How Will Anteris’ A$38.5M Raise Accelerate DurAVR®’s Global Trial and Launch?

• A$38.5 million raised via private placement with attached warrants
• Funds to support PARADIGM pivotal trial and global commercialization
• DurAVR® device designed to mimic healthy aortic valve hemodynamics
• FDA IDE submission underway with trial sites planned across multiple countries
• Strong backing from existing and new institutional investors

Capital Raise to Fuel Next Phase

Anteris Technologies Global Corp. (NASDAQ – AVR, ASX – AVR) announced a significant capital raise of approximately A$38.5 million (US$25.2 million) through a private placement of 5,135,000 new shares and CHESS Depositary Interests (CDIs), each accompanied by warrants. This infusion of capital is earmarked to advance the global commercialization of its DurAVR® Transcatheter Aortic Valve Replacement (TAVR) device and to support the pivotal PARADIGM clinical trial.

Innovative Device Targeting a Large Market

The DurAVR® device represents a novel class of balloon-expandable TAVR designed to replicate the function and flow dynamics of a healthy native aortic valve. With 130 patients treated to date and promising one-year clinical data, the device aims to address the underpenetrated market of severe aortic stenosis, forecasted to reach nearly US$10 billion by 2028. The company’s biomimetic approach is positioned to offer advantages over existing market leaders by restoring normal aortic flow and reducing left ventricular mass.

Clinical and Regulatory Progress

Anteris has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for the PARADIGM trial, which is designed as a head-to-head study comparing DurAVR® to leading TAVR devices. The trial is planned to enroll approximately 1,000 patients across up to 85 sites in the United States, Europe, Canada, and other regions. Regulatory clearance has already been secured in Denmark, with further expansion anticipated. The company expects to initiate patient enrollment in late 2025, contingent on FDA IDE approval.

Manufacturing and Commercial Readiness

Proceeds from the placement will also support the expansion of manufacturing capabilities, including strategic infrastructure investments in Australia and the United States to reduce supply chain risks. Anteris is building a capital-efficient commercial strategy, leveraging a highly experienced leadership team with deep expertise in clinical, operational, and commercial domains. The company is preparing for a commercial launch following anticipated regulatory approvals, targeting both U.S. FDA Premarket Approval and CE Mark in Europe.

Investor Support and Market Implications

The placement attracted strong support from existing shareholders, including Nantahala Capital Management, Rhenman Partners, and new investors such as Evolution Capital Pty Ltd, which also acted as sole lead manager. The issuance of warrants alongside shares provides investors with potential upside linked to the company’s progress. However, the offering is subject to regulatory restrictions, including a Distribution Compliance Period limiting resale to U.S. persons, reflecting the company’s dual listing and compliance with U.S. securities laws.

Bottom Line?

Anteris’ successful capital raise sets the stage for a critical clinical milestone and commercial expansion in a rapidly evolving TAVR market.

Questions in the middle?

• Will FDA IDE approval be granted on schedule to enable U.S. trial site initiation?
• How quickly can patient enrollment ramp up across multiple international sites?
• What impact will regulatory restrictions on share liquidity have on investor appetite?