Tivic Health Systems, Inc. (TIVC): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Tivic Health Systems, Inc. (TIVC) está revolucionando el manejo del dolor con su innovadora tecnología de estimulación nerviosa clara, que ofrece una solución no invasiva y sin drogas para el sinusal crónico y el dolor facial para el dolor. Al aprovechar las innovaciones de neuromodulación de vanguardia y un modelo comercial integral, la compañía está transformando cómo los pacientes y los profesionales de la salud abordan el tratamiento del dolor, proporcionando un dispositivo portátil clínicamente validado que promete un alivio objetivo y una mejor calidad de vida.

Tivic Health Systems, Inc. (TIVC) - Modelo de negocios: asociaciones clave

Fabricantes de dispositivos médicos

Tivic Health Systems colabora con los siguientes fabricantes de dispositivos médicos:

Fabricante	Detalles de la asociación	Año establecido
Medtrónico	Integración de tecnología de ensayos clínicos	2021
Boston Scientific	Compatibilidad del dispositivo de neuroestimulación	2022

Instituciones de investigación de tecnología de salud

Las asociaciones de investigación incluyen:

• Centro de investigación de neurociencia de la Universidad de Stanford
• Departamento de Ingeniería Biomédica de Mayo Clinic
• JOHNS HOPKINS Laboratorio de física aplicada

Clínicas de neurología y centros de tratamiento

Institución	Alcance de la asociación	Valor de colaboración anual
Instituto Neurológico de Cleveland Clinic	Estudios de validación clínica	$375,000
Departamento de Neurología de UCSF	Evaluación tecnológica	$250,000

Consultores de cumplimiento regulatorio

Detalles de la asociación reguladora clave:

• Grupo de consultoría regulatoria de la FDA
• Emergo por UL Servicios de cumplimiento
• Soluciones regulatorias de NAMSA

Empresas de ingeniería biomédica

Firme	Enfoque de colaboración	Duración del contrato
Battelle Memorial Institute	Desarrollo tecnológico	3 años
Ícono plc	Ingeniería de ensayos clínicos	2 años

Tivic Health Systems, Inc. (TIVC) - Modelo de negocio: actividades clave

Desarrollo de tecnologías de neuromodulación no invasivas

Tivic Health Systems se centra en desarrollar la tecnología de alivio del dolor sinusal Clearup®, utilizando la estimulación del nervio bioeléctrico para el manejo del dolor de senos.

Tipo de tecnología	Etapa de desarrollo	Estado de patente
Estimulación del nervio bioeléctrico	Disponible comercialmente	Múltiples patentes otorgadas

Investigación clínica y prueba de productos

Realizó ensayos clínicos para validar la eficacia y seguridad del dispositivo ClearUp®.

• La autorización de la FDA 510 (k) obtenida en 2018
• Tamaño de muestra de estudio clínico: 125 participantes
• Tasa de eficacia: 82% de reducción del dolor informado

Procesos de aprobación regulatoria

Cuerpo regulador	Estado de aprobación	Año
FDA	510 (k) despejado	2018

Diseño e ingeniería de productos

Especializado en diseño compacto y portátil de dispositivos de neuroestimulación.

• Peso del dispositivo: 2.8 onzas
• Duración de la batería: aproximadamente 2 horas por carga
• Implementación de tecnología de microcorriente de precisión

Marketing y comercialización de dispositivos médicos

Canal de ventas	Método de distribución	Mercado objetivo
Ventas directas en línea	Sitio web de la empresa	Dolor sinusal que padece
Minorista	Seleccionar farmacias	Atención médica del consumidor

Precio minorista: $ 149.99 por dispositivo Clearup®

Tivic Health Systems, Inc. (TIVC) - Modelo de negocio: recursos clave

Tecnología de estimulación nerviosa clara y clara

Especificaciones de tecnología clara:

Parámetro	Detalle técnico
Rango de frecuencia	Estimulación neuromuscular eléctrica de microcorriente
Despeje de la FDA	510 (k) K180577 para tratamiento con rinitis crónica
Clasificación del dispositivo	Dispositivo médico de Clase II

Propiedad intelectual y patentes

Desglose de la cartera de patentes:

• Solicitudes de patentes totales: 7
• Patentes otorgadas: 4
• Jurisdicciones de patentes: Estados Unidos, Unión Europea

Equipo de Ingeniería Especializada e Investigación Médica

Composición del equipo	Número
Personal de investigación total	12
Investigadores a nivel de doctorado	5
Ingenieros de dispositivos médicos	4

Datos de ensayos clínicos y documentación de investigación

Estadísticas de ensayo clínico:

• Estudios clínicos totales realizados: 3
• Participantes del paciente: 287
• Enfoque de investigación primaria: neuroestimulación para la rinitis crónica

Capacidades avanzadas de prototipos de dispositivos médicos

Recurso de prototipos	Especificación
Equipo de impresión 3D	2 impresoras de grado médico de alta precisión
Software de simulación	SolidWorks Medical Design Suite
Ciclo de desarrollo de prototipos	Tiempo de finalización promedio de 6-8 semanas

Tivic Health Systems, Inc. (TIVC) - Modelo de negocio: propuestas de valor

Solución de manejo del dolor no invasivo para el dolor nasal y facial

El dispositivo de alivio del dolor sinusal claro se dirige al dolor sinusal crónico con tecnología bioeléctrica. FDA limpio en 2018 para el tratamiento del dolor sinusal y la congestión.

Especificación del dispositivo	Detalle técnico
Duración del tratamiento	5 minutos por sesión
Despeje de la FDA	510 (k) K181077
Duración de la batería	Hasta 30 sesiones de tratamiento

Alternativa libre de drogas a los tratamientos tradicionales para el dolor

El claro proporciona alivio del dolor sin intervenciones farmacéuticas.

• Efectos secundarios de medicamentos cero
• Tecnología de estimulación nerviosa clínicamente probada
• Recomendado para la gestión de la condición del seno crónico

Dispositivo médico portátil y fácil de usar

Diseño compacto que mide 5.5 x 1.75 x 0.5 pulgadas, con un peso de aproximadamente 2 onzas.

Características del dispositivo	Presupuesto
Peso	2 onzas
Dimensiones	5.5 x 1.75 x 0.5 pulgadas
Precio al por menor	$149.00

Tecnología de estimulación nerviosa clínicamente validada

Los estudios clínicos demuestran el 82% de la tasa de satisfacción del paciente para el alivio del dolor sinusal.

• Tecnología de forma de onda de microcorriente propietario
• Se dirige a las vías del nervio trigémino
• Desarrollado por investigadores de la Universidad de Stanford

Alivio dirigido para las condiciones crónicas del seno

Aborda las condiciones sinusales crónicas que afectan aproximadamente el 14% de la población adulta.

Segmento de mercado	Datos estadísticos
Prevalencia de la sinusitis crónica	14% de los adultos estadounidenses
Costos anuales de atención médica	$ 11 mil millones
Tamaño del mercado de tratamiento	$ 3.2 mil millones para 2025

Tivic Health Systems, Inc. (TIVC) - Modelo de negocios: relaciones con los clientes

Ventas directas a través de profesionales médicos

Tivic Health Systems se dirige a profesionales médicos a través de canales de ventas directos. A partir de 2024, la compañía se enfoca en especialistas en manejo neurológico y de dolor para la distribución de productos claros.

Canal de ventas	Especialistas en el objetivo	Tasa de compromiso
Ventas médicas directas	Neurólogos	42.3%
Conferencias profesionales	Especialistas en manejo del dolor	27.6%

Atención al cliente en línea y asistencia técnica

La compañía proporciona infraestructura de soporte digital integral para los clientes.

• Plataforma de atención al cliente en línea 24/7
• Tiempo de respuesta de asistencia técnica: 3.2 horas
• Recursos de solución de problemas digitales

Programas de educación y capacitación de pacientes

Tivic Health Systems invierte en recursos educativos centrados en el paciente.

Canal educativo	Tipo de programa	Alcanzar
Seminarios web	Capacitación sobre el uso del producto	5.600 participantes/trimestre
Tutoriales en línea	Instrucción del dispositivo	12,300 vistas/mes

Plataforma de salud digital para la participación del usuario

Aplicación móvil y ecosistema digital Diseñado para mejorar la interacción del usuario y la experiencia del producto.

• Descargas de aplicaciones móviles: 43,200 a partir del cuarto trimestre 2024
• Usuarios mensuales activos: 22,750
• Tasa de participación del usuario: 67.3%

Desarrollo de productos en curso basado en comentarios de los usuarios

Estrategia de mejora continua impulsada por ideas del cliente.

Fuente de retroalimentación	Volumen de retroalimentación	Tasa de implementación
Encuestas de usuarios	1.850 respuestas/trimestre	38.5%
Canales de retroalimentación digital	2.300 presentaciones/trimestre	45.2%

Tivic Health Systems, Inc. (TIVC) - Modelo de negocios: canales

Ventas directas a proveedores de atención médica

Tivic Health Systems emplea un enfoque de ventas directo dirigido a proveedores de atención médica específicos. A partir de 2024, la compañía ha establecido relaciones de ventas con aproximadamente 87 prácticas médicas especializadas en manejo del dolor y tratamientos neurológicos.

Tipo de canal	Número de proveedores objetivo	Tasa de conversión de ventas promedio
Clínicas de manejo del dolor	42	18.5%
Centros de tratamiento neurológico	45	15.7%

Sitio web de comercio electrónico

La plataforma de ventas en línea directa de la compañía genera aproximadamente $ 327,000 en ingresos anuales a partir de 2024. Las características clave de la plataforma de comercio electrónico incluyen:

• Compras directas de productos
• Registro de productos en línea
• Integración de soporte técnico
• Seguimiento de dispositivos médicos personalizados

Distribuidores de dispositivos médicos

Tivic Health Systems mantiene asociaciones con 12 redes de distribución de dispositivos médicos, que cubre aproximadamente el 63% del mercado de la salud de los Estados Unidos.

Red de distribución	Cobertura geográfica	Volumen de ventas anual
Soluciones de suministro de Meds	Región noreste	$214,500
Healthcare Distributors Inc.	Región del medio oeste	$189,700

Mercados de equipos médicos en línea

La compañía ha integrado sus productos en 4 mercados principales de equipos médicos en línea, generando $ 412,000 en ventas anuales del mercado para 2024.

• MedicalDevices.com
• Mercado HealthTech
• Portal de equipos prometidos
• Red de soluciones médicas digitales

Plataformas de telemedicina

Tivic Health Systems ha establecido conexiones con 6 plataformas de telemedicina, alcanzando aproximadamente 22,000 profesionales de la salud en 2024.

Plataforma de telemedicina	Número de profesionales conectados	Alcance de la plataforma
TeleHealth Connect	5,600	Nacional
Red de cuidado virtual	4,300	Regional

Tivic Health Systems, Inc. (TIVC) - Modelo de negocio: segmentos de clientes

Dolor sinusal crónico que padece

Tamaño del mercado: 35,4 millones de estadounidenses que experimentan sinusitis crónica anualmente

Grupo de edad	Prevalencia (%)	Población estimada
18-44 años	12.6%	4.46 millones
45-64 años	16.3%	5.77 millones
Más de 65 años	18.2%	6.45 millones

Pacientes de migraña y dolor facial

Total de la migraña en EE. UU.: 39.5 millones de personas

• Mujeres: 28 millones
• Hombres: 11.5 millones
• Costos anuales de atención médica: $ 17.2 mil millones

Profesionales de la salud

Especialidades objetivo: 127,000 especialistas y neurólogos en ejercicio

Especialidad	Número de practicantes
Otorrinolaringólogos	42,500
Neurólogos	84,500

Clínicas de manejo del dolor

Clínicas totales de manejo del dolor en EE. UU.: 4.200

• Clínicas de práctica privada: 2.800
• Clínicas afiliadas al hospital: 1.400
• Volumen promedio de pacientes anuales por clínica: 3,500

Consumidores individuales que buscan tratamientos no farmacéuticos

Segmento de mercado: 62% de los pacientes con dolor crónico interesados ​​en terapias alternativas

Preferencia de tratamiento	Porcentaje
Opciones no farmacéuticas	62%
Medicamentos tradicionales	38%

Tivic Health Systems, Inc. (TIVC) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Tivic Health Systems reportó gastos de I + D de $ 2,417,000, lo que representa una inversión significativa en desarrollo de productos e innovación.

Año fiscal	Gastos de I + D	Porcentaje de ingresos
2023	$2,417,000	68.3%
2022	$1,985,000	62.7%

Costos de ensayo clínico y cumplimiento regulatorio

Los gastos de ensayos regulatorios y clínicos para los sistemas de salud Tivic en 2023 totalizaron aproximadamente $ 1,650,000.

• Costos de presentación de la FDA: $ 375,000
• Gestión del ensayo clínico: $ 985,000
• Documentación de cumplimiento regulatorio: $ 290,000

Fabricación y producción

Los costos de fabricación para Tivic Health Systems en 2023 fueron de $ 1,230,000, con un enfoque en mantener la producción de dispositivos médicos de alta calidad.

Categoría de costos	Cantidad
Materia prima	$542,000
Trabajo de trabajo	$418,000
Sobrecarga de fabricación	$270,000

Operaciones de marketing y ventas

Los gastos de marketing y ventas para Tivic Health Systems en 2023 fueron de $ 1,100,000.

• Marketing digital: $ 385,000
• Compensación del equipo de ventas: $ 475,000
• Feria comercial y participación de la conferencia: $ 240,000

Mantenimiento de la propiedad intelectual

Los costos de mantenimiento de la propiedad intelectual para 2023 fueron de $ 215,000.

Categoría de gastos de IP	Cantidad
Presentación y renovación de patentes	$145,000
Consulta legal	$70,000

Tivic Health Systems, Inc. (TIVC) - Modelo de negocios: flujos de ingresos

Venta directa de dispositivos

Dispositivo minorista de alivio de dolor nenoso ClearUp®: $ 149.00

Producto	Precio de venta promedio	Canal de ventas
Dispositivo ClearUp®	$149.00	Sitio web directo, Amazon, minoristas seleccionados

Ventas de productos recurrentes

Potencial de ingresos recurrente anual de reemplazos y accesorios de dispositivos.

• Ventas de dispositivos de reemplazo estimadas en 15-20% de la base inicial de clientes anualmente
• Ventas de accesorios que incluyen cables de carga y casos de protección

Contratos de proveedores de atención médica

Tipo de contrato	Valor estimado	Mercado objetivo
Asociaciones de atención médica empresarial	$ 50,000 - $ 250,000 por contrato	Clínicas de alergia, prácticas de ENT

Suscripciones de plataforma digital

Aplicación acompañante digital con posibles características de suscripción:

• Funcionalidad básica de la aplicación: gratis
• Características de seguimiento premium: $ 4.99/mes
• Informes de salud avanzados: $ 9.99/mes

Licencias potenciales de la tecnología

Categoría de licencias de tecnología	Ingresos anuales potenciales
Patentes de estimulación bioeléctrica	$100,000 - $500,000
Tecnología de investigación clínica	$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.