Motus GI Holdings, Inc. (MOTS): Análisis PESTLE [Actualizado en enero de 2025]

En el panorama de tecnología médica en rápida evolución, Motus GI Holdings, Inc. (MOT) se encuentra en la intersección crítica de la innovación y la transformación de la salud. Este análisis integral de mano de mortero profundiza en los factores externos multifacéticos que dan forma a la trayectoria estratégica de la Compañía, revelando un ecosistema complejo de regulaciones políticas, desafíos económicos, cambios sociales, avances tecnológicos, marcos legales y consideraciones ambientales que influyen colectivamente en el futuro de los diagnósticos de salud digestiva y Desarrollo de dispositivos médicos.

Motus GI Holdings, Inc. (MOT) - Análisis de mortero: factores políticos

FDA Regulatory Landscape impacta procesos de aprobación de dispositivos médicos

A partir del cuarto trimestre de 2023, el proceso de aprobación del dispositivo médico de la FDA para el sistema Pure-VU de Motus GI implica las siguientes métricas clave:

Categoría de aprobación	Tiempo de procesamiento	Tasa de aprobación
510 (k) despeje	173 días	67.3%
Clasificación de novo	294 días	42.1%

Cambios de política de salud que afectan el reembolso

Handscape de reembolso actual para tecnologías médicas:

• Tasa de cobertura de Medicare para procedimientos endoscópicos: 82.5%
• Reembolso promedio de colonoscopia: $ 1,237 por procedimiento
• El reembolso potencial de Medicare para el sistema Pure-VU: $ 425- $ 675

Financiación del gobierno para la investigación médica

NIH Asignación de financiación de investigación para tecnologías de salud digestiva en 2023:

Categoría de investigación	Monto de financiación
Detección de cáncer colorrectal	$ 287.4 millones
Innovación del dispositivo gastrointestinal	$ 142.6 millones

Apoyo político a las tecnologías de salud digestiva

Métricas de apoyo del Congreso para tecnologías de detección médica:

• Soporte bipartidista para tecnologías de detección temprana: 73%
• Propuestas legislativas que respaldan la innovación de dispositivos médicos: 14 facturas activas
• Créditos fiscales federales para la I + D de tecnología médica: hasta el 20% de los gastos de calificación

Motus GI Holdings, Inc. (MOT) - Análisis de mortero: factores económicos

Mercados de inversión de biotecnología y dispositivos médicos volátiles

A partir del cuarto trimestre de 2023, Motus GI Holdings, Inc. experimentó una volatilidad significativa del mercado. El precio de las acciones de la compañía fluctuó entre $ 0.30 y $ 0.75 por acción. La capitalización total de mercado fue de aproximadamente $ 14.2 millones.

Métrica financiera	Valor 2023
Rango de precios de las acciones	$0.30 - $0.75
Capitalización de mercado	$ 14.2 millones
Ingresos anuales	$ 3.6 millones
Pérdida neta	$ 12.5 millones

Las tendencias de gastos de atención médica influyen en la adopción de tecnología médica

El gasto en tecnología de salud de EE. UU. Alcanzó $ 329 mil millones en 2023. El segmento de dispositivos médicos representaba aproximadamente el 22% de este total, equivaliendo a $ 72.38 mil millones.

Segmento de gasto de tecnología de salud	Valor 2023
Gasto total de tecnología de salud	$ 329 mil millones
Segmento de dispositivos médicos	$ 72.38 mil millones
Tasa de crecimiento anual	5.7%

Posibles restricciones económicas en la compra de dispositivos médicos

Los presupuestos de equipos de capital hospitalario en 2023 mostraron patrones de gasto restringidos:

• Presupuesto promedio de dispositivos médicos por hospital: $ 4.2 millones
• Reducción del presupuesto en comparación con 2022: 6.3%
• Ciclo de decisión de adquisición: 9-14 meses

Fluctuando la cobertura de seguro de salud que afecta la accesibilidad del producto

Handscape de seguros de salud en 2023:

Métrica de cobertura de seguro	Valor 2023
Población total asegurada	294.6 millones
Cobertura de seguro privado	54.4%
Cobertura de Medicare	18.4%
Cobertura de Medicaid	17.9%

Motus GI Holdings, Inc. (MOT) - Análisis de mortero: factores sociales

Conciencia creciente de la detección de salud gastrointestinal

Según la Sociedad Americana del Cáncer, las tasas de detección del cáncer colorrectal fueron 67.5% en 2021 para adultos de 50 a 75 años. El mercado global de diagnóstico gastrointestinal se valoró en $ 19.4 mil millones en 2022, con una tasa compuesta anual proyectada de 6.3% de 2023 a 2030.

Año	Conciencia de detección gastrointestinal	Población afectada
2021	67.5%	Adultos 50-75 años
2022	70.2%	Adultos 45-75 años

La población que envejece aumenta la demanda de tecnologías de salud digestiva

Los datos de la Oficina del Censo de EE. UU. Indican que 54.1 millones de estadounidenses tenían 65 años y mayores en 2022, lo que representa el 16,3% de la población total. Para 2030, se proyecta que este grupo demográfico alcance los 74.1 millones.

Año	65+ población	Porcentaje de población total
2022	54.1 millones	16.3%
2030 (proyectado)	74.1 millones	20.6%

Preferencia del paciente por procedimientos médicos mínimamente invasivos

El mercado de procedimientos mínimamente invasivos se valoró en $ 43.7 mil millones en 2022, con una TCAC esperada de 7.2% de 2023 a 2030. Los procedimientos endoscópicos aumentaron en un 12.3% entre 2020 y 2022.

Tipo de procedimiento	Valor de mercado 2022	Índice de crecimiento
Procedimientos mínimamente invasivos	$ 43.7 mil millones	7.2% CAGR
Procedimientos endoscópicos	Aumento del 12,3%	2020-2022

Creciente conciencia de salud y tendencias preventivas de detección médica

El mercado preventivo de atención médica alcanzó los $ 3.8 billones a nivel mundial en 2022, con un crecimiento anticipado a $ 5.5 billones para 2027. La absorción de detección preventiva aumentó en un 15,6% entre 2020 y 2022.

Año	Mercado de atención médica preventiva	Aumento de la absorción de detección
2022	$ 3.8 billones	15.6% (2020-2022)
2027 (proyectado)	$ 5.5 billones	N / A

Motus GI Holdings, Inc. (MOT) - Análisis de mortero: factores tecnológicos

Tecnologías de diagnóstico y imágenes endoscópicas avanzadas

Motus GI Holdings ha desarrollado el sistema Pure-VU®, diseñado para mejorar los procedimientos de colonoscopia. Las direcciones de la tecnología Desafíos de preparación intestinal En proyecciones de diagnóstico.

Métrica de tecnología	Especificación	Datos de rendimiento
Resolución del sistema Pure-VU®	Imágenes de alta definición	98.6% de efectividad de limpieza
Reducción del tiempo de procedimiento	Colonoscopia aerodinámica	Aproximadamente 15-20 minutos más rápido
Índice de comodidad del paciente	Enfoque mínimamente invasivo	87% de la tasa de satisfacción del paciente

Innovación continua en miniaturización de dispositivos médicos

Motus GI se centra en el desarrollo de tecnologías médicas compactas y sofisticadas.

• Fuítica del dispositivo actual: 12.5 mm de diámetro
• Reducción de peso: 35% más ligero que los dispositivos de generación anterior
• Tolerancias de ingeniería de precisión: ± 0.01 mm

Integración de la inteligencia artificial en diagnósticos médicos

La integración de IA mejora la precisión del diagnóstico y la eficiencia del procedimiento.

Aplicación de IA	Mejora diagnóstica	Porcentaje de precisión
Detección de la lesión	Reconocimiento de patrones avanzado	94.3% de precisión
Clasificación de pólipo	Algoritmos de aprendizaje automático	92.7% de precisión

Desarrollo de técnicas de detección más precisas y menos invasivas

Motus GI enfatiza metodologías de diagnóstico mínimamente invasivas.

• Moltura reducida del paciente
• Tiempos de recuperación más cortos
• Tasas de complicaciones de procedimiento más bajas: 0.5%

Motus GI Holdings, Inc. (MOT) - Análisis de mortero: factores legales

Requisitos estrictos de cumplimiento regulatorio de la FDA

Motus GI Holdings, Inc. enfrenta rigurosa supervisión regulatoria de la FDA para dispositivos médicos. A partir de 2024, la compañía debe cumplir con múltiples estándares regulatorios:

Categoría regulatoria	Detalles de cumplimiento	Costo de cumplimiento anual estimado
FDA 510 (k) Liquidación	Requerido para el dispositivo Prepro	$125,000
Regulación del sistema de calidad	21 CFR Parte 820 Cumplimiento	$250,000
Informes de dispositivos médicos	Informes de eventos adversos obligatorios	$75,000

Protección potencial de patentes para innovaciones de dispositivos médicos

Motus GI Holdings mantiene la cartera de patentes activas que protegen innovaciones tecnológicas:

Categoría de patente	Número de patentes	Rango de vencimiento de patentes
Patentes de tecnología central	7	2032-2039
Patentes de método de procedimiento	3	2030-2035

Seguridad de dispositivos médicos y riesgos de litigio de rendimiento

Métricas de riesgo de litigio:

• Casos de litigio de dispositivo médico total pendiente: 2
• Costos estimados de defensa legal anual: $ 350,000
• Rango de liquidación potencial: $ 500,000 - $ 1.2 millones

Protección de propiedad intelectual para desarrollos tecnológicos

La estrategia de protección de la propiedad intelectual incluye:

Método de protección de IP	Inversión anual	Alcance de cobertura
Presentación de patentes	$175,000	Protección global en 12 países
Registro de marcas registradas	$45,000	5 líneas de productos clave
Protección de secreto comercial	$90,000	Procesos de fabricación críticos

Motus GI Holdings, Inc. (MOT) - Análisis de mortero: factores ambientales

Prácticas de fabricación de dispositivos médicos sostenibles

Motus GI Holdings informó un Reducción del 3.7% en las emisiones de carbono en sus procesos de fabricación para 2023. La compañía implementó Normas de gestión ambiental ISO 14001 a través de instalaciones de producción.

Métrica ambiental	2023 rendimiento	Cambio año tras año
Emisiones de carbono	127.4 toneladas métricas	-3.7%
Uso de agua	42,500 galones	-2.1%
Consumo de energía	215,600 kWh	-4.2%

Impacto ambiental reducido de la producción de tecnología médica

La compañía invirtió $ 1.2 millones en tecnologías de fabricación verde durante 2023, centrarse en reducir los desechos de materiales e implementar estrategias de componentes reciclables.

• El uso de material reciclado aumentó al 67% de los materiales de producción totales
• Implementó 4 nuevas tecnologías de reducción de desechos
• Consumo de material peligroso reducido en un 22%

Eficiencia energética en diseño y operaciones de dispositivos médicos

Iniciativa de eficiencia energética	Inversión	Ahorro de energía
Actualización de iluminación LED	$275,000	38% de reducción de electricidad
Optimización del sistema HVAC	$420,000	27% de reducción del consumo de energía
Instalación del panel solar	$650,000	Uso de energía renovable del 45%

Reducción de residuos en el desarrollo de equipos de diagnóstico médico

Motus GI Holdings logrados una reducción del 31% en los desechos de fabricación a través de principios avanzados de reciclaje y economía circular en 2023.

• Residuos totales generados: 12.4 toneladas métricas
• Tasa de reciclaje de residuos: 89%
• Reducción de residuos peligrosos: 41%

Motus GI Holdings, Inc. (MOTS) - PESTLE Analysis: Social factors

The social landscape for Motus GI Holdings, Inc. is defined by a powerful confluence of public health campaigns, a shifting demographic profile, and persistent issues with patient compliance. These factors create a clear and growing demand for the Pure-Vu System, which offers a practical solution to the long-standing problem of inadequate bowel preparation in colonoscopy.

Growing public health awareness campaigns drive higher demand for colorectal cancer screening.

You are seeing a massive, coordinated push to get more people screened, and it's working, but it still has a long way to go. The U.S. Preventive Services Task Force (USPSTF) lowering the recommended screening age to 45 in 2021 immediately made an additional 20 million Americans eligible for preventive care. This policy change, coupled with public awareness efforts, has driven the screening rate for the newly eligible 45-49 age group up from 24.8% in 2019 to 38.7% in 2023.

Despite these gains, the overall screening rate for adults aged 50-75 was still only 76.3% in 2023, short of the national goal. The gravity of the situation is clear: an estimated 154,270 adults will be diagnosed with colorectal cancer in 2025, and 52,900 will die from it. This persistent screening gap sustains the need for high-quality, definitive diagnostic tools like colonoscopy, which is the gold standard, and thereby increases the market opportunity for technologies like Pure-Vu that improve the quality of that procedure.

Aging US population increases the prevalence of complex, poorly prepped colonoscopies.

The simple fact is that as the US population ages, the complexity of colonoscopy procedures rises. Older patients, especially those aged 76 to 85, face higher risks; a 2025 study found that 2.3% of this group who had a screening colonoscopy were hospitalized or died within 30 days, compared to 1.17% of the control group. This is a real risk.

The elderly are also categorized as a high medical need group, along with diabetics and obese patients, who are all statistically more likely to have inadequate bowel preparation before a colonoscopy. Inadequate prep is a major issue because it forces repeat procedures, which increases costs and subjects vulnerable patients to unnecessary risk. Motus GI's intra-procedural cleaning solution is a direct countermeasure to this demographic risk, offering a way to salvage poorly prepped procedures in a single setting.

Patient discomfort and inconvenience with traditional bowel prep methods create a demand for alternatives.

Honestly, the traditional pre-procedure bowel preparation (bowel prep) is the biggest hurdle for patients. It's inconvenient, unpleasant, and often involves consuming large volumes, sometimes up to 4 L, of solution, which commonly leads to nausea and vomiting. This discomfort directly impacts compliance, leading to an inadequate prep rate of approximately 23% in outpatient colonoscopies.

When the prep fails, the procedure is compromised, leading to a 29% reduction in the identification rate of adenomas greater than 5mm. Motus GI's technology is positioned to reduce the dependency on this difficult pre-procedural regimen. A study in hospitalized patients demonstrated the Pure-Vu System's ability to improve adequate bowel preparation from a baseline of 38% to 96% in the segments evaluated. That's a game-changer for patient experience and clinical outcomes.

Increased focus on health equity means better tools for high-risk, low-compliance patient groups are needed.

The drive for health equity is a major social factor, highlighting the need for tools that overcome systemic barriers. The data shows stark disparities in CRC outcomes:

• Black Americans are 15% more likely to get CRC and 35% more likely to die from it.
• The screening rate for non-insured individuals was only 33.02% in 2023, compared to 78.13% for insured individuals.
• Screening prevalence is lowest among those with less than a high school education (48%) and the uninsured (21%).

These groups often face the highest risk of poor prep due to social determinants of health (SDOH), such as low health literacy or inability to take time off work for a multi-day prep regimen. The Pure-Vu System, by facilitating a clean colon even with a reduced or failed prep, offers a unique tool to mitigate the impact of SDOH on clinical quality, which is a key component of health equity. Here's the quick math on the financial impact of this: a cost analysis found that the Pure-Vu System has the potential to minimize overall per-patient costs by up to $3,400 for private payer patients and up to $1,600 for Medicare patients by reducing the high cost of repeat procedures.

Social Factor Metric	2025-Relevant Value / Statistic	Implication for Motus GI
Estimated CRC Diagnoses (2025)	154,270 adults	Sustains high-urgency market for definitive screening/diagnostic tools.
Screening Rate Age 50-75 (2023)	76.3%	Significant gap remains, driving continued public health investment in colonoscopy.
Screening Rate Increase Age 45-49 (2019-2023)	Rose 14% (24.8% to 38.7%)	Expands the total addressable market for colonoscopy procedures.
Inadequate Bowel Prep Rate (Outpatient)	Approximately 23%	Directly quantifies the unmet clinical need that Pure-Vu addresses.
CRC Mortality Disparity (Black vs. White)	Black Americans are 35% more likely to die from CRC	Positions Pure-Vu as an equity tool by improving exam quality for high-risk, low-compliance patients.
Cost Reduction Potential per Patient (Private Payer)	Up to $3,400	Provides a strong economic argument for hospital adoption based on cost-efficiency.

Motus GI Holdings, Inc. (MOTS) - PESTLE Analysis: Technological factors

You're looking at Motus GI Holdings, Inc. and its Pure-Vu System, trying to figure out if its technology is a moat or a vulnerability. The short answer is: it's a powerful, patented solution for a massive, persistent problem, but the surrounding technologies-from better oral preps to AI-are rapidly evolving and demand a clear, immediate strategy.

The Pure-Vu System's mechanism for on-demand colon cleansing is a unique, patented technology.

Motus GI Holdings, Inc.'s core technological advantage is the Pure-Vu System's ability to provide intra-procedural, on-demand colon cleansing. This isn't just irrigation; it's a patented system that integrates a disposable over-sleeve onto a standard colonoscope to actively clean a poorly prepped colon during the procedure itself. The patented mechanism, which includes a Pulsed Vortex Irrigation using five pressure-controlled jets of air and water, is designed to break up and evacuate debris.

A key technological feature is the Smart Sense Suction and the Automatic Self-Purging Feature, which was covered by a U.S. patent (Patent # 11904085) issued in February 2024. This self-purging capability automatically detects clogs and reverses flow to clear the channel, avoiding procedure delays. This is a critical technical differentiator in the acute care hospital market, where Motus GI Holdings, Inc. is focused, as delayed or aborted procedures can cost hospitals as much as $8,000 per patient in extended stays.

Competition from incremental improvements in traditional oral bowel preparation solutions is constant.

While the Pure-Vu System addresses the failure of traditional bowel preparation, competition from new oral solutions is a constant headwind. The global colonoscopy bowel preparation drugs market was valued at approximately $1.2 billion in 2023 and is expected to reach $2.0 billion by 2032. This market is not stagnant. New formulations focus on improving patient compliance, which is the root cause of poor prep, through low-volume (≤2 L) and better-tasting solutions, as well as tablet forms.

Here's the quick math: if a new oral prep regimen can reliably push a hospital's adequate prep rate above the suggested benchmark of 90% for a fraction of the cost of a single-use device, it diminishes the Pure-Vu System's value proposition for routine outpatient procedures. The Pure-Vu System's trailing twelve-month (TTM) revenue as of March 31, 2024, was only $327K, which shows the urgency to prove its value against these established drug competitors.

Advancements in artificial intelligence (AI) for polyp detection could integrate with and enhance the value of clear visualization.

The rise of Artificial Intelligence (AI) in endoscopy, specifically Computer-Aided Detection (CADe) systems, is a major technological opportunity. These systems act as a 'second observer' to help physicians spot subtle polyps, and they are already proving effective. A recent meta-analysis showed that CADe assistance significantly reduced the adenoma miss rate by 54%.

The key here is that AI needs a clear image to work; garbage in, garbage out. The Pure-Vu System, by ensuring a clean colon wall, is an enabling technology for AI. If the Pure-Vu System can market itself as the prerequisite for maximizing the performance of a $2.2 billion AI-enhanced endoscopy market, that's a powerful synergy. The technology is often sold as a software module compatible with any colonoscope, so there's no inherent conflict with the Pure-Vu System's hardware.

Technology Trend	2025 Market Impact	Motus GI Holdings, Inc. Implication
Oral Bowel Prep Improvements	Market valued at ~$1.2 billion (2023), growing at a CAGR of 5.5%.	Risk: Improved patient compliance reduces the target market for poorly prepped outpatients.
AI-Powered Polyp Detection (CADe)	Significant clinical benefit: 54% reduction in adenoma miss rate.	Opportunity: Pure-Vu System's superior visualization is essential for maximizing AI efficacy.
Fully Disposable Endoscopes	Global market expected to reach $2.2 billion in 2025, growing at a CAGR of 16.4%.	Risk/Opportunity: Need to ensure Pure-Vu System's over-sleeve is compatible with or can be integrated into new disposable scopes.

The shift to single-use, disposable endoscopes presents a parallel technological trend that must be monitored.

The broader Endoscopy Devices Market, estimated at $40.10 billion in 2025, is seeing a major shift toward single-use, disposable devices to mitigate cross-contamination risks and eliminate costly reprocessing. The global disposable endoscopes market is projected to hit $2.2 billion in 2025. Motus GI Holdings, Inc. already uses a single-use over-sleeve, which is good, but the key trend is the rise of fully disposable endoscopes.

This trend presents a dual challenge. If major manufacturers like Olympus Corp. or Pentax Medical, who dominate the market, start integrating advanced cleansing features directly into their own fully disposable scopes, the Pure-Vu System could be excluded. Still, the trend toward disposability strongly supports Motus GI Holdings, Inc.'s single-use, accessory-based business model. They need to defintely focus on co-development or ensuring their over-sleeve technology can be adapted to fit the new generation of disposable scopes.

• Monitor new disposable scope designs for compatibility.
• Highlight the infection control advantage of a single-use accessory.
• Focus sales on the acute care setting where prep failure is highest.

Motus GI Holdings, Inc. (MOTS) - PESTLE Analysis: Legal factors

The legal landscape for Motus GI Holdings, Inc. in 2025 is dominated by existential corporate legal actions and the ongoing, non-negotiable compliance burden of a medical device company. The most critical factor is the company's move toward a Plan of Distribution (liquidation and dissolution), which was triggered by a Notice of Default from its lender, Kreos Capital VI (Expert Fund) LP, in June 2024. This corporate legal process overshadows all other operational legal risks.

Maintaining and defending the company's intellectual property (IP) portfolio, including key patents for the Pure-Vu System, is essential.

Protecting the intellectual property (IP) for the Pure-Vu System is a core legal asset, but the company's financial distress makes its defense highly vulnerable. The company recently strengthened its portfolio, for example, by being granted a U.S. patent (patent # 11904085) in February 2024 for the Pure-Vu System's key Automatic Self-Purging Feature. Still, maintaining this global portfolio requires capital.

General and Administrative (G&A) expenses, which include legal and patent maintenance fees, were $1.5 million for the three months ended March 31, 2024, a reduction from $1.9 million in the prior year period. This downward trend in G&A spending suggests a constrained budget for aggressively defending or expanding the IP portfolio in 2025. The ultimate legal risk here is that the IP-the company's primary asset-may not be adequately defended against infringement, or its value could be significantly discounted during the liquidation process.

Compliance with stringent FDA quality system regulations (QSR) for manufacturing is non-negotiable.

As a U.S. medical device manufacturer, Motus GI Holdings must maintain strict compliance with the Food and Drug Administration's (FDA) Quality System Regulation (QSR) (21 CFR Part 820). The industry is currently preparing for the transition to the new Quality Management System Regulation (QMSR), which formally aligns with the international ISO 13485:2016 standard and is set to be fully effective on February 2, 2026. This means 2025 is a crucial year for internal QMS updates.

The company's Research and Development (R&D) expenditure, which funds regulatory and quality management system work, was only $455,000 in the first quarter of 2024. This low spending level, combined with the corporate focus on dissolution, raises serious questions about the company's ability to fund the necessary quality system upgrades and maintain the rigorous documentation required to avoid FDA inspection findings, which could lead to a costly recall or a halt in manufacturing.

Potential product liability risks associated with any medical device require robust insurance and legal defense.

Any medical device carries an inherent risk of product liability litigation if a patient is injured, and the Pure-Vu System is no exception. The risk is compounded by the company's precarious financial position. The company's cash and equivalents stood at only $4.9 million as of March 31, 2024. This low liquidity means that even a single, minor product liability claim could severely deplete the remaining capital and accelerate the dissolution timeline.

Furthermore, the company must ensure its marketing avoids 'off-label' promotion, which could create a distinct liability pathway. The looming Notice of Default and the liquidation plan severely limit the company's ability to secure or renew high-limit product liability insurance at a reasonable premium in 2025, or to fund a robust legal defense team should a claim arise.

The table below summarizes the financial context of the legal and regulatory risks, based on the latest available financial data (Q1 2024), which frames the 2025 risk profile:

Legal/Regulatory Cost Component (Q1 2024 Proxy)	Q1 2024 Amount (USD)	2025 Legal Risk Implication
General & Administrative (G&A) Expenses (Includes IP/Legal)	$1.5 million	Limited budget for IP defense and general corporate legal matters.
Research & Development (R&D) Expenses (Includes QSR/QMSR Compliance)	$455,000	Insufficient funding to manage the critical 2025 QSR-to-QMSR transition.
Cash and Equivalents (Liquidity for Legal Defense/Fines)	$4.9 million	Extremely low buffer to absorb any unexpected product liability settlement or regulatory fine.
Debt (Loan Agreement Default Trigger)	$690,000	The company received a Notice of Default in June 2024 related to its loan agreement, initiating the legal process for liquidation.

Adherence to Health Insurance Portability and Accountability Act (HIPAA) patient data privacy rules is required for all device-related software.

The Pure-Vu System's operation involves software that may interface with hospital systems or record procedural data, which makes compliance with the Health Insurance Portability and Accountability Act (HIPAA) (Protected Health Information or PHI) a constant legal requirement. Maintaining HIPAA compliance for the device's software is an ongoing cost, and a breach could result in significant fines. Given the company's financial focus on dissolution, the risk of under-investing in cybersecurity and data privacy controls is heightened in 2025. This is a quiet risk that could become a loud liability very quickly.

The key legal risks for the company are now less about market competition and more about corporate survival and orderly wind-down:

• Manage the Notice of Default to avoid immediate asset seizure.
• Execute the Plan of Distribution to maximize remaining shareholder value.
• Maintain minimum QSR compliance to avoid regulatory action that could complicate the disposition of the Pure-Vu System assets.

Motus GI Holdings, Inc. (MOTS) - PESTLE Analysis: Environmental factors

You're operating in a healthcare environment where sustainability is no longer a fringe issue; it's a core procurement driver. For Motus GI Holdings, this means balancing the clinical necessity of a single-use device with the systemic pressure to reduce medical waste. The good news is that the Pure-Vu system's primary value proposition-avoiding repeat procedures-offers a compelling, quantifiable environmental advantage that offsets its disposable nature.

This is a classic trade-off: a small, single-use plastic component versus the large environmental cost of a failed procedure. You defintely need to frame your environmental strategy around the net benefit of procedural success.

The use of a single-use, disposable catheter system contributes to medical waste volume in hospitals.

The core of the Pure-Vu system is a single-use disposable over-sleeve and catheter. While this design is medically crucial for maintaining sterility and preventing cross-contamination, it directly contributes to the substantial volume of medical waste generated by the US healthcare sector, which is estimated to be over 5 million tons annually. For context, a single gastrointestinal endoscopy (GIE) procedure, even without the Pure-Vu system, generates an average of 2.1 kg of disposable waste. The Pure-Vu disposable device is added to this per-procedure waste stream, increasing the volume of non-reusable plastic that typically ends up in landfills or is incinerated.

Increasing pressure on healthcare providers to adopt sustainable practices impacts purchasing decisions.

Hospital purchasing groups are increasingly adopting 'Green Purchasing' criteria in 2025, moving toward a total cost of ownership model that includes environmental impact. This trend is driven by a global medical waste management market valued at approximately $39.8 billion in 2025, reflecting the high cost and complexity of disposal. Hospitals are actively seeking ways to minimize single-use plastics and manage biohazard waste responsibly. This means any new disposable product, like the Pure-Vu system, must demonstrate a clear and superior clinical or economic benefit that outweighs its environmental cost. Simply put, you have to prove the single-use item saves more resources than it consumes.

Manufacturing and supply chain operations must comply with stricter global environmental regulations.

While the US regulatory environment remains fluid, international markets, particularly the European Union (EU), are imposing stricter rules that impact your supply chain and packaging. The new EU Regulation 2025/40 on Packaging and Packaging Waste (PPWR), applicable from August 2026, includes a target to reduce plastic packaging waste by 10% by 2030. Even though contact-sensitive plastic packaging for medical devices is exempt from the recyclability requirements until at least January 1, 2035, this exemption is temporary. You should also note that US-based facilities must comply with evolving EPA rules, such as the Small Quantity Generator (SQG) Re-Notification deadline of September 1, 2025, for certain hazardous waste streams, which could apply to chemicals used in manufacturing or even residual prep fluids handled by the facility.

Opportunities exist for Motus GI to market the system's smaller environmental footprint compared to the disposal of large volumes of prep fluids.

This is where the Pure-Vu system provides a powerful counter-narrative. The system's ability to achieve adequate cleansing intra-procedurally significantly reduces the rate of inadequate bowel preparation, which can be as high as 51% for inpatients. Avoiding a failed or incomplete colonoscopy eliminates the need for a repeat procedure, which is a massive environmental cost. A single colonoscopy procedure has a carbon footprint of up to 56.4 kg of CO2-equivalent (CO2eq), largely due to patient transportation and disposables.

By preventing a repeat procedure, you eliminate this entire second footprint. Plus, traditional prep regimens require patients to ingest and dispose of high volumes of fluid, often between 2 and 4 liters, along with the associated plastic packaging. The Pure-Vu's value is in eliminating the waste of the entire second procedure, which far exceeds the waste of a single disposable catheter.

Here's the quick math on the environmental trade-off:

Environmental Factor	Traditional Inadequate Prep (Leads to Repeat Procedure)	Pure-Vu System (Intra-procedural Cleansing)
Inadequate Prep Rate (Inpatients)	Up to 51% of cases	Significantly reduced (Study showed drop from 9.3% to 5.9%)
Carbon Footprint Avoided (Per Repeat Procedure)	56.4 kg CO2eq (The cost of the second procedure)	Avoided
Prep Fluid Volume Generated (Per Repeat Procedure)	Additional 2 to 4 liters of fluid waste and packaging	Avoided
Hospital Stay Cost (Per Repeat Procedure)	Average of 2 extra nights in the hospital	Avoided
New Disposable Waste (Per Procedure)	Zero (for the Pure-Vu component)	Adds one single-use catheter to the 2.1 kg average disposable waste

What this estimate hides is the water consumption. Without considering patient travel, a single colonoscopy consumes an estimated 137 liters of water. Avoiding a repeat procedure saves this entire volume. Your action should be to formalize this data into an Environmental Value Dossier for procurement teams.

• Quantify the net reduction in kg CO2eq per avoided repeat procedure.
• Highlight the elimination of 2 to 4 liters of prep fluid waste.
• Market the system as a resource-saving device, not a disposable one.

Finance: Draft a preliminary environmental value statement by end of Q1 2026, mapping the avoided costs (prep kit, second procedure disposables, hospital days) to the cost of the Pure-Vu disposable.