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Anteris Technologies Receives FDA Approval for PARADIGM Trial

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Anteris Technologies Receives FDA Approval for PARADIGM Trial

Meet Your ETF AI Analyst

An announcement from Anteris Technologies Global Corp. ( (AVR) ) is now available.

On November 3, 2025, Anteris Technologies Global Corp. announced that it received FDA approval to commence its PARADIGM Trial, a global pivotal study of the DurAVR® Transcatheter Heart Valve (THV). This trial, which has already begun in Denmark, marks a significant milestone for the company as it aims to provide robust clinical evidence to support a future Premarket Approval (PMA) submission in the United States and CE Mark approval in Europe. The trial will enroll approximately 1000 patients across the United States, Europe, and Canada to evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs).

The most recent analyst rating on (AVR) stock is a Buy with a $15.00 price target. To see the full list of analyst forecasts on Anteris Technologies Global Corp. stock, see the AVR Stock Forecast page.

Spark’s Take on AVR Stock

According to Spark, TipRanks’ AI Analyst, AVR is a Neutral.

Anteris Technologies Global Corp. has a low overall stock score due to significant financial challenges, including declining revenues and persistent losses. The technical analysis suggests a bearish trend, although there is some potential for upward momentum. The valuation is unattractive due to a negative P/E ratio and lack of dividend yield. Improvements in gross profit margin and free cash flow growth are positive but insufficient to offset the broader financial weaknesses.

To see Spark’s full report on AVR stock, click here.

More about Anteris Technologies Global Corp.

Anteris Technologies Global Corp. is a global structural heart company focused on designing, developing, and commercializing advanced medical devices to restore healthy heart function. Founded in Australia and with a significant presence in Minneapolis, USA, Anteris specializes in solutions for structural heart disease, with its lead product being the DurAVR® Transcatheter Heart Valve (THV), designed to treat aortic stenosis.

Average Trading Volume: 182,658

Technical Sentiment Signal: Hold

Current Market Cap: $161.9M

Learn more about AVR stock on TipRanks’ Stock Analysis page.

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