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About Artivion, Inc. (NYSE: AORT)
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a prominent medical device company dedicated to developing elegant and straightforward solutions addressing the complex challenges faced by cardiac and vascular surgeons in treating aortic diseases. The company offers a wide array of aortic-centric products, including aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues, distributed in over 100 countries worldwide.
Recent Achievements and Financial Performance:
- For the third quarter of 2023, Artivion reported revenues of $87.9 million, marking a 14% increase year-over-year, with notable growth in aortic stent grafts and On-X mechanical heart valves.
- Completed enrollment in the PERSEVERE clinical trial, targeting PMA approval for the AMDS Hybrid Prosthesis by 2025, showcasing significant reductions in all-cause mortality and major adverse events.
- Announced a comprehensive $350 million non-dilutive credit agreement to address debt maturities and further optimize the capital structure, highlighting the company's strategic growth initiatives.
Product Innovation and Clinical Trials:
- The On-X Aortic Heart Valve Low INR post-market study demonstrated superior patient outcomes, significantly reducing major bleeding events compared to historic controls.
- Artivion's product portfolio includes innovative solutions like the AMDS Hybrid Prosthesis, aimed at improving outcomes for patients with acute DeBakey Type I aortic dissections.
With a strong focus on clinical efficacy and market expansion, Artivion continues to be a pivotal player in the cardiac and vascular surgery market, striving to deliver life-saving products and technologies that improve patient outcomes.
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.
Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company specializing in aortic disease, has announced the release date for its second quarter 2024 financial results. The results will be made public on Thursday, August 8, 2024, after market close. Following the release, the company will host a teleconference call and live webcast at 4:30 p.m. ET to discuss the results and conduct a Q&A session led by Pat Mackin, Chairman, President and CEO of Artivion.
Interested parties can access the live teleconference by dialing 201-689-8261 shortly before 4:30 p.m. ET. A replay will be available approximately one hour after the event. The live webcast and replay can be accessed through the Investors section of Artivion's website at www.artivion.com.
Artivion has revised its agreements with Endospan, providing up to $25 million in debt financing to assist in obtaining FDA approval for the NEXUS Stent Graft System. The upfront payment for a potential purchase of Endospan has been reduced to $135 million, inclusive of loan offsets, and the $100 million minimum earnout has been eliminated. NEXUS offers a minimally invasive treatment for aortic arch disease, targeting a $600 million annual global market. Artivion retains the option to acquire Endospan within 90 days of NEXUS FDA approval, with terms allowing for up to $12.5 million in equity as part of the payment.
Artivion, Inc. (NYSE: AORT) reported strong first quarter 2024 financial results with revenue of $97.4 million, an increase of 17% on a GAAP basis. Net income was $7.5 million, and non-GAAP adjusted EBITDA increased by 60%. The company revised its FY24 revenue guidance to 9-12% growth. The On-X aortic valve post-market clinical study showed promising results, lowering the risk of major bleeding by 87%. Artivion raised the lower end of its revenue guidance for 2024 and expects non-GAAP adjusted EBITDA to increase by 26-34% compared to 2023.
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