Pulse Biosciences, Inc. (PLSE): Business Model Canvas [Dec-2025 Updated]

You're looking at Pulse Biosciences, Inc. right at that critical inflection point: deep in the clinical trial grind but holding a solid war chest. As of late 2025, their business model canvas shows a company focused on proving out their proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology across cardiac and thyroid indications. Honestly, with only $\mathbf{\$86}$ thousand in Q3 revenue against $\mathbf{\$20.5}$ million in expenses, the structure is that of a classic pre-commercial biotech play, heavily reliant on that $\mathbf{\$95.2}$ million cash position to push through pivotal data. Dive in below to see exactly how they are structuring their value capture across R&D, clinical sites, and that nascent direct sales effort.

Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Key Partnerships

You're looking at how Pulse Biosciences, Inc. (PLSE) is structuring its external relationships to drive clinical validation and future commercial scale, especially in the complex electrophysiology space. Honestly, for a company at this stage, partnerships are the bridge between R&D success and broad market adoption.

Clinical trial sites and investigators for multi-center studies

The company is running concurrent clinical programs across different modalities, each relying on a network of clinical sites and investigators. This network is crucial for generating the data needed for FDA pivotal studies and European feasibility expansion. As of the third quarter of 2025, the progress across these sites looks like this:

For the soft tissue ablation market, Pulse Biosciences, Inc. had identified five sites to participate in a post-market study for benign thyroid disease, with enrollment planned for Q3 2025. The company has invested approximately $400 million in developing the M-Pulse technology platform to support these clinical efforts.

Key Opinion Leaders (KOLs) for technology validation and advocacy

While specific KOL names aren't public in the latest filings, the company's engagement with the broader medical and financial community serves as a form of validation. Management presented at major industry events, which is how they gain advocacy from leading physicians and surgeons. Here are the key public engagements around the late 2025 period:

• Stifel 2025 Healthcare Conference presentation on November 13, 2025.
• Piper Sandler 37th Annual Healthcare Conference presentation on December 3, 2025.
• Positive clinical results for the Surgical AF feasibility study presented at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting.

The company is focused on generating clinical evidence to drive adoption by these key influencers.

Contract Research Organizations (CROs) for trial execution

The search results do not provide specific names or financial details regarding any Contract Research Organizations (CROs) engaged by Pulse Biosciences, Inc. for trial execution as of late 2025.

Potential strategic partners for electrophysiology market commercialization

The electrophysiology market represents a significant commercial opportunity for Pulse Biosciences, Inc., and they are clearly looking externally to accelerate this. The strategy involves leveraging established commercial channels for this larger market segment. The commitment to this path is clear:

• Pulse Biosciences, Inc. is actively seeking partnerships in the electrophysiology market.
• Management stated they 'continue to explore potential collaborations with established leaders in electrophysiology.'

This external collaboration is intended to support the commercialization of the nPulse technology platform beyond the initial limited market release in soft tissue ablation, which generated $86 thousand in revenue in Q3 2025. The company maintains a cash reserve of $95.2 million as of September 30, 2025, to support these strategic initiatives.

Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Key Activities

You're looking at the core engine driving Pulse Biosciences, Inc. right now-the activities that consume the most capital and are designed to deliver the next wave of value. For Pulse Biosciences, Inc., this centers on clinical execution and initial commercial traction for its Nanosecond Pulsed Field Ablation (nsPFA) technology.

Research and Development (R&D) of new nsPFA devices

The R&D function is heavily intertwined with clinical trial support, which is driving up operating expenses. You can see this clearly in the quarterly spend. For the three months ended March 31, 2025, total GAAP costs and expenses, which include R&D and general and administrative expenses, were $18.0 million. That figure climbed to $20.3 million for the three months ended June 30, 2025. By the third quarter ended September 30, 2025, total GAAP costs and expenses, now including cost of product revenue, R&D, and selling, general, and administrative expenses, reached $20.5 million. This reflects the expanding organization needed to support the clinical trials and commercialization efforts. The cash burn associated with these activities is significant; cash used in operating activities for Q3 2025 totaled $13.0 million.

Execution of pivotal clinical trials (e.g., PRECISE-BTN, NANOCLAMP AF)

Clinical trial execution is arguably the most critical activity, as it directly feeds regulatory pathways for broader market access. Pulse Biosciences, Inc. is running parallel studies across its three main development programs. Here's a breakdown of the patient counts and status as of the Q3 2025 report:

The company is driving early targeted adoption for the Vybrance percutaneous electrode system in soft tissue ablation. Overall, over 200 patients have been treated across the pilot program, the PRECISE-BTN Study, and initial commercial procedures as of Q3 2025.

Manufacturing and quality control of the nPulse System

While specific manufacturing costs aren't broken out separately from the total GAAP expense of $20.5 million for Q3 2025, the activity is evidenced by the initial revenue generation. Quality control is implicitly tied to the positive clinical outcomes reported, such as the European feasibility study for the surgical clamp showing durable isolation with rapid ablation times. The focus here is on preparing for scale once pivotal trials conclude.

Direct sales and support for the limited market release

Pulse Biosciences, Inc. began its limited market release, which is the start of direct sales activity, during Q3 2025. This is a nascent but important step. The results from this initial commercial push are detailed in the revenue figures:

• Total revenue for the third quarter of 2025 was $86 thousand.
• This initial revenue was comprised of both nPulse capital equipment sales and Vybrance disposable sales.
• Management expects disposables and nPulse system sales to grow in line with increased procedure acceptance moving into Q4 2025.

The current sales volume is low because a large portion of procedures are still under pilot or study protocols, meaning they aren't fully recognized as revenue yet. Finance: draft Q4 2025 cash flow projection incorporating increased operating cash burn by Monday.

Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Key Resources

You're looking at the core assets Pulse Biosciences, Inc. (PLSE) relies on to drive its business forward, especially as it moves closer to potential commercialization. These aren't just line items; they are the engine for their novel approach to medicine.

The most critical resource is the Proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology platform. This is the foundation, often referred to as nPulse™ technology, which is a revolutionary energy modality. It works by delivering nanosecond-duration pulses of electrical energy to non-thermally clear targeted cells while sparing adjacent noncellular tissue. This precision is what they believe will disrupt markets like atrial fibrillation (AF) and soft tissue ablation. The technology is embodied in systems like the CellFX System and various application-specific tools.

Financially, Pulse Biosciences, Inc. maintained a solid war chest as of late 2025. You can see the cash position clearly:

• Cash and cash equivalents of $95.2 million as of September 30, 2025.

To be fair, this cash position is being actively deployed. Cash used in operating activities for the third quarter of 2025 totaled $13.0 million, which reflects the ongoing investment required to advance clinical trials and build out the organization ahead of initial product revenue. Total GAAP costs and expenses for that same quarter hit $20.5 million.

Next up is the Patent portfolio protecting the nPulse/CellFX technology. This intellectual property is what creates the barrier to entry for competitors trying to replicate their non-thermal ablation method. This portfolio covers the core technology and its specific applications, such as the nPulse Vybrance Percutaneous Electrode, the nPulse Cardiac Clamp, and the nPulse Cardiac Catheter.

Finally, the human capital is essential for translating the technology into clinical reality. This includes the Specialized R&D and clinical science personnel. The company has been expanding its organization to support clinical trial advancement and commercialization preparations. As of a recent count, Pulse Biosciences, Inc. has a total employee count of 129, up from 75 at the end of 2024, showing a clear ramp-up in the teams needed to execute on their development pipeline across benign thyroid nodules and cardiac ablation programs.

Here's a quick look at the key quantitative resources as of the third quarter of 2025:

Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Value Propositions

Non-thermal cell ablation, sparing adjacent non-cellular tissue

Pulse Biosciences, Inc.'s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue.

Minimally invasive treatment for benign thyroid nodules (Vybrance system)

• Initiated multi-center clinical study, PRECISE-BTN, for benign thyroid nodules (BTN) with the nPulse Vybrance percutaneous electrode system.
• Enrolled 40% of PRECISE-BTN study subjects as of the third quarter of 2025.
• Treated over 200 patients to date across the pilot program, the PRECISE-BTN Study, and initial commercial procedures as of September 30, 2025.
• Generated $86 thousand in revenue through commencement of the limited market release in Q3 2025.

Durable and consistent pulmonary vein isolation in cardiac surgery

Late-Breaking data from the nPulse™ Cardiac Surgical System first-in-human feasibility study presented at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting highlighted durable and consistent pulmonary vein isolation and posterior box isolation.

Potential for significantly reduced ablation procedure times (~12 minutes)

Clinical data indicates nsPFA technology reduces ablation times to about 12 minutes, contrasted with 30 minutes for competitors.

Cash and cash equivalents totaled $95.2 million as of September 30, 2025.

Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Customer Relationships

You're looking at how Pulse Biosciences, Inc. (PLSE) manages its relationships with the physicians and institutions adopting its nPulse technology. Honestly, in this early commercial phase, the relationship is everything; it's about deep partnership, not just transactions.

High-touch, collaborative engagement with clinical Key Opinion Leaders

The initial push relies heavily on clinical champions. You see this reflected in the patient numbers coming out of the studies, which are the bedrock of future adoption. The engagement is clearly high-touch because they are still generating the core evidence base.

• PRECISE-BTN Study enrollment is at 40% completion as of Q3 2025.
• The company treated 44 patients in the European feasibility study for the nPulse Cardiac Surgery System.
• The European feasibility study for the nsPFA 360° catheter has treated 150 total patients to date.

Dedicated field support for physicians during initial commercial procedures

When you start generating revenue, which was a modest $86 thousand in Q3 2025 from nPulse capital and Vybrance disposables, you need to ensure those first procedures go perfectly. That requires boots on the ground. The structure suggests a high level of hands-on support to drive procedural success and build physician confidence in the new technology.

The total patient count across all early access points-pilot, PRECISE-BTN, and initial commercial-is over 200 patients treated as of September 30, 2025. That volume requires dedicated support staff to manage the learning curve.

Scientific and clinical data sharing to drive adoption

Adoption is directly tied to the clinical narrative Pulse Biosciences, Inc. can build. They are actively using data from their studies to convince the broader market. For instance, late-breaking data from the European feasibility study for the cardiac system showed durable pulmonary vein isolation in the first 24 patients treated, achieved with rapid ablation times.

Here's a quick look at the utilization metrics that feed this data sharing:

Direct sales and service model for capital equipment and disposables

The company is clearly building a direct commercial infrastructure. They are hiring direct commercial resources, specifically mentioning capital equipment sales personnel and therapy adoption managers. This points directly to a direct sales and service approach, especially for the capital equipment side, which is typical for high-value medical devices.

The model is designed to capture revenue from both the initial capital placement and the recurring disposable component. While Q3 2025 revenue was nascent at $86 thousand, management expects procedural adoption and disposable sales to grow in Q4 2025. The initial revenue stream is a mix of nPulse capital and Vybrance disposables sales.

• Commercial headcount is planned to be maintained through Q4 2025.
• Targeting account utilization expansion in large metropolitan areas.
• The CellFX System, a related platform, uses a utilization-based revenue model, suggesting a similar strategy for disposables.

Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Channels

You're looking at how Pulse Biosciences, Inc. gets its products and information to the market as of late 2025. The strategy is clearly phased, moving from clinical evidence generation to limited commercial release, which dictates the channels they use right now.

Direct sales force for the limited market release of nPulse Vybrance

The commercial channel for the nPulse Vybrance percutaneous electrode system is in its infancy, tied directly to the limited market release. Pulse Biosciences, Inc. explicitly stated they expanded direct commercial resources for this launch, which was expected in the second half of 2025. This expansion is part of a broader organizational growth, as the company had 129 total employees as of September 30, 2025. The initial financial results from this channel show early traction; total revenue for the third quarter of 2025 was $86 thousand, which included both nPulse capital and Vybrance disposables sales. Honestly, this initial revenue figure reflects the early stage of this channel, which is still being built out to support the nPulse Vybrance system.

The current channel structure for this product line can be summarized:

Multi-center clinical trial sites for physician training and evidence generation

The clinical trial sites serve as crucial channels for both physician training and generating the necessary evidence base for broader adoption. For the nPulse Vybrance system treating benign thyroid nodules (BTN), the PRECISE-BTN multi-center clinical study was initiated, and as of the third quarter of 2025, it had enrolled 40% of the study subjects. This shows a steady flow of procedural activity through these sites. Separately, for the nPulse Cardiac Surgery System, the NANOCLAMP AF study received FDA IDE approval, and the initial subject was enrolled on October 24, 2025. Furthermore, the European feasibility study for the nsPFA 360° catheter had treated 150 total patients to date. These sites are where the next generation of users learns the technology.

The clinical evidence generation channels include:

• Multi-center IRB study for nPulse Vybrance (PRECISE-BTN) with 40% enrollment.
• NANOCLAMP AF Study (Surgical AF Ablation) treating patients in the U.S..
• European feasibility study for 360° catheter with 150 patients treated.
• European feasibility study for Surgical Clamp with 44 patients treated.

Medical conferences and peer-reviewed publications for data dissemination

Dissemination of clinical findings is a key channel to reach the broader medical community. Pulse Biosciences, Inc. actively presented data throughout 2025. For instance, late-breaking data from the nPulse Cardiac Surgical System first-in-human feasibility study was presented at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in October 2025. Earlier in the year, management presented at the 43rd Annual J.P. Morgan Healthcare Conference on January 15, 2025. The company also highlighted its nPulse Vybrance technology at the American Thyroid Association Annual Meeting in September 2025. Looking toward the end of the year, management was scheduled to present at the Stifel 2025 Healthcare Conference on November 13, 2025, and the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025. These events are the primary vehicles for peer-to-peer education.

Investor Relations website for transparency on clinical progress

The Investor Relations website acts as the direct, controlled channel for financial and clinical updates to the investment community. You can find webcasts and presentations there, such as the one for the J.P. Morgan conference, available at http://investors.pulsebiosciences.com/. This channel is critical for maintaining market confidence, especially as the company is still in a pre-profitability phase, reporting a GAAP net loss of ($19.4) million for the third quarter of 2025. The company ended Q3 2025 with $95.2 million in cash and cash equivalents, a number frequently updated via this channel to assure stakeholders of runway. The latest Investor Presentation was noted as November 2025.

The Investor Relations channel provides access to key financial checkpoints:

• Cash and cash equivalents as of September 30, 2025: $95.2 million.
• Q3 2025 GAAP Net Loss: ($19.4) million.
• Latest Investor Presentation Date: November 2025.

Finance: draft 13-week cash view by Friday.

Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Customer Segments

Cardiac Surgeons treating Atrial Fibrillation (AF) concomitantly

• Treated 44 patients to date in the nsPFA Cardiac Surgery System AF feasibility study in Europe as of September 30, 2025.
• Initial subject enrolled in the nPulse Cardiac Surgery System Study, NANOCLAMP AF, following FDA IDE approval.
• Clinical evidence expansion planned for the surgical cardiac clamp in 2025.

Electrophysiologists focused on catheter-based AF ablation

• Treated 150 total patients with the nsPFA 360° catheter in the European AF feasibility study as of September 30, 2025.
• Treated 100 total patients in Europe with the nsPFA 360° catheter as of Q1 2025.
• Plan to commence a U.S. IDE study in Q1 2026.

Interventional Endocrinologists/Radiologists for benign thyroid nodules

Pulse Biosciences, Inc. is targeting physicians performing soft tissue ablation for benign thyroid nodules (BTN) with the nPulse Vybrance percutaneous electrode system. The M-Pulse Vibrance system targets 200 ultrasound-trained physicians.

Clinical Research Institutions in the US and Europe

Clinical investigation is a key segment supporting evidence generation for regulatory submissions.

• The PRECISE-BTN study is a multi-center clinical study.
• The European feasibility study for the catheter-based treatment has multiple sites.
• The NANOCLAMP AF study is a multi-center, first-in-human AF feasibility study in Europe.

The patient treatment volume across key clinical programs as of the end of Q3 2025 is detailed below:

Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Cost Structure

You're looking at the cost structure for Pulse Biosciences, Inc. as they push their nPulse technology through clinical validation and early commercialization. The spending reflects heavy investment in R&D and the necessary build-out to support ongoing trials and initial market release.

The headline number for the third quarter of 2025 is the $20.5 million in Total GAAP costs and expenses, which covers cost of product revenue, research and development (R&D), and selling, general, and administrative (SG&A) expenses. This figure represents a significant jump of $6.8 million compared to the $13.7 million reported in the same period last year. Honestly, this burn rate is typical when a company is scaling clinical programs simultaneously.

A large portion of this cost increase is tied to the expanding organization supporting clinical trials and commercialization efforts. To be fair, non-cash stock-based compensation was a major component, hitting $5.6 million in Q3 2025, which accounted for 38% of that year-over-year increase in costs. On a non-GAAP basis, which strips out items like stock compensation, the costs were $14.6 million for the quarter.

The cash impact is also clear: cash used in operating activities for Q3 2025 totaled $13.0 million. This cash burn is anticipated to rise as they scale up the pivotal studies for their cardiac devices.

High Research and Development (R&D) expenses are inherent to developing the device platform. While the specific Q3 2025 R&D dollar amount isn't broken out from the total GAAP figure, the scale of the clinical work driving these costs is evident across the three major programs:

• The thyroid program, using the nPulse Vybrance percutaneous electrode system in the PRECISE-BTN study, has treated over 200 patients to date across pilot, study, and initial commercial procedures.
• The Surgical AF Ablation program (NANOCLAMP AF) has treated 44 patients to date in its European feasibility study, with the first U.S. subject enrolled in the FDA IDE pivotal study.
• The Endocardial Catheter AF Ablation program (nsPFA 360° catheter) has treated 150 total patients in its European feasibility study, with the U.S. IDE pivotal study planned to commence in Q1 2026.

Expanding administrative and commercialization expenses are directly linked to supporting the limited market release of the Vybrance system and preparing for broader adoption. Here's a quick look at the overall financial intensity for the quarter:

The cost structure is clearly weighted toward advancing the pipeline through these expensive, multi-center clinical trials. Finance: draft 13-week cash view by Friday.

Pulse Biosciences, Inc. (PLSE) - Canvas Business Model: Revenue Streams

You're looking at a company just starting to convert clinical progress into dollars, so the initial revenue numbers are small but represent a key validation point for the entire business plan. Pulse Biosciences, Inc. generated its initial commercial revenue during the third quarter of 2025 from the limited market release of its core offerings. This early revenue stream is built on two primary components: the capital equipment and the consumables needed to run procedures.

The total revenue reported for the third quarter of 2025 was $86 thousand. This figure is comprised of sales from both the nPulse capital system and the Vybrance disposables. Honestly, this is just the starting line, but management expects procedural adoption to increase, which should drive revenue growth in the subsequent quarter, Q4 2025. The real financial leverage here is expected to come from the recurring sales.

Future revenue growth is heavily weighted toward the high-margin, single-use disposable electrodes. While the initial revenue included some system sales, the ongoing use of the nPulse technology platform relies on these disposables, which are the true engine for scalable, repeatable income. You should watch for management commentary on the utilization rates of the capital systems placed, as that directly translates to disposable consumption.

Plus, don't forget the non-operating income stream generated by the substantial cash reserves Pulse Biosciences, Inc. holds. As of September 30, 2025, the company reported cash and cash equivalents totaling $95.2 million. That cash pile earns interest income, which contributes to the overall top line, even if it's secondary to product sales right now. Here's the quick math on the cash position change from the prior quarter:

The revenue generation is tied directly to the adoption of the nPulse technology across its various applications. You can break down the initial revenue sources like this:

• Initial sales of the nPulse capital system.
• Sales of Vybrance disposables for soft tissue ablation.
• Revenue tied to procedures in the limited market release.

The total revenue for the third quarter of 2025 was $86 thousand. This is the baseline from which future growth in disposable sales will be measured. What this nascent revenue hides is the significant investment required to get there; GAAP costs and expenses for the same period reached $20.5 million.