Artivion, Inc. (AORT): PESTLE Analysis [Nov-2025 Updated]

You're looking at Artivion, Inc. (AORT) and trying to map their next move, but honestly, the external environment is pulling them in two directions. On one side, the aging population defintely ensures a sustained, high demand for their core cardiovascular products, which is a massive tailwind. But, on the other, persistent global inflation is squeezing margins-you need to understand the real impact when a 3% raw material cost increase hits a supply chain already burdened by the European Union Medical Device Regulation (EU MDR) compliance. This isn't just about sales; it's about navigating a complex web of geopolitical friction and technological shifts like transcatheter aortic valve replacement (TAVR) that could redefine their market share. Let's break down the Political, Economic, Sociological, Technological, Legal, and Environmental factors Artivion must manage to maximize returns.

Artivion, Inc. (AORT) - PESTLE Analysis: Political factors

US regulatory stability under the Food and Drug Administration (FDA) remains critical for new product approvals.

The stability of the U.S. Food and Drug Administration (FDA) regulatory pathway is not just a compliance issue for Artivion, it is a direct driver of future revenue. You have a massive opportunity in your pipeline, but it is locked behind the FDA's final approval sign-off. The good news is that the process is moving forward with tangible milestones in 2025.

For example, your AMDS Hybrid Prosthesis-a device with an estimated U.S. market opportunity of $150 million-is still on track for Premarket Approval (PMA) in late 2025, following the Humanitarian Device Exemption (HDE) granted in late 2024. Also, the FDA granted Investigational Device Exemption (IDE) approval in the second quarter of 2025 to start the ARTIZEN pivotal trial for the Arcevo LSA, which is a key step toward bringing that next-generation technology to market. This regulatory progress is what converts R&D spend into sales. It's defintely worth tracking the PMA timeline weekly.

Increased scrutiny on foreign manufacturing sites affects supply chain security and compliance costs.

You need to be realistic about the rising political pressure on foreign manufacturing, which translates directly into increased compliance costs and supply chain risk. Artivion operates manufacturing facilities in the U.S. (Georgia and Texas) and overseas in Hechingen, Germany. The FDA announced a policy shift in May 2025 to expand its use of unannounced inspections of foreign manufacturing facilities, including those for medical products, to eliminate the 'double standard' compared to domestic sites.

This is a serious headwind because foreign facilities were already found to have compliance violations (Official Action Indicated or Voluntary Action Indicated) nearly three times more frequently than domestic facilities in 2023 and 2024. Any inspection delay or adverse finding at your German facility could disrupt the supply of critical components. Plus, you already dealt with a major supply chain disruption in 2024 from the cybersecurity incident that caused a short-term backlog in tissue processing, a risk you want to avoid repeating in 2025.

Global trade tariffs and geopolitical tensions impact the cost of raw materials and international sales margins.

While Artivion's core business is well-diversified geographically, with products sold in over 100 countries, global political volatility is still a factor in your margins. Your Q2 2025 regional constant currency revenue growth shows strong international performance, but the foreign exchange environment remains volatile.

Here's a quick look at your Q2 2025 regional constant currency revenue growth, showing where your international exposure lies:

• North America: 18% growth
• Asia-Pacific: 15% growth
• EMEA (Europe, Middle East, and Africa): 10% growth

Geopolitical tensions-like the escalating U.S.-China rivalry and broader trade protectionism-don't just affect tariffs on finished goods; they increase the cost and complexity of sourcing specialized raw materials for medical devices. Your forward guidance for full-year 2025 revenue of $439 million to $445 million and Adjusted EBITDA of $88 million to $91 million reflects this ongoing currency and trade uncertainty.

US Inflation Reduction Act (IRA) provisions could influence long-term Medicare reimbursement rates for medical devices.

The Inflation Reduction Act (IRA) is primarily known for its drug pricing reforms, but its effects ripple through the entire U.S. healthcare reimbursement system. For Artivion, which sells medical devices covered under Medicare Part A and Part B, the direct impact is more nuanced than the Part D drug changes.

The major 2025 IRA changes-like the $2,000 annual out-of-pocket cap for Part D beneficiaries-affect patient affordability for drugs and shift costs to manufacturers and insurers. However, the general political trend toward cost containment is the real long-term risk for devices.

In the near term, the most relevant policy update is the Inpatient Prospective Payment System (IPPS) Final Rule for Fiscal Year (FY) 2025. This rule, which governs hospital reimbursement for inpatient procedures, includes a 3.1% net payment increase for acute care hospitals that meet quality standards, along with updates to MS-DRGs (Medicare Severity Diagnosis Related Groups) for cardiac procedures. This is a positive signal for hospital budgets, which ultimately pay for your devices like aortic stent grafts and heart valves. You still need to ensure your new products, like AMDS, secure favorable New Technology Add-on Payment (NTAP) status or a strong MS-DRG assignment to maximize hospital adoption.

Artivion, Inc. (AORT) - PESTLE Analysis: Economic factors

You need to understand how the global economic environment is shaping Artivion, Inc.'s bottom line, because the macro picture is dictating the cost of capital and the capacity of your customers-hospitals-to use your products. The good news is that Artivion's strong product mix is currently overriding some serious inflationary and interest rate pressures.

Persistent global inflation drives up manufacturing and logistics costs, squeezing gross margins.

While global headline inflation is projected to cool slightly to around 4.4% in 2025, the cost pressure on manufacturing and logistics remains a real headwind for medical device companies. For Artivion, this means the raw materials for stent grafts and the energy costs for tissue processing are higher, pushing up your Cost of Goods Sold (COGS). The impact of this inflation is a persistent drag on profitability, forcing management to seek efficiencies.

Here's the quick math on how Artivion is handling this: despite the rising input costs, the company's Q3 2025 GAAP Gross Margin actually expanded to 65.6%, up from 63.7% a year ago. This is a testament to the favorable product mix, particularly the higher-margin AMDS and On-X products, and strong pricing power in the market. Still, the underlying inflationary environment means any slip in product mix or pricing strategy could quickly reverse this margin expansion.

High interest rates make capital expenditures and R&D financing more expensive for new product development.

The high interest rate environment, a deliberate move by central banks to fight inflation, directly impacts Artivion's cost of capital. In the US, the Federal Funds Effective Rate is sitting around 4.00% (October 2025), which translates to a Bank Prime Loan rate of 7.00%. In the Eurozone, the ECB Main Refinancing Operations Rate is 2.15% (effective June 2025). These rates make any new borrowing for expansion or development more expensive.

Artivion finished Q3 2025 with total debt of $214.9 million. This debt load is more costly to service and refinance in the current environment. Plus, the company projected negative free cash flow for the full year 2025, largely driven by a significant $12 million facility purchase to ramp up On-X production. That is a major CapEx investment that becomes more financially burdensome when the cost of debt is this high.

The elevated cost of capital also pressures your R&D pipeline. Your Trailing Twelve Months (TTM) R&D expense was approximately $28 million as of June 2025, and high interest rates mean the net present value (NPV) calculation for new, long-horizon projects like the ARTIZEN pivotal trial for Arcevo LSA has a higher discount rate, demanding a faster or higher return on investment.

Hospital staffing shortages in the US and Europe slow elective procedure volumes, impacting product utilization.

Artivion's revenue is fundamentally tied to the number of aortic and cardiac procedures performed in hospitals. The persistent, severe staffing crisis in the US and Europe is limiting hospital capacity for these elective surgeries. A survey in March 2025 found that nearly half (48%) of US hospital executives feel they are not equipped to handle current patient volumes. The most significant gaps are in specialists (49%) and nurses (46%).

When hospitals lack the specialized staff-like operating room nurses and cardiothoracic surgical assistants-they cannot run their operating rooms at full capacity. This creates a bottleneck that slows down the utilization of your products, specifically the On-X valves and stent grafts, even if demand from patients is high. It's a capacity problem, not a clinical one.

• Specialist shortages: 49% of US executives cite this as a top gap.
• Nurse shortages: 46% of US executives cite this as a top gap.
• Overall capacity: 48% of US hospitals are not equipped for current patient volumes.

Strong US dollar creates currency headwinds, reducing the value of international sales revenue.

As a US-based company with significant international sales, a strong US dollar (USD) acts as a currency headwind-it makes your products more expensive overseas and reduces the USD value of foreign-denominated sales when translated back to the US. This is a critical factor since Artivion is actively growing its international footprint, particularly in Asia Pacific and EMEA (Europe, Middle East, and Africa).

The Q3 2025 results clearly illustrate this dynamic: total revenue grew by 18% on a GAAP (as-reported) basis, but only 16% on a constant currency basis. That 2 percentage point difference represents the negative currency translation impact, which is money lost on the income statement simply due to foreign exchange rates. The lower reported growth in the EMEA region (+12%) compared to North America (+19%) is consistent with this currency pressure.

Artivion, Inc. (AORT) - PESTLE Analysis: Social factors

You're operating in a healthcare landscape fundamentally shaped by demographics and provider fatigue. The core takeaway for Artivion, Inc. is that the massive, sustained demand from aging populations provides a strong revenue floor, but you must accelerate the shift to minimally invasive products to capture the market's high-growth, high-margin segments.

Aging populations in key markets (US, Europe) drive sustained, high demand for cardiovascular and aortic repair products.

The sheer volume of older patients in North America and Europe is the primary social tailwind for Artivion's aortic-centric portfolio. Cardiovascular disease (CVD) is not just prevalent; it's a demographic certainty. In the United States, between 2017 and 2020, an estimated 127.9 million adults (48.6%) had some form of CVD. This translates directly to a growing pool of patients needing aortic repair, heart valve replacement, and surgical sealants like BioGlue.

In Europe, the situation is similar, with diseases of the circulatory system causing 1.68 million deaths in the European Union in 2022, representing 32.7% of all deaths. As the global populace ages, crude cardiovascular mortality is projected to rise, ensuring a long-term, non-cyclical demand for Artivion's products. This is a foundational market advantage.

Growing patient preference for minimally invasive surgical techniques requires product portfolio adaptation.

Patients and physicians are increasingly choosing less traumatic procedures, a trend that demands Artivion continues to invest heavily in its catheter-based solutions. The global minimally invasive cardiac surgery market is projected to grow at a Compound Annual Growth Rate (CAGR) of 5-10%, which is a clear signal of where the market is heading. Your stent graft portfolio, which grew 22% on a constant currency basis in Q2 2025, is a direct beneficiary of this trend.

The shift is evident in aortic valve replacement (AVR), where Transcatheter Aortic Valve Replacement (TAVR) is often preferred over traditional surgical AVR for many patients. Artivion's acquisition of Jotec, a German stent graft company, was a smart move to focus on the catheter-based, minimally invasive treatment of the aorta. Your challenge is to maintain the strong growth of the surgical-focused On-X mechanical heart valve (up 24% in Q2 2025) while accelerating the development and adoption of your endovascular (catheter-based) technologies like the AMDS Hybrid Prosthesis.

Increased public awareness of heart disease risk factors boosts early diagnosis and intervention rates.

Public health campaigns and growing awareness of risk factors mean more patients are being diagnosed earlier, which expands the overall addressable market for Artivion. For example, the American Heart Association's 2025 report highlights that nearly 47% of U.S. adults have high blood pressure, a major risk factor for aortic disease. This high prevalence, coupled with increased screening, drives earlier intervention.

When patients are diagnosed sooner, they are often healthier candidates for more complex, but ultimately life-saving, aortic procedures. This supports the strong performance of your aortic arch solutions and stent grafts, which address these complex segments.

Healthcare provider burnout and labor costs pressure hospitals to adopt more efficient, single-use devices.

Hospital economics are under immense strain from labor shortages and provider burnout, which directly impacts their purchasing decisions. Physicians are spending an estimated 30-50% of their time on non-clinical administrative tasks, fueling a crisis that persists into 2025. Moreover, the cost of replacing a single physician can reach up to $500,000, creating a powerful incentive for hospitals to prioritize efficiency and staff retention.

This pressure makes devices that streamline procedures and reduce complications highly desirable. Artivion's products that simplify complex surgeries and reduce hospital stays are a direct solution. For instance, the AMDS Hybrid Prosthesis has been shown to reduce mortality, complications, and reoperations compared to the standard of care, leading to significant cost savings for the healthcare system. This efficiency-driven purchasing is a key factor in your sales conversations.

Here's the quick math on the social factors:

The market is there, but it demands speed and efficiency.

Your next step: Product Strategy: Prioritize R&D spend to ensure the AMDS and other endovascular pipeline products hit their launch targets, specifically focusing on surgeon training to drive adoption.

Artivion, Inc. (AORT) - PESTLE Analysis: Technological factors

The technological landscape for Artivion, Inc. is a high-stakes race where innovation is not just about a better product, but about a less-invasive procedure. Your core challenge is balancing the long-term clinical superiority of your established surgical solutions with the rapid, less-invasive advancements from competitors in the Transcatheter Aortic Valve Replacement (TAVR) space. This requires a focused R&D spend and a clear digital strategy.

Significant R&D focus on next-generation tissue-engineered heart valves to compete with traditional grafts.

You are defintely prioritizing your product pipeline, which is a necessity in this industry. For the third quarter of 2025, Artivion's Research and Development (R&D) expenses were $8.1 million, representing 7.1% of sales. This consistent investment is aimed squarely at next-generation solutions and expanding the market for existing products like the On-X heart valve.

The On-X aortic valve is a critical technological differentiator, as it is the only mechanical aortic heart valve that can be maintained at a low International Normalized Ratio (INR) of 1.5 to 2.0. This unique clinical profile is what opens a new estimated $100 million annual market opportunity for Artivion, specifically targeting younger patients (under 65) who might otherwise receive a bioprosthetic valve.

In the next-generation stent graft category, the pivotal ARTIZEN U.S. Investigational Device Exemption (IDE) trial for the Arcevo LSA Hybrid Stent Graft System began enrolling its first patient in the third quarter of 2025. This trial for a next-generation product is the kind of clinical validation that will define your market position for the next decade.

Use of advanced materials and 3D printing accelerates prototyping and customization of surgical implants.

The industry is moving toward personalized medicine, and 3D printing is the key enabler. Artivion has already leveraged this technology, specifically using 3D-printed prototypes in the development of its stent graft systems for the U.S. market. This use of Additive Manufacturing (AM) accelerates the design-to-production cycle, allowing for rapid iteration and customization of complex surgical implants.

This is a cost-saving and speed advantage, but the broader industry is pushing further. For example, AI-driven innovation in 3D-printed vascular tissues has been shown to improve graft success rates and durability by as much as 35% in 2025, setting a new bar for material science and manufacturing precision. You need to move past prototyping and into final product manufacturing with these advanced techniques to remain competitive.

Integration of artificial intelligence (AI) in surgical planning and post-operative monitoring systems is a necessity.

AI is no longer a futuristic concept; it's a necessary tool for surgical precision and efficiency. AI-powered surgical planning can create detailed 3D models of patient anatomy, helping surgeons plan complex procedures and reducing operative time by an estimated 25% and intraoperative complications by 30% in some AI-assisted robotic surgery meta-analyses. This is a huge shift in the standard of care.

Artivion is strategically addressing this necessity, as evidenced by the appointment of a new Chief Strategy and Digital Officer in May 2025, who is tasked with driving digital technology initiatives. This organizational move signals a recognition that digital and AI-driven solutions must be integrated into your product strategy, not just your operations, especially as competitors launch AI-integrated platforms.

Competitors are pushing innovation in less-invasive transcatheter aortic valve replacement (TAVR) technology.

The biggest technological headwind you face is the shift toward less-invasive procedures, primarily TAVR (Transcatheter Aortic Valve Replacement). The global TAVR market size was valued at $6.78 billion in 2024 and is projected to grow significantly, with one forecast anticipating a market increase of $2.4 billion between 2023 and 2028. This growth is fueled by an aging population and expanding indications for the procedure.

Your competitors are moving fast. For example, Medtronic plc received FDA approval for its Evolut PRO+ TAVR system in January 2024, and Abbott Laboratories is actively developing an investigational TAVI platform that is specifically designed to be AI-integrated and software-guided. This is the competitive reality: they are combining minimally invasive access with cutting-edge digital guidance.

Here's the quick math on the competitive landscape you are navigating:

Your action is clear: you must continue to invest in the clinical data for your surgical solutions, like the On-X valve, while accelerating the digital and AI integration into your next-generation endovascular devices like Arcevo and the potential acquisition of Endospan's NEXUS system. Finance: Model the capital expenditure required to move from 3D prototyping to 3D manufacturing for a key product line by Q2 2026.

Artivion, Inc. (AORT) - PESTLE Analysis: Legal factors

European Union Medical Device Regulation (EU MDR) requires significant investment for re-certification of existing products.

The shift to the European Union Medical Device Regulation (EU MDR) is more than a paperwork exercise; it is a major financial and operational hurdle for Artivion, Inc. and the entire MedTech industry. The regulation demands a complete overhaul of technical documentation and a deeper commitment to post-market clinical follow-up (PMCF) for all legacy devices, including key products like BioGlue and the On-X heart valves. Artivion is actively working through this transition, having a formal application with a Notified Body for an MDR CE Mark for its portfolio.

This re-certification process is a significant drag on resources. Industry analysis from early 2025 indicates that certification and maintenance costs under the new MDR have escalated by as much as 100% or more compared to the previous directives. For medical device manufacturers specifically, maintenance and re-certification costs are projected to be approximately 50% more than the initial certification fees over a five-year cycle. This cost is largely hidden within the company's research and development (R&D) and quality assurance budgets.

Here's the quick math on the R&D proxy: Artivion's R&D expenses for the third quarter of 2025 were $8.1 million, representing 7.1% of sales. A substantial portion of this ongoing R&D spend is diverted from new product innovation to regulatory compliance, essentially becoming a mandatory tax on maintaining market access in Europe. The extended compliance deadlines for high-risk devices (until the end of 2027 or 2028) provide a temporary buffer, but the investment must continue.

Stricter global data privacy laws (e.g., GDPR, CCPA) increase compliance costs for patient data management.

As Artivion's products, particularly connected medical devices and services, integrate more deeply into hospital networks and patient care pathways, the cost and complexity of data privacy compliance soar. Regulations like the European Union's General Data Protection Regulation (GDPR) and the California Consumer Privacy Act (CCPA) require substantial investment in IT infrastructure, data mapping, and personnel. Artivion's public-facing policies confirm its commitment to addressing rights under both GDPR and CCPA. This is defintely a non-negotiable cost of doing business globally.

The financial risk of non-compliance is massive, but the investment itself is also significant. Globally, end-user spending on security and risk management is projected to reach $212 billion in 2025, a 15% increase from 2024, reflecting this heightened regulatory focus. For a company like Artivion that handles sensitive patient health information (PHI), compliance isn't just a legal shield; it's a competitive advantage that builds trust with hospital systems. The table below outlines the dual nature of this regulatory environment:

Intellectual property (IP) litigation risks remain high, especially around biological tissue processing and valve design.

The medical device and biotech space is a hotbed for IP litigation, and Artivion's core products-biological tissue processing, surgical sealants like BioGlue, and the On-X heart valves-are in high-value, patent-dense areas. Patent disputes are fueling exposure growth for nearly half (46%) of companies in the sector in 2025, with non-practicing entities (NPEs) increasingly targeting MedTech firms. The stakes are high: a single patent infringement case in the heart valve space, for a competitor, recently resulted in a jury award of $106.5 million, though it was later overturned on appeal.

Artivion faces two primary IP risks:

• Patent Defense: Protecting its own core technology, like the unique design of its mechanical heart valves.
• Product Liability/Design Risk: Navigating litigation that blends product design claims with failure-to-warn issues, which can be linked to patent disclosures. For example, a 2024 MAUDE report related to the On-X Heart Valve mentioned potential litigation based on the valve's sound being a legally cognizable product defect, which ties back to the product's fundamental design and IP.

While specific 2025 litigation charges aren't disclosed, the company must maintain a significant legal defense budget. This constant legal pressure is a factor in maintaining Artivion's strong guidance of 2025 adjusted EBITDA between $88 million and $91 million, as legal costs are a necessary operational expense to protect revenue.

Increased focus on cybersecurity regulations for connected medical devices and hospital network integration.

The regulatory focus on cybersecurity is rapidly intensifying, particularly for connected medical devices (CMDs) that transmit patient data and integrate with hospital IT systems. The US federal government, in 2025, has placed increased scrutiny on data security as a national security matter. For Artivion, this means its stent grafts and other devices that may rely on digital platforms for planning, inventory, or monitoring must adhere to evolving standards from the FDA and other global bodies.

The legal mandate here is shifting from simple data protection to system-wide resilience. This requires a dedicated budget for compliance with new cybersecurity frameworks and for continuous vulnerability testing. The cost of cybercrime is anticipated to reach an astonishing $10.5 trillion annually by the end of 2025, underscoring the severity of the threat that Artivion's legal and compliance teams must mitigate. This risk profile means that the legal team must work closely with IT to ensure:

• Device Security: Adherence to FDA pre-market submission requirements for device cybersecurity.
• Network Integrity: Contractual compliance with hospital system security protocols.
• Incident Response: A legally sound plan for mandatory breach reporting under HIPAA and GDPR.

Finance: draft a 13-week cash view by Friday that explicitly models the high-end of estimated MDR compliance costs.

Artivion, Inc. (AORT) - PESTLE Analysis: Environmental factors

Growing pressure from investors and regulators to reduce the environmental impact of Ethylene Oxide (EtO) sterilization.

The regulatory environment for Ethylene Oxide (EtO) sterilization-a critical process for many of Artivion's products, including their implantable cardiac and vascular human tissues-is tightening dramatically in 2025. This creates a clear operational and financial risk. The U.S. Environmental Protection Agency (EPA) issued an Interim Decision on EtO in January 2025, which mandates new, stringent risk mitigation measures for medical device sterilization. This regulatory push is a direct response to public and investor concerns over EtO's carcinogenic properties and its release into communities.

Artivion, which relies primarily on large-scale EtO facilities, must manage the capital expenditure and compliance costs associated with these new rules. The EPA's 2024 National Emissions Standards for Hazardous Air Pollutants (NESHAP) for commercial sterilizers is expected to reduce EtO emissions by over 90% nationwide, affecting nearly 90 facilities operated by 50 companies. The compliance deadlines are phased, extending up to ten years, but the immediate pressure is real. This is not a distant threat; it's a cost-of-doing-business increase right now.

• Reduce EtO concentration rate limit to 600 mg/L for new cycles (10-year compliance).
• Lower the occupational exposure limit incrementally to 0.1 ppm (10-year compliance).
• Require continuous emissions monitoring and quarterly reports for most commercial sterilizers.

Mandates for sustainable packaging and reduction of single-use plastic waste in medical device production.

The global shift toward Extended Producer Responsibility (EPR) legislation marks 2025 as a watershed year for sustainable packaging, directly impacting Artivion's product logistics. EPR laws, already implemented in at least six US states including California and Oregon, force companies to financially manage the entire lifecycle of their packaging, including recycling and disposal. For a medical device company, this means redesigning sterile barrier systems while maintaining product integrity, a complex and costly challenge.

The company also faces increasing regulatory scrutiny on specific materials, such as Per- and Polyfluoroalkyl Substances (PFAS), which are subject to increasing regulation and potential bans by the EPA and various states. While Artivion has not reported a material impact yet, the compliance burden and the potential need to immediately scrap raw or in-process materials if a supplier is shut down pose a clear financial risk, as acknowledged in their 2025 10-K filing. The goal is to reduce packaging weight and volume, which some industry leaders are achieving by over 50% through redesign.

Company ESG (Environmental, Social, and Governance) reporting is now a key factor for institutional investment decisions.

Institutional investors, who own a significant portion of Artivion's stock, are increasingly using ESG metrics as a non-financial performance indicator, moving beyond simple financial statements. The availability of the company's Corporate Responsibility Report (ESG) is now a standard expectation, and the lack of strong environmental performance data can trigger divestment or a higher cost of capital. Artivion is exposed to new international rules like the Corporate Sustainability Reporting Directive, which will increase the scope and detail of mandatory disclosure.

Here's the quick math on investor influence: Artivion's market value of voting stock held by non-affiliates was approximately $1.017 billion as of June 30, 2024. A negative ESG rating from a major institutional investor like BlackRock or State Street could directly impact this valuation, as they factor in environmental risk. Honest transparency on EtO use and waste reduction is defintely a prerequisite for maintaining institutional confidence.

Climate change-related supply chain disruptions pose a risk to global logistics and raw material sourcing.

Climate volatility is no longer a long-term theoretical risk; it is a near-term operational threat to Artivion's global supply chain, which spans more than 100 countries. Extreme weather events were ranked as the second most significant short-term material crisis risk in the World Economic Forum's 2025 Global Risk Report. This translates into tangible financial impacts on global logistics.

The total global economic losses from natural catastrophes rose to $162 billion in the first half of 2025, up from $156 billion the previous year, highlighting the increasing frequency and severity of these events. For Artivion, this means higher freight costs, delays in receiving raw materials-like the bovine and porcine tissues used in their bioprosthetic products-and the risk of supplier shutdowns. In 2024, over 76% of European shippers reported supply chain disruption, a trend expected to continue in 2025, which directly impacts Artivion's European procedure volume.

Next step: Finance: Draft a sensitivity analysis on your 2025 gross margin, mapping the impact of a 3% increase in raw material costs and a 2% decline in European procedure volume by the end of the quarter.