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AVR 资讯
AVR 事件
Anteris Receives German Approval for DurAVR Heart Valve Trial
Anteris Technologies announced that it has received full regulatory clearance from the German Federal Institute for Drugs and Medical Devices, or BfArM, for the DurAVR Transcatheter Heart Valve, or THV, global pivotal trial for patients with severe calcific aortic stenosis. This clearance enables Anteris to initiate patient recruitment at leading German centers and represents an important step in expanding the PARADIGM Trial's European footprint. Germany is Europe's largest and most established transcatheter aortic valve replacement market, with an extensive network of experienced structural heart centers and investigators. Activating sites in this high-volume environment is anticipated to increase access to eligible patients and accelerate enrollment in the PARADIGM Trial. The company continues to execute its global clinical strategy through coordinated site activation and patient enrollment across the United States and Europe. Germany's inclusion strengthens the trial's European presence and adds meaningful scale to the PARADIGM Trial.
Anteris Technologies Files to Sell 5.39M Shares of Common Stock
Anteris Technologies files to sell 5.39M shares of common stock
Anteris Technologies Enrolls First Patients in U.S. Heart Valve Trial
Anteris Technologies announced that the first patients in the United States have been enrolled and successfully treated in the DurAVR Transcatheter Heart Valve global pivotal trial for patients with severe calcific aortic stenosis. The procedures were performed by Azeem Latib, M.D. at Montefiore Medical Center, New York, United States.
Anteris Technologies Secures U.S. Medicare Reimbursement Eligibility
Anteris Technologies has secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services, or CMS, national coverage policy. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement, or TAVR, National Coverage Determination 20.32. This milestone is expected to facilitate U.S. site activation, accelerating operational momentum across participating centers. The PARADIGM Trial will evaluate the safety and effectiveness of the DurAVR Transcatheter Heart Valve, or THV, compared to commercially available transcatheter aortic valve replacements, or TAVRs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.
Anteris Reports FY25 SG&A Expenses of $26.1M
Reports FY25 SG&A expenses $26.1M. "2025 was a pivotal year for Anteris, advancing DurAVR with disciplined execution, strengthening our clinical foundation, and positioning the company for long term leadership in structural heart. We converted strategy into measurable progress, reinforcing our competitive position and accelerating our path toward commercial readiness. The progress achieved in 2025 has strengthened our foundation and sharpened our trajectory toward becoming a leader in next-generation TAVR. We remained focused on what matters most; advancing clinical evidence, strengthening our balance sheet, and building sustainable long-term value," said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.
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