Anteris Technologies Global Corp.

What they do

Anteris develops the DurAVR THV System, a single-piece biomimetic aortic valve made with its proprietary ADAPT anti-calcification tissue technology and deployed with the ComASUR balloon-expandable delivery system, to treat aortic stenosis. The company is development-stage: it has incurred net losses since inception and reported revenue of $1.9 million in 2025. Clinical experience includes more than 130 patients implanted with DurAVR THV worldwide as of December 2025. Its ADAPT tissue has been distributed in over 55,000 patients globally in other indications.

Revenue drivers

• Product revenue (development-stage) — Annual revenue was $1.9 million in 2025 versus $2.7 million in 2024; quarterly revenue was $310,000 in Q4 2025, $494,000 in Q1 2026 and $1.0 million in Q2 2026. The filings describe the company as development-stage with no approved DurAVR THV commercialization in the United States.
• DurAVR THV System (lead product) — The lead product is a balloon-expandable single-piece biomimetic valve plus the ComASUR Delivery System; U.S. commercialization requires Premarket Approval, which the company expects to be based on the PARADIGM Trial.
• ADAPT tissue technology — Proprietary anti-calcification tissue shaping technology used in DurAVR; the company states the patented ADAPT tissue has been clinically demonstrated calcium free for up to 10 years post-procedure and has been distributed in over 55,000 patients globally in other indications.

Recent performance

Second quarter 2026 revenue was $1.0 million, up from $494,000 in Q1 2026 and $310,000 in Q4 2025. Net operating cash outflows for the three months ended June 30, 2026 were $20.8 million, which the company attributed primarily to clinical, regulatory and manufacturing requirements for the PARADIGM Trial. R&D expenses were $23.4 million in the quarter, driven by scaling of manufacturing and quality capabilities, process development and validation, expanded headcount and PARADIGM trial activities, partly offset by reduced DurAVR THV product research costs. Full-year 2025 revenue was $1.9 million with a net loss of $94.1 million and operating cash outflow of $77.8 million, versus a $76.3 million net loss and $61.2 million operating cash outflow in 2024.

Strategy

The company's stated priority is executing the global pivotal PARADIGM Trial, a prospective, randomized, controlled multicenter international study in which subjects are randomized to DurAVR THV or a commercially available approved THV, with a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year, evaluated as non-inferiority. Recruitment began in Europe in October 2025; the company received FDA IDE approval in November 2025, secured U.S. Medicare reimbursement eligibility in April 2026 and enrolled the first U.S. patients in May 2026. It received French ANSM clearance in June 2026 and reported active recruitment in the U.S., Denmark and the Netherlands, with regulatory clearance in Canada and France. Management states it expects the PARADIGM Trial design to provide the primary clinical evidence for a potential FDA Premarket Approval, with CE Mark approval anticipated in parallel.

Risks

• History of losses and negative cash flow — The company reported total losses after income tax of $94.2 million in 2025 and $76.0 million in 2024, negative operating cash flows of $77.8 million and $61.2 million respectively, and an accumulated deficit of $370.5 million at December 31, 2025.
• Dependence on DurAVR THV and PARADIGM Trial success — The 10-K states there is substantial risk the company may not complete development of the DurAVR THV System, and it is possible none of its products will be successfully commercialized.
• Need for additional capital — The company states it will need additional capital to fund operations and may be unable to raise funds or enter arrangements on favorable terms or at all.
• Regulatory and reimbursement dependence — U.S. commercialization of DurAVR THV requires Premarket Approval based on the PARADIGM Trial, and PARADIGM U.S. enrollment depends on the CMS TAVR National Coverage Determination 20.32 framework.

Outlook

Management says PARADIGM Trial recruitment remains ongoing, with planned expansion into additional clinical sites and countries and continued U.S. site activation following the CMS coverage determination. The company expects to use the trial as the primary clinical evidence for a potential FDA Premarket Approval for the DurAVR THV System, with CE Mark approval anticipated in parallel. It also states that expenses for research, clinical validation, development, design, manufacturing and marketing will increase and that it will need additional capital.