1-Year Data from Endospan's NEXUS TRIOMPHE IDE Trial Demonstrate High Patient Survival with Low Morbidity 2-Year Data from the AMDS PERSEVERE IDE Trial Further Demonstrate the Persistent Clinical Benefit of AMDS ndATLANTA, Feb. 2, 2026 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced the presentation of new clinical data from Endospan's NEXUS TRIOMPHE IDE trial and its AMDS PERSEVERE IDE trial at the 62 Annual Meeting of ...

Core Viewpoint - Artivion, Inc. is set to release its fourth quarter 2025 financial results on February 12, 2026, after market close, followed by a teleconference to discuss the results [1]. Financial Results Announcement - The financial results will be released on February 12, 2026, after market close [1]. - A teleconference call and live webcast will take place at 4:30 p.m. ET on the same day, hosted by Pat Mackin, the Chairman, President, and CEO of Artivion [1]. Teleconference Details - To participate in the live teleconference, interested parties should dial 201-689-8261 a few minutes before the scheduled time [2]. - A replay of the teleconference will be available approximately one hour after the event, accessible by calling toll-free 877-660-6853 or 201-612-7415, with the conference number 13758212 [2]. Webcast and Earnings Release Access - The live webcast and its replay can be accessed through the Investors section of Artivion's website [3]. - A copy of the earnings press release, containing financial and statistical information for the quarter and full year, will also be available in the Investors section of the website [3]. Company Overview - Artivion, Inc. is headquartered in suburban Atlanta, Georgia, and focuses on developing solutions for cardiac and vascular surgeons dealing with aortic diseases [4]. - The company offers four major product groups: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues [4]. - Artivion markets its products in over 100 countries worldwide [4].

Core Viewpoint - The value of Artivion (AORT) is largely tied to clinical outcomes, FDA approvals, and successful commercialization, but the company is demonstrating strong execution, which builds confidence in its long-term prospects [1] Company Performance - Artivion continues to execute well, which is crucial for building investor confidence in its future performance [1]

Core Viewpoint - Idexx Laboratories (IDXX) is currently outperforming its peers in the Medical sector, with a year-to-date gain of 66.5% compared to the sector average of 8.2% [4]. Company Performance - Idexx Laboratories is ranked 2 (Buy) in the Zacks Rank system, indicating strong analyst sentiment and a positive earnings outlook, with a 2.5% increase in the consensus estimate for full-year earnings over the past 90 days [3]. - The stock has significantly outperformed the Medical - Instruments industry, which has an average gain of 4.7% this year [5]. Industry Context - The Medical sector consists of 946 individual stocks, with Idexx Laboratories contributing to the sector's overall performance, which is ranked 6 in the Zacks Sector Rank [2]. - Another stock in the Medical sector, Artivion (AORT), has also shown strong performance with a year-to-date return of 62% and a Zacks Rank of 2 (Buy) [4][5].

Summary of Artivion Conference Call Company Overview - **Company**: Artivion - **Industry**: Medical Devices, specifically focusing on aortic technologies Key Points and Arguments Strategic Focus and Vision - Artivion has shifted its focus to cardiac and vascular surgeons treating the aorta, divesting non-aortic products to concentrate on unmet clinical needs in this area [2][3][5] - The company has made several strategic acquisitions over the past five years, including On-X, Jotec, and Ascyrus, to enhance its product offerings and address significant clinical challenges [3][5][6] Product Pipeline and Growth - Artivion has a robust pipeline with seven PMAs (Premarket Approvals) in progress, indicating a strong future growth trajectory without the immediate need for further acquisitions [9][10] - The company anticipates double-digit revenue growth and EBITDA growth at twice the rate of revenue for many years, with recent quarters showing even higher growth rates [15][17][40] AMDS Technology - The AMDS (Aortic Malperfusion Device System) is expected to expand the market for treating acute type A aortic dissections, potentially reducing mortality rates significantly [18][20] - AMDS is positioned to be used in a wider range of centers, which could lead to increased adoption and market expansion [18][20][21] Competitive Landscape - AMDS competes with existing technologies like the Frozen Elephant Trunk and hemianchor repair, but its ease of use and effectiveness may lead to broader adoption among surgeons [21][23] - The company aims to maintain a comprehensive aortic strategy by offering multiple treatment options, ensuring they meet diverse patient needs [23][24] Financial Performance and Projections - The mechanical heart valve business, particularly On-X, has seen significant growth, with recent quarters showing over 20% growth, driven by new clinical data demonstrating advantages over bioprosthetic valves [28][30][31] - The company expects gross margins to improve, with a target of reaching 70% in the long term, driven by the introduction of high-margin products [42][45] Operational and Financial Management - Artivion is focused on maintaining operational scalability to support growth, ensuring that infrastructure keeps pace with increasing demand for high-margin products [49][50] - The company has a solid cash flow management strategy, with priorities including funding for potential acquisitions and debt repayment [57] Market Dynamics and Reimbursement - The introduction of a new DRG (Diagnosis-Related Group) for complex aortic arch procedures is expected to facilitate AMDS adoption by improving reimbursement rates [27] - The company has successfully navigated previous reimbursement challenges, and the new DRG is seen as a positive development for market entry [27] Future Outlook - Artivion is optimistic about its growth prospects, with plans to train surgeons on AMDS and leverage new clinical data to drive market share [33][36] - The company is committed to a long-term growth strategy, focusing on innovation and customer needs in the aortic space [60][61] Additional Important Insights - The company has experienced a significant shift in its market positioning and is now seen as a leader in aortic technologies, with a clear focus on addressing critical clinical needs [1][2][60] - Artivion's management emphasizes the importance of aligning all teams towards a common goal of delivering innovative aortic solutions to improve patient outcomes [60][61]

Financial Performance & Growth - Artivion achieved approximately $400 million in revenue and around $70 million in EBITDA for FY24[5] - The company is driving sustained double-digit revenue growth and expects 2x+ EBITDA growth[14] - Full year 2025 revenue guidance is between $439 million and $445 million, representing a year-over-year constant currency growth of 13-14%[73] - Full year 2025 adjusted EBITDA is expected to be between $88 million and $91 million, a year-over-year growth of 24-28%[76] - Net debt leverage is expected to decrease to less than 20x by year-end 2025, with net debt at 18x as of September 30, 2025[69] Business Segments & Market Opportunities - Preservation Services (CryoValve® SG) generated $98 million in revenue in 2024, holding the 1 market position with a 65% share in a $150 million global TAM[17] - Surgical Sealant (BioGlue) had $74 million in revenue in 2024, holding the 2 market position with a 28% share in a $260 million global TAM[17] - On-X aortic valve is uniquely positioned for younger AVR patients, creating a new $100 million U S market opportunity[24] - The company is focused on more complex, less competitive stent graft segments, with a 16% 3-year CAGR[38] - AMDS addresses a $150 million addressable market opportunity and is expected to receive PMA approval by mid-2026[41,46] Clinical Data & Product Performance - On-X aortic heart valve post-approval study (PAS) shows a 66% reduction in major events and an 87% reduction in major bleeding compared to the PROACT IDE study[20] - TRIOMPHE US IDE Trial for Endospan NEXUS® demonstrates a 63% reduction in major adverse event (MAE) rate compared to the reference performance goal[53] - AMDS use significantly lowers 30-day Major Adverse Events (MAEs) compared to hemiarch control, with 269% MAEs in PERSEVERE vs 580% in the Hemiarch Reference Cohort[47]

Group 1 - The article does not provide any relevant content regarding the company or industry [1]

Market Risk and Financial Reporting - As of September 30, 2025, there has been no material change in the market risk disclosures compared to the previous annual report [158]. - The CEO and CFO concluded that the Disclosure Controls were effective at a reasonable assurance level as of September 30, 2025 [161]. - No changes in internal controls over financial reporting materially affected the company during the three months ended September 30, 2025 [162]. - The company faces significant risks from international operations, including currency exchange rate fluctuations, particularly with the Euro [167]. - Continued fluctuation of foreign currencies relative to the US Dollar could materially affect future revenues, particularly as most foreign revenues are denominated in Euros [180]. Legal and Regulatory Risks - The Italian parliament agreed to a 75% reduction in payment obligations related to alleged overpayments for medical devices, resulting in a payment of approximately €0.1 million [168]. - The company is engaged in various legal actions, but does not believe there are pending matters that could materially affect its financial condition [164]. - The transition to the European Union's Medical Device Regulation (MDR) has faced difficulties, potentially delaying the commercialization of products in the European Economic Area [209]. - The FDA's proposed reclassification of the CryoValve SG pulmonary heart valve to Class III could make its processing commercially infeasible, with a 30-month timeline to submit a PMA application [211]. - Increased environmental regulations regarding EtO sterilization processes could adversely affect the company's ability to commercialize products [220]. - The company faces potential fines and penalties for promoting products for unapproved uses, which could impact financial performance [223]. - Changes in U.S. policy, including tariffs and trade regulations, could negatively impact supply chain costs and revenue streams [226]. - The new administration's policies may impact federal spending and workforce, affecting regulatory reviews and approvals critical to operations [227]. - Changes in healthcare laws and regulations, including the Affordable Care Act, could impact costs, reimbursement, and regulatory environment, potentially delaying clinical trials and product launches [228]. - The company faces risks related to product liability claims, with existing insurance coverage potentially being insufficient to cover liabilities [229]. - Compliance with data privacy and security laws is increasingly complex, with potential penalties for noncompliance that could adversely affect business operations [232]. - Recent healthcare and tax legislation, including the "One Big Beautiful Bill Act," may have a material adverse effect on the company's financial condition and operations [233]. Operational and Supply Chain Risks - The company is significantly dependent on revenues from tissue preservation services, which face risks related to supply and regulatory changes [172]. - The company relies on approximately 60 organ and tissue procurement organizations (OPOs) and tissue banks for tissue donations, which are critical for its preservation services business [191]. - The company is dependent on single or sole-source suppliers for many materials and components, which limits its ability to negotiate favorable terms and increases operational risks [188]. - The company is susceptible to disruptions in the global supply chain due to geopolitical and labor issues, which may impact operations [187]. - The company experienced a write-off of $0.4 million in 2023 due to the abandonment of its CardioGenesis cardiac laser therapy assets [189]. - The company faced negative impacts on business operations and sales during the COVID-19 pandemic, affecting procedure volumes and outstanding receivables [183]. Strategic and Competitive Risks - The company operates in a highly competitive market with significant competition from established medical device companies [170]. - The company continues to evaluate expansion through acquisitions and licensing, which may carry significant risks and affect market value [196]. - The company has three internal manufacturing facilities located in Austin, Texas; Hechingen, Germany; and Kennesaw, Georgia, with reliance on contract manufacturers for certain products [193]. - The company’s ability to attract and retain a specialized workforce is critical, with significant competition for qualified personnel in its primary facilities [195]. - The company’s technologies and products are subject to intellectual property risks, including potential disputes that could be costly [182]. - The company’s financial results may be adversely affected by acquisition-related adjustments, including potential impairments and increased costs [197]. Cybersecurity and Insurance Risks - The company experienced a cybersecurity incident in Q4 2024 that disrupted operations and impacted revenue, manufacturing, and order processing [204]. - The company has limited cyber-insurance coverage, which may not cover all financial losses associated with security breaches [206]. - Claims-made insurance policies are in place to mitigate financial exposure, but significant claims could increase insurance rates or jeopardize coverage [230]. Financial Position and Stockholder Considerations - The company has significant indebtedness, which could limit operational flexibility and the ability to raise additional capital [235]. - The company has pledged substantially all US assets as collateral under existing credit agreements, raising concerns about asset sufficiency in case of default [236]. - Stockholder activism could disrupt business operations and management focus, potentially leading to fluctuations in stock price [239]. - The company does not anticipate paying dividends on common stock for the foreseeable future, limiting returns for stockholders to share price appreciation [240].

Financial Performance - Revenue for Q3 was GBP 191.7 million, reflecting a decrease of 1% on a like-for-like basis and 3.4% on a reported basis [2] - Year-to-date revenue reached GBP 552.1 million, down 8.4% like-for-like and 11.1% reported [2] - Net revenue for the quarter was GBP 167 million, down 4.4% like-for-like and 6.9% reported [2] - Year-to-date net revenue was GBP 495.2 million, down 8.2% like-for-like and 10.8% reported [2] Operational Insights - The company anticipates stronger profitability in the second half of the year, particularly in Q4, due to new business wins and cost reduction measures [3] - The workforce, referred to as "Monks," decreased to approximately 6,500, down 5% from 6,900 in June 2025 and down 13% from 7,500 a year ago [3] - The reduction in workforce primarily targeted non-billable roles and aimed at enhancing back-office efficiencies [3] Debt Position - The company closed the period with a net debt of GBP 151 million, which is lower than previous figures [3]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $113.4 million, representing a 16% increase compared to Q3 2024 [15] - Adjusted EBITDA increased approximately 39% from $17.7 million to $24.6 million in Q3 2025 [15] - Adjusted EBITDA margin improved to 21.7%, a 320 basis point increase year-over-year [16] - Gross margins were 65.6% in Q3 2025, up from 63.7% in Q3 2024, reflecting a 200 basis point increase [17] Business Line Data and Key Metrics Changes - Stent Graft revenues grew 31% on a constant currency basis in Q3 2025 [16] - ON-X revenues increased by 23% year-over-year on a constant currency basis [16] - Tissue processing revenue rose 5% year-over-year on a constant currency basis [11] - BioGlue revenues grew 1% in Q3 compared to the same period last year [11] Market Data and Key Metrics Changes - Revenues in North America increased by 19% [16] - Asia-Pacific revenues grew by 18% [16] - EMEA revenues increased by 12% [16] - Latin America revenues rose by 10% [16] Company Strategy and Development Direction - The company aims to replicate its successful Stent Graft strategy in the U.S. and Japan, expanding its total addressable market [5] - The establishment of a new MS-DRG code for complex aortic procedures is expected to enhance the economic value proposition of AMDS [7] - The company is focused on advancing a robust pipeline of high-margin innovations, estimating a $1 billion incremental market opportunity over the next five-plus years [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining double-digit revenue growth while growing adjusted EBITDA at twice the rate of revenue growth [15] - The company anticipates continued growth driven by AMDS, On-X heart valves, and the Nexus PMA [24] - Management highlighted the importance of new clinical data and reimbursement dynamics as tailwinds for growth [24] Other Important Information - The company expects to be slightly cash flow negative for the full year 2025 due to a one-time cash payment related to facility purchases [18] - As of September 30, 2025, the company had approximately $73.4 million in cash and $214.9 million in debt [19] Q&A Session Summary Question: What is the expected annualized cost for the Arcevo trial? - Management indicated that R&D funding is expected to be 7%-8% of sales annually, with a full year of trial costs anticipated in 2026 [27] Question: What is driving the growth of ON-X? - Management noted that growth is attributed to market share gains and new clinical data showing benefits of mechanical valves over bioprosthetic valves [29] Question: Can you elaborate on the new DRG and its economic implications? - Management explained that the new DRG reflects the high cost and complexity of advanced aortic arch procedures, which should alleviate previous economic challenges [31] Question: What is the expected market size for Arcevo? - The estimated market size for the frozen elephant trunk in the U.S. is about $80 million [38] Question: How is AMDS performing in terms of sell-through versus sell-in? - Management stated that revenue is currently weighted towards initial stocking, with increasing implantations expected [35] Question: What are the expectations for AMDS in international markets? - The company plans to pursue PMA approval in the U.S. before moving towards approvals in Japan and China [42]