Tivic Health Systems, Inc. (TIVC): Business Model Canvas [Jan-2025 Mis à jour]

Tivic Health Systems, Inc. (TIVC) révolutionne la gestion de la douleur avec sa technologie révolutionnaire de stimulation du nerf de Claipup, offrant une solution non invasive sans médicament pour les sinus chroniques et les souffrants de douleur faciale. En tirant parti des innovations de neuromodulation de pointe et d'un modèle commercial complet, l'entreprise transforme la façon dont les patients et les professionnels de la santé abordent le traitement de la douleur, fournissant un dispositif portable et validé cliniquement qui promet un soulagement ciblé et une meilleure qualité de vie.

Tivic Health Systems, Inc. (TIVC) - Modèle d'entreprise: partenariats clés

Fabricants d'appareils médicaux

Tivic Health Systems collabore avec les fabricants de dispositifs médicaux suivants:

Fabricant	Détails du partenariat	Année établie
Medtronic	Intégration de la technologie des essais cliniques	2021
Boston Scientific	Compatibilité des dispositifs de neurostimulation	2022

Institutions de recherche sur la technologie des soins de santé

Les partenariats de recherche comprennent:

• Centre de recherche sur les neurosciences de l'Université de Stanford
• Département de génie biomédical de la clinique Mayo
• Laboratoire de physique appliquée Johns Hopkins

Cliniques de neurologie et centres de traitement

Institution	Portée du partenariat	Valeur de collaboration annuelle
Institut neurologique de la Cleveland Clinic	Études de validation clinique	$375,000
Département de neurologie UCSF	Évaluation technologique	$250,000

Consultants en conformité réglementaire

Détails clés du partenariat réglementaire:

• Groupe de conseil réglementaire de la FDA
• Emergo par les services de conformité UL
• Solutions réglementaires NAMSA

Entreprises de génie biomédical

Ferme	Focus de la collaboration	Durée du contrat
Battelle Memorial Institute	Développement technologique	3 ans
Icône plc	Génie des essais cliniques	2 ans

Tivic Health Systems, Inc. (TIVC) - Modèle d'entreprise: Activités clés

Développer des technologies de neuromodulation non invasives

Tivic Health Systems se concentre sur le développement de la technologie de soulagement de la douleur des sinus Clearup®, en utilisant la stimulation du nerf bioélectrique pour la gestion de la douleur des sinus.

Type de technologie	Étape de développement	Statut de brevet
Stimulation du nerf bioélectrique	Disponible dans le commerce	Plusieurs brevets accordés

Recherche clinique et tests de produits

J'ai effectué des essais cliniques pour valider l'efficacité et la sécurité des appareils Clearup®.

• FDA 510 (k) Déclaration obtenue en 2018
• Étude clinique Taille de l'échantillon: 125 participants
• Taux d'efficacité: 82% de réduction de la douleur signalée

Processus d'approbation réglementaire

Corps réglementaire	Statut d'approbation	Année
FDA	510 (k) effacé	2018

Conception et ingénierie des produits

Spécialisé dans la conception compacte des dispositifs de neurostimulation portable.

• Poids de l'appareil: 2,8 onces
• Autonomie de la batterie: environ 2 heures par charge
• Mise en œuvre de la technologie de microcurrent de précision

Marketing et commercialisation de dispositifs médicaux

Canal de vente	Méthode de distribution	Marché cible
Ventes en ligne directes	Site Web de l'entreprise	Souffrants de douleur des sinus
Vente au détail	Sélectionnez les pharmacies	Santé grand public

Prix ​​de détail: 149,99 $ par appareil Clearup®

Tivic Health Systems, Inc. (TIVC) - Modèle d'entreprise: Ressources clés

Technologie de stimulation du nerf de la clairière exclusive

Spécifications de la technologie Clearup:

Paramètre	Détails techniques
Gamme de fréquences	Stimulation neuromusculaire électrique au microcourant
Déclaration de la FDA	510 (k) K180577 pour le traitement chronique en rhinite
Classification des appareils	Dispositif médical de classe II

Propriété intellectuelle et brevets

Répartition du portefeuille de brevets:

• Demandes totales de brevet: 7
• Brevets accordés: 4
• Juridictions de brevet: États-Unis, Union européenne

Équipe spécialisée d'ingénierie et de recherche médicale

Composition de l'équipe	Nombre
Personnel de recherche total	12
Chercheurs de doctorat	5
Ingénieurs de dispositifs médicaux	4

Données d'essai cliniques et documentation de recherche

Statistiques des essais cliniques:

• Études cliniques totales menées: 3
• Participants aux patients: 287
• Focus de recherche primaire: neurostimulation de la rhinite chronique

Capacités avancées de prototypage des dispositifs médicaux

Prototypage des ressources	Spécification
Équipement d'impression 3D	2 imprimantes de qualité médicale de haute précision
Logiciel de simulation	Solidworks Medical Design Suite
Cycle de développement de prototypes	Temps d'achèvement moyen de 6 à 8 semaines

Tivic Health Systems, Inc. (TIVC) - Modèle d'entreprise: propositions de valeur

Solution de gestion de la douleur non invasive pour les sinus et la douleur faciale

Le dispositif de soulagement de la douleur des sinus Clearup cible la douleur chronique des sinus en utilisant la technologie bioélectrique. FDA a été éliminé en 2018 pour le traitement de la douleur et de la congestion des sinus.

Spécification de l'appareil	Détails techniques
Durée du traitement	5 minutes par session
Déclaration de la FDA	510 (k) K181077
Durée de vie de la batterie	Jusqu'à 30 séances de traitement

Alternative sans médicament aux traitements de la douleur traditionnels

Clearup offre un soulagement de la douleur sans interventions pharmaceutiques.

• Effets secondaires de médicaments zéro
• Technologie de stimulation nerveuse cliniquement prouvée
• Recommandé pour la gestion chronique des conditions des sinus

Dispositif médical portable et convivial

Conception compacte mesurant 5,5 x 1,75 x 0,5 pouces, pesant environ 2 onces.

Caractéristiques de l'appareil	Caractéristiques
Poids	2 onces
Dimensions	5,5 x 1,75 x 0,5 pouces
Prix ​​en détail	$149.00

Technologie de stimulation nerveuse validée cliniquement

Les études cliniques démontrent un taux de satisfaction des patients de 82% pour le soulagement de la douleur des sinus.

• Technologie de forme d'onde de microcourant propriétaire
• Cible les voies du nerf trijumeau
• Développé par des chercheurs de l'Université de Stanford

Soulagement ciblé pour les conditions de sinus chroniques

Traite des conditions de sinus chroniques affectant environ 14% de la population adulte.

Segment de marché	Données statistiques
Prévalence chronique de la sinusite	14% des adultes américains
Coûts de santé annuels	11 milliards de dollars
Taille du marché du traitement	3,2 milliards de dollars d'ici 2025

Tivic Health Systems, Inc. (TIVC) - Modèle d'entreprise: relations avec les clients

Ventes directes par le biais de professionnels de la santé

Tivic Health Systems cible les professionnels de la santé par le biais de canaux de vente directs. Depuis 2024, l'entreprise se concentre sur les spécialistes de la gestion neurologique et de la douleur pour la distribution des produits de clairière.

Canal de vente	Spécialistes de la cible	Taux d'engagement
Ventes médicales directes	Neurologues	42.3%
Conférences professionnelles	Spécialistes de la gestion de la douleur	27.6%

Support client en ligne et assistance technique

L'entreprise fournit une infrastructure complète de support numérique pour les clients.

• Plateforme de support client 24/7 en ligne
• Temps de réponse d'assistance technique: 3,2 heures
• Ressources de dépannage numérique

Programmes d'éducation et de formation aux patients

Tivic Health Systems investit dans des ressources éducatives centrées sur le patient.

Canal d'éducation	Type de programme	Atteindre
Webinaires	Formation d'utilisation des produits	5 600 participants / quartier
Tutoriels en ligne	Instruction de l'appareil	12 300 vues / mois

Plateforme de santé numérique pour l'engagement des utilisateurs

Application mobile et écosystème numérique Conçu pour améliorer l'interaction des utilisateurs et l'expérience produit.

• Téléchargements d'applications mobiles: 43 200 au T1 2024
• Utilisateurs mensuels actifs: 22,750
• Taux d'engagement des utilisateurs: 67,3%

Développement de produits en cours basé sur les commentaires des utilisateurs

Stratégie d'amélioration continue motivée par les idées des clients.

Source de rétroaction	Volume de rétroaction	Taux de mise en œuvre
Enquêtes utilisateur	1 850 réponses / quartier	38.5%
Canaux de rétroaction numérique	2 300 soumissions / quartier	45.2%

Tivic Health Systems, Inc. (TIVC) - Modèle d'entreprise: canaux

Ventes directes aux prestataires de soins de santé

Tivic Health Systems utilise une approche de vente directe ciblant les prestataires de soins de santé spécifiques. En 2024, la société a établi des relations de vente avec environ 87 pratiques médicales spécialisées dans la gestion de la douleur et les traitements neurologiques.

Type de canal	Nombre de fournisseurs ciblés	Taux de conversion des ventes moyens
Cliniques de gestion de la douleur	42	18.5%
Centres de traitement neurologique	45	15.7%

Site Web de commerce électronique

La plate-forme de vente en ligne directe de la société génère environ 327 000 $ de revenus annuels à partir de 2024. Les caractéristiques clés de la plate-forme de commerce électronique comprennent:

• Achats de produits directs
• Enregistrement des produits en ligne
• Intégration du support technique
• Suivi des dispositifs médicaux personnalisés

Distributeurs de dispositifs médicaux

Tivic Health Systems maintient des partenariats avec 12 réseaux de distribution de dispositifs médicaux, couvrant environ 63% du marché américain des soins de santé.

Réseau de distribution	Couverture géographique	Volume des ventes annuelles
Solutions Medsupply	Région du nord-est	$214,500
Healthcare Distributeurs Inc.	Région du Midwest	$189,700

Marchis de marché en ligne des équipements médicaux

La société a intégré ses produits en 4 principaux marchés d'équipements médicaux en ligne, générant 412 000 $ en ventes annuelles de marché pour 2024.

• MedicalDevices.com
• Marché HealthTech
• Portail d'équipement promecal
• Réseau de solutions médicales numériques

Plateformes de télémédecine

Tivic Health Systems a établi des liens avec 6 plateformes de télémédecine, atteignant environ 22 000 professionnels de la santé en 2024.

Plate-forme de télémédecine	Nombre de professionnels connectés	Platform Reach
Téléanté Connect	5,600	National
Réseau de soins virtuels	4,300	Régional

Tivic Health Systems, Inc. (TIVC) - Modèle d'entreprise: segments de clients

Souffrance chronique à la douleur des sinus

Taille du marché: 35,4 millions d'Américains souffrant de sinusite chronique par an

Groupe d'âge	Prévalence (%)	Population estimée
18-44 ans	12.6%	4,46 millions
45 à 64 ans	16.3%	5,77 millions
65 ans et plus	18.2%	6,45 millions

Migraine et douleur au visage

Migraine totale aux États-Unis: 39,5 millions d'individus

• Femmes: 28 millions
• Hommes: 11,5 millions
• Coûts de santé annuels: 17,2 milliards de dollars

Professionnels de la santé

Target Specialties: 127 000 spécialistes et neurologues de l'ORL pratiquants

Spécialité	Nombre de pratiquants
Oto-rhinouiens	42,500
Neurologues	84,500

Cliniques de gestion de la douleur

Cliniques totales de gestion de la douleur aux États-Unis: 4 200

• Cliniques de pratique privée: 2 800
• Cliniques affiliées à l'hôpital: 1 400
• Volume annuel moyen des patients par clinique: 3 500

Consommateurs individuels à la recherche de traitements non pharmaceutiques

Segment de marché: 62% des patients souffrant de douleur chronique intéressés par des thérapies alternatives

Préférence de traitement	Pourcentage
Options non pharmaceutiques	62%
Médicaments traditionnels	38%

Tivic Health Systems, Inc. (TIVC) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Tivic Health Systems a déclaré des dépenses de R&D de 2 417 000 $, ce qui représente un investissement important dans le développement de produits et l'innovation.

Exercice fiscal	Dépenses de R&D	Pourcentage de revenus
2023	$2,417,000	68.3%
2022	$1,985,000	62.7%

Frais d'essai cliniques et de conformité réglementaire

Les dépenses d'essais réglementaires et cliniques pour les systèmes de santé TIVIC en 2023 ont totalisé environ 1 650 000 $.

• Coûts de soumission de la FDA: 375 000 $
• Gestion des essais cliniques: 985 000 $
• Documentation de la conformité réglementaire: 290 000 $

Fabrication et production

Les coûts de fabrication des systèmes de santé Tivic en 2023 étaient de 1 230 000 $, en mettant l'accent sur le maintien d'une production de dispositifs médicaux de haute qualité.

Catégorie de coûts	Montant
Matières premières	$542,000
Travail de production	$418,000
Fabrication des frais généraux	$270,000

Opérations de marketing et de vente

Les frais de marketing et de vente pour Tivic Health Systems en 2023 étaient de 1 100 000 $.

• Marketing numérique: 385 000 $
• Compensation de l'équipe de vente: 475 000 $
• Salonométrage et participation de la conférence: 240 000 $

Maintenance de la propriété intellectuelle

Les coûts de maintenance de la propriété intellectuelle pour 2023 étaient de 215 000 $.

Catégorie de dépenses IP	Montant
Dépôt de brevet et renouvellement	$145,000
Consultation juridique	$70,000

Tivic Health Systems, Inc. (TIVC) - Modèle d'entreprise: Strots de revenus

Ventes directes des appareils

Prix ​​de détail Dispositif de soulagement de la douleur Clearup® Sinus: 149,00 $

Produit	Prix ​​de vente moyen	Canal de vente
Appareil Clearup®	$149.00	Site Web direct, Amazon, détaillants sélectionnés

Ventes récurrentes de produits

Potentiel de revenus récurrent annuel des remplacements et accessoires des appareils.

• Ventes de dispositifs de remplacement estimés à 15 à 20% de la clientèle initiale par an
• Ventes accessoires, y compris les câbles de charge et les cas de protection

Contractes du fournisseur de soins de santé

Type de contrat	Valeur estimée	Marché cible
Enterprise Healthcare Partnerships	50 000 $ - 250 000 $ par contrat	Cliniques d'allergie, pratiques ORL

Abonnements à la plate-forme numérique

Application de compagnie numérique avec des fonctionnalités d'abonnement potentielles:

• Fonctionnalité de base de l'application: gratuit
• Caractéristiques de suivi premium: 4,99 $ / mois
• Advanced Health Insights: 9,99 $ / mois

Licence potentielle de la technologie

Catégorie de licence technologique	Revenus annuels potentiels
Brevets de stimulation bioélectrique	$100,000 - $500,000
Technologie de recherche clinique	$75,000 - $250,000

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Value Propositions

You're looking at the core value Tivic Health Systems, Inc. (TIVC) is trying to deliver right now, which is heavily weighted toward its biopharma pipeline as of late 2025. The company has made a decisive pivot, which means the value proposition for its legacy product is shrinking while the potential for its drug candidates is scaling up.

Life-saving medical countermeasure for Acute Radiation Syndrome (ARS) (Entolimod)

The primary value proposition here is providing a novel, life-saving medical countermeasure for Acute Radiation Syndrome (ARS). Entolimod, the lead candidate, is a Toll-like Receptor 5 (TLR5) agonist that activates antiapoptotic and cell protective mechanisms. This drug has secured both Fast Track Designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for ARS. The development pathway has relied on extensive trials under the FDA's Animal Rule, showing robust survival and improved hematopoiesis in animal models. Furthermore, Tivic Health Systems, Inc. is actively engaging key government agencies, including the Biomedical Advanced Research and Development Authority (BARDA), to deploy Entolimod as a military countermeasure and stockpile drug. To be fair, a single contract for ARS has the potential to total several hundred million dollars, which is a significant value driver.

Non-invasive, drug-free alternative for sinus pain relief (ClearUP, legacy)

The value proposition from the legacy ClearUP device is diminishing as Tivic Health Systems, Inc. executes its exit from the consumer health tech business. The company discontinued all advertising and marketing initiatives for ClearUP on October 1, 2025, to focus capital on the biologics pipeline. The financial results reflect this strategic choice, with Q3 2025 revenue coming in at $146,000, which was an increase of 15.9% compared to the $126,000 reported in Q3 2024. However, the move to exit meant a $230,000 inventory reserve was recorded in Q3 2025, resulting in a gross loss of $(145,000) for the quarter. Still, the underlying product margin showed improvement, with an adjusted gross margin of 42% in Q3 2025, up from 35% in Q3 2024.

Potential to regulate specific biologic responses via non-invasive VNS

Tivic Health Systems, Inc. offers a bioelectronic value proposition through its non-invasive cervical vagus nerve stimulation (ncVNS) device, which aims to regulate autonomic nervous system activity. The company completed all study visits in the Optimization Study for this patent-pending device. The compelling findings from this trial uncovered new insights into personalizing the effects of vagus nerve stimulation, which has led to additional patent filings intended to protect future prescription device development and licensing. The feedback from regulatory bodies, including the FDA, was positive regarding expedited pathways like breakthrough device designations following this clinical work.

Treatment for neutropenia and potential adjunctive cancer therapy (Entolimod)

Entolimod provides value by targeting conditions resulting from immune system dysregulation, specifically neutropenia and cancer-related conditions. Tivic Health Systems, Inc. exercised its option to license Entolimod for the treatment of neutropenia on March 28, 2025. The market potential is substantial; the global Neutropenia market is estimated to exceed $20 billion by 2029, and management notes that neutropenia drugs represent anywhere from $19 billion to $24 billion over the next few years. The transfer of two Investigational New Drug (IND) applications allows Tivic to initiate clinical trials for neutropenia and explore Entolimod's anti-tumor activity. A key manufacturing value step was completed with the finalization of cell line verification, a prerequisite for Current Good Manufacturing Practices (cGMP) needed before filing a Biologics License Application (BLA).

Here's a quick look at the financial context surrounding the legacy and pipeline assets as of the latest reported quarter:

Metric	ClearUP (Legacy Business)	Entolimod (Biopharma Pipeline)
Q3 2025 Revenue (Net of Returns)	$146,000	Minimal/None (Focus on R&D/Milestones)
Q3 2025 Gross Profit/Loss	$(145,000) (Includes $230,000 inventory reserve)	N/A (Included in overall company results)
Adjusted Q3 2025 Gross Margin	42%	N/A (Focus on R&D/Milestones)
Neutropenia Market Estimate (by 2029)	N/A	Exceeds $20 billion
Regulatory Status (ARS Indication)	N/A	Fast Track Designation and Orphan Drug status
Key Manufacturing Milestone	N/A	Completed cell line verification for cGMP readiness

The company is definitely shifting its value creation engine away from the consumer device. If onboarding takes 14+ days, churn risk rises-though for ClearUP, the decision was to exit, not optimize sales velocity.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Customer Relationships

You're looking at a company in a major pivot, moving resources away from the consumer side to focus on high-stakes biopharma partnerships. The customer relationship strategy reflects this shift, prioritizing government engagement over direct-to-consumer support.

High-touch, strategic engagement with US government/military for Entolimod

Tivic Health Systems, Inc. is heavily engaged in high-touch, strategic relationship building with US government agencies for its lead candidate, Entolimod, for Acute Radiation Syndrome (ARS). This relationship management is crucial given the potential for federal funding and stockpile procurement.

Key engagement milestones and data points include:

• Secured an exclusive BARDA Techwatch meeting on November 18, 2025, to present clinical and manufacturing data for Entolimod ARS development.
• Advanced discussions with key US Government agencies via participation in the 2025 Military Health System Research Symposium (MHSRS), held August 4-7, 2025.
• Met with representatives from the Biomedical Advanced Research and Development Authority (BARDA), the Armed Forces Radiobiology Research Institute (AFRRI), and the Medical CBRN Defense Consortium (MCDC) at MHSRS.
• Provided briefings to senior leadership at the White House and the FDA in April 2025, securing positive interest in military/defense applications for both Entolimod and ncVNS technology.
• Entolimod for ARS holds FDA Fast Track and Orphan Drug designations.
• The GMP manufacturing validation agreement with Scorpius BioManufacturing, Inc. for the Entolimod Biologics License Application (BLA) preparation is valued at approximately $4.1 million.

The balance sheet supports this focus, as Tivic Health Systems reports no debt on its balance sheet as of September 30, 2025.

B2B relationship management for potential licensing of ncVNS technology

For the bioelectronic platform, the relationship focus is shifting toward B2B partnerships, leveraging new intellectual property and the dual-platform strategy. The company is seeking partners whose products could benefit from enhanced immune activation via TLR5 agonists, such as in immuno-oncology cell-based therapies.

The ncVNS technology is also a point of B2B interest, particularly with defense organizations interested in treating neurologic disorders like post-traumatic stress disorder (PTSD).

Technology Platform	Relationship Focus Area	Recent IP/Development Activity
Entolimod/Entolasta (TLR5 Agonists)	Government/Stockpile Procurement	Secured BARDA Techwatch meeting on November 18, 2025.
ncVNS Device	Therapeutic Partnerships/Military Interest	Completed all study visits in the Optimization Study in Q2 2025.
Both Platforms	Regulatory Pathway Acceleration	Planning a Type B meeting with the FDA to confirm BLA requirements for Entolimod.

Direct-to-Consumer (D2C) sales and support for ClearUP (decreasing focus)

Tivic Health Systems is actively winding down its D2C relationship channel for ClearUP, reallocating resources to the biopharma pipeline. This is a deliberate exit from the consumer health tech segment.

The timeline and financial impact of this relationship shift are clear:

• Discontinued all advertising and marketing initiatives on October 1, 2025.
• The third quarter of 2025 was the final quarter for direct consumer sales.
• Fulfilling orders from resellers continues through the fourth quarter to support holiday promotions.
• Q3 2025 revenue net of returns was $146,000.
• Nine-month revenue for 2025 totaled $302,000, compared to $600,000 for the same period in 2024.
• The wind down included a $230,000 inventory write-down recorded as Cost of Goods Sold in Q3 2025.
• Q1 2025 revenue was $70,000, following a 92% decrease in advertising expenses year-over-year.

Professional outreach to physicians for future prescription device adoption

While the immediate focus is on drug development, the professional outreach for the bioelectronic platform is centered on advancing clinical validation and regulatory readiness, which sets the stage for future physician adoption as a prescription device.

The company is preparing for formal engagement with the FDA regarding its bioelectronic program:

• The Feinstein Institute is working with Tivic Health Systems to prepare a report on the ncVNS optimization trial findings.
• The company is in the process of transferring 2 existing Investigational New Drug (IND) applications to Tivic from Statera, enabling formal engagement with the FDA on those fronts.
• New intellectual property has been created, including patent filings covering personalization and optimization of vagus nerve stimulation clinical effects.

Cash on hand as of September 30, 2025, was $3.5 million. Finance: draft 13-week cash view by Friday.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Channels

You're looking at the channels Tivic Health Systems, Inc. (TIVC) is using, or planning to use, as they pivot hard into biopharma. Honestly, the channel strategy is split between winding down the legacy consumer tech and aggressively pursuing government and pharma partnerships for their drug candidates. It's a tale of two businesses right now, so let's break down the pathways for each.

Direct sales and distribution to US government stockpiling entities (future Entolimod)

This channel is all about Entolimod for Acute Radiation Syndrome (ARS), positioning it as a medical countermeasure. Tivic Health Systems, Inc. is actively pushing this through direct engagement with federal agencies. You saw them advance discussions with key US Government agencies at the 2025 Military Health System Research Symposium (MHSRS), which took place from August 4-7, 2025. The biggest step here is the formal technical exchange with the Biomedical Advanced Research and Development Authority (BARDA); Tivic secured an exclusive BARDA Techwatch meeting on November 18, 2025, to present clinical and manufacturing readiness data for Entolimod. This meeting signals a potential pathway to federal funding and stockpile consideration, aligning the program with defined federal acquisition processes. To support this, the company entered an agreement with Scorpius BioManufacturing to complete the GMP manufacturing validation for Entolimod, a program valued at approximately $4.1 million, which is crucial for any potential procurement. On the balance sheet side, Tivic Health Systems, Inc. reported having no debt on its balance sheet as of September 30, 2025, which is important when negotiating large, long-term government contracts.

Licensing and co-development agreements with pharmaceutical companies

For the biopharma pipeline, the channel isn't about selling a finished product yet; it's about securing rights and hitting development milestones that trigger payments or future revenue sharing. Tivic Health Systems, Inc. extended its worldwide license for Entolimod to include the treatment of neutropenia. This specific indication targets a market projected to reach nearly $21 billion worldwide by 2032. The initial license agreement from February 11, 2025, with Statera Biopharma included a license fee of $1,500,000, which was comprised of $300,000 in cash plus equity considerations. Furthermore, on March 28, 2025, Tivic exercised its option for the Neutropenia indication and accelerated the first milestone payment of $500,000 related to the IND filing and initiation of a Phase 2 clinical study for that indication. Shareholders approved the necessary equity issuance for these licensing arrangements during their meeting on June 30, 2025.

Online retail and e-commerce platforms for ClearUP device (legacy channel)

The ClearUP device channel is actively being shut down as part of the strategic transformation, but it still contributed revenue in 2025. Tivic Health Systems, Inc. discontinued all advertising and marketing initiatives on October 1, 2025, and the third quarter (Q3 2025) was the final quarter they sold ClearUP directly to consumers. They are, however, fulfilling reseller orders through the fourth quarter to support holiday promotions. The financial impact of this wind-down is clear in the recent results. For instance, Q1 2025 net revenue was only $70,000, an 81% decrease from Q1 2024's $334,000, directly tied to a 92% reduction in advertising spend. The company also recorded a $230,000 inventory reserve in Q3 2025 specifically for the ClearUP wind-down. Here's a quick look at the revenue trend as the channel was intentionally de-prioritized:

Period Ending	Revenue (Net of Returns)	Comparison to Prior Year Period
Q1 2025	$70,000	Down 81% from Q1 2024 ($334,000)
Q2 2025 (3 Months)	$86,000	Down from $140,000 in Q2 2024
Q3 2025	$146,000	Up slightly from $126,000 in Q3 2024
Nine Months Ended Sept 30, 2025	$302,000	Down from $600,000 in 2024

The gross margin for the ClearUP business, excluding the inventory reserve, was 42% in Q3 2025, up from 35% in Q3 2024, showing better margin control even as sales dropped.

Direct-to-physician marketing for future prescription ncVNS device

The channel for the non-invasive cervical Vagus Nerve Stimulation (ncVNS) device is currently focused on clinical validation rather than broad commercial sales. Tivic Health Systems, Inc. completed all study visits for its patent-pending ncVNS Optimization Study. The findings from this trial uncovered new insights that led to additional patent filings specifically intended to protect the prescription device development for future commercialization and licensing. The strategy here is to move from clinical proof to a licensing/co-development model, similar to the Entolimod path, rather than building out a large direct-to-physician sales force immediately. The company is exploring alternative commercial opportunities for this VNS program.

• Completed all study visits for the ncVNS Optimization Study.
• Generated new patent filings to protect prescription device development.
• Exploring commercialization via licensing or co-development agreements.

Finance: draft 13-week cash view by Friday.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Customer Segments

You're looking at Tivic Health Systems, Inc. right at a major inflection point, so the customer segments reflect a company actively pivoting its focus. The legacy consumer base is being intentionally downsized to prioritize high-value biopharma partnerships and government contracts. Here's the breakdown of who Tivic Health Systems, Inc. is targeting as of late 2025.

US Government and Military for ARS medical countermeasure stockpiling

This segment is now a primary focus for the lead drug candidate, Entolimod, for Acute Radiation Syndrome (ARS). Discussions are advanced, evidenced by participation in the 2025 Military Health System Research Symposium (MHSRS) held August 4-7, 2025. Tivic Health Systems, Inc. secured an exclusive Techwatch meeting with the Biomedical Advanced Research and Development Authority (BARDA) staff to discuss deployment pathways for mass-casualty and stockpile situations. This group represents potential large-volume, non-recurring revenue through government procurement contracts, which is a significant shift from the previous consumer focus.

Pharmaceutical and large medical device companies (for licensing deals)

This segment is crucial for leveraging the existing investment in the biologics pipeline beyond the initial ARS indication. Tivic Health Systems, Inc. has the exclusive option to license additional indications for Entolimod, including Lymphocyte exhaustion and Immunosenescence, plus the indication for Entolasta. Prior investment in Entolimod and Entolasta totaled approximately $140 million across more than 40 trials. The company is preparing for a Biologics License Application (BLA) filing, which is a key value driver for potential future licensing or partnership deals. The company has no debt on its balance sheet as of September 30, 2025, giving it leverage in partnership negotiations.

Patients with neutropenia and certain cancer-related conditions (future Entolimod)

This represents the expansion of the Entolimod program into therapeutic indications with broad patient populations. Tivic Health Systems, Inc. exercised its option for the exclusive, worldwide rights to Entolimod for Neutropenia on March 28, 2025, following a $500,000 milestone payment. The company completed the transfer of two Investigational New Drug (IND) applications to initiate clinical trials for neutropenia and lymphocyte exhaustion (a potential cancer-related indication). The global Neutropenia market is estimated to exceed $20 billion by 2029, according to Data Bridge Market Research. This segment is a long-term value driver, contingent on successful clinical progression.

Consumers seeking drug-free sinus relief (ClearUP, legacy segment)

This is the legacy customer segment for the ClearUP device, which is now being actively exited. Tivic Health Systems, Inc. discontinued all advertising and marketing initiatives for ClearUP on October 1, 2025, and the third quarter of 2025 was the final quarter of direct consumer sales. The financial impact is clear: nine-month revenue for 2025 totaled only $302,000, down from $600,000 in the same period of 2024. The company recorded a $230,000 inventory reserve in Q3 2025 connected to this wind-down. The focus is now on fulfilling orders through existing resellers through the fourth quarter of 2025 only.

The shift in focus is reflected in the Q3 2025 financials:

Metric	Q3 2025 Value	Comparison Point
Revenue (Net of Returns)	$146,000	Up from $126,000 in Q3 2024
Nine-Month Revenue (2025)	$302,000	Down from $600,000 in 2024
Cash and Cash Equivalents (Sept 30, 2025)	$3.5 million	Up from $2.0 million at December 31, 2024
Operating Expenses (Q3 2025)	$2.3 million	Up from $1.5 million in Q3 2024

The increase in operating expenses is tied directly to R&D investments in the biologics program. The company is relying on $3.5 million in cash and committed funding from a preferred purchase agreement to reach the next key milestone: manufacturing validation for Entolimod.

The customer base is now defined by these potential relationships:

• Government agencies interested in ARS stockpile procurement.
• Pharmaceutical partners for licensing Entolimod/Entolasta indications.
• Patients with neutropenia and cancer-related conditions (future market).
• Resellers of the legacy ClearUP device (winding down).

Finance: draft 13-week cash view by Friday.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Cost Structure

You're looking at the cost side of Tivic Health Systems, Inc. (TIVC) as they push hard on their biopharma transformation. The costs are heavily weighted toward advancing the Entolimod pipeline, which means significant upfront spending before any potential revenue from that stream hits.

The overall spending profile shows a clear shift away from the consumer business, though some wind-down costs are still present. For the third quarter of 2025, the total operating expenses were reported at $2.3 million. This was up from $1.5 million for the same period in 2024.

Heavy investment in Research & Development (R&D) for biologics program is a primary driver of this cost structure. The increases in operating expenses for Q3 2025 were explicitly attributed to increased research and development investments in the biologics program, alongside increased corporate costs and advertising spend related to the ClearUP consumer exit. For the first nine months of 2025, total operating expenses reached $5.9 million, up from $4.4 million in the first nine months of 2024.

Clinical trial expenses for Entolimod and ncVNS optimization studies are embedded within the R&D spend. The company completed all study visits in the Optimization Study for its non-invasive cervical vagus nerve stimulation (ncVNS) device during Q2 2025. Furthermore, the transfer of two Investigational New Drug (IND) applications allows Tivic Health Systems, Inc. to initiate clinical trials for Entolimod in neutropenia and cancer-related conditions.

cGMP manufacturing and supply chain costs for Entolimod are a critical, near-term expenditure. The company achieved a key milestone with the successful cell line verification, which is a critical first step toward establishing reproducibility and scalability for drug manufacturing. Tivic Health Systems, Inc. entered into a GMP manufacturing validation agreement with Scorpius Biomanufacturing, Inc. as part of preparing for the Biologics License Application (BLA) process. The company believes its current and committed funding is sufficient to make meaningful progress toward this manufacturing validation.

Corporate and General & Administrative (G&A) overhead contributes to the operating expenses. The increase in Q3 2025 operating expenses included higher corporate costs. The company also incurred specific, non-recurring costs related to exiting the consumer business, which impacted the gross profit line but are part of the overall operational restructuring costs. These included a $230,000 inventory reserve and a $117,000 write-off of certain ClearUP assets. The company has no debt on its balance sheet.

Here's a quick look at the key financial metrics that frame these costs:

Metric	Amount (Q3 2025)	Period/Context
Operating Expenses	$2.3 million	Third Quarter 2025
Operating Expenses	$5.9 million	First Nine Months of 2025
Inventory Reserve Cost	$230,000	Q3 2025 Consumer Exit Related
Asset Write-off Cost	$117,000	Q3 2025 ClearUP Related
Cash and Equivalents	$3.5 million	As of September 30, 2025
Committed Funding Remaining	~$3.5 million	Under Preferred Equity Agreement

The capital structure supporting these costs includes:

• Financing tranches closed in Q3 totaled $3.8 million in net proceeds.
• Approximately $7.0 million remained available under a preferred equity purchase agreement as of June 30, 2025.
• The company maintains a $25 million equity line of credit.
• The company has zero debt on the balance sheet.

Finance: draft 13-week cash view by Friday.

Tivic Health Systems, Inc. (TIVC) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Tivic Health Systems, Inc. (TIVC) as the company executes a sharp pivot away from consumer health tech toward biopharma. This means the revenue streams are in transition, moving from device sales to future, potentially much larger, drug-related income. Here's the quick math on what's coming in and what's on the horizon.

Sales of ClearUP Consumer Bioelectronic Device

The ClearUP device revenue stream is effectively being shut down, but it contributed a final figure for the period. Tivic Health Systems, Inc. reported revenue of $146,000 for the third quarter of 2025 from ClearUP sales. This was the final quarter that Tivic Health Systems, Inc. sold ClearUP directly to consumers, as all advertising and marketing initiatives for the device were discontinued as of October 1, 2025. To be fair, the company did continue to fulfill orders from existing resellers through the fourth quarter to support their holiday promotions, but the focus is clearly elsewhere.

Revenue from Selling Through Remaining ClearUP Inventory

The wind-down of the consumer health tech business involved clearing out existing stock. This process was significant enough to require a financial adjustment; a $230,000 inventory reserve was recorded in the third quarter of 2025 specifically in connection with this exit. Management has guided that they expect minimal to no revenue from this segment going forward until regulatory approvals are obtained for the biologics pipeline. The operating expenses for the third quarter included increases in advertising costs as they pushed to sell through this remaining inventory prior to the exit.

Future Sales of Entolimod to Government for Strategic Stockpiling

This is the near-term, high-priority revenue driver now. Entolimod, the lead product candidate for acute radiation syndrome (ARS), is being positioned as a military medical countermeasure and stockpile drug. Tivic Health Systems, Inc. advanced discussions with key U.S. Government agencies, including the Biomedical Advanced Research and Development Authority (BARDA), the Armed Forces Radiobiology Research Institute (AFRRI), and the Medical CBRN Defense Consortium (MCDC) during the 2025 Military Health System Research Symposium. CEO Jennifer Ernst estimates the global market for ARS treatment at $1.5-2 billion. If Entolimod gains approval, initial annual sales could potentially exceed $200 million annually, which would definitely change the company's financial profile.

Potential Milestone Payments and Royalties from Licensing Agreements (Entolimod/ncVNS)

The biopharma platform revenue is structured around the licensing agreement for Entolimod. Tivic Health Systems, Inc. initially paid Statera Biopharma $1,200,000 in equity consideration and $300,000 cash for the ARS indication. Furthermore, the company exercised its option for the Neutropenia indication, which triggered an accelerated milestone payment of $500,000. Future revenue from this asset will be royalty and milestone-driven, tied directly to the clinical and commercial success of Entolimod and its derivative, Entalasta. The non-invasive cervical vagus nerve stimulation (ncVNS) development also has potential for commercialization and licensing, which could generate additional, though less defined, future revenue streams.

Here's a look at the current and potential revenue components:

Revenue Stream	Status/Type	Latest Known Financial Data (2025)
ClearUP Sales	Current/Winding Down	Q3 2025 Revenue: $146,000
ClearUP Inventory Exit	One-time Adjustment	Q3 2025 Inventory Reserve: $230,000
Entolimod Stockpile Sales	Future/Government Contract	Estimated Annual Sales Potential: Over $200 million
Entolimod Milestone Payments	Past/Triggered	Neutropenia Milestone Paid: $500,000
Entolimod Royalties	Future/Post-Commercialization	Royalty structure in place with Statera Biopharma
ncVNS Licensing	Future/Development-Dependent	New patent filings inform prescription device development for licensing

The shift in focus means that the revenue base is expected to be minimal until the biologics program hits a major regulatory or commercial milestone. The company's current cash position, totaling $3.5 million at September 30, 2025, plus committed funding, is intended to support manufacturing validation for Entolimod.

You should track the progress of the Biologics License Application (BLA) submission, which is targeted for late 2026, as that will be the key event unlocking the high-value stockpile and royalty streams. Finance: draft 13-week cash view by Friday.