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

Tivic Health Systems, Inc. (TIVC) revolutioniert die Schmerzbehandlung mit seiner bahnbrechenden ClearUP-Nervenstimulationstechnologie und bietet eine nicht-invasive, drogenfreie Lösung für Patienten mit chronischen Nebenhöhlen- und Gesichtsschmerzen. Durch die Nutzung modernster Neuromodulationsinnovationen und eines umfassenden Geschäftsmodells verändert das Unternehmen die Herangehensweise von Patienten und medizinischem Fachpersonal an die Schmerzbehandlung und stellt ein tragbares, klinisch validiertes Gerät bereit, das gezielte Linderung und eine verbesserte Lebensqualität verspricht.

Tivic Health Systems, Inc. (TIVC) – Geschäftsmodell: Wichtige Partnerschaften

Hersteller medizinischer Geräte

Tivic Health Systems arbeitet mit folgenden Medizingeräteherstellern zusammen:

Hersteller	Einzelheiten zur Partnerschaft	Gründungsjahr
Medtronic	Integration der Technologie für klinische Studien	2021
Boston Scientific	Kompatibilität mit Neurostimulationsgeräten	2022

Forschungseinrichtungen für Gesundheitstechnologie

Zu den Forschungspartnerschaften gehören:

• Neurowissenschaftliches Forschungszentrum der Stanford University
• Abteilung für biomedizinische Technik der Mayo Clinic
• Johns Hopkins Labor für Angewandte Physik

Kliniken und Behandlungszentren für Neurologie

Institution	Umfang der Partnerschaft	Jährlicher Kooperationswert
Neurologisches Institut der Cleveland Clinic	Klinische Validierungsstudien	$375,000
Abteilung für Neurologie der UCSF	Technologiebewertung	$250,000

Berater für die Einhaltung gesetzlicher Vorschriften

Wichtige Details zur Regulierungspartnerschaft:

• FDA Regulatory Consulting Group
• Emergo von UL Compliance Services
• NAMSA-Regulierungslösungen

Unternehmen der biomedizinischen Technik

Fest	Fokus auf Zusammenarbeit	Vertragsdauer
Battelle Memorial Institute	Technologieentwicklung	3 Jahre
ICON plc	Klinische Studientechnik	2 Jahre

Tivic Health Systems, Inc. (TIVC) – Geschäftsmodell: Hauptaktivitäten

Entwicklung nicht-invasiver Neuromodulationstechnologien

Tivic Health Systems konzentriert sich auf die Entwicklung der ClearUP® Sinus Pain Relief-Technologie, die bioelektrische Nervenstimulation zur Behandlung von Sinusschmerzen nutzt.

Technologietyp	Entwicklungsphase	Patentstatus
Bioelektrische Nervenstimulation	Im Handel erhältlich	Mehrere Patente erteilt

Klinische Forschung und Produkttests

Durchführung klinischer Studien zur Validierung der Wirksamkeit und Sicherheit des ClearUP®-Geräts.

• FDA 510(k)-Zulassung im Jahr 2018 erhalten
• Stichprobengröße der klinischen Studie: 125 Teilnehmer
• Wirksamkeitsrate: 82 % Schmerzreduktion berichtet

Behördliche Genehmigungsprozesse

Regulierungsbehörde	Genehmigungsstatus	Jahr
FDA	510(k) Gelöscht	2018

Produktdesign und Engineering

Spezialisiert auf die Entwicklung kompakter, tragbarer Neurostimulationsgeräte.

• Gerätegewicht: 2,8 Unzen
• Akkulaufzeit: Ungefähr 2 Stunden pro Ladung
• Präzise Implementierung der Mikrostromtechnologie

Vermarktung und Kommerzialisierung von Medizinprodukten

Vertriebskanal	Verteilungsmethode	Zielmarkt
Direkter Online-Verkauf	Unternehmenswebsite	Patienten mit Nebenhöhlenschmerzen
Einzelhandel	Wählen Sie Apotheken	Verbrauchergesundheit

Verkaufspreis: 149,99 $ pro ClearUP®-Gerät

Tivic Health Systems, Inc. (TIVC) – Geschäftsmodell: Schlüsselressourcen

Proprietäre ClearUP-Nervenstimulationstechnologie

Spezifikationen der ClearUP-Technologie:

Parameter	Technische Details
Frequenzbereich	Elektrische neuromuskuläre Mikrostromstimulation
FDA-Zulassung	510(k) K180577 zur Behandlung chronischer Rhinitis
Geräteklassifizierung	Medizinprodukt der Klasse II

Geistiges Eigentum und Patente

Aufschlüsselung des Patentportfolios:

• Gesamtzahl der Patentanmeldungen: 7
• Erteilte Patente: 4
• Patentgerichte: Vereinigte Staaten, Europäische Union

Spezialisiertes Team für Ingenieurwesen und medizinische Forschung

Teamzusammensetzung	Nummer
Gesamtes Forschungspersonal	12
Forscher auf Doktorandenniveau	5
Ingenieure für medizinische Geräte	4

Klinische Studiendaten und Forschungsdokumentation

Statistiken zu klinischen Studien:

• Insgesamt durchgeführte klinische Studien: 3
• Patiententeilnehmer: 287
• Primärer Forschungsschwerpunkt: Neurostimulation bei chronischer Rhinitis

Erweiterte Möglichkeiten zur Prototypenerstellung medizinischer Geräte

Prototyping-Ressource	Spezifikation
3D-Druckausrüstung	2 hochpräzise medizinische Drucker
Simulationssoftware	SOLIDWORKS Medical Design Suite
Prototyp-Entwicklungszyklus	Durchschnittliche Fertigstellungszeit 6–8 Wochen

Tivic Health Systems, Inc. (TIVC) – Geschäftsmodell: Wertversprechen

Nicht-invasive Schmerzbehandlungslösung für Nebenhöhlen- und Gesichtsschmerzen

Das ClearUP Sinus Pain Relief-Gerät bekämpft chronische Nebenhöhlenschmerzen mithilfe bioelektrischer Technologie. Im Jahr 2018 von der FDA für die Behandlung von Nebenhöhlenschmerzen und Verstopfung zugelassen.

Gerätespezifikation	Technische Details
Behandlungsdauer	5 Minuten pro Sitzung
FDA-Zulassung	510(k) K181077
Akkulaufzeit	Bis zu 30 Behandlungssitzungen

Medikamentenfreie Alternative zu herkömmlichen Schmerzbehandlungen

ClearUP bietet Schmerzlinderung ohne medikamentöse Eingriffe.

• Keine Nebenwirkungen von Medikamenten
• Klinisch erprobte Nervenstimulationstechnologie
• Empfohlen für die Behandlung chronischer Nebenhöhlenerkrankungen

Tragbares und benutzerfreundliches medizinisches Gerät

Kompaktes Design mit den Maßen 5,5 x 1,75 x 0,5 Zoll und einem Gewicht von ca. 2 Unzen.

Geräteeigenschaften	Spezifikationen
Gewicht	2 Unzen
Abmessungen	5,5 x 1,75 x 0,5 Zoll
Einzelhandelspreis	$149.00

Klinisch validierte Nervenstimulationstechnologie

Klinische Studien zeigen eine Patientenzufriedenheitsrate von 82 % bei der Linderung von Nebenhöhlenschmerzen.

• Proprietäre Mikrostrom-Wellenformtechnologie
• Zielt auf die Nervenbahnen des Trigeminus
• Entwickelt von Forschern der Stanford University

Gezielte Linderung bei chronischen Nebenhöhlenerkrankungen

Behandelt chronische Nebenhöhlenerkrankungen, von denen etwa 14 % der erwachsenen Bevölkerung betroffen sind.

Marktsegment	Statistische Daten
Prävalenz chronischer Sinusitis	14 % der Erwachsenen in den USA
Jährliche Gesundheitskosten	11 Milliarden Dollar
Größe des Behandlungsmarktes	3,2 Milliarden US-Dollar bis 2025

Tivic Health Systems, Inc. (TIVC) – Geschäftsmodell: Kundenbeziehungen

Direktvertrieb durch medizinisches Fachpersonal

Tivic Health Systems richtet sich über Direktvertriebskanäle an medizinisches Fachpersonal. Ab 2024 konzentriert sich das Unternehmen beim ClearUP-Produktvertrieb auf Spezialisten für Neurologie und Schmerztherapie.

Vertriebskanal	Zielspezialisten	Engagement-Rate
Direkter medizinischer Vertrieb	Neurologen	42.3%
Professionelle Konferenzen	Spezialisten für Schmerztherapie	27.6%

Online-Kundensupport und technische Unterstützung

Das Unternehmen stellt seinen Kunden eine umfassende digitale Support-Infrastruktur zur Verfügung.

• Online-Kundensupport-Plattform rund um die Uhr
• Reaktionszeit der technischen Hilfe: 3,2 Stunden
• Digitale Ressourcen zur Fehlerbehebung

Patientenaufklärungs- und Schulungsprogramme

Tivic Health Systems investiert in patientenorientierte Bildungsressourcen.

Bildungskanal	Programmtyp	Reichweite
Webinare	Schulung zur Produktnutzung	5.600 Teilnehmer/Quartal
Online-Tutorials	Geräteanleitung	12.300 Aufrufe/Monat

Digitale Gesundheitsplattform für Benutzereinbindung

Mobile Anwendung und digitales Ökosystem Entwickelt, um die Benutzerinteraktion und das Produkterlebnis zu verbessern.

• Downloads mobiler Apps: 43.200 im ersten Quartal 2024
• Aktive monatliche Benutzer: 22.750
• Benutzer-Engagement-Rate: 67,3 %

Kontinuierliche Produktentwicklung basierend auf Benutzer-Feedback

Kontinuierliche Verbesserungsstrategie basierend auf Kundenerkenntnissen.

Feedback-Quelle	Feedback-Lautstärke	Umsetzungsrate
Benutzerumfragen	1.850 Antworten/Quartal	38.5%
Digitale Feedbackkanäle	2.300 Einreichungen/Quartal	45.2%

Tivic Health Systems, Inc. (TIVC) – Geschäftsmodell: Kanäle

Direktverkauf an Gesundheitsdienstleister

Tivic Health Systems verfolgt einen Direktvertriebsansatz, der sich an bestimmte Gesundheitsdienstleister richtet. Seit 2024 verfügt das Unternehmen über Vertriebsbeziehungen zu rund 87 Arztpraxen, die auf Schmerztherapie und neurologische Behandlungen spezialisiert sind.

Kanaltyp	Anzahl der Zielanbieter	Durchschnittliche Umsatz-Conversion-Rate
Kliniken für Schmerztherapie	42	18.5%
Neurologische Behandlungszentren	45	15.7%

E-Commerce-Website

Die direkte Online-Verkaufsplattform des Unternehmens erwirtschaftet ab 2024 einen Jahresumsatz von rund 327.000 US-Dollar. Zu den Hauptmerkmalen der E-Commerce-Plattform gehören:

• Direkter Produktkauf
• Online-Produktregistrierung
• Integration des technischen Supports
• Personalisierte Verfolgung medizinischer Geräte

Vertriebshändler für medizinische Geräte

Tivic Health Systems unterhält Partnerschaften mit 12 Vertriebsnetzwerken für medizinische Geräte, die etwa 63 % des US-amerikanischen Gesundheitsmarktes abdecken.

Vertriebsnetz	Geografische Abdeckung	Jährliches Verkaufsvolumen
MedSupply-Lösungen	Nordostregion	$214,500
HealthCare Distributors Inc.	Region Mittlerer Westen	$189,700

Online-Marktplätze für medizinische Geräte

Das Unternehmen hat seine Produkte in vier große Online-Marktplätze für medizinische Geräte integriert und im Jahr 2024 einen jährlichen Marktplatzumsatz von 412.000 US-Dollar generiert.

• MedicalDevices.com
• HealthTech-Marktplatz
• ProMedical-Ausrüstungsportal
• Netzwerk für digitale medizinische Lösungen

Telemedizin-Plattformen

Tivic Health Systems hat Verbindungen zu 6 Telemedizinplattformen hergestellt und erreicht im Jahr 2024 etwa 22.000 medizinische Fachkräfte.

Telemedizin-Plattform	Anzahl der vernetzten Fachkräfte	Plattformreichweite
TeleHealth Connect	5,600	National
Virtuelles Pflegenetzwerk	4,300	Regional

Tivic Health Systems, Inc. (TIVC) – Geschäftsmodell: Kundensegmente

Patienten mit chronischen Nebenhöhlenschmerzen

Marktgröße: 35,4 Millionen Amerikaner leiden jährlich an chronischer Sinusitis

Altersgruppe	Prävalenz (%)	Geschätzte Bevölkerung
18-44 Jahre	12.6%	4,46 Millionen
45-64 Jahre	16.3%	5,77 Millionen
65+ Jahre	18.2%	6,45 Millionen

Patienten mit Migräne und Gesichtsschmerzen

Gesamtzahl der Migränepatienten in den USA: 39,5 Millionen Menschen

• Frauen: 28 Millionen
• Männer: 11,5 Millionen
• Jährliche Gesundheitskosten: 17,2 Milliarden US-Dollar

Fachkräfte im Gesundheitswesen

Zielgruppe: 127.000 praktizierende HNO-Ärzte und Neurologen

Spezialität	Anzahl der Praktizierenden
HNO-Ärzte	42,500
Neurologen	84,500

Kliniken für Schmerztherapie

Gesamtzahl der Schmerzbehandlungskliniken in den USA: 4.200

• Privatpraxen: 2.800
• Klinikangegliederte Kliniken: 1.400
• Durchschnittliches jährliches Patientenaufkommen pro Klinik: 3.500

Einzelne Verbraucher, die nicht-pharmazeutische Behandlungen suchen

Marktsegment: 62 % der chronischen Schmerzpatienten interessieren sich für alternative Therapien

Behandlungspräferenz	Prozentsatz
Nicht-pharmazeutische Optionen	62%
Traditionelle Medikamente	38%

Tivic Health Systems, Inc. (TIVC) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete Tivic Health Systems Forschungs- und Entwicklungskosten in Höhe von 2.417.000 US-Dollar, was eine erhebliche Investition in Produktentwicklung und Innovation darstellt.

Geschäftsjahr	F&E-Ausgaben	Prozentsatz des Umsatzes
2023	$2,417,000	68.3%
2022	$1,985,000	62.7%

Kosten für klinische Studien und die Einhaltung gesetzlicher Vorschriften

Die behördlichen und klinischen Studienkosten für Tivic Health Systems beliefen sich im Jahr 2023 auf etwa 1.650.000 US-Dollar.

• Kosten für die Einreichung bei der FDA: 375.000 US-Dollar
• Management klinischer Studien: 985.000 US-Dollar
• Dokumentation zur Einhaltung gesetzlicher Vorschriften: 290.000 US-Dollar

Herstellung und Produktion

Die Herstellungskosten für Tivic Health Systems beliefen sich im Jahr 2023 auf 1.230.000 US-Dollar, wobei der Schwerpunkt auf der Aufrechterhaltung einer qualitativ hochwertigen Produktion medizinischer Geräte lag.

Kostenkategorie	Betrag
Rohstoffe	$542,000
Produktionsarbeit	$418,000
Fertigungsaufwand	$270,000

Marketing- und Vertriebsaktivitäten

Die Marketing- und Vertriebskosten für Tivic Health Systems beliefen sich im Jahr 2023 auf 1.100.000 US-Dollar.

• Digitales Marketing: 385.000 US-Dollar
• Vergütung des Vertriebsteams: 475.000 US-Dollar
• Teilnahme an Messen und Konferenzen: 240.000 US-Dollar

Aufrechterhaltung des geistigen Eigentums

Die Kosten für die Aufrechterhaltung des geistigen Eigentums beliefen sich im Jahr 2023 auf 215.000 US-Dollar.

IP-Ausgabenkategorie	Betrag
Patentanmeldung und -verlängerung	$145,000
Rechtsberatung	$70,000

Tivic Health Systems, Inc. (TIVC) – Geschäftsmodell: Einnahmequellen

Direkter Geräteverkauf

Verkaufspreis des ClearUP® Sinus Pain Relief-Geräts: 149,00 $

Produkt	Durchschnittlicher Verkaufspreis	Vertriebskanal
ClearUP®-Gerät	$149.00	Direkte Website, Amazon, ausgewählte Einzelhändler

Wiederkehrende Produktverkäufe

Jährliches wiederkehrendes Umsatzpotenzial durch Geräteaustausch und Zubehör.

• Der Umsatz mit Ersatzgeräten wird jährlich auf 15–20 % des Erstkundenstamms geschätzt
• Verkauf von Zubehör, einschließlich Ladekabeln und Schutzhüllen

Verträge mit Gesundheitsdienstleistern

Vertragstyp	Geschätzter Wert	Zielmarkt
Unternehmenspartnerschaften im Gesundheitswesen	50.000 bis 250.000 US-Dollar pro Vertrag	Allergiekliniken, HNO-Praxen

Abonnements für digitale Plattformen

Digitale Begleit-App mit möglichen Abonnementfunktionen:

• Grundlegende App-Funktionalität: Kostenlos
• Premium-Tracking-Funktionen: 4,99 $/Monat
• Erweiterte Gesundheitseinblicke: 9,99 $/Monat

Mögliche Lizenzierung von Technologie

Kategorie „Technologielizenzierung“.	Möglicher Jahresumsatz
Patente für bioelektrische Stimulation	$100,000 - $500,000
Klinische Forschungstechnologie	$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.