The press release also provided insights into the global prevalence of acute DeBakey Type I aortic dissections and the potential market opportunities, both in the U.S. and worldwide. However, the company's forward-looking statements caution that actual results may differ due to various risks and uncertainties. InvestingPro analysis reveals the stock has gained an impressive 65.88% year-to-date and is currently trading near its 52-week high, with analysts projecting profitability this year. For deeper insights into Artivion's financial health and growth prospects, investors can access comprehensive analysis through InvestingPro's detailed research reports, available for over 1,400 US stocks. InvestingPro analysis reveals the stock has gained an impressive 65.88% year-to-date and is currently trading near its 52-week high, with analysts projecting profitability this year. For deeper insights into Artivion's financial health and growth prospects, investors can access comprehensive analysis through InvestingPro's detailed research reports, available for over 1,400 US stocks.
The press release also provided insights into the global prevalence of acute DeBakey Type I aortic dissections and the potential market opportunities, both in the U.S. and worldwide. However, the company's forward-looking statements caution that actual results may differ due to various risks and uncertainties. InvestingPro analysis reveals the stock has gained an impressive 65.88% year-to-date and is currently trading near its 52-week high, with analysts projecting profitability this year. For deeper insights into Artivion's financial health and growth prospects, investors can access comprehensive analysis through InvestingPro's detailed research reports, available for over 1,400 US stocks.
The AMDS is recognized as the first device of its kind for treating acute DeBakey Type I aortic dissections. It is designed to complement standard hemiarch replacement procedures without adding complexity and has demonstrated a significant reduction in major adverse events (MAEs) compared to the current standard of care. Data from the PERSEVERE US IDE trial, consisting of 93 U.S. participants, revealed a 72% reduction in all-cause mortality and a 54% reduction in primary MAEs at 30-days post-implantation, with no occurrences of distal anastomotic new entry (DANE).
Dr. Wilson Szeto, Chief of Cardiovascular Surgery at the Perelman School of Medicine at the University of Pennsylvania, emphasized the FDA's recognition of the AMDS as a testament to its unique ability to treat this rare and emergent condition. The PERSEVERE trial results and the device's ease of use are expected to broaden the treatment options available to cardiac surgeons.
Artivion's Chairman, President, and CEO, Pat Mackin, expressed the company's commitment to making the AMDS accessible to U.S. facilities and physicians while pursuing PMA approval, anticipated in late 2025. In preparation for the launch, the company is focusing on obtaining hospital IRB approvals, submitting to hospital value analysis committees, and training surgeons.
The press release also provided insights into the global prevalence of acute DeBakey Type I aortic dissections and the potential market opportunities, both in the U.S. and worldwide. However, the company's forward-looking statements caution that actual results may differ due to various risks and uncertainties.
This article is based on a press release statement from Artivion, Inc.
In other recent news, Artivion Inc. reported a cybersecurity incident, but the company does not anticipate a material impact from this event. Alongside this, Artivion continues to exhibit solid financial performance, with recent developments including a 10% year-over-year increase in revenue to $95.8 million in Q3 2024 and a 28% rise in adjusted EBITDA to $17.7 million. These gains are attributed to robust sales of key products and expansion into international markets, particularly Latin America and Asia Pacific.
For the full year, Artivion anticipates a revenue growth of 10% to 12%, with projected revenues between $389 million and $396 million. Adjusted EBITDA for the full year is expected to be between $69 million and $72 million, marking a 28% to 34% increase.
In addition to financial growth, Artivion has made progress in regulatory milestones, including the filing of the first module of the AMDS PMA and NMPA approval for BioGlue in China. Analysts have discussed a $20 million opportunity related to BioGlue in China, with significant progress expected in H2 2025. Despite some challenges, these recent developments suggest a solid growth trajectory for Artivion.
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