On October 15, 2025, Anteris Technologies Global Corp. announced that it has received regulatory clearance from the Danish Medicines Agency to initiate the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in patients with severe aortic stenosis. The announcement was made from Minneapolis and Brisbane, Australia, and confirms that the company can now begin enrolling patients in the trial across multiple European sites.
This clearance marks the first regulatory approval for the DurAVR program in a European jurisdiction, a key prerequisite for the company’s planned global pivotal study. The Danish Medicines Agency’s approval signals that the trial design, investigational product, and safety data meet European regulatory standards, allowing Anteris to move forward with patient recruitment and data collection.
The DurAVR® THV is built on the company’s proprietary ADAPT anti‑calcification tissue technology and a biomimetic valve design intended to improve durability and hemodynamics compared to existing transcatheter aortic valve replacements. The pivotal trial will evaluate the device’s safety, efficacy, and long‑term performance in a large, diverse patient population, providing the evidence needed for future regulatory submissions in the U.S. and other markets.
For investors, this regulatory milestone represents a significant step toward potential market entry and revenue generation. While the company remains in a development phase with substantial cash burn, the clearance reduces regulatory uncertainty and positions Anteris closer to achieving the approvals that will unlock commercial sales of its flagship product.
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