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About Artivion, Inc.
Artivion, Inc. (NYSE: AORT), headquartered in suburban Atlanta, Georgia, is a global leader in the development and commercialization of innovative medical devices for cardiac and vascular surgery, with a specialized focus on aortic disease. The company’s mission is to provide surgeons with simple, elegant solutions to address some of the most complex challenges in treating patients with life-threatening aortic conditions, such as acute DeBakey Type I dissections and aortic aneurysms.
Core Product Portfolio
Artivion’s product offerings are organized into four major categories:
- Aortic Stent Grafts: Minimally invasive devices designed for the repair of aortic aneurysms and dissections, including the NEXUS® Stent Graft System.
- On-X Mechanical Heart Valves: Advanced mechanical valves that offer durability and reduced anticoagulation requirements, supported by extensive clinical data.
- Surgical Sealants: BioGlue® and BioFoam® surgical adhesives used to control bleeding and enhance surgical outcomes in cardiac and vascular procedures.
- Implantable Human Tissues: Cryopreserved cardiac and vascular tissues for use in a variety of reconstructive surgeries.
These products are marketed and sold in over 100 countries, enabling the company to address a global patient population and support healthcare providers worldwide.
Innovative Technologies and Clinical Excellence
Artivion is at the forefront of innovation in aortic repair technologies. Its flagship product, the AMDS Hybrid Prosthesis, is the world’s first aortic arch remodeling device designed for use in acute DeBakey Type I dissections. The device has demonstrated groundbreaking clinical outcomes, including reductions in mortality and major adverse events, as validated by the PERSEVERE and DARTS clinical trials.
The company also markets the On-X Aortic Heart Valve, which has been shown to deliver superior patient outcomes with low-dose anticoagulation therapy, as evidenced by long-term clinical studies.
Strategic Market Position
Artivion operates in a highly specialized and competitive industry, with key competitors including Medtronic and Edwards Lifesciences. The company differentiates itself through its focus on aortic-centric solutions, leveraging proprietary technologies and robust clinical data to establish a leadership position in the market. Artivion’s strategic initiatives include geographic expansion into high-growth regions such as Asia-Pacific and Latin America, as well as investments in regulatory approvals and product innovation.
Regulatory and Clinical Milestones
Artivion’s commitment to clinical excellence is reflected in its rigorous regulatory strategy. The company has achieved significant milestones, including FDA Humanitarian Device Exemption (HDE) for the AMDS Hybrid Prosthesis and CE Mark approval for the NEXUS Stent Graft System. These approvals enable the company to address unmet medical needs and expand its market presence globally.
Commitment to Excellence
With a focus on delivering life-saving technologies and improving patient outcomes, Artivion continues to invest in research and development, clinical trials, and strategic partnerships. The company’s dedication to innovation, quality, and patient care underscores its role as a trusted partner for cardiac and vascular surgeons worldwide.
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.
Artivion Inc. (NYSE: AORT), a leading cardiac and vascular surgery company, has announced its participation in two upcoming investor conferences. The company will present at the Canaccord Genuity 44th Annual Growth Conference on August 14, 2024, at 2:00 p.m. ET in Boston. A live webcast of the presentation will be available on Artivion's website and archived for 90 days.
Additionally, Artivion's management team will participate in investor meetings at the 9th Annual Needham Virtual MedTech & Diagnostics 1x1 Conference on August 12-13, 2024. No webcast will be available for this virtual event due to its format. These conferences provide Artivion an opportunity to showcase its focus on aortic disease and engage with investors.
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