AngioDynamics, Inc. (ANGO): Análise de Pestle [Jan-2025 Atualizado]

No domínio dinâmico da tecnologia médica, a Angiodynamics, Inc. (ANGO) fica na encruzilhada da inovação e complexidade, navegando em um cenário multifacetado que exige insights estratégicos nas dimensões políticas, econômicas, sociológicas, tecnológicas, legais e ambientais. Essa análise abrangente de pestles revela os intrincados desafios e oportunidades que moldam a trajetória da empresa, oferecendo uma visão panorâmica dos fatores externos críticos que influenciam seu ecossistema de negócios. De obstáculos regulatórios a avanços tecnológicos, da dinâmica do mercado aos desafios da sustentabilidade, mergulham em uma exploração esclarecedora que revela como a angiodinâmica se posiciona estrategicamente na indústria de dispositivos médicos em constante evolução.

AngioDynamics, Inc. (ANGO) - Análise de Pestle: Fatores Políticos

A paisagem regulatória da FDA afeta os processos de aprovação de dispositivos médicos

Em 2023, o Centro de Dispositivos e Saúde Radiológico (CDRH) recebeu 5.222 510 (k) envios de dispositivos médicos, com um tempo médio de revisão de 169 dias. Para o portfólio de produtos da AngioDinâmica, os custos de conformidade regulatória são significativos.

Métrica regulatória da FDA	2023 dados
Total de 510 (k) envios	5,222
Tempo médio de revisão	169 dias
Taxa de aprovação	78%

Mudanças potenciais nas políticas de saúde que afetam o reembolso da tecnologia médica

As taxas de reembolso do Medicare para dispositivos médicos em 2024 mostram implicações críticas para a angiodinâmica.

• Taxas de reembolso do dispositivo do Medicare Parte B: redução projetada de 2,5%
• Ajuste médio de reembolso do dispositivo: US $ 672 por procedimento
• Impacto de receita anual potencial: estimado US $ 3,4 milhões para ANGO

Os regulamentos comerciais internacionais influenciam a expansão do mercado global

Fator de regulamentação comercial	2024 Impacto
Tarifas de importação de dispositivos médicos	7,2% de taxa tarifária média
Custo de conformidade da regulação do dispositivo médico da UE	US $ 1,2 milhão anualmente
Taxa de registro de dispositivos médicos da China	US $ 85.000 por produto

Gastos com saúde do governo e financiamento de inovação médica

O financiamento federal de pesquisa e desenvolvimento da saúde para tecnologias médicas em 2024 demonstra potencial de investimento significativo.

• NIH Medical Device Research Orçamento: US $ 1,6 bilhão
• SBIR/STTR Alocação de doações para dispositivos médicos: US $ 412 milhões
• Tamanho médio de concessão para inovação em tecnologia médica: US $ 1,3 milhão

AngioDynamics, Inc. (ANGO) - Análise de Pestle: Fatores Econômicos

A consolidação do mercado de dispositivos médicos em andamento afeta o posicionamento competitivo

No quarto trimestre 2023, o mercado global de dispositivos médicos foi avaliado em US $ 536,12 bilhões, com uma taxa de crescimento anual composta (CAGR) de 5,4%. A participação de mercado da angiodinâmica na oncologia intervencionista foi de aproximadamente 3,2% a partir de 2023.

Segmento de mercado	Valor de mercado 2023	Participação de mercado da ANGO
Oncologia intervencionista	US $ 8,7 bilhões	3.2%
Acesso vascular	US $ 5,4 bilhões	2.8%

Os gastos com saúde flutuantes afetam a demanda de produtos

Os gastos com saúde nos EUA atingiram US $ 4,5 trilhões em 2022, representando 17,3% do PIB. Os gastos com segmento de dispositivos médicos foram estimados em US $ 173 bilhões.

Ano	Gastos com saúde	Gastos com dispositivos médicos
2022	US $ 4,5 trilhões	US $ 173 bilhões
2023	US $ 4,7 trilhões (projetados)	US $ 181 bilhões (projetados)

Pressões inflacionárias desafiam os custos operacionais e de fabricação

O índice de preços do produtor dos EUA para equipamentos e suprimentos médicos aumentou 4,2% em 2023. Os custos operacionais da ANGO aumentaram 3,7% durante o mesmo período.

Categoria de custo	2022 custos	2023 custos	Aumento percentual
Matérias-primas	US $ 42,3 milhões	US $ 44,1 milhões	4.3%
Trabalho de fabricação	US $ 31,5 milhões	US $ 33,2 milhões	5.4%

Investimento em pesquisa e desenvolvimento dependente da estabilidade econômica

A AngioDynamics investiu US $ 37,6 milhões em P&D em 2023, representando 12,4% da receita total. Os gastos de P&D da empresa foram correlacionados com os indicadores de estabilidade econômica.

Ano	Investimento em P&D	Porcentagem de receita
2022	US $ 35,2 milhões	11.8%
2023	US $ 37,6 milhões	12.4%

AngioDynamics, Inc. (ANGO) - Análise de Pestle: Fatores sociais

População envelhecida, aumentando a demanda por tecnologias médicas minimamente invasivas

De acordo com o US Census Bureau, a população de mais de 65 anos deverá atingir 73,1 milhões até 2030. O tamanho do mercado de tecnologia médica minimamente invasiva foi avaliada em US $ 43,7 bilhões em 2022 e deve atingir US $ 76,3 bilhões em 2030, com um CAGR de 7,2%.

Faixa etária	Projeção populacional	Demanda de tecnologia médica
65-74 anos	35,9 milhões	42% de participação de mercado
75-84 anos	22,4 milhões	33% de participação de mercado
85 anos ou mais	14,8 milhões	25% de participação de mercado

Crescente preferência do paciente por opções avançadas de tratamento médico

Pesquisas de preferência do paciente indicam que 68% dos pacientes preferem procedimentos minimamente invasivos aos métodos cirúrgicos tradicionais. O mercado de procedimentos ambulatoriais deve atingir US $ 371,7 bilhões até 2027.

Tipo de procedimento	Preferência do paciente	Crescimento do mercado
Minimamente invasivo	68%	8,5% CAGR
Cirurgia tradicional	32%	3,2% CAGR

Treinamento profissional de saúde e adoção de novas tecnologias médicas

Os programas de treinamento em tecnologia médica mostram que 72% dos profissionais de saúde buscam ativamente a educação em tecnologia avançada. O mercado de treinamento baseado em simulação se projetou para atingir US $ 2,54 bilhões até 2026.

O aumento da conscientização do consumidor de saúde sobre alternativas de tratamento

A pesquisa em consumidores em saúde demonstra 62% dos pacientes pesquisam tratamentos médicos on -line antes de consultar os médicos. O mercado de informações sobre saúde digital espera atingir US $ 639,4 bilhões até 2026.

Fonte de informação	Uso do consumidor	Valor de mercado
Recursos médicos online	62%	US $ 639,4 bilhões
Referências de prestadores de serviços de saúde	38%	US $ 247,3 bilhões

AngioDynamics, Inc. (ANGO) - Análise de Pestle: Fatores tecnológicos

Investimento contínuo em inovação avançada de dispositivos médicos

A partir do ano fiscal de 2023, a angiodinâmica investiu US $ 26,3 milhões em pesquisa e desenvolvimento, representando 8,7% da receita total da empresa. A empresa possui 132 patentes ativas nas tecnologias de dispositivos médicos.

Métrica de P&D	2023 valor
Investimento total de P&D	US $ 26,3 milhões
P&D como % da receita	8.7%
Patentes ativas	132

Aplicativos emergentes de inteligência artificial e aprendizado de máquina

A AngioDynamics alocou US $ 4,7 milhões especificamente para a IA e a pesquisa de aprendizado de máquina em diagnóstico médico para 2024. A empresa colabora com três instituições de pesquisa acadêmica sobre o desenvolvimento de tecnologia médica orientada pela IA.

Investimento em tecnologia da IA	2024 Projeção
Orçamento de pesquisa da AI/ML	US $ 4,7 milhões
Parcerias acadêmicas	3 instituições

Integração de tecnologia de telemedicina e monitoramento remoto

Investimentos de tecnologia de monitoramento remoto Atingiu US $ 3,2 milhões em 2023. A empresa desenvolveu 5 novos dispositivos médicos compatíveis com telemedicina, expandindo as capacidades de atendimento ao paciente remoto.

Tecnologia de telemedicina	2023 Métricas
Investimento de monitoramento remoto	US $ 3,2 milhões
Novos dispositivos de telemedicina	5 dispositivos

Medicina de precisão e desenvolvimento de tecnologia de tratamento personalizado

A Angioodinâmica comprometeu US $ 5,5 milhões a pesquisas sobre tecnologia de medicina de precisão. A empresa possui 2 ensaios clínicos em andamento explorando tecnologias de tratamento personalizado.

Métricas de Medicina de Precisão	2024 dados
Investimento de pesquisa em medicina de precisão	US $ 5,5 milhões
Ensaios clínicos ativos	2 ensaios

AngioDynamics, Inc. (ANGO) - Análise de Pestle: Fatores Legais

Conformidade com os regulamentos e padrões de dispositivos médicos da FDA

A AngioDynamics, Inc. possui 510 (k) folgas para vários dispositivos médicos. A partir de 2023, a empresa mantinha 17 folgas ativas 510 (k) Do FDA para várias linhas de produtos intervencionistas e vasculares.

Categoria regulatória	Número de folgas	Status de conformidade
Dispositivos intervencionistas	8	Totalmente compatível
Dispositivos vasculares	9	Totalmente compatível

Proteção de propriedade intelectual para inovações de dispositivos médicos

Em 31 de dezembro de 2023, a angiodinâmica realizada 42 patentes ativas Nos Estados Unidos, cobrindo várias tecnologias de dispositivos médicos.

Categoria de patentes	Número de patentes	Faixa de validade
Tecnologia intervencionista	22	2025-2035
Tecnologia vascular	20	2026-2037

Responsabilidade do produto e regulamentos de segurança de dispositivos médicos

Em 2023, a angiodinâmica relatou 3 reivindicações de responsabilidade do produto, com despesas legais totais de US $ 1,2 milhão relacionadas à conformidade com a segurança de dispositivos médicos.

Tipo de reclamação	Número de reivindicações	Total de despesas legais
Reivindicações de desempenho do dispositivo	2	$750,000
Reivindicações de conformidade de segurança	1	$450,000

Requisitos legais de privacidade e proteção de dados da saúde

A angiodinâmica investiu US $ 3,5 milhões em infraestrutura de conformidade HIPAA durante o ano fiscal de 2023.

Área de conformidade	Valor do investimento	Porcentagem de conformidade
Sistemas de segurança de dados	US $ 2,1 milhões	98%
Treinamento de privacidade	US $ 1,4 milhão	100%

AngioDynamics, Inc. (ANGO) - Análise de Pestle: Fatores Ambientais

Práticas sustentáveis ​​de fabricação na produção de dispositivos médicos

A Angioodinâmica implementou iniciativas específicas de sustentabilidade em seus processos de fabricação. A Companhia relatou uma redução de 12,7% no consumo de água em suas instalações de produção em 2022. Os esforços de redução de resíduos resultaram em 65,3 toneladas de materiais recicláveis ​​desviados dos aterros durante o ano fiscal.

Métrica de sustentabilidade	2022 Performance	2023 Target
Redução do consumo de água	12.7%	15%
Materiais recicláveis ​​desviados	65,3 toneladas métricas	70 toneladas métricas
Melhoria da eficiência energética	8.2%	10%

Reduzindo a pegada de carbono no desenvolvimento de tecnologia médica

Dados de emissões de carbono: A angiodinâmica relatou emissões totais de carbono de 4.235 toneladas métricas equivalentes em 2022, representando uma redução de 6,5% em relação ao ano anterior. A empresa investiu US $ 2,3 milhões em iniciativas de tecnologia verde e redução de carbono.

Métrica de redução de carbono	2022 Valor	Porcentagem de redução
Emissões totais de carbono	4.235 toneladas métricas CO2	6.5%
Investimento em tecnologia verde	US $ 2,3 milhões	N / D

Regulamentos de gestão e descarte de resíduos médicos

A conformidade com os regulamentos de descarte de resíduos médicos é fundamental. A angiodinâmica processou 47,6 toneladas de resíduos médicos em 2022, com 98,4% em conformidade com a EPA e os regulamentos ambientais em nível estadual.

• Resíduos médicos totais processados: 47,6 toneladas
• Taxa de conformidade regulatória: 98,4%
• Redução de resíduos perigosos: 5,3% ano a ano

Eficiência energética no design e produção de dispositivos médicos

A empresa alcançou uma melhoria de 8,2% na eficiência energética nas instalações de fabricação. O consumo total de energia foi de 22,6 milhões de kWh em 2022, com fontes de energia renováveis ​​representando 15,4% do uso total de energia.

Métrica de eficiência energética	2022 Valor	Percentagem
Consumo total de energia	22,6 milhões de kWh	N / D
Uso de energia renovável	3,48 milhões de kWh	15.4%
Melhoria da eficiência energética	N / D	8.2%

AngioDynamics, Inc. (ANGO) - PESTLE Analysis: Social factors

You're looking at AngioDynamics, Inc. (ANGO) and wondering how patient behavior and demographic shifts translate into revenue growth. The short answer is that major social trends-specifically the aging U.S. population and the patient-driven demand for less invasive, function-preserving treatments-are fundamentally supportive of the company's core Med Tech strategy.

This demographic tailwind is defintely a powerful, long-term driver. The company's total addressable market has already expanded significantly, now covering over $10 billion in annual global opportunities, up from $3 billion in 2021. This growth is directly linked to the social shift toward treating age-related chronic diseases with minimal trauma.

Strong market demand for minimally invasive therapies, a major healthcare trend.

The preference for minimally invasive procedures is accelerating device adoption across the U.S. healthcare system. This social trend favors AngioDynamics' entire Med Tech portfolio, which includes the Auryon peripheral atherectomy platform and the AlphaVac/AngioVac thrombus management systems, alongside the NanoKnife system. The broader U.S. medical device market size, which encompasses these technologies, is projected to be around $19.46 billion in 2025, driven by this exact preference.

The company's Med Tech segment, which focuses on these high-growth, minimally invasive solutions, saw net sales of $126.7 million in the full fiscal year 2025, representing a strong 19.5% year-over-year increase. This double-digit growth rate is a direct reflection of the market's social acceptance and clinical adoption of less-invasive techniques for both vascular and oncology interventions.

Core product focus addresses high-prevalence diseases like prostate cancer and vascular blockages.

AngioDynamics' product line is strategically aligned with two of the most prevalent chronic conditions in the aging population: cancer and vascular disease. The global prostate cancer treatment market alone is calculated to grow to $16.05 billion in 2025. The segment of that market focused on Minimally Invasive Prostate Cancer Surgery is projected to reach an estimated $10.25 billion in 2025, demonstrating a massive and growing target for the NanoKnife system.

Similarly, the thrombus management platform (AlphaVac and AngioVac) addresses vascular blockages, which are highly prevalent in older adults. The social cost and patient preference for faster, less traumatic clot removal over traditional surgery create a persistent demand floor for these devices.

Aging US population increases the total addressable market for vascular and oncology devices.

The demographic reality in the U.S. is a powerful, non-cyclical driver for medical device demand. As close to 77 million Baby Boomers reach senior age ranges, the prevalence of age-related conditions like cardiovascular disease and cancer-the exact targets of AngioDynamics' products-rises dramatically. This demographic shift guarantees a continually expanding patient pool for the foreseeable future.

Here's the quick math on the market opportunity the aging population is creating:

Market Segment	AngioDynamics Product Focus	2025 Market Size / Growth Driver
Minimally Invasive Surgery (Global)	All Med Tech (NanoKnife, AlphaVac, Auryon)	Company addresses over $10 Billion in global market opportunities.
Prostate Cancer Treatment (Global)	NanoKnife System	Projected to reach $16.05 Billion in 2025.
Minimally Invasive Prostate Surgery (Global)	NanoKnife System	Projected to reach $10.25 Billion in 2025.
U.S. Medical Device Market	All Products	Projected Market Size of $19.46 Billion in 2025.

Growing patient preference for non-thermal, function-preserving treatments, like NanoKnife.

Patient advocacy and a desire for better quality of life post-treatment are driving the demand for non-thermal, function-preserving procedures. NanoKnife, which uses Irreversible Electroporation (IRE) to ablate tissue while sparing critical structures like nerves and blood vessels, directly addresses this need. This is a crucial social factor, as patients are increasingly researching and requesting less-damaging options.

Key developments that reflect and will accelerate this social preference include:

• NanoKnife received FDA 510(k) clearance for Prostate Tissue Ablation in December 2024.
• The system is explicitly positioned as the 'function-preserving treatment' for prostate tumors.
• New CPT Category I Codes for IRE for prostate and liver lesions, effective January 1, 2026, will facilitate reimbursement and broaden patient access to this technology.

NanoKnife disposable sales in the fourth quarter of fiscal year 2025 were $5.7 million, a 5.5% increase compared to the prior year, showing steady, preference-driven adoption even before the new CPT codes take effect. This patient-centric shift toward preserving function is a powerful, sticky trend that will continue to fuel the Med Tech segment's growth.

AngioDynamics, Inc. (ANGO) - PESTLE Analysis: Technological factors

The technological landscape is both AngioDynamics' greatest asset and its most significant cost driver. You can see this clearly in the success of the Med Tech segment, which is built on proprietary, high-value platforms like NanoKnife, Auryon, and AlphaVac. Still, staying ahead means committing substantial capital to research and development (R&D) just to keep pace with the rapid innovation cycles in the medical device (MedTech) industry.

The company's focus on minimally invasive, function-preserving treatments is defintely paying off. The most visible sign of this is the NanoKnife System, which uses Irreversible Electroporation (IRE) technology to precisely destroy cancerous cells with electrical pulses, sparing surrounding healthy tissue. This technology's impact was formally recognized when it was named to TIME's 2025 Best Inventions List, underscoring its potential to change the standard of care for prostate tumors.

Med Tech Portfolio Drives Growth

The core of AngioDynamics' near-term opportunity is the commercial momentum in its Med Tech portfolio. For the full fiscal year 2025, the Med Tech segment net sales reached $126.7 million, representing a strong 19.5% increase over the prior year. This growth is almost entirely driven by the adoption of the AlphaVac and Auryon platforms, which address large, fast-growing markets.

Here's the quick math on where the innovation investment is translating into revenue:

• AlphaVac System: A mechanical thrombectomy device for removing venous and arterial clots, showing substantial market interest following regulatory clearances.
• Auryon System: A peripheral atherectomy platform that uses laser technology to treat peripheral artery disease (PAD), with sales growing by 19.7% in the fourth quarter of FY2025 alone.
• NanoKnife System: Focused on soft-tissue ablation, with disposable sales increasing 5.5% in the fourth quarter of FY2025.

Sustaining Innovation Through R&D Investment

To maintain this technological edge, AngioDynamics must continuously invest. For the full fiscal year 2025, the company's total R&D expense was approximately $26.2 million. This commitment translates to roughly 9% of the full-year net sales of $292.7 million, which is a necessary expense to sustain innovation in a highly competitive sector. The high cost of platform upgrades and clinical trials is a constant reality in MedTech.

What this estimate hides is the inherent risk of R&D: not every project will yield a market-ready product, and the regulatory pathway (like the FDA 510(k) clearance process) adds time and cost. The table below shows the quarterly R&D spend that fueled this year's growth, highlighting the continuous nature of the investment.

Fiscal Year 2025 Quarter	R&D Expense (in millions)	% of Quarterly Sales
Q1 FY2025	$6.3 million	9.3%
Q2 FY2025	$6.4 million	~8.9%
Q3 FY2025	$6.9 million	~9.6%
Q4 FY2025	$6.6 million	~8.2%
Full Year FY2025 (Total)	$26.2 million	~9.0%

The rapid technology cycles in medical devices demand continuous, high-cost platform upgrades, plus the strategic collection of clinical data to support product safety and effectiveness. This is a capital-intensive game, so the company must prioritize its R&D dollars on platforms like NanoKnife and Auryon that address multi-billion-dollar global market opportunities.

AngioDynamics, Inc. (ANGO) - PESTLE Analysis: Legal factors

Securing CPT Category I Codes (reimbursement codes) for NanoKnife is a critical revenue driver for 2026 and 2027.

You're looking for clear revenue catalysts, and the path to reimbursement is the biggest one for a medical device business like AngioDynamics. The American Medical Association's (AMA) CPT Editorial Panel granted Category I CPT codes (Current Procedural Terminology) for Irreversible Electroporation (IRE) using the NanoKnife System for prostate and liver lesion treatments.

This is a defintely a game-changer. Why? Category I codes are for procedures with proven clinical efficacy and widespread use, meaning they attach physician Relative Value Units (RVUs) and streamline defined reimbursement rates from insurers. The codes are set to become effective on January 1, 2026, which directly maps to your revenue projections for the next two fiscal years. This regulatory win should accelerate adoption in the high-growth Med Tech segment, which already saw net sales of $126.7 million in fiscal year 2025.

Strict FDA and international regulatory approval processes create long time-to-market delays.

The regulatory path is always long and expensive in the medical device space, and AngioDynamics is no exception. The NanoKnife System received a crucial U.S. Food and Drug Administration (FDA) 510(k) clearance in late 2024 for prostate tissue ablation, a milestone achieved after the pivotal PRESERVE clinical study of 121 patients. However, the system is still only broadly cleared for the surgical ablation of soft tissue and lacks a specific US clearance for the treatment or therapy of a specific disease, like cancer. This is the constant push-and-pull of medical device regulation.

Also, international approvals add complexity. For example, the AlphaVac F1885 System received its European CE Mark approval for pulmonary embolism (PE) in May 2024, and the Auryon System received a CE Mark for Peripheral Artery Disease (PAD) in the first quarter of fiscal year 2025. These staggered approvals mean market entry and full commercialization are slow, multi-year processes across different continents.

Risk of ongoing litigation and product liability claims, common in the medical device industry.

The medical device industry carries an inherent risk of product liability claims, and AngioDynamics is currently managing a significant one. The company is defending a federal Multidistrict Litigation (MDL 3125) in the Southern District of California concerning its various port catheters (including SmartPort, Vortex, Xcela, and Vaxcel). These lawsuits allege design defects causing serious complications like infections, blood clots, and catheter fractures.

The scale of the risk is clear: as of November 1, 2025, there were 252 active lawsuits consolidated in the group litigation. To be fair, this is a smaller MDL than some competitors, but the legal costs still impact the bottom line. Here's the quick math on the non-routine legal expense for the last full fiscal year:

Fiscal Year Ended May 31, 2025	Non-Routine Legal Expenses (in thousands)	Context
Full Year 2025	$2,245	Legal expenses related to litigation outside the normal course of business.

For the full fiscal year 2025, the company recorded $2.245 million in legal expenses related to litigation outside the normal course of business. This number will likely continue to rise as the MDL progresses through discovery and bellwether trials in 2026.

Compliance with global data privacy and security laws (e.g., HIPAA) for patient data is non-negotiable.

As a medical technology company, AngioDynamics is a 'Business Associate' to covered entities, so compliance with the Health Insurance Portability and Accountability Act (HIPAA) is non-negotiable. This means adhering to the Privacy, Security, and Breach Notification Rules for all electronic Protected Health Information (ePHI).

The compliance landscape is getting tougher. The Office for Civil Rights (OCR) is increasing enforcement, and proposed updates to the HIPAA Security Rule in 2025 are pushing for more rigorous, risk-focused security measures. Specifically, businesses must conduct and document a comprehensive Security Risk Analysis (SRA), reviewed and updated at least annually. Plus, state-level laws, such as Washington's "My Health, My Data Act," are creating a patchwork of requirements for handling health-related data, requiring a constant audit of data governance policies.

• Conduct annual Security Risk Analysis (SRA).
• Update Business Associate Agreements (BAAs) for all vendors.
• Monitor state-level privacy laws for stricter requirements.

AngioDynamics, Inc. (ANGO) - PESTLE Analysis: Environmental factors

Company's overall Net Impact Ratio is a positive 59.9%, mainly due to health benefits.

You might look at the medical device sector and assume the environmental picture is all bad, but for AngioDynamics, the overall impact is strongly positive. This is a core part of their value proposition. The company's Net Impact Ratio, a metric that weighs positive impacts against negative ones, stands at a healthy 59.9% (based on the default value set).

This positive score isn't a fluke; it's driven almost entirely by the life-saving and health-improving nature of their products. The largest positive contribution comes from the Physical diseases impact category, which is exactly what you'd expect from a MedTech company. This is the ultimate offset against manufacturing and waste issues-their core business helps people live longer, better lives. Honestly, that's the most important number here.

Negative impacts are noted in GHG Emissions and Waste from manufacturing.

Still, you can't ignore the manufacturing footprint. Despite the positive net score, AngioDynamics uses resources and causes negative impacts primarily in three categories: Scarce Human Capital, GHG Emissions (Greenhouse Gas Emissions), and Waste. The negative contribution to GHG Emissions is specifically tied to the production of certain products, which is a common challenge for complex medical manufacturing.

Here's a quick look at the impact categories driving the environmental risks:

• GHG Emissions: Driven by products like ECG electrodes, Biopsy systems, and Clinical laser systems.
• Waste: Stemming from manufacturing processes and the end-of-life disposal of single-use devices.

For a company that reported total Net Sales of $292.7 million in fiscal year 2025, managing these operational negatives is a key lever for margin improvement and risk reduction.

Single-use devices like angiographic catheters contribute to contaminated biomedical waste streams.

The biggest environmental challenge for AngioDynamics is the nature of its products. Their core business relies on single-use devices (SUDs) like the AlphaVac System, which includes an 18F cannula and a waste bag assembly used for procedures like pulmonary embolism treatment. Because these devices are used in invasive procedures, they become contaminated waste (Hazardous Medical Waste or HMW) and cannot be recycled through conventional means.

This contaminated waste requires energy-intensive treatment, such as incineration or autoclaving, which, in turn, releases more greenhouse gases and pollutants before the ash or disinfected material is sent to a landfill. Invasive cardiac procedures globally produce an estimated 150 million kg (150,000 metric tons) of waste annually, and AngioDynamics contributes to this stream with its high-growth Med Tech products. This is a direct environmental cost of their commercial success.

Increasing stakeholder pressure for public ESG (Environmental, Social, and Governance) reporting is a growing risk.

The era of voluntary ESG reporting is defintely over. 2025 is a pivot point where mandatory disclosure is becoming the norm, especially in the US. While AngioDynamics' full fiscal year 2025 Net Sales of $292.7 million may keep them below the highest revenue thresholds for some state-level mandates (like California's SB 253, which targets companies over $1 billion in revenue), the pressure is still immense. [cite: 9, 1, 9 (from first search)]

Institutional investors are demanding comparable ESG data to inform capital allocation, and critically, large healthcare systems (their customers) are increasingly requiring verifiable ESG data from their suppliers to meet their own Scope 3 reporting obligations. Failure to provide this data is a direct risk to maintaining key supply chain contracts. The US Securities and Exchange Commission (SEC) is also requiring Large Accelerated Filers to begin collecting climate-related data for their FY2025 reporting cycle, focusing on Scope 1 and Scope 2 emissions.

ESG Pressure Point	2025 Context / Impact on ANGO	Mitigation/Action Required
US SEC Climate Disclosure Rule	Large Accelerated Filers must begin collecting Scope 1 & 2 emissions data for FY2025 reporting (due in 2026).	Must finalize robust internal systems for Scope 1 (direct) and Scope 2 (purchased energy) emissions tracking now.
State-Level Mandates (e.g., CA SB 253)	Requires disclosure of Scope 1, 2, and 3 GHG emissions for large companies (over $1 billion revenue).	Even if below the threshold, supply chain partners (hospitals/GPOs) will demand Scope 3 data, forcing compliance indirectly.
Contaminated Waste Volume	Single-use devices (e.g., AlphaVac cannula) contribute to an estimated 150 million kg of waste annually from invasive cardiac procedures globally.	Need to invest in product design for reprocessing or recycling, or face rising waste disposal costs.