Tivic Health Systems, Inc. (TIVC): Modelo de negócios Canvas [Jan-2025 Atualizado]

A Tivic Health Systems, Inc. (TIVC) está revolucionando o manejo da dor com sua inovadora tecnologia de estimulação nervosa de limpeza, oferecendo uma solução não invasiva e sem drogas para os sofradores de seio crônico e dor facial. Ao alavancar as inovações de neuromodulação de ponta e um modelo de negócios abrangente, a empresa está transformando como pacientes e profissionais de saúde abordam o tratamento da dor, fornecendo um dispositivo portátil e clinicamente validado que promete alívio direcionado e melhoria da vida de vida.

Tivic Health Systems, Inc. (TIVC) - Modelo de negócios: Parcerias -chave

Fabricantes de dispositivos médicos

Os sistemas de saúde Tivic colaboram com os seguintes fabricantes de dispositivos médicos:

Fabricante	Detalhes da parceria	Ano estabelecido
Medtronic	Integração de tecnologia de ensaios clínicos	2021
Boston Scientific	Compatibilidade do dispositivo de neuroestimulação	2022

Instituições de pesquisa em tecnologia da saúde

As parcerias de pesquisa incluem:

• Centro de Pesquisa em Neurociência da Universidade de Stanford
• Departamento de Engenharia Biomédica da Clínica Mayo
• Johns Hopkins Applied Physics Laboratory

Clínicas de neurologia e centros de tratamento

Instituição	Escopo da parceria	Valor anual de colaboração
Instituto Neurológico da Clínica Cleveland	Estudos de validação clínica	$375,000
Departamento de Neurologia da UCSF	Avaliação de tecnologia	$250,000

Consultores de conformidade regulatória

Principais detalhes da parceria regulatória:

• Grupo de consultoria regulatória da FDA
• Emergo by UL Conformy Services
• Soluções regulatórias da NAMSA

Empresas de engenharia biomédica

Empresa	Foco de colaboração	Duração do contrato
Instituto Memorial Battelle	Desenvolvimento de Tecnologia	3 anos
Icon plc	Engenharia de ensaios clínicos	2 anos

Tivic Health Systems, Inc. (TIVC) - Modelo de negócios: Atividades -chave

Desenvolvimento de tecnologias de neuromodulação não invasivas

A Tivic Health Systems se concentra no desenvolvimento da tecnologia de alívio da dor sinusal Clearup®, utilizando estimulação do nervo bioelétrico para o manejo da dor sinusal.

Tipo de tecnologia	Estágio de desenvolvimento	Status de patente
Estimulação do nervo bioelétrico	Disponível comercialmente	Múltiplas patentes concedidas

Pesquisa clínica e teste de produto

Conduziu ensaios clínicos para validar a eficácia e a segurança do dispositivo ClearUp®.

• FDA 510 (k) de folga obtida em 2018
• Estudo clínico Tamanho da amostra: 125 participantes
• Taxa de eficácia: 82% de redução da dor relatada

Processos de aprovação regulatória

Órgão regulatório	Status de aprovação	Ano
FDA	510 (k) limpo	2018

Design de produto e engenharia

Especializado em design compacto de dispositivo de neuroestimulação portátil.

• Peso do dispositivo: 2,8 onças
• Vida da bateria: aproximadamente 2 horas por carga
• Implementação de tecnologia de microcorrente de precisão

Marketing e comercialização de dispositivos médicos

Canal de vendas	Método de distribuição	Mercado -alvo
Vendas on -line diretas	Site da empresa	Sofredores de dor sinusal
Varejo	Selecione farmácias	Assistência médica ao consumidor

Preço de varejo: US $ 149,99 por dispositivo Clearup®

Tivic Health Systems, Inc. (TIVC) - Modelo de negócios: Recursos -chave

Tecnologia de estimulação nervosa de limpeza proprietária

ClearUp Technology Especificações:

Parâmetro	Detalhes técnicos
Faixa de frequência	Estimulação neuromuscular elétrica microcorrente
Apuração da FDA	510 (k) K180577 para tratamento de rinite crônica
Classificação do dispositivo	Dispositivo médico de classe II

Propriedade intelectual e patentes

Patente portfólio Redução:

• Total de pedidos de patente: 7
• Patentes concedidas: 4
• Jurisdições de patentes: Estados Unidos, União Europeia

Equipe especializada de engenharia e pesquisa médica

Composição da equipe	Número
Pessoal de pesquisa total	12
Pesquisadores de nível de doutorado	5
Engenheiros de dispositivos médicos	4

Dados de ensaios clínicos e documentação de pesquisa

Estatísticas do ensaio clínico:

• Estudos clínicos totais realizados: 3
• Participantes do paciente: 287
• Foco da pesquisa primária: neuroestimulação para rinite crônica

Recursos avançados de prototipagem de dispositivos médicos

Recurso de prototipagem	Especificação
Equipamento de impressão 3D	2 impressoras de nível médico de alta precisão
Software de simulação	Suíte de Design Médico SolidWorks
Ciclo de desenvolvimento de protótipo	6-8 semanas de tempo de conclusão média

Tivic Health Systems, Inc. (TIVC) - Modelo de negócios: proposições de valor

Solução de gerenciamento de dor não invasiva para dores sinusais e faciais

O dispositivo de alívio da dor do seio ClearUp tem como alvo a dor do seio crônico usando a tecnologia bioelétrica. FDA limpou em 2018 para o tratamento da dor e congestionamento do seio.

Especificação do dispositivo	Detalhes técnicos
Duração do tratamento	5 minutos por sessão
Apuração da FDA	510 (K) K181077
Duração da bateria	Até 30 sessões de tratamento

Alternativa livre de drogas aos tratamentos tradicionais para a dor

O ClearUp fornece alívio da dor sem intervenções farmacêuticas.

• Zero efeitos colaterais da medicação
• Tecnologia de estimulação nervosa clinicamente comprovada
• Recomendado para gerenciamento de condições sinusais crônicas

Dispositivo médico portátil e fácil de usar

Design compacto Medindo 5,5 x 1,75 x 0,5 polegadas, pesando aproximadamente 2 onças.

Características do dispositivo	Especificações
Peso	2 onças
Dimensões	5,5 x 1,75 x 0,5 polegadas
Preço de varejo	$149.00

Tecnologia de estimulação nervosa validada clinicamente

Estudos clínicos demonstram 82% da taxa de satisfação do paciente para alívio da dor nos seios.

• Tecnologia de forma de onda microcorrente proprietária
• Alvos vias nervosas trigêmeas
• Desenvolvido por pesquisadores da Universidade de Stanford

Alívio direcionado para condições de seio crônico

Aborda as condições crônicas do seio que afetam aproximadamente 14% da população adulta.

Segmento de mercado	Dados estatísticos
Prevalência de sinusite crônica	14% de nós adultos
Custos anuais de saúde	US $ 11 bilhões
Tamanho do mercado de tratamento	US $ 3,2 bilhões até 2025

Tivic Health Systems, Inc. (TIVC) - Modelo de Negócios: Relacionamentos do Cliente

Vendas diretas por meio de profissionais médicos

A Tivic Health Systems tem como alvo profissionais médicos por meio de canais de vendas diretas. A partir de 2024, a empresa se concentra em especialistas neurológicos e de gerenciamento da dor para a distribuição de produtos para limpar.

Canal de vendas	Especialistas -alvo	Taxa de engajamento
Vendas médicas diretas	Neurologistas	42.3%
Conferências profissionais	Especialistas em gerenciamento da dor	27.6%

Suporte ao cliente online e assistência técnica

A empresa fornece infraestrutura abrangente de suporte digital para os clientes.

• Plataforma de suporte ao cliente online 24/7
• Assistência técnica Tempo de resposta: 3,2 horas
• Recursos de solução de problemas digitais

Programas de educação e treinamento do paciente

A Tivic Health Systems investe em recursos educacionais centrados no paciente.

Canal de educação	Tipo de programa	Alcançar
Webinars	Treinamento de uso do produto	5.600 participantes/trimestre
Tutoriais online	Instrução do dispositivo	12.300 visualizações/mês

Plataforma de saúde digital para envolvimento do usuário

Aplicativo móvel e ecossistema digital Projetado para aprimorar a interação do usuário e a experiência do produto.

• Downloads de aplicativos móveis: 43.200 a partir do primeiro trimestre 2024
• Usuários mensais ativos: 22.750
• Taxa de envolvimento do usuário: 67,3%

Desenvolvimento contínuo de produtos com base no feedback do usuário

Estratégia de melhoria contínua impulsionada pelas idéias do cliente.

Fonte de feedback	Volume de feedback	Taxa de implementação
Pesquisas de usuário	1.850 respostas/trimestre	38.5%
Canais de feedback digital	2.300 envios/trimestre	45.2%

Tivic Health Systems, Inc. (TIVC) - Modelo de negócios: canais

Vendas diretas para profissionais de saúde

A Tivic Health Systems emprega uma abordagem de vendas direta direcionada a prestadores de serviços de saúde específicos. A partir de 2024, a Companhia estabeleceu relações de vendas com aproximadamente 87 práticas médicas especializadas em tratamento da dor e tratamentos neurológicos.

Tipo de canal	Número de fornecedores direcionados	Taxa média de conversão de vendas
Clínicas de gerenciamento da dor	42	18.5%
Centros de tratamento neurológico	45	15.7%

Site de comércio eletrônico

A plataforma de vendas on -line direta da empresa gera aproximadamente US $ 327.000 em receita anual a partir de 2024. Os principais recursos da plataforma de comércio eletrônico incluem:

• Compra de produto direto
• Registro de produtos on -line
• Integração de suporte técnico
• Rastreamento de dispositivos médicos personalizados

Distribuidores de dispositivos médicos

A Tivic Health Systems mantém parcerias com 12 redes de distribuição de dispositivos médicos, cobrindo aproximadamente 63% do mercado de saúde dos Estados Unidos.

Rede de distribuição	Cobertura geográfica	Volume anual de vendas
Soluções Medsupply	Região nordeste	$214,500
Healthcare Distributores Inc.	Região do meio -oeste	$189,700

Mercados de equipamentos médicos online

A empresa integrou seus produtos em 4 principais mercados de equipamentos médicos on -line, gerando US $ 412.000 em vendas anuais do mercado para 2024.

• MedicalDevices.com
• HealthTech Marketplace
• Portal de Equipamento Promedical
• Rede de soluções médicas digitais

Plataformas de telemedicina

A Tivic Health Systems estabeleceu conexões com 6 plataformas de telemedicina, atingindo aproximadamente 22.000 profissionais de saúde em 2024.

Plataforma de telemedicina	Número de profissionais conectados	Alcance da plataforma
TeleHealth Connect	5,600	Nacional
Rede de Cuidados Virtuais	4,300	Regional

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

Pacientes com dor sinusal crônica

Tamanho do mercado: 35,4 milhões de americanos com sinusite crônica anualmente

Faixa etária	Prevalência (%)	População estimada
18-44 anos	12.6%	4,46 milhões
45-64 anos	16.3%	5,77 milhões
65 anos ou mais	18.2%	6,45 milhões

Pacientes com enxaqueca e dor facial

Total de sofredores de enxaqueca nos EUA: 39,5 milhões de indivíduos

• Mulheres: 28 milhões
• Homens: 11,5 milhões
• Custos anuais de saúde: US $ 17,2 bilhões

Profissionais de saúde

Especialidades -alvo: 127.000 especialistas em ENT praticantes

Especialidade	Número de praticantes
Otolaryngologists	42,500
Neurologistas	84,500

Clínicas de gerenciamento da dor

Total de clínicas de gerenciamento da dor nos EUA: 4.200

• Clínicas de consultório particular: 2.800
• Clínicas afiliadas ao hospital: 1.400
• Volume médio anual do paciente por clínica: 3.500

Consumidores individuais que buscam tratamentos não farmacêuticos

Segmento de mercado: 62% dos pacientes com dor crônica interessados ​​em terapias alternativas

Preferência de tratamento	Percentagem
Opções não farmacêuticas	62%
Medicação tradicional	38%

Tivic Health Systems, Inc. (TIVC) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Tivic Health Systems registrou despesas de P&D de US $ 2.417.000, representando um investimento significativo no desenvolvimento e inovação de produtos.

Ano fiscal	Despesas de P&D	Porcentagem de receita
2023	$2,417,000	68.3%
2022	$1,985,000	62.7%

Ensino clínico e custos de conformidade regulatória

As despesas regulatórias e de ensaios clínicos para sistemas de saúde Tivic em 2023 totalizaram aproximadamente US $ 1.650.000.

• Custos de envio da FDA: US $ 375.000
• Gerenciamento de ensaios clínicos: US $ 985.000
• Documentação de conformidade regulatória: US $ 290.000

Fabricação e produção

Os custos de fabricação para os sistemas de saúde Tivic em 2023 foram de US $ 1.230.000, com foco na manutenção da produção de dispositivos médicos de alta qualidade.

Categoria de custo	Quantia
Matérias-primas	$542,000
Trabalho de produção	$418,000
Manufatura de sobrecarga	$270,000

Operações de marketing e vendas

As despesas de marketing e vendas para sistemas de saúde Tivic em 2023 foram de US $ 1.100.000.

• Marketing digital: US $ 385.000
• Compensação da equipe de vendas: US $ 475.000
• Feira de feira e participação da conferência: US $ 240.000

Manutenção da propriedade intelectual

Os custos de manutenção da propriedade intelectual para 2023 foram de US $ 215.000.

Categoria de despesa IP	Quantia
Arquivamento de patentes e renovação	$145,000
Consulta legal	$70,000

Tivic Health Systems, Inc. (TIVC) - Modelo de negócios: fluxos de receita

Vendas diretas de dispositivos

ClearUp® Sinus Dor Relief Disposition Preço de varejo: US $ 149,00

Produto	Preço médio de venda	Canal de vendas
Dispositivo ClearUp®	$149.00	Site direto, Amazon, varejistas selecionados

Vendas recorrentes de produtos

Potencial anual de receita recorrente de substituições e acessórios do dispositivo.

• Vendas de dispositivos de substituição estimados em 15-20% da base inicial de clientes anualmente
• Vendas de acessórios, incluindo cabos de carregamento e casos de proteção

Contratos de prestadores de serviços de saúde

Tipo de contrato	Valor estimado	Mercado -alvo
Enterprise Healthcare Partnerships	$ 50.000 - $ 250.000 por contrato	Clínicas de alergia, práticas ONT

Assinaturas de plataforma digital

App Digital Companion com possíveis recursos de assinatura:

• Funcionalidade básica do aplicativo: grátis
• Recursos de rastreamento premium: US $ 4,99/mês
• Insights avançados de saúde: US $ 9,99/mês

Licenciamento potencial de tecnologia

Categoria de licenciamento de tecnologia	Receita anual potencial
Patentes de estimulação bioelétrica	$100,000 - $500,000
Tecnologia de Pesquisa 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.