Anteris receives Danish approval for heart valve pivotal trial

MINNEAPOLIS/BRISBANE - Anteris Technologies Global Corp. (NASDAQ:AVR, ASX: AVR), a $160 million market cap medical device company, has received regulatory clearance from the Danish Medicines Agency to begin its global pivotal trial for the DurAVR Transcatheter Heart Valve in patients with severe calcific aortic stenosis, the company announced Wednesday. According to InvestingPro data, the company maintains a strong liquidity position with cash reserves exceeding debt obligations.

Patient recruitment at Danish centers for the PARADIGM Trial is expected to begin in the fourth quarter of 2025, with planned expansion to sites across the United States, Europe and Canada. With the company’s next earnings report due on October 29, investors will gain additional insights into the trial’s progress and financial outlook.

The multi-center study will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements. Approximately 1,000 patients will be enrolled in the "All Comers Randomized Cohort" with 1:1 randomization.

"Receiving initial approval in Europe is an important milestone as it signals the launch of the global PARADIGM Trial," said Anteris Chief Medical Officer Chris Meduri in the press release statement.

The trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.

In parallel, an Investigational Device Exemption application remains under review by the U.S. Food and Drug Administration, with approval expected in the near term according to the company.

The DurAVR THV is described as a biomimetic valve designed to mimic the performance of a healthy human aortic valve. It utilizes ADAPT tissue, the company’s patented anti-calcification tissue technology that has been used in over 55,000 patients worldwide.

Anteris Technologies Global Corp. is a structural heart company focused on developing medical devices to restore healthy heart function. While the company currently shows negative EBITDA of -$83.17 million, analysts maintain an optimistic outlook with price targets significantly above current trading levels. InvestingPro subscribers can access 8 additional key insights about Anteris’s financial health, valuation metrics, and growth prospects.

In other recent news, Anteris Technologies Global Corp. shareholders have approved two significant proposals. The first proposal, known as the ASX Waiver Proposal, permits the company to issue new securities without needing further shareholder approval under the Australian Securities Exchange Listing Rule 7.1. This proposal saw 13,655,466 votes in favor, 2,601,191 against, and 2,431,083 abstentions. This development follows a special meeting where these decisions were made, as detailed in a recent SEC filing. These approvals could potentially impact the company’s capital-raising strategies. The approval of the ASX Waiver Proposal is a strategic move for Anteris Technologies Global Corp., allowing more flexibility in financial operations. The company’s ability to issue new securities without additional approvals may influence its future financial maneuvers.

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