Anteris Technologies Ltd. ((AMEUF)) announced an update on their ongoing clinical study.
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Anteris Technologies Ltd. has announced a new clinical study titled A Prospective Randomized Trial Assessing the Safety and Effectiveness of the DurAVR® Biomimetic Valve Designed for Physiologic Flow Compared to Commercial TAVR Devices. The study aims to evaluate the safety and effectiveness of the DurAVR® THV System in treating severe native calcific aortic stenosis. This trial is significant as it seeks to provide a new treatment option that could potentially improve patient outcomes compared to existing transcatheter aortic valve replacement (TAVR) devices.
The study will test the DurAVR® THV System, a device designed for TAVR procedures. This system is intended to offer a biomimetic valve that supports physiological blood flow, potentially enhancing the treatment of aortic stenosis.
The study is interventional, randomized, and employs a parallel assignment model. It involves single masking, where the care provider is unaware of the treatment allocation. The primary purpose of the study is treatment-focused, aiming to compare the new DurAVR® THV System against existing TAVR devices from the SAPIEN and Evolut series.
The study is set to begin on September 5, 2025, with a primary completion date yet to be determined. The latest update was submitted on October 10, 2025. These dates are crucial as they mark the timeline for recruitment and data collection, impacting the study’s progress and eventual findings.
This update could influence Anteris Technologies’ stock performance positively, as successful trial outcomes may enhance the company’s market position in the TAVR device industry. Investors should monitor this study closely, as it could shift competitive dynamics, especially against established players like the SAPIEN and Evolut series.
The study is ongoing, and further details are available on the ClinicalTrials portal.
