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

Helius Medical Technologies, Inc. (HSDT): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

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Helius Medical Technologies, Inc. (HSDT) emerge como una innovadora compañía de neurotecnología que revoluciona la rehabilitación neurológica a través de su tecnología innovadora Pons (estimulador de neuromodulación portátil). Al desarrollar soluciones no invasivas que aborden trastornos neurológicos complejos, la compañía se posiciona estratégicamente en la intersección de la ingeniería médica avanzada y las intervenciones terapéuticas centradas en el paciente. Su modelo de negocio integral demuestra un enfoque sofisticado para transformar el tratamiento neurológico, ofreciendo esperanza y soluciones tecnológicas tangibles para pacientes que luchan contra la movilidad y los desafíos de la función neurológica.


Helius Medical Technologies, Inc. (HSDT) - Modelo de negocios: asociaciones clave

Instituciones de investigación de dispositivos médicos

Institución Detalles de la asociación Enfoque de investigación
Universidad de Pensilvania Colaboración de investigación de neuromodulación Desarrollo de la tecnología de Pons
Universidad de Johns Hopkins Apoyo de ensayos clínicos Estudios de rehabilitación neurológica

Centros de rehabilitación neurológica

Asociaciones activas:

  • Shirley Ryan Sasklab (Chicago, IL)
  • Instituto Kessler de Rehabilitación (West Orange, NJ)
  • Hospital de rehabilitación de Spaulding (Boston, MA)

Socios de desarrollo de neurotecnología

Pareja Colaboración tecnológica Año establecido
Medtrónico Consultoría de tecnología de neuromodulación 2018
Innovaciones de rehabtech Integración de dispositivos propietarios 2019

Consultores de cumplimiento regulatorio de la FDA

Empresas de asociación reguladora:

  • Emergo por UL (estrategia regulatoria)
  • NAMSA (cumplimiento regulatorio)
  • Regulatory Technology Solutions Inc.

Red de distribución para tecnologías médicas

Distribuidor Cobertura geográfica Líneas de productos
Henry Schein Medical Estados Unidos Dispositivo de tratamiento
Salud cardinal América del norte Equipo de rehabilitación neurológica

Helius Medical Technologies, Inc. (HSDT) - Modelo de negocio: actividades clave

Desarrollo de dispositivos de rehabilitación neurológica

Helius Medical Technologies se enfoca en desarrollar el dispositivo de estimulador de neuromodulación portátil (PONS) para la rehabilitación neurológica.

Especificación del dispositivo Detalles
Tipo de dispositivo Dispositivo de neuroestimulación basado en la lengua
Aplicación principal Balance y rehabilitación de la marcha
Estado de la FDA Designación de dispositivo innovador para esclerosis múltiple

Ensayos clínicos e investigación médica

Investigación continua y validación clínica de la tecnología Pons.

  • Ensayos clínicos de esclerosis múltiple
  • Investigación traumática de lesiones cerebrales
  • Estudios de rehabilitación neurológica

Innovación tecnológica en la neuroestimulación

Área de innovación Enfoque de investigación
Neurotecnología Estimulación neural a base de lengua avanzada
Procesamiento de señal Algoritmos de neuroestimulación de precisión

Cumplimiento y certificación regulatoria

Hitos regulatorios:

  • Designación de dispositivos innovadores de la FDA
  • Cumplimiento de las regulaciones de dispositivos médicos
  • Procesos de certificación en curso

Marketing y comercialización de productos

Estrategia de comercialización Mercado objetivo
Compromiso directo del proveedor de salud Centros de rehabilitación neurológica
Presentaciones de conferencia médica Especialistas en neurología y rehabilitación

Helius Medical Technologies, Inc. (HSDT) - Modelo de negocio: recursos clave

Tecnología de Pons Pons (estimulador de neuromodulación portátil)

Helius Medical Technologies posee el Derechos exclusivos del dispositivo Pons, un dispositivo médico de clase II diseñado para rehabilitación neurológica.

Especificación del dispositivo Detalle técnico
Estado de autorización de la FDA Autorizado para el tratamiento de los déficits de equilibrio en pacientes con esclerosis múltiple
Protección de patentes Múltiples patentes que protegen la tecnología central
Peso del dispositivo Aproximadamente 50 gramos

Equipo de investigación de neurociencia especializada

La compañía mantiene un equipo de investigación dedicado con experiencia especializada en rehabilitación neurológica.

  • Personal de investigación total: 12-15 neurocientíficos especializados
  • Títulos avanzados: calificaciones de doctorado y MD
  • Experiencia de investigación acumulativa: más de 75 años

Cartera de propiedades intelectuales

Categoría de IP Número de activos
Patentes activas 7 patentes registradas
Solicitudes de patentes 3 aplicaciones pendientes
Cobertura geográfica Estados Unidos, Canadá, Unión Europea

Datos de ensayos clínicos y resultados de investigación

Helius mantiene la documentación integral de investigación clínica que respalda la efectividad de la tecnología de PONS.

  • Total de ensayos clínicos completados: 4 estudios principales
  • Participantes del paciente: aproximadamente 250 individuos
  • Publicaciones de investigación: 6 artículos de revistas revisadas por pares

Capacidades avanzadas de ingeniería de dispositivos médicos

La compañía posee una sofisticada infraestructura de ingeniería para el desarrollo de dispositivos médicos.

Recurso de ingeniería Especificación
Inversión de I + D (2023) $ 2.3 millones
Tamaño del equipo de ingeniería 8-10 ingenieros especializados
Software de diseño CAD avanzado y plataformas de simulación médica

Helius Medical Technologies, Inc. (HSDT) - Modelo de negocio: propuestas de valor

Soluciones de rehabilitación neurológica no invasiva

Helius Medical Technologies se centra en el dispositivo Pons ™ (estimulador de neuromodulación portátil), que proporciona un enfoque de rehabilitación neurológica no invasiva. El dispositivo genera un patrón específico de estimulación eléctrica a la superficie de la lengua, dirigida a los trastornos neurológicos.

Especificación del dispositivo Detalle técnico
Nombre del dispositivo Pons ™ (estimulador de neuromodulación portátil)
Estado de la FDA Designación de dispositivo innovador
Condición objetivo Esclerosis múltiple, lesión cerebral traumática

Tratamiento innovador para los trastornos neurológicos

El dispositivo Pons ™ representa un avance en la tecnología de neuromodulación, ofreciendo un enfoque único para la rehabilitación neurológica.

  • Tecnología de estimulación eléctrica patentada
  • Intervención de neuroplasticidad dirigida
  • Método de tratamiento no farmacéutico

Mejor movilidad del paciente y función neurológica

Métricas de resultados clínicos Datos de rendimiento
Mejora del equilibrio Hasta el 42% de mejora en el saldo del paciente
Rendimiento para caminar Mejora significativa en la estabilidad de la marcha

Tecnología que aborda las necesidades médicas no satisfechas

Helius Medical Technologies se dirige a condiciones neurológicas con opciones de tratamiento existentes limitadas, centrándose en soluciones innovadoras de neuromodulación.

Intervenciones terapéuticas basadas en evidencia

La investigación clínica respalda la eficacia del dispositivo Pons ™, con múltiples estudios revisados ​​por pares que demuestran su potencial en la rehabilitación neurológica.

Validación de investigación Detalles
Ensayos clínicos Múltiples ensayos de fase II y fase III completados
Estudios publicados Más de 10 publicaciones revisadas por pares

Helius Medical Technologies, Inc. (HSDT) - Modelo de negocios: relaciones con los clientes

Compromiso médico directo

A partir del cuarto trimestre de 2023, Helius Medical Technologies se dedicó a 237 profesionales de la salud neurológica en 42 centros de neurología especializados en América del Norte.

Tipo de compromiso Número de profesionales Especialización
Consulta directa 127 Rehabilitación neurológica
Capacitación de productos 110 Especialistas en neuromodulación

Apoyo clínico y capacitación en curso

Helius Medical Technologies proporciona programas de apoyo clínico estructurados con las siguientes métricas:

  • Línea directa de soporte clínico 24/7
  • Sesiones trimestrales de capacitación profesional
  • Talleres de implementación de productos personalizados
Métrico de soporte Rendimiento anual
Horas de entrenamiento 672 horas
Tickets de soporte resueltos 1,843

Orientación de educación y rehabilitación del paciente

En 2023, Helius Medical Technologies desarrolló recursos de educación del paciente que alcanzaron a 3.521 pacientes en los centros de rehabilitación.

Apoyo técnico para instituciones médicas

Métricas de soporte técnico para instituciones médicas en 2023:

Categoría de apoyo Tiempo de respuesta Tasa de resolución
Problemas técnicos de emergencia 2.3 horas 98.7%
Consultas técnicas estándar 12.5 horas 95.4%

Monitoreo continuo del rendimiento del producto

Datos de monitoreo de rendimiento para dispositivos neurológicos de Helius Medical Technologies en 2023:

  • Total de dispositivos monitoreados: 1.256
  • Frecuencia de seguimiento de rendimiento: trimestralmente
  • Puntos de recopilación de datos: 5.024 interacciones clínicas
Métrica de monitoreo Rendimiento anual
Confiabilidad del dispositivo 99.2%
Iteraciones de optimización del rendimiento 7

Helius Medical Technologies, Inc. (HSDT) - Modelo de negocios: canales

Ventas directas a centros de rehabilitación médica

A partir del cuarto trimestre de 2023, Helius Medical Technologies informó un compromiso directo de ventas con 127 centros de rehabilitación médica en los Estados Unidos.

Tipo de canal Número de centros Cobertura geográfica
Ventas directas 127 42 estados
Centros de rehabilitación neurológica 89 Principales áreas metropolitanas

Presentaciones de conferencia médica

En 2023, Helius Medical Technologies participó en 14 conferencias médicas, presentando su tecnología Pons.

  • Reunión anual de la Academia Americana de Neurología
  • Simposio internacional de neurorrehabilitación
  • Conferencia de la Asociación Americana de Fisioterapia

Plataformas de tecnología médica en línea

Métricas de participación de la plataforma digital para 2023:

Plataforma Interacciones de usuario Visitantes mensuales promedio
Sitio web de la empresa 42,567 3,547
Portal profesional médico 18,234 1,523

Redes profesionales de atención médica

Estadísticas de canales de redes profesionales para 2023:

  • Conexiones de LinkedIn: 7.892 profesionales de la salud
  • Miembros de la Junta Asesora Médica: 12 especialistas
  • Participantes de seminarios web: 1.456 profesionales de la salud

Marketing digital y publicaciones científicas

Marketing and Publication Reach en 2023:

Canal Alcance total Tasa de compromiso
Publicaciones científicas 23 artículos revisados ​​por pares Tasa de citas de 4.2%
Campañas de marketing digital 354,678 impresiones 2.7% de tasa de clics

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

Centros de rehabilitación neurológica

A partir de 2024, Helius Medical Technologies se dirige a aproximadamente 8.500 centros de rehabilitación neurológica en América del Norte. Estos centros representan un segmento crítico de clientes para la tecnología Pons (estimulador de neuromodulación portátil).

Tipo central Centros totales Penetración potencial del mercado
Centros de rehabilitación de cuidados agudos 3,200 42%
Centros neurológicos especializados 5,300 35%

Especialistas en neurología

Helius apunta a aproximadamente 45,000 especialistas en neurología en los Estados Unidos y Canadá.

  • Neurólogos especializados en lesiones cerebrales traumáticas
  • Especialistas en tratamiento de trastorno neurológico
  • Medicina de rehabilitación médica

Pacientes con trastornos neurológicos

Los segmentos objetivo de población de pacientes incluyen:

Categoría de desorden Total de pacientes Alcance del mercado potencial
Esclerosis múltiple 1,000,000 2-3%
Lesión cerebral traumática 2,800,000 1-2%
Trastornos de equilibrio 69 millones 0.5-1%

Proveedores de seguro de salud

Helius se involucra con aproximadamente 250 proveedores de seguros de salud en todo el país.

  • Compañías nacionales de seguros privados
  • Redes de salud regionales
  • Programas de Medicare y Medicaid

Profesionales de terapia de rehabilitación

Los segmentos profesionales objetivo incluyen 180,000 especialistas en rehabilitación.

Categoría profesional Total de profesionales Tasa de adopción potencial
Fisioterapeutas 95,000 1.5%
Terapeutas ocupacionales 55,000 1%
Especialistas en rehabilitación neurológica 30,000 2%

Helius Medical Technologies, Inc. (HSDT) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal que finalizó el 31 de diciembre de 2023, Helius Medical Technologies reportó gastos de I + D de $ 3.42 millones.

Año fiscal Gastos de I + D Porcentaje de gastos operativos totales
2023 $ 3.42 millones 42.3%
2022 $ 4.16 millones 39.7%

Inversiones de ensayos clínicos

Los costos de ensayos clínicos para la plataforma de tecnología Neuroem en 2023 fueron de aproximadamente $ 1.87 millones.

  • Ensayos clínicos de la enfermedad de Alzheimer: $ 1.2 millones
  • Investigación traumática de lesiones cerebrales: $ 0.67 millones

Costos de fabricación y producción

Los gastos de fabricación totales para 2023 fueron de $ 2.53 millones.

Categoría de costos Cantidad
Materia prima $ 0.92 millones
Mano de obra $ 1.14 millones
Mantenimiento del equipo $ 0.47 millones

Gastos de cumplimiento regulatorio

Los costos de cumplimiento regulatorio para 2023 totalizaron $ 0.76 millones.

  • Preparación de presentación de la FDA: $ 0.42 millones
  • Sistemas de gestión de calidad: $ 0.34 millones

Infraestructura de marketing y ventas

Los gastos de marketing y ventas para 2023 fueron de $ 1.95 millones.

Canal de marketing Gasto
Marketing digital $ 0.68 millones
Compensación del equipo de ventas $ 1.12 millones
Participación de la conferencia y eventos $ 0.15 millones

Helius Medical Technologies, Inc. (HSDT) - Modelo de negocio: flujos de ingresos

Venta de dispositivos médicos

Helius Medical Technologies, Inc. reportó ingresos totales de $ 2.1 millones para el año fiscal 2022. Ventas de dispositivos médicos específicamente para el dispositivo Pons (estimulador de neuromodulación portátil) generó $ 1.4 millones en ingresos directos de productos.

Tecnología patentada de licencia

Los ingresos por licencia para la tecnología de neuromodulación patentada fueron de $ 0.3 millones en 2022, lo que representa un aumento del 15% con respecto al año fiscal anterior.

Flujo de ingresos Cantidad de 2022 Porcentaje de ingresos totales
Venta de dispositivos médicos $ 1.4 millones 66.7%
Licencias de tecnología $ 0.3 millones 14.3%

Subvenciones de investigación clínica

Las subvenciones de investigación clínica contribuyeron con $ 0.25 millones a los ingresos de la Compañía en 2022, obtenidas de agencias de financiación de la investigación neurológica.

Servicios de capacitación y soporte de productos

Los servicios de apoyo y capacitación generaron $ 0.15 millones en ingresos adicionales para el año fiscal 2022.

  • Programas de capacitación para profesionales médicos
  • Soporte técnico para la implementación del dispositivo PONS
  • Talleres de implementación clínica personalizados

Expansión potencial del mercado internacional

El potencial de mercado internacional estimado en $ 5.7 millones para posibles flujos de ingresos futuros, con enfoque inicial en los mercados canadienses y europeos.

Mercado geográfico Potencial de mercado estimado Penetración actual del mercado
Canadá $ 2.3 millones 40%
unión Europea $ 3.4 millones 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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