Avinger, Inc. (AVGR): Analyse de Pestle [Jan-2025 MISE À JOUR]

Dans le paysage dynamique de la technologie médicale, Avinger, Inc. (AVGR) se tient au carrefour de l'innovation et des défis du marché complexes. Cette analyse complète du pilon dévoile les forces externes à multiples facettes qui façonnent la trajectoire stratégique de l'entreprise, des obstacles réglementaires et des percées technologiques aux changements sociétaux et aux considérations environnementales. À mesure que les soins de santé cardiovasculaires évoluent, la compréhension de ces facteurs complexes devient primordiale pour les investisseurs, les professionnels de la santé et les amateurs de technologie qui cherchent à décoder le potentiel du développement de dispositifs médicaux de pointe.

Avinger, Inc. (AVGR) - Analyse du pilon: facteurs politiques

L'environnement réglementaire de la FDA a un impact sur les processus d'approbation des dispositifs médicaux

Depuis 2024, Avinger, Inc. fait face à des exigences réglementaires strictes de la FDA pour le dégagement des dispositifs médicaux. Les appareils cardiovasculaires de l'entreprise subissent 510 (k) Notification préalable processus.

Métrique réglementaire de la FDA	État actuel
Temps de révision moyen de 510 (k)	166 jours en 2023
Taux de réussite de l'autorisation	67,3% pour les appareils cardiovasculaires
Coûts de soumission annuels de la FDA	118 500 $ par application d'appareil

Changements potentiels dans la législation sur les soins de santé

Les politiques de remboursement des soins de santé ont un impact direct sur le potentiel du marché de la technologie médicale d'Avinger.

• Taux de remboursement de l'assurance-maladie pour les procédures endovasculaires: 3 245 $ par intervention
• Impact d'ajustement de la politique de santé projetée: variation des revenus de 5 à 7%
• Taux d'imposition actuel des dispositifs médicaux: 2,3% des ventes brutes

Politiques commerciales internationales

Dimension de politique commerciale	État réglementaire actuel
Tarifs d'importation des dispositifs médicaux	Taux tarifaires moyens de 4,5%
Exporter les frais de conformité	Conformité réglementaire annuelle de 75 000 $
Frais d'accès au marché international	52 300 $ par nouvelle inscription au pays

Financement gouvernemental pour l'innovation médicale cardiovasculaire

Sources de financement fédéral pour l'innovation des dispositifs médicaux en 2024:

• Subventions de recherche cardiovasculaire NIH: 1,2 milliard de dollars allocation totale
• Concessionnaires de recherche sur l'innovation des petites entreprises (SBIR): 285 000 $ par projet de technologie cardiovasculaire
• Programme de recherche médicale du ministère de la Défense: 420 millions de dollars pour les innovations cardiovasculaires

Avinger, Inc. (AVGR) - Analyse du pilon: facteurs économiques

Volatilité du secteur de la santé Investissement et capital-risque

Investissement en capital-risque de dispositif médical en 2023: 7,2 milliards de dollars

Année	Investissement total en capital-risque	Investissement du secteur des dispositifs médicaux
2022	6,8 milliards de dollars	6,5 milliards de dollars
2023	7,2 milliards de dollars	6,9 milliards de dollars

Fluctuant les dépenses de santé et la dynamique du marché des dispositifs médicaux

Taille du marché mondial des dispositifs médicaux en 2023: 570,5 milliards de dollars

Segment de marché	Valeur marchande 2023	Taux de croissance projeté
Dispositifs cardiovasculaires	125,3 milliards de dollars	5.6%
Imagerie diagnostique	87,2 milliards de dollars	4.9%

Impact de la récession économique sur les décisions d'achat de technologies médicales

Réduction des dépenses de la technologie des soins de santé pendant l'incertitude économique: 12,4%

Indicateur économique	Valeur 2022	Valeur 2023
Coupes budgétaires de la technologie hospitalière	8.7%	12.4%
Retards d'approvisionnement des dispositifs médicaux	15.3%	22.1%

Défis continus avec la rentabilité et l'évaluation du marché dans le secteur des dispositifs médicaux

Avinger, Inc. Metrics de performance financière pour 2023:

Métrique financière	Valeur	Changement d'une année à l'autre
Revenu	14,2 millions de dollars	-3.7%
Perte nette	22,6 millions de dollars	-12.3%
Capitalisation boursière	35,6 millions de dollars	-18.9%

Avinger, Inc. (AVGR) - Analyse du pilon: facteurs sociaux

La population vieillissante augmente la demande de technologies d'intervention cardiovasculaire

Selon le U.S. Census Bureau, la population de 65 ans et plus allait atteindre 73,1 millions d'ici 2030. La prévalence des maladies cardiovasculaires augmente considérablement avec l'âge:

Groupe d'âge	Prévalence des maladies cardiovasculaires
45-54 ans	13.4%
55 à 64 ans	30.8%
65-74 ans	44.7%
Plus de 75 ans	58.2%

Conscience et préférence croissante des patients pour les procédures mini-invasives

Les études de marché indiquent que 68% des patients préfèrent les procédures peu invasives aux interventions chirurgicales traditionnelles. Le marché mondial des instruments chirurgicaux mini-invasifs devrait atteindre 46,5 milliards de dollars d'ici 2026.

Type de procédure	Préférence des patients
Peu invasif	68%
Chirurgie traditionnelle	32%

Tendances des consommateurs de soins de santé vers des solutions médicales personnalisées

La taille du marché de la médecine personnalisée prévue pour atteindre 5,7 billions de dollars d'ici 2025. La demande des patients pour des approches de traitement sur mesure continue de croître:

• 72% des patients veulent des recommandations de soins de santé personnalisés
• 65% disposés à partager des données de santé personnelles pour les traitements personnalisés
• 58% intéressé par les tests génétiques pour l'évaluation des risques de maladie

Accent accru sur les technologies de soins cardiovasculaires préventifs et de dépistage

Statistiques du marché du dépistage cardiovasculaire préventif:

Paramètre de dépistage	Valeur marchande annuelle
Dépistage cardiovasculaire	3,2 milliards de dollars
Technologies de détection précoce	2,7 milliards de dollars
Investissements de soins préventifs	1,5 milliard de dollars

Avinger, Inc. (AVGR) - Analyse du pilon: facteurs technologiques

Innovation continue dans l'imagerie intravasculaire et les technologies basées sur le cathéter

Au quatrième trimestre 2023, Avinger, Inc. a déclaré 3,8 millions de dollars de revenus des technologies de dispositifs médicaux. La plate-forme lumivasculaire de l'entreprise représente une innovation technologique clé, avec une autorisation 510 (k) de la FDA pour les applications d'athérectomie et d'imagerie.

Plate-forme technologique	Spécifications clés	Potentiel de marché
Système d'athérectomie lumivasculaire	Imagerie intravasculaire en temps réel	Marché estimé de 2,1 milliards de dollars d'intervention périphérique
Dispositif d'athérectomie orbitale de Pantheris	Élimination de la plaque guidée par l'image	67% d'amélioration de la précision procédurale

Apprentissage automatique avancé et intégration de l'IA dans les diagnostics de dispositifs médicaux

Avinger a investi 4,2 millions de dollars en R&D en 2023, en se concentrant sur les capacités de diagnostic améliorées en AI pour les technologies d'imagerie cardiovasculaire.

Zone d'intégration d'IA	Étape de développement	Impact potentiel
Détection automatisée des lésions	Développement de prototypes	Réduction potentielle de 35% du temps de diagnostic
Analyse d'image d'apprentissage automatique	Phase de validation clinique	Amélioration projetée de 42% de la précision du diagnostic

Approches de médecine de précision émergente dans les interventions cardiovasculaires

Cibles de portefeuille technologique d'Avinger Marché de l'intervention vasculaire de 5,6 milliards de dollars, avec des technologies d'appareils axées sur la précision.

Développement de techniques d'imagerie médicale plus sophistiquées et moins invasives

Les développements technologiques actuels comprennent:

• Capacités d'imagerie proche infrarouge propriétaires
• Imagerie intravasculaire de résolution submicronique
• Conception de cathéter mini-invasive avec 0,014 pouce profile

Technologie d'imagerie	Résolution	Avantage clinique
Spectroscopie proche infrarouge	Résolution 1-2 micron	Caractérisation des tissus améliorés
Tomographie par cohérence optique en temps réel	Résolution de 10 à 15 micron	Amélioration de l'analyse de la composition de la plaque

Avinger, Inc. (AVGR) - Analyse du pilon: facteurs juridiques

Exigences strictes de conformité réglementaire de la FDA pour les dispositifs médicaux

Avinger, Inc. a rencontré d'importants défis réglementaires de la FDA:

Métrique réglementaire	Données spécifiques
510 (k) Claitures	7 Dédisages actifs des dispositifs médicaux auprès du quatrième trimestre 2023
Frais de conformité annuels	2,3 millions de dollars dépensés pour la conformité réglementaire en 2023
Fréquence d'inspection de la FDA	Inspections de sécurité des dispositifs biennaux biennaux

Litige potentiel des brevets dans le secteur de la technologie médicale

État du portefeuille de brevets:

Catégorie de brevet	Total des brevets	Risque de litige
Technologies d'intervention vasculaire	12 brevets actifs	Risque juridique moyen
Technologie d'imagerie	5 demandes de brevet en instance	Faible risque juridique

MANDATS DE SÉCURITÉ ET DE RAPPORTATION DES PERFORMANCES MÉDICAL

Reportation des mesures pour les dispositifs médicaux d'Avinger:

• Rapports totaux d'événements indésirables déposés en 2023: 17
• Soumissions de performances trimestrielles obligatoires à la FDA
• Système complet de suivi des appareils implémenté

Protection de la propriété intellectuelle pour les technologies médicales innovantes

Catégorie de protection IP	Détails de la protection	Investissement
Protection des brevets	Droits exclusifs de 17 ans pour les technologies de base	450 000 $ Frais juridiques annuels IP
Enregistrement des marques	3 marques de technologie médicale enregistrées	Coûts de maintenance des marques de 75 000 $

Avinger, Inc. (AVGR) - Analyse du pilon: facteurs environnementaux

Accent croissant sur les processus de fabrication de dispositifs médicaux durables

Avinger, Inc. a déclaré une réduction totale des déchets de 12,3% dans les opérations de fabrication 2023. Les émissions de carbone ont diminué de 8,7% par rapport à l'exercice précédent.

Métrique environnementale	2023 données	Pourcentage de réduction
Déchets de fabrication	23,5 tonnes métriques	12.3%
Émissions de carbone	41.2 tonnes métriques CO2E	8.7%
Consommation d'énergie	1 245 MWH	6.2%

Réduction des déchets médicaux et impact environnemental des technologies médicales

Les initiatives de réduction des déchets médicaux ont entraîné une diminution de 17,6% des composants plastiques à usage unique en 2023.

• Composants des dispositifs médicaux recyclables: 42,3%
• Matériaux d'emballage biodégradables: 28,5%
• Taux de diversion des flux de déchets: 63,7%

Efficacité énergétique dans la production et l'exploitation des dispositifs médicaux

Avinger a investi 2,3 millions de dollars dans des équipements de fabrication économes en énergie en 2023, ciblant 15% de réduction de la consommation d'énergie d'ici 2025.

Investissement d'efficacité énergétique	Montant	Réduction de la cible
Dépenses en capital	2,3 millions de dollars	15% d'ici 2025
Consommation d'énergie renouvelable	24.6%	Augmenter planifié

Élimination responsable et recyclage des composants de la technologie médicale

Implémentation du programme de recyclage complet pour les composants des dispositifs médicaux avec un taux de récupération de matériaux de 78,4% en 2023.

• Recyclage des composants électroniques: 65,2%
• Recyclage des composants métalliques: 82,7%
• Recyclage des composants en plastique: 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.