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ARTIVION (AORT)

Recent press releases and 8-K filings for AORT.

Artivion (AORT) Highlights Strong Product Performance, Pipeline, and Financial Outlook at Stifel Healthcare Conference
AORT
Product Launch
Revenue Acceleration/Inflection
M&A
  • Artivion (AORT) is strategically focused on aortic technologies, with past acquisitions yielding a robust pipeline including seven PMAs.
  • The company is experiencing significant growth from its AMDS product, contributing to 31% organic growth in the aortic stent graft line in Q3. Additionally, the On-X mechanical heart valve business has seen 20%+ growth in recent quarters, driven by new clinical data indicating a survival advantage for mechanical valves and a $100 million market expansion opportunity in the US.
  • Artivion projects double-digit revenue growth and EBITDA growth twice as fast as revenue for many years, with an expectation to reach total company gross margins of 70% through product mix.
  • Key upcoming product launches include Nexus, with a US Total Addressable Market (TAM) of $150 million and potential revenue contribution in 2027-2028, and Arcevo, with a US TAM of $80 million, expected in 2029-2030. The company's immediate financial priorities include being positioned to acquire EndoSpan for Nexus and funding a $25 million milestone payment for AMDS PMA approval.
7 days ago
Artivion Highlights Strong Growth in Key Product Lines and Robust Pipeline at Stifel Healthcare Conference
AORT
Revenue Acceleration/Inflection
Product Launch
New Projects/Investments
  • Artivion (AORT) is experiencing accelerating revenue growth driven by its focused strategy on aortic treatments and a strong product pipeline.
  • The company reported 31% organic growth in its aortic stent graft line in Q3, largely due to the U.S. launch of AMDS, which is also seen as market-expanding for acute type A dissections. New MS-DRG 209 is expected to further improve reimbursement for complex aortic arch procedures.
  • The On-X mechanical heart valve business grew over 20% in the last two quarters, fueled by new clinical data showing a survival advantage for mechanical valves in patients aged 60 and younger compared to tissue valves. Artivion plans to target the $100 million bioprosthetic valve market with this data.
  • Artivion maintains a long-term outlook of double-digit revenue growth and EBITDA growth at twice the rate of revenue, with expectations to achieve 70% total company gross margins through product mix.
  • The company has a robust pipeline, with AMDS, Nexus, and Arcevo representing U.S. Total Addressable Markets (TAMs) of $150 million, $150 million, and $80 million respectively, with Japanese markets adding $50 million-$70 million for each.
7 days ago
Artivion Highlights Double-Digit Growth and Margin Expansion at Stifel 2025 Healthcare Conference
AORT
Revenue Acceleration/Inflection
New Projects/Investments
Guidance Update
  • Artivion projects double-digit revenue growth and EBITDA growth at twice the rate of revenue for many years, aligning with 2026 consensus estimates of 11% revenue growth and 18% adjusted EBITDA growth.
  • The company anticipates reaching 70% total company gross margins through the introduction of high-margin aortic products in the U.S., such as AMDS, which is already contributing to gross margin expansion.
  • The On-X Mechanical Heart Valve business is experiencing 20%+ growth, driven by new clinical data demonstrating a survival advantage and opening a $100 million market expansion opportunity in the U.S..
  • Artivion's product pipeline includes AMDS (US TAM $150 million), Nexus (US TAM $150 million, potential launch 2027/2028), and Arcevo (US TAM $80 million, potential launch 2029/2030), with Japanese markets adding $50 million-$70 million for each.
  • Strategic financial priorities include securing the potential acquisition of EndoSpan with a $150 million delayed draw term loan and funding a $25 million milestone payment for AMDS PMA approval, followed by aggressive debt reduction.
7 days ago
Artivion Reports FY24 Results and Provides FY25 Guidance with Key Product Updates
AORT
Guidance Update
Product Launch
Revenue Acceleration/Inflection
  • Artivion (AORT) reported approximately $400 million in FY24 revenue and $71.3 million in FY24 Adjusted EBITDA.
  • For FY25, the company projects revenue guidance of $439M-$445M, reflecting 13-14% year-over-year constant currency growth, and Adjusted EBITDA guidance of $88M-$91M, representing 24-28% year-over-year growth.
  • Growth is driven by products like the On-X Aortic Heart Valve, which has a new $100 million U.S. market opportunity, and the early U.S. launch of AMDS through Humanitarian Device Exemption, targeting a $150 million addressable market.
  • Clinical trial progress includes the AMDS PERSEVERE US IDE Study demonstrating significantly lower 30-day Major Adverse Events and the Endospan NEXUS TRIOMPHE US IDE Trial showing a 63% reduction in MAE rate.
7 days ago
AORT Reports Strong Q3 2025 Results and Raises Full-Year Guidance
AORT
Earnings
Guidance Update
M&A
  • AORT reported strong Q3 2025 financial results, with total constant currency revenue growth of 16% and adjusted EBITDA growth of 39% year-over-year, reaching $113.4 million and $24.6 million respectively.
  • The company raised its full-year 2025 constant currency revenue growth guidance to between 13% and 14% and adjusted EBITDA to a range of $88 million-$91 million.
  • Key product lines, Stent Graft and ON-X, demonstrated significant constant currency revenue growth of 31% and 23% respectively in Q3 2025.
  • AORT is expanding its ON-X operational footprint and secured a new $150 million delayed draw term loan facility to enhance financial flexibility for a potential Endospan acquisition.
  • The AMDS product is gaining commercial traction, supported by a new MS-DRG (DRG-209) effective October 1, 2025, which increases reimbursement for complex aortic procedures.
Nov 6, 2025, 9:30 PM
AORT Reports Q3 2025 Results and Updates Full-Year Guidance
AORT
Earnings
Guidance Update
New Projects/Investments
  • AORT reported Q3 2025 total revenue of $113.388 million and adjusted diluted income per common share of $0.16.
  • The company updated its full-year 2025 revenue guidance to $439 million - $445 million and its adjusted EBITDA guidance to $88 million - $91 million.
  • In the ARTIZEN Pivotal IDE Study, the ARTIZEN arm achieved a primary endpoint of 11.4% compared to 22.2% for the Historical Control, with a p-value of 0.0001.
  • The ARTIZEN study's first enrollment is in November 2025, with potential approval anticipated around 2029.
Nov 6, 2025, 9:30 PM
Artivion Reports Strong Q3 2025 Financial Results and Raises Full Year Guidance
AORT
Earnings
Guidance Update
Debt Issuance
  • Artivion, Inc. reported Q3 2025 revenue of $113.4 million, an 18% increase on a GAAP basis and 16% on a non-GAAP constant currency basis compared to Q3 2024.
  • For Q3 2025, the company achieved net income of $6.5 million, or $0.13 per fully diluted share, and non-GAAP net income of $7.9 million, or $0.16 per fully diluted share.
  • Adjusted EBITDA increased 39% to $24.6 million in the third quarter of 2025 compared to the same period in 2024.
  • Artivion raised its full year 2025 constant currency revenue growth guidance to 13% to 14% (reported revenues of $439 million to $445 million) and adjusted EBITDA growth guidance to 24% to 28% (adjusted EBITDA of $88 million to $91 million).
  • The company strengthened its balance sheet by refinancing its credit agreement, extending the maturity to 2031, and securing access to a new $150 million delayed draw term loan facility.
Nov 6, 2025, 9:09 PM
Artivion Reports Strong Third Quarter 2025 Financial Results and Raises Full Year Guidance
AORT
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Artivion achieved revenue of $113.4 million in the third quarter of 2025, marking an 18% increase on a GAAP basis and 16% on a non-GAAP constant currency basis compared to the third quarter of 2024.
  • The company reported net income of $6.5 million, or $0.13 per fully diluted share, for Q3 2025, a significant improvement from a net loss of $(2.3) million, or $(0.05) per fully diluted share in Q3 2024.
  • Adjusted EBITDA increased 39% to $24.6 million in the third quarter of 2025, up from $17.7 million in the third quarter of 2024.
  • Artivion raised the midpoint of its full year 2025 reported revenue guidance to a range of $439 to $445 million and its adjusted EBITDA guidance to $88 to $91 million.
Nov 6, 2025, 9:05 PM
Artivion Announces Positive Data from AMDS PERSEVERE and PROTECT Trials
AORT
New Projects/Investments
  • Artivion, Inc. announced the presentation of positive 30-day data from its AMDS PERSEVERE trial, showing resolution of visceral malperfusion in 83% and renal malperfusion in 74% of affected subjects following AMDS implantation.
  • The AMDS PERSEVERE trial demonstrated a 72% reduction in all-cause mortality and a 54% reduction in primary major adverse events (MAEs) at 30 days when compared to the current standard of care hemiarch procedure.
  • Real-world data from the AMDS PROTECT trial further validated these outcomes, reporting 4.2% renal failure requiring dialysis and 1.4% unanticipated reoperation among 141 patients.
  • The AMDS, designed for acute DeBakey Type I aortic dissections, targets an estimated $150 million market opportunity in the United States and $540 million globally, pending regulatory approvals.
Oct 13, 2025, 12:00 PM
ARTIVION, INC. Amends Credit Agreement and Secures New Delayed Draw Term Loan Commitments
AORT
Debt Issuance
  • ARTIVION, INC. executed a Second Amendment to its Credit and Guaranty Agreement on September 12, 2025.
  • This amendment includes $150,000,000 in Second Amendment Delayed Draw Term Loan Commitments from various lenders, including Ares Capital Corporation.
  • The total Credit and Guaranty Agreement amount was increased from $350,000,000 to $400,000,000.
  • A financial covenant specifies that the Total Net Leverage Ratio must not exceed 5.75:1.00 for Q1-2025 and thereafter.
Sep 15, 2025, 11:58 AM

Recent SEC filings and earnings call transcripts for AORT.

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