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]

Core Points - Anteris has received FDA approval to initiate the PARADIGM clinical trial for the DurAVR Transcatheter Heart Valve (THV) aimed at patients with severe calcific aortic stenosis [1][2] - The trial will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) [4][5] - The PARADIGM Trial will enroll approximately 1000 patients across the United States, Europe, and Canada [5] Company Overview - Anteris Technologies Global Corp. is a global structural heart company focused on designing and commercializing advanced medical devices for heart function restoration [8] - The DurAVR THV is the first biomimetic valve designed to replicate the performance of a healthy human aortic valve, utilizing Anteris' patented ADAPT tissue technology [9] Trial Details - The PARADIGM Trial is a prospective randomized controlled trial (RCT) assessing non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure [5][6] - The trial is co-chaired by prominent cardiology experts, Dr. Michael J. Reardon and Professor Stephan Windecker [3] - The trial aims to provide robust clinical evidence to support a future Premarket Approval (PMA) application to the FDA [6][7]

Core Insights - Anteris Technologies Global Corp. announced positive one-year clinical outcomes for the DurAVR Transcatheter Heart Valve (THV) in patients with symptomatic severe aortic stenosis and small aortic annuli, demonstrating significant improvements in hemodynamics and safety [1][8]. Clinical Outcomes - The DurAVR THV achieved a mean pressure gradient (MPG) of 8.6 ± 2.6 mmHg and an effective orifice area (EOA) of 2.1 ± 0.2 cm at one year, with no valve-related mortality and no moderate or severe paravalvular leaks [8]. - At 30 days, the prosthesis-patient mismatch was only 1.5%, significantly lower than the 11.2% to 35.3% range seen with current commercial devices, indicating a reduction in a key predictor of valve failure [8]. Study Details - The pooled cohort included 65 patients from the ongoing EMBARK Study and the US Early Feasibility Study (EFS) who received the DurAVR THV [4]. - The encouraging results from over 100 patients will be further validated in the global pivotal trial known as the PARADIGM Trial, which is a prospective, randomized controlled trial comparing the DurAVR THV to existing transcatheter aortic valve replacements [5]. Product Information - The DurAVR THV is designed to mimic the performance of a healthy human aortic valve and is made from Anteris' patented ADAPT tissue, which has been clinically used for over 10 years in more than 55,000 patients worldwide [7]. - The system includes the DurAVR valve, ADAPT tissue, and the balloon-expandable ComASUR Delivery System, aimed at restoring normal aortic blood flow [7]. Company Overview - Anteris Technologies is a global structural heart company focused on developing innovative medical devices to restore heart function, with a significant presence in both Australia and the USA [6].

Core Insights - Anteris Technologies has initiated the global pivotal trial for its DurAVR Transcatheter Heart Valve (THV) aimed at patients with severe calcific aortic stenosis, marking a significant step towards commercialization [1][2] - The PARADIGM Trial will provide comparative evidence on the safety and effectiveness of the DurAVR THV against existing transcatheter aortic valve replacements (TAVRs) [3][4] Company Overview - Anteris Technologies is a global structural heart company focused on developing innovative medical devices to restore heart function, with a strong presence in both Australia and the United States [7] - The DurAVR THV is designed to treat aortic stenosis and is the first biomimetic valve, utilizing Anteris' patented ADAPT tissue technology, which has been clinically used for over 10 years [8][9] Trial Details - The PARADIGM Trial is a prospective randomized controlled trial that will enroll approximately 1,000 patients, comparing the DurAVR THV to commercially available TAVRs [4][6] - The primary endpoint of the trial is to assess non-inferiority in terms of all-cause mortality, stroke, and cardiovascular hospitalization at one year post-procedure [4]

Core Insights - Anteris Technologies Global Corp. announced the presentation of one-year clinical outcomes for the DurAVR Transcatheter Heart Valve (THV) at the TCT 2025 conference, highlighting its commitment to innovative heart solutions [1][2]. Company Overview - Anteris Technologies is a global structural heart company focused on designing, developing, and commercializing advanced medical devices aimed at restoring healthy heart function. The company has a significant presence in both Australia and Minneapolis, USA [4]. - The DurAVR THV is the company's lead product, designed in collaboration with leading interventional cardiologists and cardiac surgeons to treat aortic stenosis, a serious condition caused by the narrowing of the aortic valve [5]. Product Details - The DurAVR THV is the first biomimetic valve, engineered to replicate the performance of a healthy human aortic valve and normal aortic blood flow. It is constructed from a single piece of molded ADAPT tissue, which is FDA-cleared and has been used in over 55,000 patients globally [5]. - The DurAVR THV System includes the DurAVR valve, ADAPT tissue, and the balloon-expandable ComASUR Delivery System [5]. Clinical Trials - The clinical outcomes for the DurAVR THV have been encouraging, with over 100 patients implanted. These outcomes will be further assessed in the global pivotal PARADIGM Trial, which is a prospective randomized controlled trial evaluating the safety and effectiveness of the DurAVR THV against existing transcatheter aortic valve replacements [3].

Core Insights - Anteris Technologies has received regulatory clearance from the Danish Medicines Agency to initiate the global pivotal trial for the DurAVR Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis, known as the PARADIGM Trial, with patient recruitment expected to start in Q4 2025 [1][2][3] Company Overview - Anteris Technologies is a global structural heart company focused on designing, developing, and commercializing advanced medical devices aimed at restoring healthy heart function [12] - The company's lead product, the DurAVR THV, is designed to treat aortic stenosis and is the first biomimetic valve that mimics the performance of a healthy human aortic valve [13] PARADIGM Trial Details - The PARADIGM Trial is a prospective randomized controlled trial that will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs) [7][8] - The trial aims to enroll approximately 1,000 patients with a 1:1 randomization between the DurAVR THV and TAVR, assessing non-inferiority on a primary composite endpoint of all-cause mortality, all stroke, and cardiovascular hospitalization at one year post-procedure [8] Regulatory and Market Implications - The successful completion of the PARADIGM Trial could lead to multiple approvals and labels for the DurAVR THV, marking a significant milestone in the company's commercialization planning phase [5] - Anteris is also awaiting an Investigational Device Exemption (IDE) application review by the U.S. FDA, which is expected to facilitate the initiation of study sites in the U.S. [6]

Core Points - Anteris Technologies Global Corp. has postponed its Special Meeting of Stockholders to September 11, 2025, to allow more time for stockholder participation [1][2] - The Board of Directors recommends voting FOR the proposals in the definitive Proxy Statement filed with the SEC on August 18, 2025 [2] - The company’s lead product, the DurAVR Transcatheter Heart Valve, is designed to treat aortic stenosis and utilizes patented ADAPT tissue technology [8] Voting Details - Stockholders who have already voted do not need to take further action as their votes will remain counted [3] - Proxies must be submitted by 11:59 p.m. Eastern time on September 10, 2025, for Internet or telephone submissions, and by the close of business on the same date for mail submissions [4] - CDI holders must direct CDN to vote by 5:00 p.m. Central time on September 9, 2025 [5] Company Overview - Anteris Technologies is a global structural heart company focused on developing medical devices to restore heart function [7] - The company is based in Australia with a significant presence in Minneapolis, USA, and is committed to delivering solutions for structural heart disease [7]

Core Insights - Anteris Technologies reported significant progress in the second quarter of 2025, particularly in the clinical development of its DurAVR transcatheter heart valve (THV) [3][4] - The company is preparing for the PARADIGM trial, which aims to further validate the clinical benefits of DurAVR THV [5][8] Financial Performance - For the six months ended June 30, 2025, Anteris recorded net operating cash outflows of $41.0 million, primarily due to increased clinical, regulatory, and manufacturing activities [11] - Research and development (R&D) expenses for the second quarter were $16.3 million, focusing on the PARADIGM trial preparations and patient enrollment [11] - The company held $28.4 million in cash and cash equivalents as of June 30, 2025 [11] Clinical Development - A total of 130 patients have been treated with the DurAVR THV, with 49 patients treated in the first half of 2025 and 21 in the second quarter [4][15] - The company has qualified 79 sites for the PARADIGM trial, with significant preparatory work completed [5][15] - Anteris hosted both European and Global Investigator Meetings to align operational efforts for the PARADIGM trial [6][7] Corporate Governance - On June 10, 2025, Anteris appointed David Roberts and Gregory Moss to its Board of Directors to enhance leadership capabilities [9]

Core Insights - Anteris Technologies Global Corp. has appointed Mr. David Roberts and Mr. Gregory Moss to its Board of Directors, enhancing its leadership team as it prepares for the upcoming global pivotal clinical trial for its DurAVRTHV product [1][2][4] - The company is transitioning to a new growth phase following its NASDAQ listing in Q4 2024 and aims for U.S. and EMA licensure of the DurAVRTHV for patients with aortic stenosis [2][4] Leadership Appointments - Mr. David Roberts has extensive experience in the healthcare sector, currently serving as President of LeMaitre Vascular, Inc. since 2007, and has held various leadership roles since joining the company in 1997 [2][3] - Mr. Gregory Moss brings a strong legal and compliance background, having served as Chief Business and Legal Officer at Evommune, Inc., and previously held senior roles at Kadmon, culminating in a $1.9 billion acquisition in 2021 [3] Product Overview - Anteris' lead product, the DurAVR Transcatheter Heart Valve (THV), is designed to treat aortic stenosis and is the first biomimetic valve, aiming to replicate normal aortic blood flow [6] - The DurAVR THV is made from Anteris' patented ADAPT tissue technology, which has been clinically used for over 10 years and distributed to over 55,000 patients worldwide [6]

Core Viewpoint - Anteris Technologies reported its financial results for Q1 2025, highlighting significant clinical milestones and ongoing preparations for the PARADIGM Trial, which is crucial for the commercialization of its DurAVR Transcatheter Heart Valve (THV) [1][2]. Business & Operations - The company successfully submitted its Investigational Device Exemption (IDE) application to the FDA for the PARADIGM Trial, which is designed to assess the safety and effectiveness of the DurAVR THV [4][6]. - Over 100 patients have been treated with the DurAVR THV, marking a significant clinical milestone and demonstrating growing physician confidence in the technology [3][8]. - The PARADIGM Trial is set to commence in Q3 2025, pending FDA approval, and aims to provide robust clinical evidence for FDA Premarket Approval (PMA) [4][5]. - Anteris is expanding its global manufacturing capacity to support the PARADIGM Trial, with production facilities being scaled to at least three times the 2024 capacity levels [13]. Clinical Milestones - The company achieved a major clinical milestone with 100 patients treated with the DurAVR THV, including complex cases such as bicuspid aortic valve patients and valve-in-valve patients [8][9]. - One-year clinical data for DurAVR THV patients showed sustained favorable hemodynamic outcomes and a strong safety profile, with no valve or cardiovascular-related mortality reported [15][11]. Financial Results - For Q1 2025, net sales were $0.6 million, a decrease of 27% compared to $0.8 million in Q1 2024, primarily due to lower demand for tissue products [16]. - The loss after income tax for the quarter was $21.9 million, an increase of 36% from $16.2 million in the same period last year [17]. - Research and development expenses rose to $16.5 million, a 42% increase from $11.6 million in Q1 2024, driven by upscaling manufacturing capabilities and preparatory activities for the PARADIGM Trial [24]. Corporate and Financing Activities - Anteris was included in the FTSE Russell 2000 Index as of March 24, 2025, reflecting its position in the small-cap segment of the US equity market [20]. - The company raised an additional $0.47 million through the partial exercise of a green shoe option related to its December 2024 IPO [19].