Total Revenue

+1.6% (from $97.43M in Q1 2024 to $98.98M in Q1 2025)

Modest revenue growth reflects only a slight increase in overall sales. While Medical Devices helped drive gains, the limited increase signals that other segments did not perform as robustly as they did in previous periods. " "

Medical Devices revenue

+10.8% (from $71.11M to $78.80M)

Strong device sales contributed to a significant increase, consistent with prior periods where higher demand and improved product performance, particularly in aortic stent grafts and On‑X products, boosted Medical Devices revenue. " "

Preservation Services revenue

-23.4% (from $26.32M to $20.18M)

A sharp decline occurred due to a backlog of tissue shipments related to a cybersecurity incident, contrasting with previous periods where increases in average sales prices had driven revenue growth. " "

North America Revenue

-6.2% (from $50.93M to $47.79M)

Declines in North America revenue were primarily due to the underperformance of Preservation Services in the region, even though previous periods had shown growth driven by On‑X products and market share gains. " "

EMEA Revenue

+10.3% (to $37.05M)

Robust growth in EMEA is maintained by continued strength in selling higher-priced products and favorable pricing, echoing earlier constraints that drove strong performance in FY 2024. " "

APAC Revenue

+7.9% (to $8.21M)

Moderate growth in APAC continues from FY 2024 trends, supported by market expansion and improved distributor buying patterns, albeit at a lesser pace compared to regions like LATAM or EMEA. " "

LATAM Revenue

+11.6% (to $5.93M)

Notable improvement in LATAM revenue is driven by increased unit sales in indirect markets, a continuation of the strong performance observed in previous periods. " "

Operating Income

-91% (from $25.31M to $2.15M)

Severe margin compression occurred as a 63% jump in operating expenses, driven by higher administrative costs (including cybersecurity incident expenses and increased stock compensation), outpaced the modest revenue gains compared to the previous period. " "

Net Income

Swing to a loss of $0.505M (from a profit of $7.533M)

A dramatic reversal in net income resulted from significantly increased operating costs and expense pressures—such as the cybersecurity incident—that overwhelmed the modest revenue increase, unlike the more positive margins seen in Q1 2024. " "

Total Operating Expenses

+63% (from $37.64M to $61.43M)

Operating expenses surged mainly due to a significant increase in general, administrative, and marketing expenses (including $4.5M related to the cybersecurity incident and higher non‑cash stock compensation), contrasting sharply with the more controlled expenses in the prior period. " "

Revenue Growth

FY 2025

10% to 14% "

11% to 14% " "

raised

Reported Revenues

FY 2025

$420 million to $435 million "

$423 million to $435 million " "

raised

Adjusted EBITDA

FY 2025

$84 million to $91 million "

$84 million to $91 million "

no change

Adjusted EBITDA Margin Expansion

FY 2025

200 basis points "

over 200 basis points "

raised

Gross Margin Expansion

FY 2025

improvement by about 100 basis points "

1 point of gross margin expansion "

no change

R&D Expenses

FY 2025

closer to 8% of sales "

at the higher end of the 7% to 8% range "

no change

Free Cash Flow

FY 2025

expected to be positive "

free cash flow positive "

no change

Quarterly Revenue Guidance

Q2 2025

no prior guidance

$107.5 million to $109.5 million (13% growth) "

no prior guidance

Tissue Processing Revenue Recovery

Q3 2025

no prior guidance

unfavorable impact fully caught up by end of Q3 2025 " "

no prior guidance

AMDS Sales Growth

Each quarter of 2025

no prior guidance

expected sequential growth each quarter "

no prior guidance

AMDS device launch momentum

In Q4 2024, Q3 2024, and Q2 2024 the AMDS launch was described as progressing with HDE approval, early commercial shipments, and a “soft launch” with plans for gradual ramp-up. " " " " " "

Q1 2025 updates show strong momentum following HDE approval, with positive surgeon feedback, active training sessions, and about 150 facilities pursuing approvals. " " " "

Improved momentum with accelerated clinical engagement and training.

Regulatory approval challenges

Previous periods detailed regulatory hurdles (e.g. PMA delays, IRB and value committee approvals) with anticipated approval timelines and submission milestones. " " " "

Q1 2025 acknowledged the complex process—with hospitals needing IRB, committee approvals, and training—but noted a 100% success rate with targeted facilities. " " "

Consistent challenges with clear progress and facility onboarding success.

On‑X valve market growth and strong clinical performance improvements

Q4 2024, Q3 2024, and Q2 2024 highlighted On‑X revenue growth (10–15% YoY), strong clinical data (significant mortality and bleeding reductions), and expanding market share globally. " " " " " " "

Q1 2025 reported 11% YoY growth and reiterated positive clinical data (improved mortality outcomes via low INR regimen) despite some supply constraints. " " "

Stable, strong performance with minor supply constraints noted.

NEXUS aortic arch stent graft progress with FDA approval dependency

In Q4 2024, Q3 2024, and Q2 2024, NEXUS progress was discussed with completed enrollment/data milestones and an anticipated FDA approval in the second half of 2026. " " " " " " "

Q1 2025 presented new 30‑day clinical data showing a significant reduction in major adverse events and reaffirmed the FDA timeline with acquisition option details. " " " "

Consistent progress with promising clinical data and clear acquisition contingency.

Regulatory process complexities and variability in hospital approval timing

Q4 2024 explained the multi‐step approval (IRB, value analysis, training) and PMA delay, while Q3 2024 touched on complex hospital processes (in China for BioGlue), with no mention in Q2 2024. " " "

Q1 2025 reiterated the need for individualized hospital approvals—with variable timing—but emphasized a 100% success rate among the 150 targeted facilities. " " "

Ongoing complexities persist with consistent progress.

Cybersecurity incident impacts leading to tissue backlog and revenue recovery challenges

Q4 2024 detailed a significant negative revenue impact (≈$4.5M), extended tissue processing lead times, and shipment delays due to the cybersecurity incident; Q3 and Q2 2024 did not mention this topic. " " " " "

Q1 2025 noted a 23% decline in tissue processing revenue due to backlog, but about one‑third of the backlog was cleared and recovery is expected by Q3 2025. " " " "

Recovery is underway with improvements from the previous significant impact.

Convertible debt risks and potential shareholder dilution concerns

Q4 2024 described plans to convert debt to common stock to lower net leverage and noted shareholder views, while Q3 2024 discussed cash/stock flexibility; Q2 2024 did not mention these issues. " " "

No mention of convertible debt risks or dilution concerns in Q1 2025.

Not discussed in current period, suggesting a deprioritization or resolution.

Global market expansion and increased geographic revenue segmentation

Q4 2024, Q3 2024, and Q2 2024 described international growth through regulatory approvals, footprint expansion in Latin America, Asia Pacific, and steady gains in EMEA and North America. " " " " " " " " " "

Q1 2025 provided a detailed geographic revenue breakdown: Latin America up 26%, Asia Pacific up 8%, EMEA up 14%, and North America down 6%. " " "

Consistent global expansion with healthy growth outside North America despite regional disparities.

Evolving clinical data on mortality reduction and reduced major bleeding outcomes

Prior periods (Q4 2024, Q3 2024, Q2 2024) showcased evolving evidence from AMDS and On‑X trials with strong results—showing significant reductions in mortality and bleeding events. " " " " " " " "

Q1 2025 reinforced these findings with new STS data demonstrating statistically significant mortality benefits for mechanical valves and low–INR On‑X advantages. " " "

Continued robust clinical improvements reinforcing product superiority.

Emerging concerns over declining mechanical valve usage trends

Q4 2024 included commentary addressing declining usage trends but countered them with strong clinical data and potential market expansion; Q3 and Q2 2024 did not mention declines. "

Q1 2025 did not mention any emerging concerns, focusing instead on positive clinical data and market expansion for On‑X. " " "

Shift from concern to optimism as robust data supports mechanical valve adoption.

Transparency issues in detailed product performance and revenue breakdown

Q2 2024 offered limited product‐level details; Q3 2024 discussed higher‐level performance without granularity; Q4 2024 provided detailed breakdowns (including impacts of cybersecurity). " " " " " "

Q1 2025 delivered a comprehensive overview of product performance across stent graft, On‑X, BioGlue, and tissue processing with detailed geographical and financial metrics. " " " "

Increasing transparency with more granular and comprehensive disclosures.

Pipeline expansion and acquisition upside opportunities

Q4 2024 and Q2 2024 discussed AMDS progress, NEXUS timelines, BioGlue strides in China, and strategic acquisition options (e.g. Endospan) with detailed terms; Q3 2024 focused on pipeline progress without acquisition comments. " " " " " "

Q1 2025 emphasized active pipeline expansion with robust AMDS launch, promising NEXUS trial results, and reiterated Endospan acquisition option details as part of long-term strategy. " " " "

Robust and consistent pipeline expansion with maintained acquisition upside opportunities.

New market challenges from delayed revenue streams (e.g., BioGlue in China, reduced PerClot orders)

Q4 2024, Q3 2024, and Q2 2024 highlighted delays: BioGlue faced administrative and reimbursement hurdles delaying commercialization, and PerClot orders declined due to inventory management issues. " " " " " " " "

Q1 2025 did not mention these specific challenges.

Not a focus in Q1 2025, suggesting either resolution or reduced impact from previous delays.