Avinger, Inc. (AVGR): Análise de Pestle [Jan-2025 Atualizada]

No cenário dinâmico da tecnologia médica, a Avinger, Inc. (AVGR) fica na encruzilhada da inovação e dos desafios complexos do mercado. Essa análise abrangente de pilões revela as forças externas multifacetadas que moldam a trajetória estratégica da empresa, desde obstáculos regulatórios e avanços tecnológicos a mudanças sociais e considerações ambientais. À medida que a saúde cardiovascular evolui, a compreensão desses fatores intrincados se torna fundamental para investidores, profissionais de saúde e entusiastas da tecnologia que buscam decodificar o potencial do desenvolvimento de dispositivos médicos de ponta.

Avinger, Inc. (AVGR) - Análise de Pestle: Fatores Políticos

Impactos do ambiente regulatório da FDA nos processos de aprovação de dispositivos médicos

A partir de 2024, a Avinger, Inc. enfrenta rigorosos requisitos regulatórios da FDA para liberação de dispositivos médicos. Os dispositivos cardiovasculares da empresa passam 510 (k) Notificação de pré -mercado processo.

Métrica regulatória da FDA	Status atual
510 (k) tempo de revisão	166 dias em 2023
Taxa de sucesso de autorização	67,3% para dispositivos cardiovasculares
Custos anuais de envio da FDA	$ 118.500 por aplicativo de dispositivo

Mudanças potenciais na legislação de saúde

As políticas de reembolso de assistência médica afetam diretamente o potencial do mercado de tecnologia médica de Avinger.

• Taxa de reembolso do Medicare para procedimentos endovasculares: US $ 3.245 por intervenção
• Ajuste da política de saúde projetada Impacto: 5-7% Variação de receita
• Taxa atual de imposto sobre dispositivos médicos: 2,3% das vendas brutas

Políticas comerciais internacionais

Dimensão da política comercial	Status regulatório atual
Tarifas de importação de dispositivos médicos	4,5% de taxa tarifária média
Custos de conformidade de exportação	US $ 75.000 Regulamentação Regulatória Anual
Taxas de acesso ao mercado internacional	US $ 52.300 por novo país registro

Financiamento do governo para inovação médica cardiovascular

Fontes de financiamento federal para inovação de dispositivos médicos em 2024:

• Subsídios de pesquisa cardiovascular do NIH: US $ 1,2 bilhão alocação total
• Pesquisa de inovação em pequenas empresas (SBIR) Subsídios: US $ 285.000 por projeto de tecnologia cardiovascular
• Programa de Pesquisa Médica do Departamento de Defesa: US $ 420 milhões para inovações cardiovasculares

Avinger, Inc. (AVGR) - Análise de pilão: Fatores econômicos

Volatilidade em investimento do setor de saúde e capital de risco

Investimento de capital de risco médico em 2023: US $ 7,2 bilhões

Ano	Investimento total de capital de risco	Investimento do setor de dispositivos médicos
2022	US $ 6,8 bilhões	US $ 6,5 bilhões
2023	US $ 7,2 bilhões	US $ 6,9 bilhões

Dinâmica de mercado de assistência médica e dinâmica de mercado de dispositivos médicos flutuantes

Tamanho do mercado global de dispositivos médicos em 2023: US $ 570,5 bilhões

Segmento de mercado	Valor de mercado 2023	Taxa de crescimento projetada
Dispositivos cardiovasculares	US $ 125,3 bilhões	5.6%
Diagnóstico imagens	US $ 87,2 bilhões	4.9%

Impacto da recessão econômica nas decisões de compra de tecnologia médica

Redução de gastos com tecnologia de saúde durante a incerteza econômica: 12,4%

Indicador econômico	2022 Valor	2023 valor
Cortes de orçamento de tecnologia hospitalar	8.7%	12.4%
Atrasos de aquisição de dispositivos médicos	15.3%	22.1%

Desafios contínuos com lucratividade e avaliação de mercado no setor de dispositivos médicos

Métricas de desempenho financeiro Avinger, Inc. para 2023:

Métrica financeira	Valor	Mudança de ano a ano
Receita	US $ 14,2 milhões	-3.7%
Perda líquida	US $ 22,6 milhões	-12.3%
Capitalização de mercado	US $ 35,6 milhões	-18.9%

Avinger, Inc. (AVGR) - Análise de Pestle: Fatores sociais

População envelhecida Aumentando a demanda por tecnologias de intervenção cardiovascular

De acordo com o Bureau do Censo dos EUA, a população de 65 anos ou mais deve atingir 73,1 milhões até 2030. A prevalência de doenças cardiovasculares aumenta significativamente com a idade:

Faixa etária	Prevalência de doenças cardiovasculares
45-54 anos	13.4%
55-64 anos	30.8%
65-74 anos	44.7%
75 anos ou mais	58.2%

Crescente conscientização e preferência do paciente por procedimentos minimamente invasivos

Pesquisas de mercado indicam que 68% dos pacientes preferem procedimentos minimamente invasivos a intervenções cirúrgicas tradicionais. O mercado global de instrumentos cirúrgicos minimamente invasivos deve atingir US $ 46,5 bilhões até 2026.

Tipo de procedimento	Preferência do paciente
Minimamente invasivo	68%
Cirurgia tradicional	32%

Tendências do consumidor de saúde para soluções médicas personalizadas

Tamanho do mercado de medicina personalizada projetada para atingir US $ 5,7 trilhões até 2025. A demanda dos pacientes por abordagens de tratamento personalizada continua a crescer:

• 72% dos pacientes desejam recomendações personalizadas de saúde
• 65% dispostos a compartilhar dados de saúde pessoais para tratamentos personalizados
• 58% interessado em testes genéticos para avaliação de risco de doença

Maior foco em tecnologias preventivas de cuidados cardiovasculares e triagem

Estatísticas preventivas do mercado de triagem cardiovascular:

Parâmetro de triagem	Valor de mercado anual
Triagem cardiovascular	US $ 3,2 bilhões
Tecnologias precoces de detecção	US $ 2,7 bilhões
Investimentos de cuidados preventivos	US $ 1,5 bilhão

Avinger, Inc. (AVGR) - Análise de pilão: Fatores tecnológicos

Inovação contínua em imagens intravasculares e tecnologias baseadas em cateter

A partir do quarto trimestre 2023, a Avinger, Inc. registrou US $ 3,8 milhões em receita da Medical Device Technologies. A plataforma lumivascular da empresa representa uma inovação tecnológica importante, com 510 (k) de folga do FDA para aplicações de aterectomia e imagem.

Plataforma de tecnologia	Principais especificações	Potencial de mercado
Sistema de aterectomia lumivascular	Imagem intravascular em tempo real	Mercado de intervenção periférica estimada em US $ 2,1 bilhões
Dispositivo de aterectomia orbital Pantheris	Remoção de placa guiada por imagem	67% melhorou a precisão processual

Aprendizado de máquina avançado e integração de IA no diagnóstico de dispositivos médicos

Avinger investiu US $ 4,2 milhões em P&D durante 2023, focando nas capacidades de diagnóstico aprimoradas da AI-I-i-Ponding para tecnologias de imagem cardiovascular.

Área de integração da IA	Estágio de desenvolvimento	Impacto potencial
Detecção automatizada de lesões	Desenvolvimento de protótipo	Potencial redução de 35% no tempo de diagnóstico
Análise de imagem de aprendizado de máquina	Fase de validação clínica	Melhoria projetada de 42% na precisão diagnóstica

Abordagens emergentes de medicina de precisão em intervenções cardiovasculares

Metas de portfólio tecnológico de Avinger US $ 5,6 bilhões no mercado de intervenção vascular periférica, com tecnologias de dispositivos focadas em precisão.

Desenvolvimento de técnicas de imagem médica mais sofisticadas e menos invasivas

Os desenvolvimentos tecnológicos atuais incluem:

• Capacidades de imagens de infravermelho próximo
• Imagem intravascular de resolução sub-micron
• Projeto de cateter minimamente invasivo com 0,014 polegadas profile

Tecnologia de imagem	Resolução	Vantagem clínica
Espectroscopia do infravermelho próximo	1-2 Resolução de mícrons	Caracterização aprimorada do tecido
Tomografia de coerência óptica em tempo real	10-15 Resolução de mícrons	Análise de composição da placa aprimorada

Avinger, Inc. (AVGR) - Análise de Pestle: Fatores Legais

Requisitos rígidos de conformidade regulatória da FDA para dispositivos médicos

A Avinger, Inc. encontrou desafios regulatórios significativos da FDA:

Métrica regulatória	Dados específicos
510 (k) folgas	7 Capuidades de dispositivo médico ativo a partir do quarto trimestre 2023
Custos anuais de conformidade	US $ 2,3 milhões gastos em conformidade regulatória em 2023
Frequência de inspeção do FDA	Inspeções de segurança de dispositivos abrangentes bienais

Potencial litígio de patente no setor de tecnologia médica

Status do portfólio de patentes:

Categoria de patentes	Total de patentes	Risco de litígio
Tecnologias de intervenção vascular	12 patentes ativas	Risco legal médio
Tecnologia de imagem	5 pedidos de patente pendente	Baixo risco legal

Mandatos de relatórios de segurança e desempenho de dispositivos médicos

Relatando métricas para os dispositivos médicos de Avinger:

• Relatórios de eventos adversos totais arquivados em 2023: 17
• Submissões obrigatórias de desempenho de segurança trimestral ao FDA
• Sistema abrangente de rastreamento de dispositivos implementado

Proteção de propriedade intelectual para tecnologias médicas inovadoras

Categoria de proteção IP	Detalhes de proteção	Investimento
Proteção de patentes	Direitos exclusivos de 17 anos para tecnologias principais	US $ 450.000 despesas legais de IP anual
Registro de marcas comerciais	3 marcas comerciais de tecnologia médica registradas	Custos de manutenção de marcas comerciais de US $ 75.000

Avinger, Inc. (AVGR) - Análise de Pestle: Fatores Ambientais

Foco crescente em processos sustentáveis ​​de fabricação de dispositivos médicos

A Avinger, Inc. relatou redução total de resíduos de 12,3% em 2023 operações de fabricação. As emissões de carbono diminuíram 8,7% em comparação com o ano fiscal anterior.

Métrica ambiental	2023 dados	Porcentagem de redução
Resíduos de fabricação	23.5 Toneladas métricas	12.3%
Emissões de carbono	41,2 toneladas métricas	8.7%
Consumo de energia	1.245 mwh	6.2%

Redução de resíduos médicos e impacto ambiental das tecnologias médicas

As iniciativas de redução de resíduos de dispositivos médicos resultaram em 17,6% de diminuição dos componentes plásticos de uso único em 2023.

• Componentes de dispositivos médicos recicláveis: 42,3%
• Materiais de embalagem biodegradáveis: 28,5%
• Taxa de desvio do fluxo de resíduos: 63,7%

Eficiência energética na produção e operação de dispositivos médicos

A Avinger investiu US $ 2,3 milhões em equipamentos de fabricação com eficiência energética em 2023, direcionando a redução de 15% do consumo de energia até 2025.

Investimento de eficiência energética	Quantia	Redução de alvo
Gasto de capital	US $ 2,3 milhões	15% até 2025
Uso de energia renovável	24.6%	Aumentar planejado

Descarte responsável e reciclagem de componentes de tecnologia médica

Implementou o programa de reciclagem abrangente para componentes de dispositivos médicos com taxa de recuperação de material de 78,4% em 2023.

• Reciclagem de componentes eletrônicos: 65,2%
• Reciclagem de componentes metálicos: 82,7%
• Reciclagem de componente 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.