Core Insights - Anteris Technologies Global Corp. reported financial results for Q3 2025 and highlighted significant progress in regulatory approvals for the PARADIGM Trial in both Europe and the U.S. [1][3] Business & Operations - The company engaged positively with the FDA to advance the Investigational Device Exemption (IDE) for the PARADIGM Trial, with U.S. patient recruitment approval announced in November 2025 [4][8] - European regulatory activities progressed, with the first approval for the PARADIGM Trial secured in Denmark in October 2025, and the first patients treated in Denmark following this approval [5][8] - Operational infrastructure was strengthened, including advancements in quality management systems and manufacturing scale-up to support clinical activities and ISO 13485 certification for DurAVR THV production [6][8] Financial Performance - For the nine months ended September 30, 2025, the company's net operating cash outflows were $59.3 million, reflecting increased clinical, regulatory, and manufacturing requirements [9] - Research and Development (R&D) expenses for Q3 2025 were $16.8 million, primarily for preparatory activities related to the PARADIGM Trial and manufacturing capability upscaling [9] - The company held $9.1 million in cash and cash equivalents as of September 30, 2025 [9] PARADIGM Trial Overview - The PARADIGM Trial is a prospective randomized controlled trial designed to evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) [11][12] - Approximately 1,000 patients will be enrolled across the U.S., Europe, and Canada, with a primary endpoint assessing non-inferiority on all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure [12][13] - The trial aims to provide robust clinical evidence to support an application for Premarket Approval (PMA) in the U.S. and CE Mark approval in Europe [13]
Anteris Announces Results for the Third Quarter of 2025