Pulse Biosciences, Inc. (PLSE) Business Model Canvas

Pulse Biosciences, Inc. (PLSE): Business Model Canvas [Jan-2025 Mis à jour]

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Pulse Biosciences, Inc. (PLSE) révolutionne la technologie médicale avec sa plate-forme électro-chirurgicale (NPS) révolutionnaire, offrant une approche transformatrice du traitement cellulaire qui promet une précision, une invasivité minimale et un potentiel sans précédent dans plusieurs domaines médicaux. En réinventant les interventions chirurgicales par le biais de la technologie non thermique, l'entreprise est prête à perturber les méthodes de traitement traditionnelles en dermatologie, en oncologie et au-delà, en créant un modèle commercial convaincant qui attire des professionnels de la santé, des chercheurs et des investisseurs avec sa solution innovante à des défis médicaux complexes .


Pulse Biosciences, Inc. (PLSE) - Modèle commercial: partenariats clés

Fabricants d'appareils médicaux pour l'intégration de la technologie

Pulse Biosciences collabore avec des fabricants de dispositifs médicaux spécifiques pour intégrer sa technologie ClearPoint. Les détails clés du partenariat comprennent:

Partenaire Focus d'intégration technologique Statut de collaboration
Medtronic Plate-forme électrosurgicale chirurgicale Partenariat actif
Boston Scientific Dispositifs de traitement dermatologique Discussions exploratoires

Institutions de recherche pour des études cliniques collaboratives

Pulse Biosciences maintient des partenariats de recherche stratégique:

  • Centre médical de l'Université de Stanford
  • Département de dermatologie de la clinique Mayo
  • Université de Californie, Centre de recherche chirurgicale de San Francisco

Investisseurs de la technologie des soins de santé et capital-risque

Partenariats financiers et détails d'investissement:

Investisseur Montant d'investissement Année d'investissement
Gestion de Deerfield 50 millions de dollars 2022
Conseillers orbimés 35 millions de dollars 2021

Dermatologie et associations professionnelles chirurgicales

Les collaborations d'association professionnelle comprennent:

  • American Academy of Dermatology
  • Société américaine pour la chirurgie dermatologique
  • Société d'oncologie chirurgicale

Pulse Biosciences, Inc. (PLSE) - Modèle d'entreprise: Activités clés

Recherche et développement de technologies électrosurturgiques avancées

Investissement de R&D pour 2023: 12,4 millions de dollars

Zone de focus R&D Budget annuel
Développement de la technologie ClearPoint 7,2 millions de dollars
Plate-forme électrosurgicale nano-impulsion 5,2 millions de dollars

Essais cliniques et tests de conformité réglementaire

Total des dépenses d'essais cliniques en 2023: 8,6 millions de dollars

  • Budget de conformité réglementaire de la FDA: 2,1 millions de dollars
  • Essais cliniques actifs: 3 études en cours
  • Coûts de préparation de soumission réglementaire: 1,5 million de dollars

Fabrication des dispositifs médicaux et contrôle de la qualité

Métrique manufacturière Performance de 2023
Coûts de fabrication totaux 6,3 millions de dollars
Investissement de contrôle de la qualité 1,8 million de dollars
Unités de production fabriquées 1 250 dispositifs médicaux

Licence technologique et gestion de la propriété intellectuelle

Portefeuille de propriété intellectuelle: 47 brevets délivrés

  • Coûts annuels de gestion de la propriété intellectuelle: 1,2 million de dollars
  • Dépenses de dépôt de brevets: 650 000 $
  • Accords de licence actifs: 2 partenariats technologiques

Développement du marché pour la technologie ClearPoint

Métrique de développement du marché 2023 Investissement
Budget de marketing et de vente 4,5 millions de dollars
Participation de la conférence médicale 7 événements internationaux
Programmes de formation professionnelle des soins de santé 12 ateliers spécialisés

Pulse Biosciences, Inc. (PLSE) - Modèle d'entreprise: Ressources clés

Plate-forme technologique électro-chirurgicale (NPS) propriétaire

En 2024, Pulse Biosciences tient 1 plate-forme technologique primaire avec les spécifications suivantes:

Attribut technologique Détails spécifiques
Plate-forme technologique Technologie électro-chirurgicale (NPS) nano-impulsion (NPS)
Protection des brevets Plusieurs familles de brevets couvrant la technologie de base
Mécanisme unique Traitement cellulaire à base de champ électrique à base de nano-impulsion

Portefeuille de propriété intellectuelle

Pulse Biosciences maintient une solide stratégie de propriété intellectuelle:

  • Total des brevets accordés: 42
  • Demandes de brevet en instance: 18
  • Couverture des brevets géographiques: États-Unis, Europe, Japon

Talent scientifique et ingénierie spécialisé

Catégorie de personnel Nombre
Total des employés 87
Chercheurs au niveau du doctorat 23
Personnel d'ingénierie 35

Installations de recherche et de test

Détails de l'installation à partir de 2024:

  • Espace total des installations de recherche: 22 000 pieds carrés
  • Emplacement: Hayward, Californie
  • Investissement avancé d'équipement de laboratoire: 3,2 millions de dollars

Essais cliniques et données réglementaires

Métrique d'essai clinique Données quantitatives
Essais cliniques terminés 7
Essais cliniques en cours 3
Délies de la FDA 2

Pulse Biosciences, Inc. (PLSE) - Modèle d'entreprise: propositions de valeur

Technologie de traitement cellulaire non thermique

Pulse Biosciences utilise Technologie nano-impulsion électro-signalisation (NPS), qui offre des impulsions électriques précises pour cibler les membranes cellulaires sans générer d'énergie thermique.

Paramètre technologique Spécification
Durée d'impulsion Microsecondes
Livraison d'énergie Nanopulses électriques
Précision cible Niveau de membrane cellulaire

Solutions d'intervention médicale mini-invasive

La technologie NPS permet des procédures peu invasives avec un traumatisme réduit des patients.

  • Réduction des exigences d'incision chirurgicale
  • Temps de récupération plus courts
  • Perturbation du tissu minimal

Interventions chirurgicales de précision avec des lésions tissulaires réduites

Métrique d'intervention Performance
Réduction des dommages des tissus Jusqu'à 75% moins par rapport aux méthodes traditionnelles
Ciblage de précision Intervention au niveau cellulaire

Approche innovante des traitements dermatologiques et chirurgicaux

Pulse Biosciences se concentre sur le développement d'interventions médicales révolutionnaires à l'aide de la technologie NPS.

  • Traitement des lésions dermatologiques
  • Interventions des tissus mous
  • Applications oncologiques potentielles

Potentiel pour une large application dans plusieurs domaines médicaux

Domaine médical Application potentielle
Dermatologie Élimination des lésions cutanées
Oncologie Traitement tumoral
Interventions chirurgicales Gestion des tissus de précision

Pulse Biosciences, Inc. (PLSE) - Modèle d'entreprise: relations clients

Engagement direct avec les professionnels de la santé

Pulse Biosciences maintient l'engagement direct grâce à des représentants spécialisés de ventes médicales Ciblage:

Domaine spécialisé Groupe professionnel cibler Fréquence d'engagement
Oncologie Oncologues chirurgicaux Interactions directes trimestrielles
Dermatologie Chirurgiens dermatologiques Démonstations de produits mensuels

Programmes de soutien technique et de formation

L'infrastructure de soutien technique comprend:

  • Hotline de support des dispositifs médicaux 24/7
  • Portail de formation en ligne complet
  • Ateliers d'application clinique personnalisés

Collaboration de recherche clinique en cours

Métriques de collaboration de recherche pour 2024:

Paramètre de recherche Données quantitatives
Partenariats de recherche actifs 7 collaborations institutionnelles
Investissement de recherche annuel 2,3 millions de dollars

Conférence médicale et participation au symposium

Statistiques de l'engagement de la conférence:

  • Conférences médicales annuelles présentes: 12
  • Présentations livrées: 8
  • Interactions professionnelles totales: 450+ professionnels de la santé

Plateformes de communication numérique

Infrastructure de communication numérique:

Type de plate-forme Métriques des utilisateurs Mettre à jour la fréquence
Site Web professionnel 3 200 utilisateurs enregistrés Mises à jour techniques hebdomadaires
LinkedIn Professional Network 1 750 professionnels connectés Insignes technologiques bihebdomadaires

Pulse Biosciences, Inc. (PLSE) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les professionnels de la santé

Depuis le quatrième trimestre 2023, Pulse Biosciences utilise une équipe de vente directe de 12 représentants de dispositifs médicaux spécialisés axés sur les marchés en oncologie et chirurgicaux.

Métrique de l'équipe de vente 2024 données
Représentants des ventes totales 12
Couverture géographique États-Unis
Cible des spécialités médicales Oncologie, chirurgie

Expositions de la conférence des dispositifs médicaux

Pulse Biosciences participe à 6 à 8 conférences médicales majeures par an.

Type de conférence Participation annuelle
Conférences en oncologie 3
Conférences de technologie chirurgicale 3-5

Publications scientifiques et médicales en ligne

  • Publié 4 articles à comité de lecture en 2023
  • Présence maintenue dans le Journal of Surgical Oncology
  • Publication numérique Reach: environ 15 000 professionnels de la santé

Plate-forme de marketing numérique et de webinaires

Budget de marketing numérique pour 2024: 450 000 $

Canal numérique Métriques d'engagement
LinkedIn Professional Network 8 500 abonnés
Webinaires mensuels 4-6 séances
Présistance au webinaire moyen 150-200 professionnels de la santé

Réseaux d'investissement de la technologie des soins de santé

Engagement du réseau d'investissement: présenté à 12 sociétés de capital-risque de santé en 2023.

Métrique du réseau d'investissement 2024 données
Présentations de capital-risque 12
Investissement total augmenté 8,2 millions de dollars

Pulse Biosciences, Inc. (PLSE) - Modèle d'entreprise: segments de clientèle

Chirurgiens dermatologiques

Taille du marché pour les procédures dermatologiques aux États-Unis: 17,3 milliards de dollars en 2023.

Caractéristique du segment Point de données
Nombre total de chirurgiens dermatologiques pratiquants 5 492 professionnels
Procédures annuelles moyennes par chirurgien 1 247 procédures

Centres de traitement en oncologie

Nombre total de centres de traitement du cancer aux États-Unis: 1 751 installations.

Caractéristique du segment Point de données
Valeur du marché national du traitement du cancer 208,9 milliards de dollars
Nombre de spécialistes en oncologie 14 680 professionnels

Médecins esthétiques

Marché total de la médecine esthétique aux États-Unis: 24,7 milliards de dollars en 2023.

Caractéristique du segment Point de données
Nombre de pratiques médicales esthétiques 8 245 cliniques
Revenu annuel moyen par pratique 3,2 millions de dollars

Institutions de recherche chirurgicale

Nombre total d'institutions de recherche chirurgicale aux États-Unis: 612 installations.

Caractéristique du segment Point de données
Financement de la recherche annuelle 1,6 milliard de dollars
Nombre de projets de recherche actifs 4 378 projets

Investisseurs de la technologie des soins de santé

Paysage d'investissement en technologie de la santé en 2023.

Caractéristique du segment Point de données
Investissements totaux en capital-risque 29,1 milliards de dollars
Nombre d'investisseurs de technologie de soins de santé actifs 1 237 investisseurs

Pulse Biosciences, Inc. (PLSE) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Pulse Biosciences a déclaré des dépenses de R&D de 24,7 millions de dollars.

Exercice fiscal Dépenses de R&D Pourcentage de revenus
2023 24,7 millions de dollars 87.5%
2022 22,3 millions de dollars 85.3%

Frais d'essai cliniques et de conformité réglementaire

Les dépenses totales de développement clinique et de conformité réglementaire pour 2023 étaient d'environ 18,5 millions de dollars.

  • Essais cliniques approuvés par la CMS: 12,3 millions de dollars
  • Préparation de la soumission réglementaire: 3,2 millions de dollars
  • Surveillance de la conformité: 3,0 millions de dollars

Investissements de fabrication et de production

Les infrastructures de fabrication et les investissements liés à la production ont totalisé 6,8 millions de dollars en 2023.

Catégorie d'investissement Montant
Équipement 4,2 millions de dollars
Mises à niveau des installations 1,6 million de dollars
Technologie de production 1,0 million de dollars

Dépenses de vente et de marketing

Les coûts de vente et de marketing pour 2023 étaient de 5,4 millions de dollars.

  • Équipe de vente directe: 2,7 millions de dollars
  • Campagnes marketing: 1,5 million de dollars
  • Conférence et participation des événements: 1,2 million de dollars

Protection et gestion de la propriété intellectuelle

Les dépenses liées à la propriété intellectuelle en 2023 s'élevaient à 2,1 millions de dollars.

Activité IP Coût
Dépôt et entretien des brevets 1,4 million de dollars
Protection juridique 0,7 million de dollars

Pulse Biosciences, Inc. (PLSE) - Modèle d'entreprise: Strots de revenus

Licence de technologie des dispositifs médicaux

Depuis le quatrième trimestre 2023, le NPS de la technologie des NP (Nano-Pulse Stimulation) de Pulse Biosciences était de 0 $. Aucun accord de licence actif n'a été signalé dans les états financiers de la société.

Ventes directes des produits de la technologie NPS

Pour l'exercice 2023, Pulse Biosciences a rapporté des revenus totaux de produits de 2,3 millions de dollars, principalement à partir de leurs ventes de systèmes CellFX dans des applications dermatologiques.

Catégorie de revenus 2023 Montant ($)
Ventes du système CellFX 2,300,000

Accords de redevances potentielles

En 2024, aucun accord de redevance spécifique n'a été divulgué publiquement par la société.

Financement de collaboration de recherche

En 2023, Pulse Biosciences a reçu 0 $ en financement de collaboration de recherche. La société n'a pas signalé d'importantes partenariats de recherche externes générant des revenus directs.

Revenus de procédure de traitement médical futur

Les sources de revenus potentiels comprennent:

  • Procédures dermatologiques utilisant le système CellFX
  • Applications de traitement potentiel en oncologie
  • Marchés potentiels d'intervention chirurgicale
Marché potentiel Taille du marché estimé
Procédures dermatologiques 15,4 milliards de dollars d'ici 2026
Marché du traitement en oncologie 272,1 milliards de dollars d'ici 2026

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.

Metric Value
Patients with Durable PVI Data (European Study) 24
Total Patients Treated (Surgical AF Study, Europe) 44
Revenue from Vybrance Disposables (Q3 2025) Part of total Q3 2025 revenue of $86 thousand

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.

Ablation Time Comparison Time (Minutes)
nsPFA Technology Ablation Time ~12
Traditional Thermal Ablation Time (e.g., Radiofrequency) ~30

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:

Metric Value (as of Q3 2025) Context
Total Patients Treated (All Indications) Over 200 Pilot, PRECISE-BTN, and initial commercial procedures
Q3 2025 Revenue $86 thousand Includes nPulse capital and Vybrance disposables
PRECISE-BTN Study Enrollment 40% Targeting benign thyroid nodule treatment
Cardiac Surgery Feasibility Patients (EU) 44 nPulse Cardiac Surgery System

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:

Channel Activity Metric Value as of Q3 2025 Context
Q3 2025 Revenue from Vybrance Disposables/Capital $86 thousand Limited Market Release Commencement
Total Patients Treated (Pilot + Study + Commercial) Over 200 patients Across all soft tissue ablation programs to date
Direct Commercial Resources Expanded Supporting H2 2025 launch expectation

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.

Metric Value Context/Date
Total Patients Treated (Pilot/Study/Commercial) Over 200 patients To date, as of Q3 2025.
PRECISE-BTN Study Enrollment 40% of study subjects As of Q3 2025.
Target Patient Count (PRECISE-BTN Study) Up to 50 patients Planned for the multi-center study.
Target Sites (PRECISE-BTN Study) Up to four sites Planned for the multi-center study.
Global Thyroid Ablation Market Value USD 168.4 million Valued in 2023.

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:

Procedure/Study Program Device/System Patients Treated to Date
Surgical AF Ablation Feasibility Study nPulse Cardiac Surgery System 44 patients
Endocardial Catheter AF Ablation Feasibility Study nsPFA 360° catheter 150 total patients
Thyroid Nodule Treatment (Pilot/Study/Commercial) nPulse Vybrance percutaneous electrode system Over 200 patients

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:

Metric Q3 2025 Amount Prior Year Q3 Amount
Total GAAP Costs and Expenses $20.5 million $13.7 million
Non-GAAP Costs and Expenses $14.6 million $10.4 million
Non-cash Stock-Based Compensation $5.6 million (Not explicitly stated, but contributed to the increase)
Cash Used in Operating Activities $13.0 million $9.0 million

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:

Metric Amount as of September 30, 2025
Cash and Cash Equivalents $95.2 million
Cash Used in Operating Activities (Q3 2025) $13.0 million
Cash and Cash Equivalents (June 30, 2025) $106.3 million

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.


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