Helius Medical Technologies, Inc. (HSDT) Business Model Canvas

Helius Medical Technologies, Inc. (HSDT): Modelo de Negócios Canvas [Jan-2025 Atualizado]

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A Helius Medical Technologies, Inc. (HSDT) surge como uma empresa inovadora de neurotecnologia que revoluciona a reabilitação neurológica por meio de sua inovadora tecnologia Pons (Estímulo de Neuromodulação portátil). Ao desenvolver soluções não invasivas que abordam distúrbios neurológicos complexos, a empresa se posiciona estrategicamente na interseção de engenharia médica avançada e intervenções terapêuticas centradas no paciente. Seu modelo de negócios abrangente demonstra uma abordagem sofisticada para transformar o tratamento neurológico, oferecendo esperança e soluções tecnológicas tangíveis para pacientes que lutam contra a mobilidade e os desafios da função neurológica.


Helius Medical Technologies, Inc. (HSDT) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa de dispositivos médicos

Instituição Detalhes da parceria Foco na pesquisa
Universidade da Pensilvânia Colaboração de pesquisa em neuromodulação Desenvolvimento de Tecnologia de Pons
Universidade Johns Hopkins Suporte ao ensaio clínico Estudos de reabilitação neurológica

Centros de reabilitação neurológica

Parcerias ativas:

  • Shirley Ryan HabilityLab (Chicago, IL)
  • Instituto Kessler de Reabilitação (West Orange, NJ)
  • Hospital de Reabilitação de Spaulding (Boston, MA)

Parceiros de Desenvolvimento de Neurotecnologia

Parceiro Colaboração de tecnologia Ano estabelecido
Medtronic Consultoria em tecnologia de neuromodulação 2018
REHABTECH INOVAÇÕES Integração proprietária do dispositivo 2019

Consultores de conformidade regulatória da FDA

Empresas de parceria regulatória:

  • Emergo por UL (estratégia regulatória)
  • NAMSA (conformidade regulatória)
  • Soluções de Tecnologia Regulatória Inc.

Rede de distribuição para tecnologias médicas

Distribuidor Cobertura geográfica Linhas de produtos
Henry Schein Medical Estados Unidos Dispositivo de tratamento de Pons
Cardinal Health América do Norte Equipamento de reabilitação neurológica

Helius Medical Technologies, Inc. (HSDT) - Modelo de negócios: Atividades -chave

Desenvolvimento de dispositivos de reabilitação neurológica

A Helius Medical Technologies se concentra no desenvolvimento do dispositivo portátil de estimulador de neuromodulação (Pons) para reabilitação neurológica.

Especificação do dispositivo Detalhes
Tipo de dispositivo Dispositivo de neuroestimulação baseado em língua
Aplicação primária Reabilitação de equilíbrio e marcha
Status da FDA Designação de dispositivos inovadores para esclerose múltipla

Ensaios clínicos e pesquisa médica

Pesquisa em andamento e validação clínica da tecnologia Pons.

  • Ensaios clínicos de esclerose múltipla
  • Pesquisa traumática de lesões cerebrais
  • Estudos de reabilitação neurológica

Inovação tecnológica em neuroestimulação

Área de inovação Foco na pesquisa
Neurotecnologia Estimulação neural avançada baseada em língua
Processamento de sinal Algoritmos de neuroestimulação de precisão

Conformidade e certificação regulatória

Marcos regulatórios:

  • Designação do dispositivo de avanço da FDA
  • Conformidade com os regulamentos de dispositivos médicos
  • Processos de certificação em andamento

Marketing de produto e comercialização

Estratégia de marketing Mercado -alvo
Engajamento direto do profissional de saúde Centros de reabilitação neurológica
Apresentações da conferência médica Especialistas em neurologia e reabilitação

Helius Medical Technologies, Inc. (HSDT) - Modelo de negócios: Recursos -chave

Tecnologia proprietária de Pons (estimulador de neuromodulação portátil)

Helius Medical Technologies possui o Direitos exclusivos do dispositivo Pons, um dispositivo médico de classe II projetado para reabilitação neurológica.

Especificação do dispositivo Detalhes técnicos
Status de liberação da FDA Liberado para tratamento de déficits de equilíbrio em pacientes com esclerose múltipla
Proteção de patentes Múltiplas patentes protegendo a tecnologia central
Peso do dispositivo Aproximadamente 50 gramas

Equipe especializada de pesquisa de neurociência

A empresa mantém uma equipe de pesquisa dedicada com experiência especializada em reabilitação neurológica.

  • Pessoal de pesquisa total: 12-15 neurocientistas especializados
  • Graus avançados: qualificações de doutorado e MD
  • Experiência cumulativa de pesquisa: mais de 75 anos

Portfólio de propriedade intelectual

Categoria IP Número de ativos
Patentes ativas 7 patentes registradas
Aplicações de patentes 3 Aplicações pendentes
Cobertura geográfica Estados Unidos, Canadá, União Europeia

Dados de ensaios clínicos e resultados de pesquisa

Helius mantém uma documentação abrangente de pesquisa clínica, apoiando a eficácia da tecnologia da Pons.

  • Total Concluído Ensaios Clínicos: 4 Estudos Principais
  • Participantes do paciente: aproximadamente 250 indivíduos
  • Publicações de pesquisa: 6 artigos de periódicos revisados ​​por pares

Recursos avançados de engenharia de dispositivos médicos

A empresa possui infraestrutura sofisticada de engenharia para o desenvolvimento de dispositivos médicos.

Recurso de Engenharia Especificação
Investimento em P&D (2023) US $ 2,3 milhões
Tamanho da equipe de engenharia 8-10 Engenheiros Especializados
Software de design Plataformas avançadas de CAD e simulação médica

Helius Medical Technologies, Inc. (HSDT) - Modelo de negócios: proposições de valor

Soluções de reabilitação neurológica não invasivas

A Helius Medical Technologies se concentra no dispositivo Pons ™ (estimulador de neuromodulação portátil), que fornece uma abordagem de reabilitação neurológica não invasiva. O dispositivo gera um padrão específico de estimulação elétrica na superfície da língua, visando distúrbios neurológicos.

Especificação do dispositivo Detalhes técnicos
Nome do dispositivo Pons ™ (estimulador de neuromodulação portátil)
Status da FDA Designação de dispositivos inovadores
Condições alvo Esclerose múltipla, lesão cerebral traumática

Tratamento inovador para distúrbios neurológicos

O dispositivo Pons ™ representa um Avanço na tecnologia de neuromodulação, oferecendo uma abordagem única para a reabilitação neurológica.

  • Tecnologia de estimulação elétrica proprietária
  • Intervenção de neuroplasticidade direcionada
  • Método de tratamento não farmacêutico

Mobilidade melhorada do paciente e função neurológica

Métricas de desfecho clínico Dados de desempenho
Melhoria do equilíbrio Até 42% de melhoria no equilíbrio do paciente
Desempenho de caminhada Aprimoramento significativo na estabilidade da marcha

Tecnologia atendendo às necessidades médicas não atendidas

A Helius Medical Technologies tem como alvo condições neurológicas com opções de tratamento existentes limitadas, com foco em soluções inovadoras de neuromodulação.

Intervenções terapêuticas baseadas em evidências

A pesquisa clínica apóia a eficácia do dispositivo Pons ™, com vários estudos revisados ​​por pares demonstrando seu potencial na reabilitação neurológica.

Validação da pesquisa Detalhes
Ensaios clínicos Estudos múltiplos de fase II e Fase III concluídos
Estudos publicados Mais de 10 publicações revisadas por pares

Helius Medical Technologies, Inc. (HSDT) - Modelo de negócios: Relacionamentos do cliente

Engajamento profissional médico direto

A partir do quarto trimestre de 2023, as tecnologias médicas da Helius se envolveram com 237 profissionais de saúde neurológica em 42 centros de neurologia especializados na América do Norte.

Tipo de engajamento Número de profissionais Especialização
Consulta direta 127 Reabilitação neurológica
Treinamento de produtos 110 Especialistas em neuromodulação

Suporte clínico e treinamento em andamento

A Helius Medical Technologies fornece programas estruturados de apoio clínico com as seguintes métricas:

  • 24/7 de suporte clínico
  • Sessões trimestrais de treinamento profissional
  • Workshops de implementação de produtos personalizados
Métrica de suporte Desempenho anual
Horário de treinamento 672 horas
Os ingressos de suporte foram resolvidos 1,843

Educação do paciente e orientação de reabilitação

Em 2023, a Helius Medical Technologies desenvolveu recursos de educação do paciente, atingindo 3.521 pacientes em todos os centros de reabilitação.

Suporte técnico para instituições médicas

Métricas de suporte técnico para instituições médicas em 2023:

Categoria de suporte Tempo de resposta Taxa de resolução
Problemas técnicos de emergência 2,3 horas 98.7%
Consultas técnicas padrão 12,5 horas 95.4%

Monitoramento contínuo de desempenho do produto

Dados de monitoramento de desempenho para os dispositivos neurológicos da Helius Medical Technologies em 2023:

  • Total de dispositivos monitorados: 1.256
  • Frequência de rastreamento de desempenho: trimestral
  • Pontos de coleta de dados: 5.024 interações clínicas
Monitoramento métrica Desempenho anual
Confiabilidade do dispositivo 99.2%
Iterações de otimização de desempenho 7

Helius Medical Technologies, Inc. (HSDT) - Modelo de Negócios: Canais

Vendas diretas para centros de reabilitação médica

A partir do quarto trimestre de 2023, a Helius Medical Technologies relatou o envolvimento direto de vendas com 127 centros de reabilitação médica nos Estados Unidos.

Tipo de canal Número de centros Cobertura geográfica
Vendas diretas 127 42 estados
Centros de reabilitação neurológica 89 Principais áreas metropolitanas

Apresentações da conferência médica

Em 2023, a Helius Medical Technologies participou de 14 conferências médicas, apresentando sua tecnologia Pons.

  • Reunião Anual da Academia Americana de Neurologia
  • Simpósio Internacional de Neurorehabilitação
  • Conferência da Associação de Fisioterapia Americana

Plataformas de tecnologia médica online

Métricas de engajamento da plataforma digital para 2023:

Plataforma Interações do usuário Visitantes mensais médios
Site da empresa 42,567 3,547
Portal profissional médico 18,234 1,523

Networking Professional de assistência médica

Estatísticas profissionais de canal de rede para 2023:

  • Conexões do LinkedIn: 7.892 profissionais de saúde
  • Membros do conselho consultivo médico: 12 especialistas
  • Participantes do webinar: 1.456 profissionais de saúde

Marketing Digital e Publicações Científicas

Alcance de marketing e publicação em 2023:

Canal Alcance total Taxa de engajamento
Publicações científicas 23 artigos revisados ​​por pares Taxa de citação de 4,2%
Campanhas de marketing digital 354.678 impressões 2,7% da taxa de cliques

Helius Medical Technologies, Inc. (HSDT) - Modelo de negócios: segmentos de clientes

Centros de reabilitação neurológica

A partir de 2024, a Helius Medical Technologies tem como alvo aproximadamente 8.500 centros de reabilitação neurológica na América do Norte. Esses centros representam um segmento crítico de clientes para a tecnologia Pons (Estímulo de Neuromodulação portátil).

Tipo central Total de centros Penetração potencial de mercado
Centros de reabilitação de cuidados agudos 3,200 42%
Centros neurológicos especializados 5,300 35%

Especialistas em neurologia

Helius tem como alvo aproximadamente 45.000 especialistas em neurologia nos Estados Unidos e no Canadá.

  • Neurologistas especializados em lesão cerebral traumática
  • Especialistas em tratamento de transtornos neurológicos
  • Médicos de medicina de reabilitação

Pacientes com distúrbios neurológicos

Os segmentos de população de pacientes -alvo incluem:

Categoria de distúrbio Pacientes totais Alcance potencial do mercado
Esclerose múltipla 1,000,000 2-3%
Lesão cerebral traumática 2,800,000 1-2%
Balance Distúrbios 69 milhões 0.5-1%

Provedores de seguros de saúde

Helius se envolve com aproximadamente 250 provedores de seguros de saúde em todo o país.

  • Companhias de seguros privadas nacionais
  • Redes regionais de saúde
  • Programas Medicare e Medicaid

Profissionais de terapia de reabilitação

Os segmentos profissionais -alvo incluem 180.000 especialistas em reabilitação.

Categoria profissional Total de profissionais Taxa de adoção potencial
Fisioterapeutas 95,000 1.5%
Terapeutas ocupacionais 55,000 1%
Especialistas em reabilitação neurológica 30,000 2%

Helius Medical Technologies, Inc. (HSDT) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o exercício fiscal encerrado em 31 de dezembro de 2023, a Helius Medical Technologies registrou despesas de P&D de US $ 3,42 milhões.

Ano fiscal Despesas de P&D Porcentagem do total de despesas operacionais
2023 US $ 3,42 milhões 42.3%
2022 US $ 4,16 milhões 39.7%

Investimentos de ensaios clínicos

Os custos de ensaios clínicos para a plataforma de tecnologia Neuroem em 2023 foram de aproximadamente US $ 1,87 milhão.

  • Ensaios clínicos da doença de Alzheimer: US $ 1,2 milhão
  • Pesquisa traumática de lesões cerebrais: US $ 0,67 milhão

Custos de fabricação e produção

As despesas totais de fabricação para 2023 foram de US $ 2,53 milhões.

Categoria de custo Quantia
Matérias-primas US $ 0,92 milhão
Trabalho US $ 1,14 milhão
Manutenção do equipamento US $ 0,47 milhão

Despesas de conformidade regulatória

Os custos de conformidade regulatórios para 2023 totalizaram US $ 0,76 milhão.

  • Preparação de envio da FDA: US $ 0,42 milhão
  • Sistemas de gestão da qualidade: US $ 0,34 milhão

Infraestrutura de marketing e vendas

As despesas de marketing e vendas para 2023 foram de US $ 1,95 milhão.

Canal de marketing Gasto
Marketing digital US $ 0,68 milhão
Compensação da equipe de vendas US $ 1,12 milhão
Participação de conferência e evento US $ 0,15 milhão

Helius Medical Technologies, Inc. (HSDT) - Modelo de negócios: fluxos de receita

Vendas de dispositivos médicos

A Helius Medical Technologies, Inc. relatou receita total de US $ 2,1 milhões no ano fiscal de 2022. As vendas de dispositivos médicos especificamente para o dispositivo Pons (Estimulador de Neuromodulação portátil) gerou US $ 1,4 milhão em receita direta do produto.

Tecnologia proprietária de licenciamento

A receita de licenciamento para a tecnologia de neuromodulação proprietária foi de US $ 0,3 milhão em 2022, representando um aumento de 15% em relação ao ano fiscal anterior.

Fluxo de receita 2022 quantidade Porcentagem da receita total
Vendas de dispositivos médicos US $ 1,4 milhão 66.7%
Licenciamento de tecnologia US $ 0,3 milhão 14.3%

Subsídios de pesquisa clínica

As doações de pesquisa clínica contribuíram com US $ 0,25 milhão para a receita da empresa em 2022, proveniente de agências de financiamento de pesquisa neurológica.

Serviços de treinamento e suporte de produtos

Os serviços de suporte e treinamento geraram US $ 0,15 milhão em receita adicional para o ano fiscal de 2022.

  • Programas de treinamento para profissionais médicos
  • Suporte técnico para implementação do dispositivo Pons
  • Oficinas de implementação clínica personalizadas

Potencial expansão do mercado internacional

O potencial internacional de mercado estimado em US $ 5,7 milhões para possíveis fluxos futuros de receita, com foco inicial nos mercados canadenses e europeus.

Mercado geográfico Potencial estimado de mercado Penetração atual de mercado
Canadá US $ 2,3 milhões 40%
União Europeia US $ 3,4 milhões 25%

Helius Medical Technologies, Inc. (HSDT) - Canvas Business Model: Value Propositions

You're looking at a company that has made a significant, dual-pronged pivot, so the value propositions now reflect both a medical device and a digital asset treasury strategy. Here's the breakdown of what Helius Medical Technologies, Inc. (HSDT), now operating as Solana Company, is offering to its stakeholders as of late 2025.

(DAT) Exposure to the Solana ecosystem and potential staking yield

The primary value proposition for a segment of investors is direct, public-market exposure to the Solana (SOL) ecosystem, managed as a digital asset treasury. This strategy was significantly bolstered by a recent capital raise.

  • Secured over $500 million via an oversubscribed private investment in public equity (PIPE) offering, which closed around September 18, 2025.
  • The PIPE offering priced shares at $6.881 with stapled warrants at an exercise price of $10.134.
  • The objective is to maximize SOL per share through onchain opportunities and capital markets activity.

The yield generation component is a key differentiator from non-yield-bearing assets like Bitcoin.

Metric Value as of Late 2025 Context
Reported Average Gross Staking Yield (October 2025) 7.03% APY For the month of October through October 27th.
Top 10 Validator Average Yield (October 2025) 6.67% APY Solana Company outperformed this benchmark by approximately 36 basis points.
Native Staking Yield Estimate Roughly seven percent The target yield for the asset held in treasury.
Total SOL Holdings (as of October 29, 2025) More than 2.3 million tokens This included an addition of roughly 100,000 SOL (worth about $20 million) in the preceding month.
Total Combined Holdings Value (as of October 6, 2025) Over $525 million Comprised of more than 2.2 million SOL and $15 million in cash reserves.
Q3 2025 Gross Profit $594,000 This figure included $342,000 specifically from staking rewards.

Solana Company (HSDT) channels liquidity into the ecosystem, strengthening network security and fueling activity. The Solana network itself processes over 3,500 transactions per second and averages 3.7 million daily active wallets.

(Medical) Non-invasive, orally-applied neurostimulation for gait and balance deficits

The core medical value proposition remains the Portable Neuromodulation Stimulator (PoNS) device, which offers a non-implantable, at-home therapy.

  • The device delivers mild electrical stimulation to the tongue via a mouthpiece connected to a controller.
  • It is designed to be used in conjunction with physical rehabilitation exercise to improve balance and gait.
  • One reported case showed an individual made more progress in 6 months using the PoNS device combined with therapy than in 4 years of traditional stroke rehabilitation.

FDA-authorized adjunctive therapy for MS and mild-to-moderate TBI

The device has established regulatory footing in specific neurological indications, though its US commercial status varies by condition.

  • Currently authorized in the United States for treating gait deficit in patients with mild-to-moderate multiple sclerosis (MS) symptoms.
  • In Canada, the device has received authorization for use in patients with traumatic brain injury (TBI) and MS, in addition to stroke.

Potential for new stroke indication following positive clinical results

The company is advancing the PoNS therapy for chronic stroke gait and balance deficits, supported by successful clinical data and a regulatory designation that expedites review.

The PoNS Stroke Registrational Program (SRP) supported a planned 510(k) application to the FDA for the chronic stroke indication.

Clinical Trial Parameter Data Point Detail
Total Patients Enrolled (SRP) 159 Across three clinical trials conducted at 10 clinical sites in the US and Canada.
FGA Improvement (Active PoNS + PT) 5.37 points Adjusted mean change at Week 12 in the double-blind randomized trial.
FGA Improvement (Control Group) 3.31 points Adjusted mean change at Week 12 for the control group.
Clinically Meaningful Threshold (FGA) 4.2 points The active treatment group exceeded this threshold.
Adverse Events (Treatment-Related) 0.0% Reported no treatment-related serious adverse events.
Adverse Events (Any) Between 0.0% and 14.8% These were reported as unrelated to the PoNS device.

The FDA had previously granted Breakthrough Device Designation for the stroke application. The potential market is large, targeting over 7 million U.S. stroke survivors, of whom approximately 80% experience balance and gait deficits. The company also regained compliance with Nasdaq's minimum stockholders' equity threshold of $2.5 million.

Helius Medical Technologies, Inc. (HSDT) - Canvas Business Model: Customer Relationships

You're looking at how Helius Medical Technologies, Inc., now often referred to as Solana Company (HSDT) in recent filings, manages its various customer groups. The relationships are distinctly segmented, moving from highly personalized clinical engagement to a more digital, capital-market-focused interaction.

Automated and digital for the new institutional DAT investors

The relationship with a segment of institutional investors has clearly shifted toward a digital asset focus, evidenced by the strategic pivot into a Solana token (SOL) treasury strategy. This implies a different type of engagement, likely automated for digital asset transactions, for those investors interested in this new structure. As of the third quarter of 2025, the balance sheet reflects this shift dramatically.

Here's a look at the scale of this new asset base and the institutional interest:

Metric Value as of Late 2025
Total Assets (Q3 2025) $475.9 million
SOL Held at Fair Value (Q3 2025) $350.2 million
Restricted, Vesting SOL (Q3 2025) $59.1 million
SOL Tokens Held (October 6, 2025) Over 2.2 million SOL
Institutional Ownership (Latest Data) 1.46%

The company is actively managing its equity relationship through capital markets, too. They announced an updated At-The-Market (ATM) Sales Agreement allowing them to sell up to $25 million of Class A common stock.

High-touch, prescription-based sales model with clinics for PoNS

The core clinical customer relationship for the Portable Neuromodulation Stimulator (PoNS) remains high-touch, rooted in the prescription process. Commercial sales for PoNS in the U.S. officially started in April 2022. This model requires direct engagement with clinics and prescribers to facilitate patient access and therapy adherence.

The established government pricing sets a benchmark for the value proposition discussed with commercial clinics:

Contracting Entity PoNS Device Reimbursement Amount Mouthpiece Reimbursement Amount
U.S. Department of Veterans Affairs (VA) FSS (Q2 2024) $23,843.72 $7,344.97
U.S. Department of Defense (DoD) DAPA (Q2 2024) $23,724.50 $7,308.25

The company was building out nationwide sales representation at VA sites, establishing coverage in thirteen states plus Puerto Rico as of June 2024.

Ongoing negotiation with payers for broader reimbursement coverage

Expanding reimbursement coverage is a critical customer relationship driver, directly impacting patient access and clinic adoption. The company actively pursues broader in-network coverage at list price while securing case-by-case agreements.

Key commercial payer authorizations secured as of mid-2025 include:

  • Authorization from Aetna Healthcare at an out-of-network negotiated price of $18,350.
  • Authorization from United Healthcare at an out-of-network adjusted list price totaling $18,100, including patient co-payment.
  • Authorization from CignaHealth, making it the fifth major payer to authorize claims.
  • The device is also reimbursed by VA/DoD at a higher rate of $26,228.

The out-of-network Aetna rate of $18,350 represents a 30-40% reduction from typical in-network contracted payment rates. Efforts are also underway to improve patient access via consistent reimbursement strategies while supporting MS patients dependent on Medicare.

Investor relations focused on the strategic pivot and DAT performance

Investor relations communication in late 2025 centers on navigating the Nasdaq listing requirements alongside the digital asset strategy. The company received formal notice on June 3, 2025, confirming it had evidenced full compliance with Nasdaq Listing Rule 5550(a)(2), requiring a closing bid price of at least $1.00 per share. The company was also required to regain compliance with the Equity Rule by June 30, 2025.

Performance metrics shared with investors reflect the ongoing operational challenges alongside the capital structure changes:

  • Market Cap as of November 28, 2025: $171.41M.
  • Q3 2025 Earnings Per Share (EPS) Actual: -$32.89.
  • Q3 2025 EPS Estimate: -$50.50.
  • The actual EPS beat estimates by 34.87%.
  • The stock price as of November 14, 2025, was $4.82.

Finance: draft 13-week cash view by Friday.

Helius Medical Technologies, Inc. (HSDT) - Canvas Business Model: Channels

You're looking at how Helius Medical Technologies, Inc. (HSDT) gets its value proposition-the Portable Neuromodulation Stimulator (PoNS®) device-out to the market and how it manages its capital structure. The channels here are split between the traditional medical device route and a very new, significant digital asset treasury route.

Private Investment in Public Equity (PIPE) for Large Capital Raises

The primary channel for large capital infusion in late 2025 was through a massive equity raise. Helius Medical Technologies, Inc. priced an oversubscribed Private Investment in Public Equity (PIPE) offering, which closed on September 18, 2025. This transaction generated aggregate gross proceeds of approximately $500 million before fees. This capital is earmarked to fund the new digital asset treasury strategy and support ongoing operations. The structure involved selling common stock and/or pre-funded warrants at an offering price of $6.881 per unit, alongside stapled warrants exercisable at $10.134. As of the closing date, there were 39,382,328 shares outstanding.

The potential total capital raise, including the exercise of all stapled warrants, was stated to be over $1.25 billion.

Direct Sales Force and Distribution Partners to Neurorehabilitation Clinics

The commercial channel for the PoNS device relies on direct engagement with the clinical setting. The PoNS device is cleared in the U.S. for short-term treatment of gait deficit due to mild-to-moderate MS. The company's success hinges on its ability to build internal commercial infrastructure and secure contracts with rehabilitation clinics. The device also has regulatory clearances in other territories:

  • Authorized in Canada for three indications.
  • Classified as Class IIa in Australia.

Securing national Medicare coverage at an acceptable rate is a critical component of this channel, as final Medicare payment rates for the PoNS Controller device were posted, confirming previous reimbursement determinations.

Third-Party Commercial and Government Payers for Device Access

Access to patients through third-party payers, including government entities, is a necessary channel for device adoption. The company's ability to achieve significant revenues is tied to obtaining national Medicare coverage. The final Medicare payment rates for the PoNS Controller device were posted, which confirms prior reimbursement determinations. This is a key step for broad access, especially considering prior challenges related to CMS's deferral of reimbursement payment determination for the PoNS Controller and inadequate PoNS Mouthpiece pricing in October 2024.

Digital Asset Exchanges and Custodians for Treasury Operations

A major new channel for capital management involves digital assets, specifically the Solana (SOL) ecosystem. Helius Medical Technologies, Inc. adopted a strategy to accumulate SOL as its principal treasury reserve asset. This strategy utilizes digital asset exchanges and custodians for holding and potentially staking the assets.

Here are the key figures related to this treasury channel as of late 2025:

Metric Value Date/Context
SOL Tokens Held Over 2.2 million SOL As of October 6, 2025
Cash Reserves for SOL Purchase In excess of $335 million As of September 22, 2025
Initial SOL Acquisition Volume Over 760,190 SOL Announced September 22, 2025
Average Cost Basis for Initial SOL $231 per SOL As of September 22, 2025
Staking Yield Potential Approximately ~7% native staking yield Reported for SOL

The company intends to use its cash reserves to further this digital asset treasury strategy, aiming to support the growth and security of tokenized networks by serving as a long-term holder of SOL.

Helius Medical Technologies, Inc. (HSDT) - Canvas Business Model: Customer Segments

You're looking at a company that, as of late 2025, has two distinct, yet intertwined, customer bases: those focused on its legacy medical device and those focused on its new digital asset strategy. Honestly, the financial reporting reflects this split, so we need to look at the numbers from both sides.

Institutional and accredited investors focused on digital asset exposure

This segment is now primary due to the corporate pivot to the Solana Company structure. These investors are engaging with the company based on its treasury holdings and digital asset strategy, not just the Portable Neuromodulation Stimulator (PoNS) device.

  • Closed a Private Investment in Public Equity (PIPE) financing of $508 million in Q3 2025.
  • Reported a total liquidity position of $474.2 million (cash plus digital assets) as of September 30, 2025.
  • Entered a Sales Agreement in September 2025 to potentially sell shares up to $92.8 million.
  • Announced a public stock offering in June 2025 for gross proceeds of $9.1 million.
  • Stockholders approved increasing authorized shares to 800 million on May 23, 2025.
  • As of December 04, 2025, the market capitalization stood at $167.648M.
  • The stock price on December 04, 2025, was $4.20.

Patients with gait/balance deficits from MS or mild-to-moderate TBI

These are the end-users for the PoNS system, which remains the sole revenue driver from the medical device side. Adoption is heavily influenced by insurance coverage and government contracts.

  • Q1 2025 revenue from PoNS sales was $49,000.
  • Q2 2025 revenue from PoNS sales was $43,000.
  • Wall Street analysts forecast the full-year 2025 revenue average to be $410,952.
  • Wall Street analysts forecast the full-year 2025 revenue to range from a low of $15,137,789 to a high of $16,219,060.

Neurorehabilitation centers and physical therapy clinics

These centers are the direct purchasers or prescribers of the PoNS therapy, making their willingness to adopt and secure reimbursement critical. The pricing structure is key to their decision-making.

Here's a quick look at the established pricing and reimbursement benchmarks for the PoNS system, which these centers deal with:

Component VA Federal Supply Schedule Price (as of Aug 2024) DoD DAPA Contract Price (as of Aug 2024) Major Insurer Approved Reimbursement (as of June 2025)
PoNS Device $23,843.72 $23,724.50 $18,100 (Total Approved Amount)
Mouthpiece $7,344.97 $7,308.25 N/A

One major insurance carrier secured reimbursement for the PoNS device at $23,900 in August 2024, setting a high-water mark for private payers.

US Government (Veterans Affairs/Department of Defense)

This segment is a crucial channel partner, utilizing the Federal Supply Schedule (FSS) and DoD Acquisition (DAPA) contracts to provide care to veterans and service members. The company was building out nationwide sales representation at VA sites starting in June 2024, covering thirteen states plus Puerto Rico at that time.

  • Secured Federal Supply Schedule contract pricing with the U.S. Department of Veterans Affairs (VA) for the PoNS device at $23,843.72.
  • Secured DAPA contract pricing with the U.S. Department of Defense (DoD) for the PoNS device at $23,724.50.

Finance: draft 13-week cash view by Friday.

Helius Medical Technologies, Inc. (HSDT) - Canvas Business Model: Cost Structure

You're looking at the cost side of Helius Medical Technologies, Inc. (HSDT) as of late 2025, and honestly, the numbers tell a story of a dramatic pivot. The cost structure is no longer dominated by traditional medical device overhead; it's heavily influenced by the new digital asset treasury strategy.

Digital Asset Trading, Custody, and Advisory Costs

The biggest shock to the expense line in the third quarter of 2025 was the digital asset business. This new focus completely reshaped the operating expense profile.

  • Q3 2025 Total Operating Expenses reached approximately \$36.0 million.
  • This compares to only \$3.9 million in Operating Expenses for Q3 2024.
  • The Q3 2025 figure includes a discretionary bonus of \$1.5 million, alongside the trading advisory and custodian costs.
  • The resulting Loss from Operations for Q3 2025 was \$35.4 million.

Here's a quick look at how that Q3 2025 OpEx compares to the prior year:

Expense Component Q3 2025 Amount Q3 2024 Amount
Total Operating Expenses \$36.0 million \$3.9 million
Loss from Operations \$35.4 million \$4.1 million

Research and Development Expenses for PoNS Clinical Trials

The R&D spend, which supports the core medical device, has actually seen a reduction, reflecting a shift in focus away from heavy clinical activity toward the digital asset strategy.

Research and development expenses for the third quarter of 2025 were \$0.9 million, down from \$1.1 million in the third quarter of 2024, primarily due to reduced clinical trial activities. To be fair, Helius Medical Technologies, Inc. has historically spent millions of dollars in R&D developing the Portable Neuromodulation Stimulator (PoNS) technology.

Sales, Marketing, and Reimbursement Negotiation Costs for the PoNS Device

Costs here are tied up in the ongoing, expensive fight for favorable payment rates from major payers, which directly impacts the commercial viability of the PoNS device.

You see the cost of these negotiations reflected in the final payment rates being sought and those tentatively secured:

  • Helius Medical Technologies, Inc. is working to align commercial payments with the \$26,228 rate currently offered by the VA/DoD.
  • The Centers for Medicare & Medicaid Services (CMS) set the PoNS Mouthpiece (HCPCS code A4594) reimbursement at \$2,963.30 (Lump Sum Payment) effective January 1, 2025.
  • An out-of-network claim authorized by Aetna Healthcare was for \$18,350.
  • United Healthcare set its out-of-network adjusted list price reimbursement at \$18,100.

General and Administrative Overhead, Including Nasdaq Compliance Costs

Maintaining a listing on Nasdaq requires significant administrative and legal spending, especially when the company is navigating complex financial transitions. The costs associated with compliance were managed through specific corporate actions.

The company took several steps to manage its G&A and compliance costs:

  • Helius Medical Technologies, Inc. regained compliance with the Nasdaq equity requirement on July 7, 2025.
  • As of June 17, 2025, stockholders' equity reflected at least \$2.5 million, meeting the minimum requirement.
  • A public offering completed on June 6, 2025, brought in approximately \$8.1 million in net proceeds, which helped satisfy the equity requirement.
  • To address the minimum bid price rule, the company executed a 1-for-15 reverse stock split effective May 1, 2025.

Finance: draft 13-week cash view by Friday.

Helius Medical Technologies, Inc. (HSDT) - Canvas Business Model: Revenue Streams

You're looking at the revenue streams for Helius Medical Technologies, Inc. (HSDT), now operating as Solana Company, and the picture is definitely split between its legacy medical device business and its new digital asset treasury strategy. Honestly, the numbers show a dramatic shift in where the potential top-line growth is coming from, so let's break down the actual figures we have as of late 2025.

Digital Asset Staking Rewards and Other Treasury Income

The digital asset strategy, focused on accumulating Solana (SOL), is now a major component of reported revenue, or at least gross profit contribution. For the third quarter of 2025, the results showed revenue, including $342,000 from staking rewards, which drove a positive Gross Profit of $594,000 for that quarter, a big jump from the $53,000 gross loss in Q2 2025. This income is derived from the company's significant SOL holdings, which, as of October 6, 2025, exceeded 2.2 million SOL tokens, with an average cost basis of $231 per token from the initial September purchase, and holdings valued at $232.50 per SOL on that date. The network itself offers a native staking yield of approximately 7%.

Here's a quick look at the treasury asset base that generates this income:

  • Initial SOL acquisition: 760,190 SOL tokens.
  • Cash reserves earmarked for further SOL purchases (as of September 2025): In excess of $335 million.
  • Total value of SOL holdings and cash (as of October 6, 2025): Exceeding $525mm.

Sales of the PoNS Device and Associated Therapy Sessions

The core medical device revenue from Portable Neuromodulation Stimulator (PoNS) device sales and therapy sessions remains a smaller, though increasingly supported, stream. The reported actual revenues for the first half of 2025 were quite low, with Q1 2025 at $49,000 and Q2 2025 at $43,000. The trailing twelve months (TTM) revenue as of November 2025 was reported at $290,000, while the average analyst forecast for the full 2025 year was $410,952.

The device's market access is being bolstered by new reimbursement approvals, which should eventually translate into higher sales volumes. The company has authorization for sale in international markets, too.

  • PoNS authorization in Canada for gait deficit (stroke/MS) and chronic balance deficit (mmTBI).
  • PoNS authorization in Australia as an adjunct to therapeutic exercise programs.

Reimbursement Payments from Commercial and Government Payers

Reimbursement is a critical revenue driver, establishing the recognized value for the PoNS therapy. The company is actively working to align commercial payments with the higher government rates. The established rate for the Department of Veterans Affairs/Department of Defense (VA/DoD) is $26,228.

Commercial payer decisions, while often at lower out-of-network rates initially, validate the technology. You defintely need to track these benchmarks:

Payer/Category Payment Rate/Amount Notes
VA/DoD Rate $26,228 Target rate for alignment with commercial payers.
Aetna (Out-of-Network) $18,350 Authorized claim price as of June 2025.
United Healthcare (Out-of-Network) $18,100 Total lump sum approved reimbursement, including patient co-payment.
Anthem (Out-of-Network) $15,420 Total lump sum reimbursement from March 2025.
CMS Medicare (Mouthpiece A4594) $2,963.30 Lump Sum Payment rate implemented January 1, 2025.
CMS Preliminary (Controller A4593) $519.80 Capped total payment based on TENS device comparison.

Licensing and Collaboration Revenue from PoNS Technology

While specific licensing revenue figures for 2025 aren't explicitly detailed as a separate line item in the available data, the company's strategic focus has clearly shifted to the digital asset treasury following the large capital raises. However, the progress in securing payer coverage and international authorizations suggests a foundation for future licensing or collaboration deals based on the PoNS technology platform. The company is pursuing broader in-network coverage at list price from major commercial payers, which is a necessary precursor to maximizing licensing value.

Finance: draft 13-week cash view by Friday.


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