Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) has secured binding commitments for around A$38.5 million (US$25.2 million) placement to fund recruitment and execution of its PARADIGM global pivotal trial of the DurAVR® transcatheter heart valve and to expand manufacturing capacity. Notably, the first IDE for PARADIGM was submitted to the FDA in Q1 2025 and remains under review; first country clearance obtained in Denmark; 78 sites qualified globally.
This is a two-tranche raise:
- US offer: 2,346,936 new shares at US$4.90 to raise ~US$11.5 million (A$17.6 million), each with a five-year warrant exercisable at US$7.50 (not exercisable for first six months).
- Australian offer: 2,788,064 new CDIs at A$7.50 to raise ~A$20.9 million (US$13.7 million), each with a five-year warrant exercisable at A$11.50 (not exercisable for first six months).
The offer received strong support from existing shareholders, including L1 Capital, Sio Capital, Nantahala Capital Management, ADAR1 Capital Management and Rhenman & Partners Asset Management. New investor Second Line Capital Management LLC also participated.
The money will fund the next phase of growth and execution of the company’s clinical strategy. Planned uses include recruitment for the DurAVR® Transcatheter Heart Valve (THV) global pivotal study in aortic stenosis (the PARADIGM Trial), ongoing study operations, and expansion of manufacturing capacity. A portion will support continuing R&D for v2vmedtech inc., with the remainder allocated to working capital and general corporate purposes.
Anticipated milestones
- PARADIGM expansion: Following initial regulatory clearance in Denmark, Anteris plans to broaden the global PARADIGM Trial by adding sites across the United States, Europe and Canada. With 78 sites qualified to participate, management expects investigator interest to support efficient recruitment and steady study progress.
- IDE approval: An Investigational Device Exemption (IDE) for PARADIGM was submitted to the US Food and Drug Administration in Q1 2025 and remains under review. Approval, when granted, will enable activation of US study sites, subject to Institutional Review Board approvals.
- Manufacturing capacity: Targeted investment in infrastructure, including diversified ADAPT tissue sourcing in the United States and Australia, is intended to reduce supply-chain dependence and de-risk future manufacturing.
Indicative timetable
An indicative timetable for the Offer is set out below:
