Anteris’ Rising Losses and Control Weaknesses Cast Shadow on DurAVR THV Path

Financial Performance and Operational Context

Anteris Technologies Global Corp. (ASX: AVR, NASDAQ: AVR) has released its audited financial results for the year ended 31 December 2025, reporting a net loss of US$94.2 million on revenues of US$1.9 million. This represents a 29% decline in revenues and a 24% increase in net loss compared to 2024. The revenue contraction primarily reflects the expiration of a transition services agreement with LeMaitre Vascular, which had previously supported sales of the CardioCel™ and VascuCel™ tissue products. Despite this, Anteris has increased demand for other higher-yielding tissue products during the year.

The company continues to invest heavily in research and development, with R&D expenses rising 34% to US$69.1 million, driven by manufacturing scale-up, clinical trial preparations, and expanded medical affairs activities. Selling, general and administrative expenses decreased slightly by 7%, reflecting lower marketing and travel costs, partially offset by increased legal and compliance expenses related to dual listing requirements.

DurAVR THV System and Clinical Progress

Anteris’ lead product, the DurAVR Transcatheter Heart Valve (THV) System, is a novel biomimetic valve designed to replicate the performance of a healthy human aortic valve. The company has advanced regulatory approvals in Europe, securing the first approval in Denmark in October 2025, and received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in November 2025. These milestones enabled the initiation of the global pivotal PARADIGM Trial, designed to generate the clinical evidence necessary for premarket approval in the U.S. and CE Mark approval in Europe.

The PARADIGM Trial represents a critical step towards commercialization, enrolling patients across multiple risk profiles and including a parallel registry for valve-in-valve procedures. Anteris is concurrently scaling manufacturing capabilities to support the trial and eventual market demand, including expanding clean room capacity and cross-training personnel.

Capital Raising and Strategic Partnership

In early 2026, Anteris significantly strengthened its financial position by completing a US$230 million public offering and a concurrent US$90 million private placement with Medtronic plc, a leading global medical technology company. Medtronic’s investment represents a strategic partnership, with the company acquiring a 16.1% stake and securing rights including board observer status and participation rights in future financings.

The capital raised is expected to fund ongoing clinical development, manufacturing scale-up, and preparation for commercialization. Anteris reported cash and cash equivalents of US$12.6 million at year-end 2025, with the recent financings providing sufficient liquidity for at least the next 12 months.

Governance and Risk Management

Anteris disclosed material weaknesses in its internal control over financial reporting related to procedural documentation and segregation of duties. Management has initiated a remediation plan, including enhanced controls and ongoing testing, under the oversight of the Audit and Risk Committee. The company also operates in a highly competitive and regulated medical device sector, facing risks from clinical trial outcomes, regulatory approvals, and market acceptance.

Dual-listed on Nasdaq and the ASX, Anteris’ shares trade as Common Stock in the U.S. and as CHESS Depositary Interests (CDIs) in Australia. The company maintains robust corporate governance practices, with a classified board and independent committees overseeing audit, compensation, and nominations.