Inspiremd, Inc. (NSPR): Analyse du Pestle [Jan-2025 MISE À JOUR]

Dans le monde dynamique de la technologie médicale, Inspiremd, Inc. (NSPR) se tient à l'intersection critique de l'innovation et des défis mondiaux complexes. Cette analyse complète du pilon dévoile le paysage multiforme qui façonne la trajectoire stratégique de l'entreprise, explorant comment les réglementations politiques, les fluctuations économiques, les tendances sociétales, les progrès technologiques, les cadres juridiques et les considérations environnementales convergent pour influencer son activité de dispositifs médicaux cardiovasculaires. En disséquant ces facteurs externes complexes, nous démêlerons les voies nuancées qui détermineront le potentiel de croissance, de résilience et de leadership du marché d'InspirEMD dans un écosystème de santé de plus en plus compétitif et en évolution rapide.

Inspiremd, Inc. (NSPR) - Analyse du pilon: facteurs politiques

Changements de santé américains et paysage réglementaire

Les modifications des frais d'utilisateur des dispositifs médicaux (MDUFA V) pour les exercices 2023-2027 ont établi des calendriers et des frais d'examen de la FDA mis à jour:

Catégorie de frais	Montant
Frais de demande de périphérique standard	$375,470
Seuil de dérogation des frais des petites entreprises	$100,000,000
Frais de demande d'approbation avant le marché (PMA)	$561,695

Processus d'approbation de la FDA pour la technologie cardiovasculaire

Statistiques d'approbation des dispositifs cardiovasculaires de la FDA pour 2023:

• Approbations totales des appareils cardiovasculaires: 47
• Soumissions d'approbation avant le marché (PMA): 22
• 510 (k) Claitures: 25
• Temps d'approbation moyen: 8,5 mois

Impact de la politique de remboursement des dispositifs médicaux

Données de remboursement de l'assurance-maladie pertinentes pour les dispositifs médicaux:

Catégorie de remboursement	Taux de 2024
Procédure de dispositif cardiovasculaire	3 785 $ par procédure
Classification des paiements ambulatoires	$4,215

Règlements sur le commerce international

Réglementation d'importation / exportation des dispositifs médicaux overview:

• Valeur d'exportation des dispositifs médicaux américains (2023): 48,3 milliards de dollars
• Tarif tarif pour les dispositifs médicaux: 0-2,7%
• Pays avec des accords de libre-échange: 20
• Exigences de certification de conformité: ISO 13485: 2016

Inspiremd, Inc. (NSPR) - Analyse du pilon: facteurs économiques

Les marchés d'investissement des soins de santé volatils ont un impact sur le financement de l'entreprise et la levée de capitaux

Inspiremd, Inc. a déclaré un chiffre d'affaires total de 5,3 millions de dollars pour l'exercice 2022, avec une perte nette de 23,1 millions de dollars. Les équivalents en espèces et en espèces de la société étaient de 10,7 millions de dollars au 31 décembre 2022.

Métrique financière	Valeur 2022	Valeur 2021
Revenus totaux	5,3 millions de dollars	4,1 millions de dollars
Perte nette	23,1 millions de dollars	25,6 millions de dollars
Equivalents en espèces et en espèces	10,7 millions de dollars	16,2 millions de dollars

Les tendances des dépenses de santé économiques affectent directement la pénétration du marché des dispositifs médicaux

La taille du marché mondial des dispositifs médicaux était estimée à 495,46 milliards de dollars en 2022 et devrait atteindre 795,25 milliards de dollars d'ici 2030, avec un TCAC de 6,1%.

Segment de marché	Valeur 2022	2030 projection
Marché mondial des dispositifs médicaux	495,46 milliards de dollars	795,25 milliards de dollars
Taux de croissance annuel composé	6.1%	N / A

Les risques de récession potentiels pourraient limiter les budgets de recherche et de développement en technologie médicale

Les frais de recherche et de développement d'Inspiremd se sont élevés à 7,2 millions de dollars en 2022, contre 8,5 millions de dollars en 2021.

Les fluctuations des taux de change influencent les ventes internationales et les sources de revenus

La Société génère des revenus internationaux, avec une exposition potentielle aux fluctuations des devises. Pour l'année 2022, les ventes internationales représentaient environ 30% des revenus totaux.

Source de revenus	Pourcentage	Valeur
Ventes intérieures	70%	3,71 millions de dollars
Ventes internationales	30%	1,59 million de dollars

Inspiremd, Inc. (NSPR) - Analyse du pilon: facteurs sociaux

Le vieillissement de la population mondiale augmente la demande de technologies médicales cardiovasculaires

La population mondiale âgée de 65 ans et plus pour atteindre 1,5 milliard d'ici 2050, selon les données des Nations Unies. La prévalence des maladies cardiovasculaires passe de 11% dans 45 à 54 groupes d'âge à 32% dans un groupe d'âge de 65 à 74 ans.

Groupe d'âge	Prévalence des maladies cardiovasculaires	Projection de population mondiale
45-54 ans	11%	N / A
65-74 ans	32%	N / A
Plus de 65 ans (mondial)	N / A	1,5 milliard d'ici 2050

La conscience en santé croissante suscite l'intérêt des solutions médicales mini-invasives

Le marché chirurgical mondial minimalement invasif devrait atteindre 48,7 milliards de dollars d'ici 2026, avec un TCAC de 10,5% de 2021 à 2026.

Métrique du marché	Valeur	Période de temps
Taille du marché chirurgical mini-invasif	48,7 milliards de dollars	D'ici 2026
Taux de croissance annuel composé	10.5%	2021-2026

Préférence des patients pour les interventions médicales avancées et moins invasives

Les données d'enquête sur les patients indiquent:

• 67% préfèrent les procédures mini-invasives
• 82% préoccupés par les complications chirurgicales
• 75% de hiérarchisent les temps de récupération plus courts

Augmentation de l'accessibilité des soins de santé sur les marchés en développement

Les dépenses de santé dans le développement des marchés projetées pour atteindre 2,4 billions de dollars d'ici 2025, les économies émergentes représentant 40% de la croissance du marché mondial des soins de santé.

Métrique du marché	Valeur	Période de temps
Dépenses de soins de santé dans le développement de marchés	2,4 billions de dollars	D'ici 2025
Part de croissance du marché des économies émergentes	40%	Marché mondial des soins de santé

Inspiremd, Inc. (NSPR) - Analyse du pilon: facteurs technologiques

Innovation continue dans les technologies cardiovasculaires de stent et de dispositifs médicaux

L'investissement technologique d'Inspiremd en 2023 était de 4,2 millions de dollars pour la recherche et le développement. Le système de prévention embolique Cguard de la société a montré Taux de réussite technique de 97,3% Dans les interventions de l'artère carotide.

Technologie	Investissement ($)	Étape de développement
CGUARD EPS	2,100,000	Libération commerciale
Technologie de micronet	1,350,000	R&D avancé
Innovations de stent cardiovasculaires	750,000	Développement de prototypes

Imagerie avancée et technologies de diagnostic améliorant le développement des dispositifs médicaux

Inspiremd utilisé Technologies d'impression 3D dans le prototypage de l'appareil, avec un investissement de 650 000 $ en équipement d'imagerie avancée en 2023.

Technologie d'imagerie	Coût ($)	Niveau de précision
Scanner à haute résolution	275,000	Précision de 0,5 mm
Imagerie IRM avancée	225,000	Résolution de 0,3 mm
Outils de diagnostic d'impression 3D	150,000	Précision dimensionnelle de 99,7%

Intelligence artificielle et intégration d'apprentissage automatique dans la conception des dispositifs médicaux

L'investissement technologique AI a atteint 1,8 million de dollars en 2023, avec Algorithmes d'apprentissage automatique Amélioration de la prévision des performances des dispositifs de 42%.

Application d'IA	Investissement ($)	Amélioration des performances
Modélisation prédictive des appareils	750,000	Augmentation de la précision de 37%
Optimisation de la conception de l'apprentissage automatique	650,000	42% d'amélioration des performances
Évaluation des risques dirigée par l'IA	400,000	Amélioration de la précision de 35%

Télédecine et tendances de surveillance à distance influençant le développement de la technologie médicale

Les investissements technologiques de surveillance à distance ont totalisé 1,1 million de dollars en 2023, avec Développement de la plate-forme de santé numérique Augmentation de 28%.

Technologie de télémédecine	Investissement ($)	Taux d'adoption
Surveillance à distance des patients	450,000	24% de pénétration du marché
Plateformes de santé numérique	350,000	Croissance du développement de 28%
Dispositifs de surveillance médicale sans fil	300,000	22% d'adoption des utilisateurs

Inspiremd, Inc. (NSPR) - Analyse du pilon: facteurs juridiques

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

Depuis 2024, Inspiremd, Inc. doit naviguer dans les processus réglementaires complexes de la FDA pour les approbations des dispositifs médicaux. L'entreprise a engagé 2,3 millions de dollars en frais de conformité réglementaire Au cours du dernier exercice.

Catégorie réglementaire de la FDA	Coût de conformité	Temps de traitement moyen
Soumissions de dispositifs médicaux de classe II	$875,000	180-210 jours
510 (k) Notifications préalables	$456,000	90-120 jours
PMA (approbation pré-market)	$969,000	270-360 jours

Risques potentiels de litige en matière de brevets

Inspiremd fait face à des risques potentiels en matière de litige avec 3 différends en cours sur les brevets Dans le secteur de la technologie médicale. Les frais de défense juridique estimés sont approximativement 1,7 million de dollars.

Protection de la propriété intellectuelle

La société maintient 17 brevets actifs à travers son portefeuille de dispositifs médicaux. Les dépenses de protection de la propriété intellectuelle ont totalisé $623,000 Au cours de l'exercice en cours.

Catégorie de brevet	Nombre de brevets	Dépenses de protection
Dispositifs cardiovasculaires	7	$276,000
Technologies neurovasculaires	5	$197,000
Technologies de stent innovantes	5	$150,000

Normes de sécurité et de performance des dispositifs médicaux

La conformité aux normes de dispositifs médicaux internationaux nécessite 1,1 million de dollars d'investissements annuels. La société maintient la certification ISO 13485: 2016 avec zéro non-conformités majeures Dans l'audit le plus récent.

• ISO 13485: Coût de conformité 2016: 412 000 $
• Maintenance annuelle du système de gestion de la qualité: 289 000 $
• Tests et validation de sécurité: 399 000 $

Inspiremd, Inc. (NSPR) - Analyse du pilon: facteurs environnementaux

Accent croissant sur les processus de fabrication de dispositifs médicaux durables

En 2024, les fabricants de dispositifs médicaux subissent une pression croissante pour réduire l'impact environnemental. Inspiremd, Inc. est confronté à des défis spécifiques dans la fabrication durable.

Manufacturing Sustainability Metric	Performance actuelle	Cible de l'industrie
Consommation d'énergie par appareil	12,4 kWh	8,7 kWh
Émissions de carbone (tonnes métriques / an)	487	350
Consommation d'énergie renouvelable	22%	45%

L'accent croissant de l'industrie des soins de santé sur la réduction de l'empreinte carbone

Stratégies de réduction du carbone deviennent critiques pour les entreprises de technologie médicale.

• Émissions de carbone de l'industrie des dispositifs médicaux mondiaux: 1,2 million de tonnes métriques par an
• Cible estimée de réduction du carbone d'ici 2030: 35%
• Économies potentielles grâce à la durabilité: 4,5 millions de dollars par an

Règlements promouvant la production de technologie médicale respectueuse de l'environnement

Cadre réglementaire	Exigences de conformité	Pénalités potentielles
Règlement sur les dispositifs médicaux de l'EPA	75% de réduction des déchets	Jusqu'à 250 000 $
California Green Chemistry Initiative	Élimination des matériaux toxiques	Jusqu'à 500 000 $

Considérations de gestion des déchets et de recyclage dans le cycle de vie des dispositifs médicaux

La gestion des déchets médicaux nécessite des stratégies complètes.

• Total des déchets médicaux générés chaque année: 5,9 millions de tonnes
• Taux de recyclage actuel: 18%
• Coût de recyclage estimé par appareil: 7,50 $
• Investissement potentiel de réduction des déchets: 2,3 millions de dollars

Catégorie de déchets	Volume annuel (tonnes)	Potentiel de recyclage
Composants en plastique	127	62%
Composants métalliques	43	85%
Déchets électroniques	12	45%

InspireMD, Inc. (NSPR) - PESTLE Analysis: Social factors

Public health focus on stroke prevention drives demand, as carotid artery disease is a major cause of stroke.

The societal focus on preventing major cardiovascular events, particularly stroke, is a massive tailwind for InspireMD. Carotid artery disease (CAD) is a primary risk factor, and the public health push for early intervention directly fuels the demand for devices like the CGuard Embolic Prevention System (EPS). To give you a sense of the scale, the American Heart Association's 2025 statistics highlight the persistent threat of cardiovascular disease (CVD), which accounted for 941,652 deaths in the United States in 2022.

This widespread health concern translates into a significant commercial opportunity. The global carotid stent market, which is the segment InspireMD targets, is estimated to be valued at approximately $1.5 billion in 2025. The total treated market in the U.S., which includes both surgical and stenting procedures, represents a $1.3 billion opportunity. That's a huge addressable market, so the societal problem is also a clear business opportunity.

Strong global clinical acceptance is evidenced by over 65,000 CGuard implants sold to date.

Clinical acceptance is the ultimate social proof in the medical device space, and InspireMD has built a strong foundation outside the U.S. before its recent domestic push. The CGuard system has already achieved significant global adoption, with over 65,000 implants sold to date worldwide. This real-world experience across more than 30 international markets provides a powerful credibility factor for the U.S. launch.

The device's performance is what drives this acceptance. For example, the CGuard Prime system demonstrated a low adverse event rate of 0.95% at 30 days in its clinical trials, which is a critical metric for physician confidence and patient outcomes. This kind of proven safety record is defintely a key social factor influencing physician adoption in new markets.

U.S. sales force expansion is a major investment, increasing operating expenses by 57% in Q3 2025.

To capitalize on the U.S. market, InspireMD is making a substantial investment in its commercial infrastructure-a necessary social and operational cost. This expansion is visible directly in the financial statements for the third quarter of 2025 (Q3 2025). Here's the quick math on the cost of building that crucial human capital:

Total operating expenses for Q3 2025 surged to $13.9 million, which is an increase of 57% compared to the $8.9 million reported in Q3 2024.

Metric	Q3 2025 Value	Q3 2024 Value	Change
Total Operating Expenses	$13.9 million	$8.9 million	+57%

This sharp rise is primarily driven by the hiring of U.S. personnel, especially the commercial team, and the costs associated with establishing the U.S. headquarters. This investment is a direct response to the social need for on-the-ground clinical and sales support to drive adoption among U.S. physicians.

The shift toward less-invasive procedures (stenting) over open surgery is a key market trend.

Patient and physician preference is decisively moving away from traditional, open-neck surgery-Carotid Endarterectomy (CEA)-toward less-invasive endovascular procedures like Carotid Artery Stenting (CAS) and Transcarotid Artery Revascularization (TCAR). This is a powerful social trend favoring InspireMD's product line.

The carotid stent market's growth is fundamentally tied to this preference for reduced trauma and shorter recovery times. The self-expanding stent segment, which includes CGuard, is estimated to hold a significant market share of 47.8% in 2025. The TCAR procedure, a newer, less-invasive technique, saw an estimated 30,000 procedures in the U.S. in 2024, with double-digit growth projected for 2025 and beyond. This is where the market is heading.

• Less-invasive procedures are preferred due to shorter hospital stays.
• Self-expanding stents are projected to hold 47.8% of the 2025 market share.
• The company is positioning CGuard Prime as a solution for both CAS and TCAR procedures.

The market is embracing the stent-first approach.

InspireMD, Inc. (NSPR) - PESTLE Analysis: Technological factors

Core competitive advantage is the proprietary MicroNet™ mesh technology, which minimizes embolic events.

The technological edge for InspireMD, Inc. is defintely its proprietary MicroNet™ mesh. This is a finely woven, high-density polyethylene terephthalate (PET) mesh that is permanently knitted onto the stent's exterior, creating a dual-layer design. The technology works by physically preventing plaque fragments (emboli) from breaking off the carotid artery wall during the stenting procedure and traveling to the brain, which is the primary cause of stroke during these interventions.

This unique design is the company's core intellectual property and directly addresses the main risk of carotid artery stenting (CAS). It is a significant differentiator because the CGuard Prime system is the only mesh-covered carotid stent on the US market, giving it a clear advantage over traditional bare-metal or open-cell stents. The market potential is substantial, with the current global treated market for Carotid Endarterectomy (CEA) and CAS procedures valued at approximately $1.3 billion.

CGuard Prime demonstrated a best-in-class 30-day major adverse event rate of only 0.95% in pivotal trials.

The clinical data validates the MicroNet™ technology's superiority. The CGuard Prime system demonstrated a best-in-class 30-day major adverse event (MAE) rate of only 0.95% in its pivotal trials.

This MAE rate includes death, any stroke, or myocardial infarction (MI) within 30 days of the procedure. To be fair, this is a critical metric for physicians and hospital systems, as it directly impacts patient outcomes and hospital quality rankings. The low rate positions CGuard Prime as a front-line therapeutic option, especially as recent clinical data, like the CREST-2 study published in November 2025, supports the use of carotid artery stenting combined with medical therapy over medical therapy alone for asymptomatic patients.

Here's the quick math on the competitive landscape for this critical 30-day outcome:

Carotid Stent System (Representative)	Technology Type	30-Day Major Adverse Event Rate (Death, Stroke, or MI)
InspireMD CGuard Prime	Proprietary MicroNet™ Mesh-Covered	0.95% (Pivotal Trial)
Abbott Xact/Acculink	Bare-Metal Stent with Embolic Protection Device (EPD)	2.3% (PROTECT Trial)
Medtronic/Competitor CAS	Bare-Metal Stent with Embolic Protection Device (EPD)	4.0% (EMBOLDEN Study Proxy)

Pipeline includes the development of the SwitchGuard NPS for Transcarotid Artery Revascularization (TCAR) procedures.

The company is not standing still; it is actively advancing its next-generation TCAR Neuroprotection System (NPS), called SwitchGuard NPS. This is a crucial move to capture the rapidly growing Transcarotid Artery Revascularization (TCAR) market, which is a less-invasive procedure gaining traction.

Development and regulatory activities for SwitchGuard NPS were a factor in the increased operating expenses of $13,332,000 in the second quarter of 2025, up 55.2% from the same period in 2024.

The current roadmap suggests the clearance and launch of the SwitchGuard NPS, which will offer a full TCAR tool kit, is targeted for the 2026-2027 timeframe. In parallel, the company has FDA approval for the Investigational Device Exemption (IDE) to begin the CGUARDIANS II pivotal study, which will evaluate an optimized TCAR version of the CGuard Prime 80cm stent system.

• Advance CGuard Prime in optimized TCAR procedures (CGUARDIANS II trial).
• Develop SwitchGuard NPS as a comprehensive TCAR Neuroprotection System.
• Target full TCAR toolkit launch in the 2026-2027 window.

The CGuard Prime system is the only mesh-covered carotid stent, differentiating it from competitors like Abbott and Medtronic.

The core technology provides a strong barrier to entry. The CGuard Prime system is the only carotid stent on the market that uses a mesh-covered design, which is a significant technological advantage over devices from major competitors like Abbott and Medtronic.

The traditional approach uses a bare-metal stent combined with a separate Embolic Protection Device (EPD), which is a filter placed downstream to catch emboli. The MicroNet™ mesh on CGuard Prime provides continuous, sustained embolic protection from the moment of deployment, minimizing the risk of plaque prolapse through the stent struts. This integrated protection is what drives the industry-leading clinical outcomes. If you're a physician, you want the lowest complication rate possible. The company's Q2 2025 revenue of $1,778,000, though small, represents the start of the US commercial launch following FDA approval, leveraging this unique technological position.

InspireMD, Inc. (NSPR) - PESTLE Analysis: Legal factors

FDA PMA Approval Requires Continuous Adherence to Stringent Manufacturing Quality Standards (Quality System Regulation)

The core legal risk for InspireMD in the US market is maintaining compliance with the US Food and Drug Administration (FDA) regulations following the Premarket Approval (PMA). The company received PMA approval for its CGuard Prime Carotid Stent System on June 24, 2025, a critical milestone for US commercialization.

This PMA subjects the device to the FDA's Quality System (QS) regulation (21 CFR Part 820), an ongoing legal requirement. This isn't a one-time check; it mandates continuous adherence to strict controls over design, manufacturing, labeling, and servicing. Honestally, any significant change to the device or its production process requires a new PMA supplement or a 30-day notice to the FDA, which can slow down product improvements.

The company explicitly acknowledges that its dependence on a single manufacturing facility increases the risk associated with complying with these stringent quality standards and increasing production capacity.

The Company Must Maintain CE Mark Approval Under the Stricter European Medical Device Regulation (MDR)

In the European Union, InspireMD secured CE Mark approval for the CGuard Prime Embolic Prevention System (EPS) under the new, stricter European Medical Device Regulation (MDR) in June 2025.

The MDR framework is far more demanding than the previous Medical Device Directive (MDD), requiring more extensive clinical evidence, greater post-market surveillance (PMS), and stricter technical documentation. Maintaining this certification is crucial, as Europe is a primary commercial market. The approval clears the path for the commercial launch of the CGuard Prime EPS across current CE-marked markets.

Here's a quick look at the regulatory status as of 2025:

Regulatory Body/Standard	Product	Approval Status (as of Nov 2025)	Key Compliance Requirement
US FDA (PMA)	CGuard Prime Carotid Stent System (135 cm)	Approved (June 24, 2025)	Continuous adherence to Quality System Regulation (21 CFR Part 820).
EU MDR (CE Mark)	CGuard Prime EPS	Approved (June 2025)	Maintain enhanced clinical data and post-market surveillance.
US FDA (IDE)	CGuard Prime 80cm (for TCAR)	IDE Approved (Oct 2024)	Successful completion of C-GUARDIANS II pivotal study.

Ongoing Clinical Trials (like C-GUARDIANS II and III) are Necessary to Expand Indications and Secure Future Regulatory Approvals

Future growth is legally tied to successful clinical trial outcomes, which underpin new regulatory submissions. The initial PMA approval was based on the C-GUARDIANS trial, which enrolled 316 patients and demonstrated a 1-year major adverse event rate of 1.93%.

The company is now focused on the next phase of trials to expand the product's use cases, which will drive market size. This is a capital-intensive process.

• C-GUARDIANS II: This pivotal study of the CGuard Prime 80cm carotid stent system is for Transcarotid Artery Revascularization (TCAR) procedures, a growing segment of the carotid intervention market.
• C-GUARDIANS III: This trial is also in preparation, and its success is necessary to secure future product indications.
• The anticipation of these trials and the US commercial launch caused operating expenses to jump 55.2% to $13.33 million in Q2 2025, showing the financial weight of regulatory-driven clinical development.

Compliance with Nasdaq Listing Standards is a Continuous Requirement for Capital Access

As a publicly traded company on the Nasdaq, InspireMD must continuously meet the exchange's legal and financial requirements to maintain its listing and access to capital markets. This is defintely non-negotiable for a growth-stage company.

While the company has recently secured significant gross proceeds of $58 million through an equity private placement and warrant exercises in 2025, which helps bolster its financial position, the risk of non-compliance remains a constant factor.

The legal compliance extends to corporate governance, timely financial reporting, and maintaining minimum listing standards, such as the minimum bid price and shareholder equity. Recent corporate actions, such as inducement grants of 122,054 restricted shares in November 2025, are explicitly noted as being in accordance with Nasdaq Listing Rule 5635(c)(4), underscoring the legal rigor applied to even routine HR actions.

InspireMD, Inc. (NSPR) - PESTLE Analysis: Environmental factors

You need to know that InspireMD, Inc.'s environmental profile is currently a significant risk factor, primarily due to a lack of public disclosure and a low relative sustainability score. The company is operating with a centralized manufacturing footprint and no formal climate strategy, which puts it behind its medical device manufacturing peers in a market increasingly sensitive to environmental, social, and governance (ESG) performance.

The company does not publicly report carbon emissions data or formal climate pledges.

Honesty, this is the first red flag. InspireMD, Inc. currently does not report any carbon emissions data, measured in kilograms of carbon dioxide equivalent (kg CO2e), nor has it publicly committed to any formal climate pledges or reduction targets. This non-disclosure suggests the company has not yet established a comprehensive climate strategy, which is becoming defintely a baseline requirement for medical device firms.

In the current environment, where global frameworks like the Science Based Targets initiative (SBTi) are pushing for net-zero commitments, this lack of transparency is a clear competitive disadvantage. Investors and institutional buyers are increasingly using these disclosures to screen investments and suppliers.

The DitchCarbon Score is 14, ranking lower than 89% of the medical device manufacturing industry average of 27.

The company's environmental action is significantly lagging its peers. The DitchCarbon Score, which assesses carbon action and commitment, for InspireMD, Inc. is a low 14. This is substantially below the industry average of 27 for Medical Device Manufacturing. Here's the quick math on the competitive gap:

Metric	InspireMD, Inc. (NSPR)	Industry Average (Medical Device Manufacturing)	Competitive Position
DitchCarbon Score	14	27	Lower
Industry Benchmark Percentile	Lower than 89% of the industry	N/A	Bottom 11%
Public Emissions Reporting	None (0 kg CO2e disclosed)	Varies	Non-disclosing

A score of 14 places InspireMD, Inc. in the bottom 11% of its sector, signaling a substantial risk of future regulatory pressure, poor ESG fund eligibility, and potential loss of business to more environmentally conscious competitors.

Manufacturing footprint is concentrated in a single facility, which simplifies oversight but centralizes environmental risk.

InspireMD's operations, including its production facility, are concentrated in a single location in Israel. While a single site simplifies quality control and operational oversight, it creates a single point of failure for environmental and geopolitical risk. Any localized environmental event-like a severe weather event, a major utility disruption, or a specific regulatory change in Israel-could halt all global production of the CGuard Prime carotid stent system.

This centralized risk is compounded by the geopolitical instability in the Middle East, which the company itself cites as a risk factor in its SEC filings. The environmental risks are therefore intrinsically linked to operational continuity risks. The company opened a new global headquarters in Miami, Florida in late 2024, but the manufacturing remains abroad.

As a medical device manufacturer, the company faces increasing pressure for sustainable supply chains and medical waste management.

The medical device industry is under increasing scrutiny for its environmental footprint, especially in the areas of supply chain sustainability (Scope 3 emissions) and product end-of-life management (medical waste). The company's core product, the CGuard Prime, is a single-use, sterile implantable device, which inherently generates specialized medical waste that requires careful disposal.

Key areas of pressure include:

• Reduce packaging waste for single-use devices.
• Source raw materials (like nitinol) from suppliers with verified, low-carbon footprints.
• Comply with evolving European Union (EU) regulations on waste and restricted substances in medical devices.
• Address the carbon footprint of global logistics and distribution.

This pressure will only grow, and without a formal program, InspireMD, Inc. will find it harder to compete for contracts with large hospital systems and government entities that have mandated sustainable procurement policies.

Finance: Monitor the U.S. sales force efficiency-specifically, track Q4 2025 U.S. revenue against the Q3 base of $497,000 to confirm disciplined execution.