Anteris Registers 9.1M Shares, Accelerates DurAVR Heart Valve Trial

Anteris Advances Capital Structure and Clinical Development

Anteris Technologies Global Corp. (NASDAQ, AVR, ASX, AVR), a development-stage medical device company focused on structural heart solutions, has taken a significant step by filing a Form S-1 registration statement with the U.S. Securities and Exchange Commission. This filing registers up to 9,103,796 shares of common stock for resale by selling stockholders, including shares issued in a recent private placement and shares issuable upon exercise of warrants.

The registration enables liquidity for investors who acquired shares and warrants in the private placement completed between October and November 2025. The warrants, exercisable starting mid-2026, carry exercise prices of $7.50 per share for common stock warrants and A$11.50 per CDI warrants. If fully exercised, Anteris could receive approximately $40.4 million in gross proceeds, which management plans to deploy primarily towards advancing the DurAVR Transcatheter Heart Valve (THV) System and its ongoing pivotal PARADIGM Trial.

DurAVR, A Biomimetic Leap in Aortic Valve Replacement

The DurAVR THV System is Anteris’ flagship innovation, designed to treat aortic stenosis by mimicking the natural function of a healthy human aortic valve. Unlike traditional three-piece valves, DurAVR features a single-piece biomimetic valve crafted with the company’s patented ADAPT anti-calcification tissue technology, which has demonstrated calcium-free durability for up to 10 years in clinical settings. As of September 2025, 130 patients worldwide have received the DurAVR valve, and the company is now enrolling patients in the PARADIGM Trial, a randomized, controlled global study comparing DurAVR to commercially approved transcatheter valves.

Regulatory progress has been notable, with the first European clearance obtained in Denmark in October 2025, enabling trial initiation there. The U.S. Food and Drug Administration granted Investigational Device Exemption approval in the fourth quarter of 2025, positioning Anteris to expand enrollment in the critical U.S. market. The trial’s primary endpoint focuses on a composite of mortality, stroke, and cardiovascular hospitalization at one year, aiming to demonstrate non-inferiority and potentially superior hemodynamic performance.

Capital Raising and Market Positioning

The private placement that underpins this registration raised capital at $4.90 per share for common stock and A$7.50 per CDI, accompanied by warrants exercisable at higher strike prices. The company’s shares trade on Nasdaq and ASX under the symbol "AVR," with recent closing prices around $3.85 per share on Nasdaq. The registration statement also details the company’s capital structure, including the issuance of CHESS Depositary Interests (CDIs) to facilitate trading on the ASX.

Anteris continues to build operational infrastructure, including manufacturing scale-up and quality management system enhancements, to support anticipated commercial demand. The company acknowledges the competitive and capital-intensive nature of the transcatheter heart valve market but highlights its unique biomimetic design and tissue technology as differentiators aimed at younger and broader patient populations.

Looking Ahead

While Anteris remains a development-stage company with ongoing net losses, the registration filing and associated capital raise underscore confidence in the DurAVR system’s potential. The company’s strategic partnerships, including a development agreement with v2vmedtech for mitral and tricuspid valve repair devices, further diversify its innovation pipeline. Investors will be watching closely as the PARADIGM Trial progresses and as warrant exercises potentially inject new capital to fuel growth.