bodily functions such as body temperature, heart rate, metabolism, and, and obviously, to the extent we can preserve thyroid function, that is the goal. For benign growth in thyroid nodules, it’s it’s extremely unfortunate that many of these patients undergo thyroid gland removal via thyroidectomy. Two hundred and fifty thousand annual diagnoses, a hundred and fifty thousand of which convert into an open surgical removal of the gland, and that’s the principal target.

How do we avoid those those surgical removal removals over the procedure that does not produce a scar and it leaves the thyroid in place and functioning? In addition to that hundred thousand 50,000, thyroidectomy volume, there are an incremental hundred thousand that go to watchful waiting. Those two pools, therefore, represent patient flow into a less invasive alternative that is nonsurgical and thyroid sparing. And we believe NSPFA is an ideal, energy source, to treat benign thyroid nodules in lieu of surgical intervention. Here you see a patient, moving from baseline through therapy, one month follow-up, twelve month follow-up, and you see what we see typically in this patient population.

No evidence of intervention, obliteration of mass, and a patient that is is restored to normal thyroid function. This is this is an extraordinarily safe procedure in comparison as an example to radiofrequency ablation, which in this particular zone where the thyroid is surrounded by critical nerve and vascular structures and and, the esophagus and trachea. It’s vital to avoid thermal damage with uncontrolled propagation of heat zones, which is exactly what RF produces. So we think NSPFA is a perfect energy, for this market, which today is predominantly surgery. Today, we are FDA cleared to apply, our soft tissue indication to the thyroid opportunity.

We have a post market study underway in 10 centers that will be completed in the middle of q two. Those 10 centers will be converted into our first commercial sites. We’ll supplement that, early clinical work with additional studies, but we will principally be focused on a commercialization strategy starting midyear and building rapidly throughout the course of ’25 and beyond. So first plan for commercialization, thyroid nodules, and we will pursue that directly. Second is the cardiac surgery ablation market.

This is an established market for, as I mentioned earlier, patients undergoing open cardiothoracic surgery or some other requirement besides a AFib, but who are already diagnosed with AFib onboard. About 28 of patients undergoing open surgery have AFib already. And so of those three hundred thousand surgeries, twenty eight percent or about eighty thousand patients are amenable and on guidelines today to receive concomitant AFib ablation, but only about thirty percent of those patients actually receive it. And that is a function of the limitations of RF ablation currently used in surgery to treat AF. And we believe that the speed, the and the efficacy of nanosecond PFA has the potential to treat all, not just thirty percent, but all of those AF indicated patients and to also open up an opportunity for prophylactic treatment of patients, a significant portion of whom will acquire AFib as a function of the cardiac surgery they’re undergoing.

So there is a significant current and an addressable market here that can increase the current surgical clamp opportunity by three to five to potentially tenfold. If you look at our status, we are undergoing, US, I’m sorry, OUS feasibility study today. That will be converted into an IDE in The US for commercialization in about twenty four months. We think the benefits of, PFA in this application are dramatic. This requires only about a second ablation, one time applied per line to complete isolation, and to render patients AFib free following surgery.

With that relatively rapid treatment, there’s very little incremental burden for the surgeon or the patient who was on pump. And as a result, we believe we can substantially expand the number of patients treated within with no expansion of of operative time or patient risk. So here, again, I alluded to this earlier. We’ve received breakthrough designation from the FDA. We’re, in the TAP program, which is an elite, selection that provides us, substantial resource and focus from the agency.

Gonna be conducting a study this year, and we expect, the results that we’re seeing in our feasibility study to play out in a larger controlled study in United States. Lastly, the largest market I alluded to, the EP ablation market, This is a dramatically larger market than anything else we’re addressing. Multiple billions today, and obviously a market that is possessed of double digit organic growth as the potential to become an $8,000,000,000 ablation market in the next several years. The the diagnostic rate for AFib is increasing, and we’re seeing already dramatic effects of pulse field ablation in this category. But we think the category can be revolutionized once again.

If you think about the relative comparison of our PFA, our nanosecond PFA versus microsecond PFA, the the favorable elements are that we drop right into the exact same treatment paradigm. There are there’s essentially no learning curve. We produce substantially deeper lesions. We dramatically reduce procedure time, with, an energy, that creates a full circumferential lesion with a single ablation of only a few seconds. And we really require, no change to operative norms for the electrophysiologist.

If you look at how we would compare to an existing PFA system, as an example, on a per vein basis, we would require only one or two energy deliveries versus four to eight for current practice. Total operative time would be reduced from an hour or an hour and a half to thirty minutes. Total ablation time would be reduced from thirty minutes to ten minutes, and this is a function of, of our nanosecond energy delivery and deeper lesion, quality and depth. So we think, these are meaningful, clinically noticeable, physician appreciated differences in, energy delivery, and they have the potential to convert into higher efficacy over time. And we hope to see that, when we, conduct larger scale, clinical trials.

This is a display of some of the data we disclosed at the AFib Symposium in Boston in January. See here, with patients followed to three months, ninety two percent isolation rates achieved in eleven and a half minute treatment times and, overall, very short procedures. And image above is an example of a physician performing his very first, NSPFA case. So no learning curve, no experience with the technology in advance, and perfect isolation with ten minutes of ablation time. And we think that’s this is disruptive, a clinical result and is indicative of the kind of disruptive potential we have for this broader market.

As with, the clamp, the catheter is also undergoing, completion of feasibility data for treating, patients in an ongoing protocol in multiple centers outside The United States, planning to file our IDE and commence a clinical trial for this technology in 2025, and we think this is a very exciting platform for, Pulse Biosciences. So in conclusion, we have a novel energy form. Nanosecond PFA is, unique in the PFA space, creates a novel mechanism of action surrounded by a wall of hundreds of issued patents, and is a clearly a next generation energy form. The clinical evidence we have is mounting in multiple, clinical fields. We are conducting additional clinicals this year to advance our programs toward commercialization in The United States.

We think the market value of the markets that we’re targeting is multiple billion now, growing to 15 plus billion in the next five years. That pipeline of current markets will be supplemented by a pipeline of future markets. We have yet to describe publicly what our next, list of targets will be, but we’re working on a number of indications that we will, bring forward in the next couple of years. As I said, we’re initializing commercialization for the very first time with our thyroid indication, within the soft tissue realm, and that will really convert PULSE from being a, a development company stage to a commercialization stage company. And we have a strong balance sheet with the cash reserves to execute plan for several years looking forward.

So thank you for your attention.

Josh Jennings, TD Cowen Medical Devices Research Team, TD Cowen: Uh-huh. Uh-huh. Uh-huh.

Paul LeViolette, CEO and Co-Chairman, Pulse Biosciences: Thank you, Josh. Yeah. The well, the buzz of course, it’s hard to quantify buzz, but I would say buzz is is very positive, for a couple of reasons. PFA is doing well. Let’s let’s be honest.

The Therapulse launch has been remarkable. It’s achieved a billion dollars of revenue thus far. It’s really, becoming the, energy of choice, and yet it’s not perfect. There’s still a fair amount of catheter manipulation. And really, overall efficacy still remains around the same as we’ve seen historically with RF or cryo in that sixty five to seventy five percent range for chronic AFib free, off antiarrhythmic drugs.

So there is room to grow in efficacy. There’s room to grow in safety. And, with closer to a hundred total cases performed, the data that we’re seeing is really quite clean. Our safety profile looks outstanding. Our isolations look clean.

The procedural times are very short. The ablation effectiveness, the energy as it addresses tissue and creates acute isolation is extremely impressive with almost no catheter manipulation, which allows a physician to enter a pulmonary vein, deliver an ablation for five seconds. If necessary, in their judgment, they can deliver a second ablation for another five seconds, and then they are done with that vein. So just think about walking through pulmonary vein isolation to paroxysmal AFib in two, lesions. Two lesions, two lesions, and then you’re effectively done with pulmonary vein isolation for the patient with under ten minutes of of ablation time and and probably five minutes of fluoro time.

It really is remarkable. So even though the buzz in today because of commercial systems, the buzz in anticipation of this next generation system, I would say

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