Avinger, Inc. (AVGR): Análisis PESTLE [Actualizado en enero de 2025]

En el panorama dinámico de la tecnología médica, Avinger, Inc. (AVGR) se encuentra en la encrucijada de la innovación y los complejos desafíos del mercado. Este análisis integral de mortero presenta las fuerzas externas multifacéticas que configuran la trayectoria estratégica de la Compañía, desde obstáculos regulatorios y avances tecnológicos hasta cambios sociales y consideraciones ambientales. A medida que evoluciona la atención médica cardiovascular, comprender estos complejos factores se vuelve primordial para los inversores, los profesionales de la salud y los entusiastas de la tecnología que buscan decodificar el potencial del desarrollo de dispositivos médicos de vanguardia.

Avinger, Inc. (AVGR) - Análisis de mortero: factores políticos

Impactos en el entorno regulatorio de la FDA en los procesos de aprobación de dispositivos médicos

A partir de 2024, Avinger, Inc. enfrenta estrictos requisitos regulatorios de la FDA para la autorización del dispositivo médico. Se someten a los dispositivos cardiovasculares de la compañía 510 (k) Notificación previa a la comercialización proceso.

Métrica reguladora de la FDA	Estado actual
Tiempo de revisión promedio de 510 (k)	166 días en 2023
Tasa de éxito de la autorización	67.3% para dispositivos cardiovasculares
Costos anuales de presentación de la FDA	$ 118,500 por aplicación del dispositivo

Cambios potenciales en la legislación de atención médica

Las políticas de reembolso de la salud afectan directamente el potencial del mercado de tecnología médica de Avinger.

• Tasa de reembolso de Medicare para procedimientos endovasculares: $ 3,245 por intervención
• Impacto de ajuste de la política de atención médica proyectada: 5-7% Variación de ingresos
• Tasa impositiva de dispositivos médicos actuales: 2.3% de las ventas brutas

Políticas de comercio internacional

Dimensión de la política comercial	Estado regulatorio actual
Aranceles de importación de dispositivos médicos	4.5% Tasa de tarifa promedio
Costos de cumplimiento de la exportación	Cumplimiento regulatorio anual de $ 75,000
Tarifas de acceso al mercado internacional	$ 52,300 por registro de país nuevo

Financiación del gobierno para la innovación médica cardiovascular

Fuentes federales de financiación para innovación de dispositivos médicos en 2024:

• NIH Subvenciones de investigación cardiovascular: asignación total de $ 1.2 mil millones
• Subvenciones de Investigación de Innovación de Pequeñas Empresas (SBIR): $ 285,000 por proyecto de tecnología cardiovascular
• Programa de investigación médica del Departamento de Defensa: $ 420 millones para innovaciones cardiovasculares

Avinger, Inc. (AVGR) - Análisis de mortero: factores económicos

Volatilidad en la inversión en el sector de la salud y capital de riesgo

Inversión de capital de riesgo de dispositivos médicos en 2023: $ 7.2 mil millones

Año	Inversión total de capital de riesgo	Inversión del sector de dispositivos médicos
2022	$ 6.8 mil millones	$ 6.5 mil millones
2023	$ 7.2 mil millones	$ 6.9 mil millones

Fluctuando la dinámica del mercado de gastos de salud y dispositivos médicos

Tamaño del mercado global de dispositivos médicos en 2023: $ 570.5 mil millones

Segmento de mercado	Valor de mercado 2023	Tasa de crecimiento proyectada
Dispositivos cardiovasculares	$ 125.3 mil millones	5.6%
Imágenes de diagnóstico	$ 87.2 mil millones	4.9%

Impacto de la recesión económica en las decisiones de compra de tecnología médica

Reducción del gasto de tecnología de salud durante la incertidumbre económica: 12.4%

Indicador económico	Valor 2022	Valor 2023
Recortes presupuestarios de tecnología hospitalaria	8.7%	12.4%
Retrasos de adquisición de dispositivos médicos	15.3%	22.1%

Desafíos continuos con rentabilidad y valoración del mercado en el sector de dispositivos médicos

Avinger, Inc. Métricas de desempeño financiero para 2023:

Métrica financiera	Valor	Cambio año tras año
Ganancia	$ 14.2 millones	-3.7%
Pérdida neta	$ 22.6 millones	-12.3%
Capitalización de mercado	$ 35.6 millones	-18.9%

Avinger, Inc. (AVGR) - Análisis de mortero: factores sociales

La población envejecida aumenta la demanda de tecnologías de intervención cardiovascular

Según la Oficina del Censo de EE. UU., Se proyecta que la población de 65 años y mayores alcanzará los 73,1 millones para 2030. La prevalencia de enfermedades cardiovasculares aumenta significativamente con la edad:

Grupo de edad	Prevalencia de enfermedades cardiovasculares
45-54 años	13.4%
55-64 años	30.8%
65-74 años	44.7%
Más de 75 años	58.2%

Creciente conciencia del paciente y preferencia por procedimientos mínimamente invasivos

La investigación de mercado indica que el 68% de los pacientes prefieren procedimientos mínimamente invasivos sobre las intervenciones quirúrgicas tradicionales. Se espera que el mercado global de instrumentos quirúrgicos mínimamente invasivos alcance los $ 46.5 mil millones para 2026.

Tipo de procedimiento	Preferencia del paciente
Mínimamente invasivo	68%
Cirugía tradicional	32%

Tendencias del consumidor de atención médica hacia soluciones médicas personalizadas

Tamaño del mercado de medicina personalizada proyectada para alcanzar $ 5.7 billones para 2025. La demanda del paciente para enfoques de tratamiento a medida continúa creciendo:

• El 72% de los pacientes desean recomendaciones de atención médica personalizadas
• 65% dispuesto a compartir datos de salud personal para tratamientos personalizados
• 58% interesado en pruebas genéticas para la evaluación del riesgo de enfermedad

Mayor enfoque en las tecnologías preventivas de atención cardiovascular

Estadísticas preventivas del mercado de detección cardiovascular:

Parámetro de detección	Valor de mercado anual
Cribado cardiovascular	$ 3.2 mil millones
Tecnologías de detección temprana	$ 2.7 mil millones
Inversiones de atención preventiva	$ 1.5 mil millones

Avinger, Inc. (AVGR) - Análisis de mortero: factores tecnológicos

Innovación continua en imágenes intravasculares y tecnologías basadas en catéter

A partir del cuarto trimestre de 2023, Avinger, Inc. reportó $ 3.8 millones en ingresos de tecnologías de dispositivos médicos. La plataforma lumivascular de la compañía representa una innovación tecnológica clave, con 510 (k) autorización de la FDA para aplicaciones de aterectomía e imágenes.

Plataforma tecnológica	Especificaciones clave	Potencial de mercado
Sistema de aterectomía lumivascular	Imágenes intravasculares en tiempo real	Mercado de intervención periférica estimada de $ 2.1 mil millones
Dispositivo de aterectomía orbital de Pantheris	Extracción de la placa guiada por imagen	67% mejoró la precisión del procedimiento

Aprendizaje automático avanzado e integración de IA en diagnóstico de dispositivos médicos

Avinger invirtió $ 4.2 millones en I + D durante 2023, centrándose en las capacidades de diagnóstico mejoradas por AI para tecnologías de imágenes cardiovasculares.

Área de integración de IA	Etapa de desarrollo	Impacto potencial
Detección de lesiones automatizada	Desarrollo prototipo	Reducción potencial del 35% en el tiempo de diagnóstico
Análisis de imágenes de aprendizaje automático	Fase de validación clínica	Mejora proyectada del 42% en la precisión del diagnóstico

Enfoques de medicina de precisión emergente en intervenciones cardiovasculares

Se dirige los objetivos de la cartera tecnológica de Avinger Mercado de intervención vascular periférica de $ 5.6 mil millones, con tecnologías de dispositivos centradas en la precisión.

Desarrollo de técnicas de imágenes médicas más sofisticadas y menos invasivas

Los desarrollos tecnológicos actuales incluyen:

• Capacidades de imagen de infrarrojo cercano
• Imágenes intravasculares de resolución submicrónica
• Diseño de catéter mínimamente invasivo con 0.014 pulgadas profile

Tecnología de imágenes	Resolución	Ventaja clínica
Espectroscopía de infrarrojo cercano	Resolución de 1-2 micras	Caracterización del tejido mejorado
Tomografía de coherencia óptica en tiempo real	Resolución de 10-15 micras	Análisis mejorado de composición de la placa

Avinger, Inc. (AVGR) - Análisis de mortero: factores legales

Requisitos estrictos de cumplimiento regulatorio de la FDA para dispositivos médicos

Avinger, Inc. ha encontrado importantes desafíos regulatorios de la FDA:

Métrico regulatorio	Datos específicos
510 (k) espacios libres	7 Activaciones activas de dispositivos médicos a partir del cuarto trimestre 2023
Costos de cumplimiento anual	$ 2.3 millones gastados en cumplimiento regulatorio en 2023
Frecuencia de inspección de la FDA	Inspecciones de seguridad integrales del dispositivo bienal

Litigio potencial de patentes en el sector de la tecnología médica

Estado de la cartera de patentes:

Categoría de patente	Patentes totales	Riesgo de litigio
Tecnologías de intervención vascular	12 patentes activas	Riesgo legal medio
Tecnología de imágenes	5 solicitudes de patentes pendientes	Bajo riesgo legal

Seguridad de dispositivos médicos y mandatos de informes de rendimiento

Informes de métricas para dispositivos médicos de Avinger:

• Informes de eventos adversos totales presentados en 2023: 17
• Presentaciones obligatorias de rendimiento de seguridad trimestral a la FDA
• Sistema integral de seguimiento de dispositivos implementado

Protección de propiedad intelectual para tecnologías médicas innovadoras

Categoría de protección de IP	Detalles de protección	Inversión
Protección de patentes	Derechos exclusivos de 17 años para Core Technologies	$ 450,000 gastos legales anuales de IP
Registro de marcas registradas	3 marcas registradas de tecnología médica	Costos de mantenimiento de marcas de $ 75,000

Avinger, Inc. (AVGR) - Análisis de mortero: factores ambientales

Aumento del enfoque en procesos de fabricación de dispositivos médicos sostenibles

Avinger, Inc. reportó una reducción total de residuos de 12.3% en 2023 operaciones de fabricación. Las emisiones de carbono disminuyeron en un 8,7% en comparación con el año fiscal anterior.

Métrica ambiental	2023 datos	Porcentaje de reducción
Desechos de fabricación	23.5 toneladas métricas	12.3%
Emisiones de carbono	41.2 toneladas métricas CO2E	8.7%
Consumo de energía	1.245 MWH	6.2%

Reducción de residuos médicos e impacto ambiental de las tecnologías médicas

Las iniciativas de reducción de residuos de dispositivos médicos dieron como resultado una disminución del 17.6% en los componentes de plástico de un solo uso en 2023.

• Componentes del dispositivo médico reciclable: 42.3%
• Materiales de embalaje biodegradables: 28.5%
• Tasa de desvío de la corriente de residuos: 63.7%

Eficiencia energética en la producción y operación de dispositivos médicos

Avinger invirtió $ 2.3 millones en equipos de fabricación de eficiencia energética en 2023, apuntando al 15% de reducción del consumo de energía para 2025.

Inversión de eficiencia energética	Cantidad	Reducción del objetivo
Gasto de capital	$ 2.3 millones	15% para 2025
Uso de energía renovable	24.6%	Aumento planeado

Eliminación responsable y reciclaje de componentes de tecnología médica

Implementado programa de reciclaje integral para componentes de dispositivos médicos con una tasa de recuperación de material del 78.4% en 2023.

• Reciclaje de componentes electrónicos: 65.2%
• Reciclaje de componentes de metal: 82.7%
• Reciclaje de componentes de plástico: 54.3%

Avinger, Inc. (AVGR) - PESTLE Analysis: Social factors

Growing prevalence of Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD) due to an aging US population.

The core social tailwind for Avinger, Inc.'s market pivot is the undeniable demographic shift in the United States. The US population is projected to be around 350 million in 2025, and the median age hit a record high of 39.1 in 2024, reflecting an older populace. The number of Americans aged 65 and older is growing faster than any other group, and since cardiovascular disease (CVD) is far more common in older adults, this creates a massive, expanding patient pool.

This aging trend directly fuels the rise in target diseases. Between 2017 and 2020, approximately 127.9 million US adults (48.6%) had some form of CVD. For Avinger's new focus, the prevalence of ischemic heart disease (Coronary Artery Disease or CAD) is projected to rise 31% by 2060 compared with 2025 figures, with the total number of adults affected expected to reach 29 million. The former focus, Peripheral Artery Disease (PAD), also remains a significant burden, with the US market alone valued at $4.31 billion in 2024 and expected to grow to $6.2 billion by 2029.

Here's the quick math: more older people means more blocked arteries, so the demand for novel, effective treatments like Avinger's image-guided devices is only going to climb.

US Cardiovascular Disease Trend	Metric	Value/Projection (2025-Proximate Data)
Adults with CVD (2017-2020)	Total US Adults	127.9 million (48.6%)
Ischemic Heart Disease (CAD)	Projected Increase by 2060 (vs. 2025)	+31%
Peripheral Artery Disease (PAD) Market Size	2024 Value	$4.31 billion
US Median Age (2024)	Indicator of Aging Population	39.1 (Record High)

Shift in company focus from PAD to the higher-need, complex CAD market (Chronic Total Occlusions).

The company's strategic pivot in early 2025 was a necessary, market-driven move toward a higher-value, more complex clinical need: Chronic Total Occlusions (CTO) in the coronary arteries. CTOs are complete blockages that are often difficult or impossible to cross with traditional wires, leading to complex and often unsuccessful procedures.

By ceasing the production and sales of its Peripheral Artery Disease (PAD) products, Avinger has fully reallocated resources to developing its image-guided system for coronary CTO-crossing. This shift targets a patient population with a greater unmet need, plus it positions the company to redefine treatment in a large, underserved market segment.

Physician adoption of new, image-guided technology (Lumivascular) requires extensive training and cultural shift in intervention.

Avinger's Lumivascular platform, which uses real-time Optical Coherence Tomography (OCT) imaging, offers a clear clinical benefit by allowing physicians to see inside the artery during treatment. However, this technology represents a significant cultural shift in interventional cardiology. Historically, physicians have relied solely on X-ray (fluoroscopy) and tactile feedback to guide their catheters.

For Avinger, the social challenge isn't just selling a device; it's driving a change in medical practice. This requires:

• Extensive initial physician training and proctoring.
• Overcoming the inertia of established, familiar procedures.
• Integrating the new imaging console (Lightbox) into the catheterization lab workflow.

What this estimate hides is the slow nature of physician adoption. The success of the CAD pivot fundamentally depends on how quickly cardiologists are willing to adopt this new, image-guided approach for their most complex cases.

The company terminated 36 employees in January 2025 as part of the strategic shift, impacting local employment.

The strategic shift to focus on the CAD market had an immediate, tangible social impact on the company's workforce. In January 2025, Avinger terminated 36 employees effective immediately. This reduction included all personnel associated with the sales and manufacturing of the now-discontinued PAD products.

This action, while intended to generate significant cost savings and focus resources, has a direct negative effect on local employment, particularly in the Redwood City, California area where the company is based. For the community, this represents a loss of specialized, high-tech manufacturing and sales jobs, which can defintely impact the local economic environment and the company's reputation as an employer.

Avinger, Inc. (AVGR) - PESTLE Analysis: Technological factors

Proprietary Lumivascular platform uses Optical Coherence Tomography (OCT) for real-time, image-guided atherectomy.

Avinger's core technological moat is the Lumivascular platform, which integrates Optical Coherence Tomography (OCT) directly into the interventional catheter. This is a game-changer because it allows physicians to see inside the artery in real-time during a procedure, essentially giving them an internal GPS for plaque removal or chronic total occlusion (CTO) crossing. Other systems force doctors to rely on X-ray fluoroscopy (angiography) and tactile feel alone, which is like driving blindfolded.

The Pantheris family of atherectomy devices, guided by the Lightbox imaging console, is the commercial manifestation of this technology. The ability to visualize the vessel wall means doctors can precisely target diseased tissue and avoid damaging the healthy arterial wall, which is a major factor in reducing restenosis (re-narrowing) risk. The latest product, the Pantheris LV (Large Vessel) device, is commercially launched, demonstrating continuous incremental innovation in their Peripheral Artery Disease (PAD) portfolio.

Pivot to developing a new coronary Chronic Total Occlusion (CTO) crossing device represents a high-risk, high-reward R&D focus.

The company's most significant technological bet right now is the pivot toward the coronary space. They are developing an image-guided system to cross Chronic Total Occlusions (CTOs) in the coronary arteries, a procedure far more complex than in the peripheral vessels. This is a high-reward strategy because the global market for CTO Crossing Devices is estimated at a substantial $1.5 billion in 2025.

The risk is in the execution, but the payoff could be huge. Avinger is moving forward, having filed an Investigational Device Exemption (IDE) pre-submission package with the FDA. Crucially, patient enrollment for the clinical study of this proprietary coronary crossing system is expected to begin in H1 2025. This transition requires them to re-allocate resources, which we saw in Q3 2024 when operating expenses were reduced to $4.1 million to specifically fund the coronary program. It's a classic small-cap move: bet the company on a revolutionary product in a massive, underserved market.

Facing intense competition from larger medical device companies with greater resources and established product lines.

Here's the reality check: Avinger is a tiny player in a field dominated by giants. Their trailing twelve-month (TTM) revenue as of late 2024 was just $7.26 million, and they reported a net loss of over $18.6 million. This is the financial backdrop against which they must compete with established players like Medtronic and BD (Becton, Dickinson and Company).

The resource disparity is staggering, and it's the biggest technological risk. You can't out-innovate a giant without massive funding, and Avinger simply doesn't have it.

Here's the quick math on the R&D gap:

Company	Primary Focus	FY 2025 Annual Revenue	FY 2025 Annual R&D Expenditure
Medtronic	Global Medical Technology	~$33.63 billion	~$2.732 billion
BD (Becton, Dickinson and Company)	Global Medical Technology	~$21.8 billion	~$1.265 billion
Avinger, Inc.	Image-Guided Vascular Devices	~$7.26 million (TTM)	Part of ~$4.1 million Q3 2024 OpEx

Continuous innovation is required to maintain a competitive advantage in minimally invasive vascular intervention.

To survive, Avinger must maintain a high rate of innovation, even with its constrained budget. The Lumivascular technology is a clear differentiator, but it's not a permanent shield. Larger competitors are constantly advancing their own imaging modalities, such as Intravascular Ultrasound (IVUS), and improving their CTO crossing and atherectomy devices.

Avinger's technology strategy must focus on three things:

• Expand OCT Applications: Successfully translate the Lumivascular advantage from peripheral (PAD) to coronary (CAD) arteries.
• Protect IP: Defintely defend the proprietary nature of the integrated OCT-guided catheter design.
• Cost-Efficient Manufacturing: Use partnerships, like the one with Zylox-Tonbridge in China, to build cost-efficient manufacturing capacity to support global sales and improve gross margins, which were 26% in Q3 2024.

The continued commercial launch of products like the Tigereye ST next-generation CTO crossing system shows they are moving, but the long-term success hinges entirely on the coronary CTO device and its ability to deliver superior clinical outcomes that justify its adoption over the massive sales and support channels of the industry behemoths.

Avinger, Inc. (AVGR) - PESTLE Analysis: Legal factors

Received a Nasdaq delisting notice in February 2025 due to non-compliance with listing rules

You need to understand the immediate legal consequence of Avinger's financial distress, which was the loss of its primary trading venue. The company's common stock was suspended from trading on the Nasdaq Stock Market on February 18, 2025, and Nasdaq formally announced the delisting on June 11, 2025. The core issue was non-compliance with the exchange's minimum bid price requirement, specifically Nasdaq Listing Rule 5550(a)(2).

This failure to meet the $1.00 minimum bid price was a clear signal of terminal financial distress. To be fair, the stock price was already down to $0.47 as of February 20, 2025, reflecting the market's grim view of the company's future. The delisting immediately reduces the stock's liquidity and makes it much harder to raise capital, a critical blow that often forces institutional investors to sell their positions.

The Assignment for the Benefit of Creditors (ABC) is a formal legal process for orderly liquidation or restructuring

The most defining legal event of 2025 was the decision to enter into an Assignment for the Benefit of Creditors (ABC). This is a formal, state-law-based legal process, often a faster and less expensive alternative to a Chapter 7 or Chapter 11 bankruptcy filing, used for an orderly liquidation or restructuring.

On February 10, 2025, Avinger executed a general assignment for the benefit of creditors, transferring control of all or substantially all of its assets to an assignee, Avinger (assignment for the benefit of creditors), LLC. This action confirmed the company was unable to meet its financial obligations, even after attempts to streamline operations, including a 24% overall headcount reduction in June 2024. Here's the quick math on their financial situation just prior to the ABC:

Metric (Q3 2024)	Value	Context
Total Revenue	$1.7 million	Down slightly year-over-year.
Net Loss	$3.7 million	Improved 17% year-over-year, but still a significant burn.
Headcount Reduction	24%	Cost-cutting effort to stem the loss.

The ABC process means the assignee now holds the legal responsibility to liquidate assets and distribute proceeds to creditors based on a strict priority of claims. Common stockholders are typically at the bottom of this priority list, so their risk of a total loss is defintely high.

New coronary devices require a rigorous Investigational Device Exemption (IDE) pre-submission pathway with the FDA

Before the ABC, Avinger had strategically pivoted to its coronary artery disease program, a move that requires navigating the most rigorous regulatory hurdles. New, high-risk devices that require clinical trials must secure an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA) before human testing can begin.

The company had submitted a pre-IDE package in September 2024 for its coronary OCT-guided CTO crossing system and expected to file the full IDE in Q4 2024, with patient enrollment slated for the first half of 2025. The ABC, however, essentially halted this process. The assignee now holds a promising but unapproved asset, and they must either find a buyer willing to take on the significant regulatory and financial burden of the IDE and subsequent clinical trial, or the asset will be liquidated.

Compliance with the FDA's Class II Special Controls and Good Manufacturing Practice (GMP) regulations is mandatory for all products

All of Avinger's commercial devices, such as the Pantheris and Tigereye systems, are classified as Class II medical devices. This classification mandates adherence to both general controls and specific Class II Special Controls set by the FDA to ensure their safety and effectiveness. This is a non-negotiable legal liability for the assignee.

Plus, the assignee must ensure the manufacturing facility complies with Good Manufacturing Practice (GMP) regulations, codified in 21 CFR Part 820, also known as the Quality System Regulation (QSR). The FDA is tightening its enforcement here; as of early September 2025, the agency had issued 19 Warning Letters citing Quality System Regulation violations, a significant jump from 12 in the same period in 2024. This trend signals that the assignee must prioritize this compliance to avoid further legal action or asset devaluation during the liquidation process.

The regulatory burden doesn't just disappear with the ABC; it transfers as a core liability with the physical assets.

Avinger, Inc. (AVGR) - PESTLE Analysis: Environmental factors

Medical device manufacturing and hospital use generate regulated biomedical and general waste requiring specialized disposal.

The core challenge for any medical device company, even one with a light manufacturing footprint like Avinger, is the downstream waste generated by hospitals. The US healthcare sector creates a massive volume of waste, estimated at 3.5 million tons of medical waste annually. Of this, approximately 15% is classified as hazardous (infectious, pathological, or chemical) and requires specialized, regulated disposal processes like autoclaving or incineration.

Hospitals, clinics, and laboratories are the primary generators, accounting for over 60% of the total waste stream. This means every single-use catheter or device Avinger sells becomes part of a complex and costly waste management system. The North America Bio-Medical Waste Management Market size is estimated to reach $19.58 billion in 2025, growing at a CAGR of 4.02%, which shows the scale of this essential, but environmentally taxing, service.

Focus on catheter-based, minimally invasive procedures generally reduces the environmental footprint compared to open surgery.

Avinger's focus on catheter-based, image-guided procedures for peripheral artery disease (PAD) and chronic total occlusions (CTO) is inherently more environmentally favorable than traditional open surgery. This is a clear benefit, but it's defintely not a clean slate.

Minimally Invasive Surgery (MIS) pathways reduce the overall environmental burden primarily by cutting down on hospital resource use. Shorter patient stays mean less energy consumption for heating, ventilation, and air conditioning (HVAC), which is a major energy hotspot in hospitals. However, the environmental impact shifts from hospital operations to the production and disposal of single-use devices-the catheters and ancillary kits that are Avinger's products.

Here's the quick math: A systematic review of MIS carbon footprints found a wide range of environmental impact, from 6 to 814 kg of CO2 emission per surgery. While a procedure like uterine artery embolization (a minimally invasive, non-surgical procedure) generated an estimated 3.9 kg of waste and 39 kg of CO2-equivalent from the procedure itself, a surgical alternative (hysterectomy) generated 7.9 kg of waste and 120 kg of CO2-equivalent, demonstrating the clear advantage of the minimally invasive approach.

Global push for sustainable healthcare supply chains and reduced single-use plastic in medical devices.

The industry is under increasing pressure to adopt circular economy principles (Circularity). Over 55% of healthcare providers are now shifting toward eco-friendly waste disposal methods, and this demand flows directly up the supply chain to device manufacturers. The key opportunity for companies like Avinger is in their product design-specifically, reducing single-use plastic and improving device recyclability.

Major players are already setting aggressive targets. For instance, Coloplast achieved a 77% production waste recycling rate in its 2023/2024 fiscal year, exceeding its 2025 goal of 75%. This sets a high benchmark for the entire sector. The pressure is on to find alternatives to the single-use model, which is a significant environmental hotspot for all catheter-based technologies.

Metric	2025 US/Global Data	Implication for Catheter-Based Devices
US Annual Medical Waste Generation	Estimated 3.5 million tons	All single-use catheters contribute to this massive volume, requiring specialized, costly disposal.
Hazardous Waste Percentage (WHO)	Approximately 15% of hospital waste	Regulated medical waste (RMW) from procedures drives up disposal costs and environmental risk.
Minimally Invasive Surgery (MIS) CO2 Footprint	Range of 6-814 kg CO2-eq per surgery	The environmental cost is primarily in the production and disposal of the single-use device itself, not the hospital stay.
Healthcare Provider Shift to Eco-Friendly Disposal	Over 55% of providers shifting	Growing customer demand for devices that are recyclable or have a lower life-cycle carbon footprint.

Company's shift away from manufacturing/sales of PAD products in January 2025 reduces its direct manufacturing environmental impact.

Avinger's strategic shift, announced in January 2025, has a dramatic, albeit involuntary, environmental consequence. The company ceased the manufacture and sale of its PAD products, leading to the termination of 36 employees, including all sales and manufacturing personnel.

This move effectively eliminates Avinger's Scope 1 and Scope 2 environmental emissions-the direct impact from owned or controlled manufacturing facilities and the indirect impact from purchased energy for those operations. The company's focus immediately shifted to Research and Development (R&D) for Coronary Artery Disease (CAD) devices.

The ultimate environmental impact reduction is tied to the stockholders' approval of a voluntary dissolution and liquidation plan in May 2025. This action signals a near-total cessation of commercial activity and manufacturing, which, while a negative financial outcome, results in the lowest possible direct corporate environmental footprint: near zero. The environmental debate for Avinger now rests solely on the end-of-life management of the remaining single-use devices already in the market.

• Eliminate all Scope 1 and 2 emissions by ending manufacturing.
• Reduce hazardous waste generation from R&D activities only, not production.
• Transfer the full environmental responsibility to the hospital for existing product disposal.