Welcome to our dedicated page for Artivion news (Ticker: AORT), a resource for investors and traders seeking the latest updates and insights on Artivion stock.
About Artivion, Inc.
Artivion, Inc. is a specialized medical device company at the forefront of addressing complex challenges in the treatment of aortic disease through innovative products tailored for cardiac surgery and vascular surgery. Headquartered in suburban Atlanta, Georgia, the company designs, develops, and markets a comprehensive suite of solutions that include advanced mechanical heart valves, aortic stent grafts, surgical sealants, and implantable cardiac and vascular human tissues. Artivion’s product portfolio is purposefully built to support cardiac and vascular surgeons in performing intricate procedures, delivering focused solutions that streamline surgical processes while optimizing patient outcomes.
Core Business Areas and Product Portfolio
Artivion’s product offerings are constructed around four major groups:
- Aortic and Mitral Heart Valves: Engineered to provide reliable and durable performance, these valves are designed to address the challenges of aortic and mitral valve replacements and repairs.
- Aortic Stent Grafts: These devices facilitate minimally invasive repairs for aortic arch diseases, reducing the need for complex open-chest surgeries and simplifying treatment protocols for aneurysms and dissections.
- Surgical Sealants and Adhesives: Developed to complement traditional surgical techniques, these products help control bleeding and support soft tissue repair, ensuring more secure post-operative outcomes.
- Implantable Human Tissues: Artivion also markets processed cardiac and vascular tissues that are used in complex surgeries, enhancing the anatomical and physiological compatibility for critical procedures.
Each of these groups benefits from robust clinical validations and regulatory approvals across multiple international markets, underscoring the company’s commitment to safe and effective medical interventions.
Clinical Evidence and Industry Impact
Artivion distinguishes itself from competitors with strong clinical data derived from rigorous studies, such as the PERSEVERE trial and supporting post-market studies. These studies demonstrate the safety, efficacy, and long-term benefits of its aortic solutions, including improvements in patient outcomes and surgical simplification during complex procedures. The company’s focus on evidence-based technology not only reinforces the credibility of its products but also positions it strategically in a competitive landscape where clinical performance is paramount.
Market Position and Global Outreach
Operating in over 100 countries, Artivion maintains a significant footprint in the global medical device market. By leveraging advanced manufacturing techniques and maintaining high standards in quality and compliance, the company meets the diverse needs of international healthcare providers. Its targeted approach in addressing aortic pathologies—coupled with strategic collaborations and partnership agreements—ensures that Artivion remains a trusted resource for cardiothoracic surgeons worldwide.
Commitment to Innovation and Quality
At the core of Artivion’s strategy is a commitment to delivering simple, elegant solutions that overcome complex surgical challenges. Through continuous research and development, the company not only refines its existing product lines but also explores new technological frontiers in cardiac and vascular surgery. The integration of clinical insights with advanced engineering reinforces its ability to serve a critical segment of healthcare, providing clinicians with tools that enhance precision, safety, and overall patient care.
Investor and Industry Insights
The comprehensive approach adopted by Artivion—from R&D innovation to global distribution and post-market clinical validation—makes it a company of focus for investors and industry analysts alike. Detailed trial data, robust product performance, and strategic market penetration collectively underpin the company’s established role in treating aortic diseases. Artivion’s neutral and fact-based communication of clinical results and market strategies demonstrates its dedication to enhancing outcomes for patients while supporting surgeons in resolving some of the most challenging aspects of cardiac and vascular procedures.
Conclusion
Artivion, Inc. stands as an influential player in the global medical device industry with its specialized focus on aortic disease. Through a well-rounded portfolio of advanced surgical devices and continuous innovation, the company addresses critical gaps in cardiac and vascular treatment. Its evidence-backed products and strategic market presence offer a transparent and comprehensive view of its operations, making it a relevant topic for investors and healthcare professionals seeking an informed understanding of its business model and market impact.
Artivion (NYSE: AORT), a cardiac and vascular surgery company specializing in aortic disease, has announced its participation in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference. The company will engage in a virtual fireside chat on March 18, 2025 at 10:40 a.m. ET.
Investors and interested parties can access the live webcast through the Investors page on Artivion's website (www.artivion.com). The recorded session will remain available for replay on the website for 90 days following the event.
Artivion (NYSE: AORT) reported its Q4 and full-year 2024 financial results. Q4 revenue reached $97.3 million, up 4% from Q4 2023, while full-year revenue grew 10% to $388.5 million. The company posted a Q4 net loss of $(16.5) million, or $(0.39) per share, and a full-year net loss of $(13.4) million.
Key growth drivers included On-X (10%), stent grafts (10%), and BioGlue (8%) in Q4. Latin America showed strong performance with 26% growth. The company received FDA Humanitarian Device Exemption for AMDS Hybrid Prosthesis and submitted its second PMA module.
For 2025, Artivion projects revenue between $420-435 million (10-14% growth) and adjusted EBITDA of $84-91 million (18-28% growth). The company noted a late November 2024 cybersecurity incident that impacted Q4 revenues but expects minimal impact on 2025 performance.
Artivion (NYSE: AORT) has scheduled the release of its fourth quarter and full year 2024 financial results for Monday, February 24, 2025, after market close. The company will host a teleconference call and live webcast at 4:30 p.m. ET on the same day, featuring Chairman, President and CEO Pat Mackin, followed by a Q&A session.
Participants can join the live teleconference by dialing 201-689-8261. A replay will be available approximately one hour after the event by calling 877-660-8653 (toll-free) or 201-612-7415, using conference number 13749878. Both the live webcast and replay will be accessible through the Investors section of Artivion's website.
Artivion (NYSE: AORT) presented one-year data from the AMDS PERSEVERE clinical trial at the 61st Annual Meeting of the Society of Thoracic Surgeons. The study analyzed outcomes of 93 participants following AMDS implantation for acute DeBakey Type I dissections with malperfusion.
Key findings show sustained benefits at one year with 80% patient survival. The trial demonstrated significantly better outcomes compared to historical controls, with all-cause mortality of 20.4% vs 42.7% at one year. Notable results include new disabling stroke (11.8%), renal failure/dialysis (20.4%), and myocardial infarction (2.2%).
Importantly, no distal anastomotic new entry (DANE) tears were detected in PERSEVERE study patients, compared to up to 70% occurrence in traditional treatments. The need for unanticipated aortic reoperations was low at 4.3%. The company expects PMA approval in late 2025.
Artivion (NYSE: AORT) has received FDA Humanitarian Device Exemption (HDE) for its AMDS Hybrid Prosthesis, the world's first aortic arch remodeling device for treating acute DeBakey Type I aortic dissections with malperfusion. The device demonstrated significant clinical benefits in the PERSEVERE US IDE trial, showing a 72% reduction in all-cause mortality and 54% reduction in primary major adverse events compared to standard care.
The HDE allows commercial distribution in the US for cases with malperfusion (approximately 40% of all cases). A full Premarket Approval (PMA) is expected in late 2025, which would expand treatment to all acute DeBakey Type I dissections, representing a $150 million annual US market opportunity.
Artivion reported its Q3 2024 financial results, highlighting a 9% revenue increase to $95.8 million compared to Q3 2023. On a non-GAAP constant currency basis, revenue grew 10%. The company reported a net loss of ($2.3) million or ($0.05) per share, but achieved a non-GAAP net income of $5.0 million or $0.12 per share. Adjusted EBITDA rose 28% to $17.7 million. Key milestones include the submission of the first PMA module for AMDS Hybrid Prosthesis to the FDA, completion of enrollment in the NEXUS TRIOMPHE trial, and regulatory approval for BioGlue in China. For 2024, Artivion expects 10-12% revenue growth, narrowing its guidance to $389-$396 million and projecting adjusted EBITDA growth of 28-34%, resulting in $69-$72 million.
Artivion (NYSE: AORT) has announced its participation in two upcoming investor conferences in New York. The company will present at the Stifel 2024 Healthcare Conference on November 19, 2024, at 1:15p.m. ET at the Lotte New York Palace, with a live webcast available on their website. The webcast recording will be accessible for 90 days afterward.
Additionally, the management team will conduct one-on-one meetings at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum on November 21, 2024. No webcast will be available for this event due to its format.
Artivion (NYSE: AORT) has scheduled its third quarter 2024 financial results release for Thursday, November 7, 2024, after market close. The company will host a teleconference call and live webcast at 4:30 p.m. ET, featuring a Q&A session with Chairman, President and CEO Pat Mackin. Participants can dial 201-689-8261 to join the call. A replay will be available at 877-660-6853 or 201-612-7415 with conference number 13748263. The webcast and earnings press release will be accessible through the Investors section of Artivion's website.
Artivion, Inc. (NYSE: AORT) presented late-breaking clinical data at the 38th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting, showcasing positive results from three trials:
1. AMDS DARTS Trial: 5-year data showed 94% of patients free from unanticipated reoperation and 95% free from total aortic diameter growth.
2. AMDS PERSEVERE Trial: 30-day data revealed cerebral malperfusion resolution in 90% of affected subjects post-AMDS implantation.
3. NEOS Study: 1-year data indicated E-vita Open Neo is safe and effective for treating aortic arch pathologies, with a lower combined major adverse event rate compared to the market-leading alternative.
These results validate Artivion's portfolio in aortic disease treatment, demonstrating positive outcomes and improved patient care across multiple studies.
Artivion announced its Q2 2024 financial results.
Revenue grew to $98.0 million, a 10% increase from Q2 2023. The company reported a net loss of ($2.1 million), or ($0.05) per share, compared to a net loss of ($3.4 million) or ($0.08) per share in Q2 2023. Non-GAAP net income was $2.9 million or $0.07 per share, up from $2.3 million or $0.06 per share last year.
Adjusted EBITDA rose by 35% to $18.6 million. The company raised its full-year revenue guidance to a growth of 10% to 12% and adjusted EBITDA guidance to a growth of 28% to 34%.
Revenue growth was driven by 15% increase in On-X and 13% increase in stent grafts. The company also saw strong revenue in Latin America and Asia Pacific, growing by 25% and 15% respectively.
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