Anteris Gains ASX Waiver, Delays PARADIGM Trial to Q4 2025
Anteris Technologies has gained shareholder approval for an ASX waiver allowing flexible capital raising and updated its PARADIGM trial timeline, now set to begin patient enrolment in Q4 2025 after addressing FDA requests.
- Shareholders approve ASX waiver for new securities issuance
- PARADIGM pivotal trial patient enrolment delayed to Q4 2025
- FDA requested additional bench testing data, now addressed
- Regulatory submissions progressing in Europe
- DurAVR Transcatheter Heart Valve remains central to company strategy
Shareholder Approval Unlocks Capital Flexibility
Anteris Technologies Global Corp., a structural heart medical device company listed on both NASDAQ and ASX, successfully secured shareholder approval at its Special Meeting held on September 29, 2025. The key outcome was the approval of an ASX waiver, permitting the company to issue new securities without needing further shareholder consent under ASX Listing Rule 7.1. This development provides Anteris with enhanced agility to raise capital as needed, a critical advantage in the competitive and capital-intensive medical device sector.
PARADIGM Trial Faces Timing Adjustment
Alongside the shareholder meeting, Anteris updated the market on its global pivotal registration trial, known as the PARADIGM Trial, for its lead product, the DurAVR Transcatheter Heart Valve (THV). Originally expected to commence patient enrolment in Q3 2025, the start has now been pushed to Q4 2025. This delay follows a request from the U.S. Food and Drug Administration (FDA) for additional bench testing information related to the device. Anteris has responded formally, addressing these concerns and reinforcing the robustness of its clinical protocol and technology package.
Regulatory Progress and Global Ambitions
While the FDA review process has introduced some timing uncertainty, Anteris is simultaneously advancing regulatory submissions in Europe. This multi-jurisdictional approach underscores the company’s commitment to establishing a broad regulatory footprint for the DurAVR THV System. The device itself is notable for its biomimetic design, crafted to replicate the natural function of a healthy aortic valve using Anteris’ patented ADAPT tissue technology, which has a decade-long clinical track record.
Strategic Implications for Investors
The approval of the ASX waiver is a strategic milestone that could facilitate future capital raises without the delays of additional shareholder votes, potentially accelerating product development and commercialization efforts. Meanwhile, the PARADIGM trial delay, while not unexpected in the regulatory landscape, invites close monitoring as it impacts the timeline for potential market entry and revenue generation. Investors will be watching how Anteris navigates these regulatory hurdles and leverages its capital flexibility in the coming months.
Bottom Line?
Anteris’ shareholder-backed capital flexibility and regulatory progress set the stage for pivotal trial milestones ahead, but timing remains a watchpoint.
Questions in the middle?
- How will the ASX waiver influence Anteris’ near-term capital raising plans?
- What are the potential impacts of the FDA’s additional bench testing requests on trial outcomes?
- How quickly can Anteris advance regulatory approvals in Europe alongside the U.S. process?
