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