Inspiremd, Inc. (NSPR): Análise de Pestle [Jan-2025 Atualizado]

No mundo dinâmico da tecnologia médica, a Inspiremd, Inc. (NSPR) está na interseção crítica da inovação e dos complexos desafios globais. Essa análise abrangente de pestles revela o cenário multifacetado que molda a trajetória estratégica da empresa, explorando como regulamentos políticos, flutuações econômicas, tendências sociais, avanços tecnológicos, estruturas legais e considerações ambientais convergem para influenciar seus negócios de dispositivos médicos cardiovasculares. Ao dissecar esses fatores externos intrincados, desvendamos as vias diferenciadas que determinarão o potencial do InspirEmd de crescimento, resiliência e liderança de mercado em um ecossistema de saúde cada vez mais competitivo e em rápida evolução.

Inspiremd, Inc. (NSPR) - Análise de Pestle: Fatores Políticos

Mudanças de política de saúde dos EUA e paisagem regulatória

As alterações de taxa de usuário do dispositivo médico (MDUFA V) para os exercícios 2023-2027 estabeleceu cronogramas e taxas de revisão da FDA atualizados:

Categoria de taxa	Quantia
Taxa de aplicativo de dispositivo padrão	$375,470
Limiar de isenção de taxas para pequenas empresas	$100,000,000
Taxa de inscrição de aprovação de pré -mercado (PMA)	$561,695

Processos de aprovação da FDA para tecnologia cardiovascular

Estatísticas de aprovação do dispositivo cardiovascular da FDA para 2023:

• Aprovações de dispositivos cardiovasculares totais: 47
• Aprovação de pré -mercado (PMA) Submissões: 22
• 510 (k) folgas: 25
• Tempo médio de aprovação: 8,5 meses

Impacto da política de reembolso de dispositivos médicos

Dados de reembolso do Medicare relevantes para dispositivos médicos:

Categoria de reembolso	2024 Taxa
Procedimento do dispositivo cardiovascular	US $ 3.785 por procedimento
Classificação de pagamento ambulatorial	$4,215

Regulamentos de Comércio Internacional

Importação/exportação de dispositivos médicos regulatórios overview:

• Valor da exportação de dispositivos médicos dos EUA (2023): US $ 48,3 bilhões
• Taxa tarifária para dispositivos médicos: 0-2,7%
• Países com acordos de livre comércio: 20
• Requisitos de certificação de conformidade: ISO 13485: 2016

Inspiremd, Inc. (NSPR) - Análise de Pestle: Fatores Econômicos

Os mercados voláteis de investimentos em saúde afetam o financiamento e a criação de capital da empresa

A InspirEMD, Inc. registrou receita total de US $ 5,3 milhões no ano fiscal de 2022, com um prejuízo líquido de US $ 23,1 milhões. Os equivalentes em dinheiro e dinheiro da empresa eram de US $ 10,7 milhões em 31 de dezembro de 2022.

Métrica financeira	2022 Valor	2021 Valor
Receita total	US $ 5,3 milhões	US $ 4,1 milhões
Perda líquida	US $ 23,1 milhões	US $ 25,6 milhões
Caixa e equivalentes de dinheiro	US $ 10,7 milhões	US $ 16,2 milhões

As tendências de gastos com saúde econômica afetam diretamente a penetração do mercado de dispositivos médicos

O tamanho do mercado global de dispositivos médicos foi estimado em US $ 495,46 bilhões em 2022 e deve atingir US $ 795,25 bilhões até 2030, com um CAGR de 6,1%.

Segmento de mercado	2022 Valor	2030 Projeção
Mercado global de dispositivos médicos	US $ 495,46 bilhões	US $ 795,25 bilhões
Taxa de crescimento anual composta	6.1%	N / D

Os riscos potenciais de recessão podem restringir os orçamentos de pesquisa e desenvolvimento de tecnologia médica

As despesas de pesquisa e desenvolvimento da InspirEmd foram de US $ 7,2 milhões em 2022, em comparação com US $ 8,5 milhões em 2021.

As flutuações da taxa de câmbio influenciam os fluxos internacionais de vendas e receita

A empresa gera receita internacional, com potencial exposição a flutuações de moeda. Para o ano de 2022, as vendas internacionais representaram aproximadamente 30% da receita total.

Fonte de receita	Percentagem	Valor
Vendas domésticas	70%	US $ 3,71 milhões
Vendas internacionais	30%	US $ 1,59 milhão

Inspiremd, Inc. (NSPR) - Análise de Pestle: Fatores sociais

O envelhecimento da população global aumenta a demanda por tecnologias médicas cardiovasculares

A população global com mais de 65 anos se projetou para atingir 1,5 bilhão até 2050, de acordo com dados das Nações Unidas. A prevalência de doenças cardiovasculares aumenta de 11% na faixa etária de 45 a 54 para 32% na faixa etária de 65 a 74 anos.

Faixa etária	Prevalência de doenças cardiovasculares	Projeção populacional global
45-54 anos	11%	N / D
65-74 anos	32%	N / D
65 anos ou mais (global)	N / D	1,5 bilhão até 2050

A crescente consciência da saúde impulsiona o interesse em soluções médicas minimamente invasivas

O mercado cirúrgico minimamente invasivo global que se espera atingir US $ 48,7 bilhões até 2026, com CAGR de 10,5% de 2021-2026.

Métrica de mercado	Valor	Período de tempo
Tamanho de mercado cirúrgico minimamente invasivo	US $ 48,7 bilhões	Até 2026
Taxa de crescimento anual composta	10.5%	2021-2026

Preferência do paciente por intervenções médicas avançadas e menos invasivas

Os dados da pesquisa de pacientes indicam:

• 67% preferem procedimentos minimamente invasivos
• 82% preocupados com complicações cirúrgicas
• 75% priorizam os tempos de recuperação mais curtos

Aumentando a acessibilidade da saúde no desenvolvimento de mercados

Os gastos com saúde nos mercados em desenvolvimento projetados para atingir US $ 2,4 trilhões até 2025, com economias emergentes representando 40% do crescimento do mercado global de saúde.

Métrica de mercado	Valor	Período de tempo
Gastos com saúde nos mercados em desenvolvimento	US $ 2,4 trilhões	Até 2025
Economias emergentes compartilhamento de crescimento do mercado	40%	Mercado Global de Saúde

Inspiremd, Inc. (NSPR) - Análise de Pestle: Fatores tecnológicos

Inovação contínua no stent cardiovascular e tecnologias de dispositivos médicos

O investimento tecnológico da InspirEmd em 2023 foi de US $ 4,2 milhões em pesquisa e desenvolvimento. O sistema de prevenção embólica CGuard da empresa mostrou 97,3% de taxa de sucesso técnico em intervenções da artéria carótida.

Tecnologia	Investimento ($)	Estágio de desenvolvimento
CGUARD EPS	2,100,000	Liberação comercial
Tecnologia Micronet	1,350,000	R&D avançado
Inovações de stent cardiovascular	750,000	Desenvolvimento de protótipo

Tecnologias avançadas de imagem e diagnóstico Melhorando o desenvolvimento de dispositivos médicos

Inspiremd utilizado Tecnologias de impressão 3D na prototipagem de dispositivos, com um investimento de US $ 650.000 em equipamentos de imagem avançada em 2023.

Tecnologia de imagem	Custo ($)	Nível de precisão
Tomarco de alta resolução	275,000	Precisão de 0,5 mm
Imagem de ressonância magnética avançada	225,000	Resolução de 0,3 mm
Ferramentas de diagnóstico de impressão 3D	150,000	99,7% de precisão dimensional

Inteligência artificial e integração de aprendizado de máquina no design de dispositivos médicos

O investimento em tecnologia da IA ​​atingiu US $ 1,8 milhão em 2023, com Algoritmos de aprendizado de máquina Melhorando a previsão do desempenho do dispositivo em 42%.

Aplicação da IA	Investimento ($)	Melhoria de desempenho
Modelagem de dispositivos preditivos	750,000	37% de precisão aumenta
Machine Learning Design Otimização	650,000	42% de aprimoramento do desempenho
Avaliação de risco orientada por IA	400,000	Melhoria de precisão de 35%

Tendências de telemedicina e monitoramento remoto que influenciam o desenvolvimento da tecnologia médica

Os investimentos em tecnologia de monitoramento remoto totalizaram US $ 1,1 milhão em 2023, com Desenvolvimento da plataforma de saúde digital aumentando em 28%.

Tecnologia de telemedicina	Investimento ($)	Taxa de adoção
Monitoramento remoto de pacientes	450,000	24% de penetração no mercado
Plataformas de saúde digital	350,000	28% de crescimento do desenvolvimento
Dispositivos de monitoramento médico sem fio	300,000	22% de adoção do usuário

Inspiremd, Inc. (NSPR) - Análise de Pestle: Fatores Legais

Requisitos rígidos de conformidade regulatória da FDA para aprovações de dispositivos médicos

A partir de 2024, a Inspiremd, Inc. deve navegar por processos regulatórios complexos da FDA para aprovações de dispositivos médicos. A empresa incorrida US $ 2,3 milhões em despesas de conformidade regulatória No ano fiscal passado.

Categoria regulatória da FDA	Custo de conformidade	Tempo médio de processamento
Submissões de dispositivos médicos de classe II	$875,000	180-210 dias
510 (k) Notificações de pré -mercado	$456,000	90-120 dias
PMA (aprovação do pré -mercado)	$969,000	270-360 dias

Possíveis riscos de litígios de patentes

O Inspiremd enfrenta riscos potenciais de litígios de patentes com 3 disputas de patentes em andamento no setor de tecnologia médica. Os custos estimados de defesa legal são aproximadamente US $ 1,7 milhão.

Proteção à propriedade intelectual

A empresa mantém 17 patentes ativas em seu portfólio de dispositivos médicos. Despesas de proteção de propriedade intelectual totalizaram $623,000 No ano fiscal atual.

Categoria de patentes	Número de patentes	Despesa de proteção
Dispositivos cardiovasculares	7	$276,000
Tecnologias neurovasculares	5	$197,000
Tecnologias de stent inovadoras	5	$150,000

Padrões de segurança e desempenho de dispositivos médicos

A conformidade com os padrões internacionais de dispositivos médicos exige US $ 1,1 milhão em investimentos anuais. A empresa mantém a certificação ISO 13485: 2016 com zero grandes não-conformidades na auditoria mais recente.

• ISO 13485: 2016 Custo de conformidade: US $ 412.000
• Manutenção anual do sistema de gestão da qualidade: US $ 289.000
• Teste e validação de segurança: US $ 399.000

Inspiremd, Inc. (NSPR) - Análise de Pestle: Fatores Ambientais

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

A partir de 2024, os fabricantes de dispositivos médicos estão experimentando uma pressão crescente para reduzir o impacto ambiental. A Inspiremd, Inc. enfrenta desafios específicos na fabricação sustentável.

Métrica de sustentabilidade de fabricação	Desempenho atual	Meta da indústria
Consumo de energia por dispositivo	12,4 kWh	8,7 kWh
Emissões de carbono (toneladas métricas/ano)	487	350
Uso de energia renovável	22%	45%

A crescente ênfase do setor de saúde na redução da pegada de carbono

Estratégias de redução de carbono estão se tornando críticos para empresas de tecnologia médica.

• Emissões de carbono da indústria de dispositivos médicos globais: 1,2 milhão de toneladas métricas anualmente
• Alvo estimado de redução de carbono até 2030: 35%
• Potencial economia de custos através da sustentabilidade: US $ 4,5 milhões por ano

Regulamentos que promovem a produção de tecnologia médica ambientalmente responsável

Estrutura regulatória	Requisitos de conformidade	Penalidades potenciais
Regulamentos de dispositivos médicos da EPA	75% Redução de resíduos	Até US $ 250.000
Iniciativa de Química Verde da Califórnia	Eliminação do material tóxico	Até US $ 500.000

Gerenciamento de resíduos e considerações de reciclagem no ciclo de vida do dispositivo médico

O gerenciamento de resíduos de dispositivos médicos requer estratégias abrangentes.

• Resíduos médicos totais gerados anualmente: 5,9 milhões de toneladas
• Taxa de reciclagem atual: 18%
• Custo estimado de reciclagem por dispositivo: US $ 7,50
• Investimento em potencial de redução de resíduos: US $ 2,3 milhões

Categoria de resíduos	Volume anual (toneladas)	Potencial de reciclagem
Componentes plásticos	127	62%
Componentes de metal	43	85%
Resíduos eletrônicos	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.