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MINNEAPOLIS and BRISBANE, Australia, May 12, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended March 31, 2026, and provided a corporate update. Q1 2026 Highlights Completed aggregate capital raises totalling $320 million in January 2026 to support execution of the PARADIGM Trial and advance the Company toward global commercialization of the DurAVR® THV System Advanced PARADIGM Trial recruitment, supported by ongoing regulatory and operational work to activate additional countries and sites – post quarter-end, U.S. enrollment commenced Presented clinical data from the ongoing EMBARK Study and U.S. Early Feasibility Study (EFS) at Cardiovascular Research Technologies (CRT 2026) and Sydney Valves 2026, supporting ongoing scientific engagement and exchange with the clinical community “Q1 2026 reflects strong execution across the PARADIGM Trial, with patient enrollment ongoing in Europe and continued progress on key recruitment activities globally. With the U.S. now on line and first patients enrolled, we are firmly executing our strategy and building momentum toward the commercial launch of DurAVR®,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations Following initiation of our global pivotal trial in Q4 2025, we are seeing continued progress across Europe, and the United States where patient enrollment has recently commenced. Clinical centers are advancing through key start up milestones, including ethics and regulatory approvals, site initiation visits and investigator training, alongside active patient screening and enrollment at activated sites. In the United States, recent coverage determination by the Centers for Medicare and Medicaid Services (CMS) is expected to facilitate patient recruitment by supporting reimbursement and facilitating site-level adoption. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32. Collectively, these activities are supporting growing enrollment momentum as additional sites come on line and contribut...

MINNEAPOLIS and BRISBANE, Australia, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR), a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the full year ended December 31, 2025, and provided a corporate update. 2025 Full Year Highlights & Recent Developments Initiated the global pivotal PARADIGM Trial, building on experience from successfully treating 130 patients with the DurAVR® THV, including de novo (first time) aortic stenosis cases, complex anatomies and valve-in-valve patients Received FDA Investigational Device Exemption (“IDE”) approval in the fourth quarter of 2025 to initiate the PARADIGM Trial in the United States Reported favorable 30-day (100 patients) and 1-year (65 patients) DurAVR® THV clinical outcomes from rolling cohorts of small annuli, symptomatic severe aortic stenosis patients Completed the first “double DurAVR®” implant in a patient receiving a valve-in-valve replacement in both the mitral and aortic valve positions Strengthened operational infrastructure and advanced quality management system buildout while advancing manufacturing scale-up to support clinical activities, including ISO 13485 certification for DurAVR® THV production Appointed David Roberts and Gregory Moss to serve as two new independent directors on the Board of Directors Received approval from the Company’s stockholders for ASX Limited’s grant to the Company of a waiver from ASX Listing Rule 7.1 Completed aggregate capital raises totalling $320 million in early 2026, including a strategic investment from Medtronic, plc to support execution of the PARADIGM Trial and advance the Company toward global commercialization of the DurAVR® THV System “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; advanci...

MINNEAPOLIS, Minn. and BRISBANE, Australia , Nov. 12, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended September 30, 2025, and provided a corporate update. Third Quarter 2025 Highlights Continued FDA engagement during the Quarter to advance the IDE for the PARADIGM Trial, with FDA approval to commence U.S. recruitment* announced in November 2025 Advanced European regulatory activities to initiate the PARADIGM Trial across multiple countries, with the first PARADIGM patients treated in Denmark following regulatory approval from the Danish Medicines Agency in October 2025 Progressed site and operational readiness across the United States, Europe and Canada ahead of anticipated trial enrolment Strengthened operational and quality systems while advancing manufacturing scale-up to support clinical activities including ISO 13485 certification for DurAVR® THV production Received approval from the Company’s stockholders for ASX Limited’s grant to the Company of a waiver from ASX Listing Rule 7.1 “Third Quarter activities were critical to set the company on its path for the rest of the year and into 2026. The company made significant progress on the regulatory front with approvals to start the PARADIGM pivotal study being achieved in both Europe and the U.S. in Q4 as a result,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations DurAVR® THV Commercialisation Update Activities supporting the launch of the PARADIGM Trial During the third quarter of 2025, the company maintained positive engagement with the United States Food and Drug Administration (FDA) to advance the Investigational Device Exemption (IDE) for the PARADIGM Trial, submitting a formal response to address requests for additional information, including a completed simulated use study. FDA approval to commence patient recruitment* in the United States was subsequently announced in November 2025. Anteris also advanced European regulatory activities aimed at securing approval to commence the PARADIGM Trial in countries including Germany, France and the Netherlands, with the first European approval secu...

Net loss: US$20.8m (loss widened by 11% from 2Q 2024). US$0.58 loss per share. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 63%. Earnings per share (EPS) missed analyst estimates by 2.5%. Looking ahead, revenue is forecast to grow 68% p.a. on average during the next 3 years, compared to a 10.0% growth forecast for the Medical Equipment industry in Australia. Performance of the Australian Medical Equipment industry. The company's shares are up 5.4% from a week ago. It is worth noting though that we have found 4 warning signs for Anteris Technologies Global (2 are concerning!) that you need to take into consideration. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

MINNEAPOLIS and BRISBANE, Australia, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercialising cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended June 30, 2025, and provided a corporate update. Second Quarter 2025 Highlights 130 patients implanted with the DurAVR® THV since the start of clinical development; 49 patients treated year-to-date; 21 in the quarter World first “double DurAVR®” implant in a patient receiving a valve-in-valve replacement in both the mitral and aortic valve positions Advanced preparatory work for the DurAVR® THV's global, pivotal clinical trial (the "PARADIGM Trial") including qualifying additional clinical sites (79 sites now qualified) Held global investigator meeting for the PARADIGM Trial in June, with Dr. Michael J. Reardon and Professor Stephan Windecker being confirmed as Co-Chairs of the PARADIGM Trial Continued ongoing engagement with the FDA to progress the Investigational Device Exemption (“IDE”) for the PARADIGM Trial Appointed two Non-Executive Directors to the Board of Directors (Mr. David Roberts and Mr. Gregory Moss) “I’m extremely pleased with the progess achieved during the second quarter as the Company enters a new phase in its life cycle. The data generated to date from 130 patients treated with DurAVR® across multiple settings, including complex anatomies, different annular sizes, bicuspids and valve-in-valve (including a double aortic and mitral replacement in the same patient) is highly compelling. By adopting a “total disease management” approach, the development of this first-in-class biomimetic transcatheter heart valve has delivered meaningful clinical benefits across a range of clinical use cases. As such, we are excited by physician enthusiasm across the globe to recruit into the PARADIGM study which is designed to further support the growing body of evidence demonstrating DurAVR® THV’s impact on patients,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations DurAVR® THV Commercialisation Update Building our Clinical data – 130 patients successfully treated with the DurAVR® THV Anteris has continued to expand the level of global experience and build...

MINNEAPOLIS and BRISBANE, Australia, May 13, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended March 31, 2025, and provided a corporate update. First Quarter 2025 Highlights Investigational Device Exemption (“IDE”) for the DurAVR® THV’s global, pivotal clinical trial (the “PARADIGM Trial”), submitted to the FDA during the First Quarter Scale up for commencement of the PARADIGM Trial ongoing – including expanding the Clinical Specialist Team and contracting with planned centers in the U.S., Canada and Europe Clinical milestone of 100 patients successfully treated with the DurAVR® THV – comprised of de novo aortic stenosis cases including complex anatomies, and valve-in-valve patients Reported one-year clinical data for DurAVR® THV – demonstrating sustained, favourable hemodynamic outcomes, a consistent safety profile and high implant success Ongoing expansion of global manufacturing capacity to scale for the PARADIGM Trial and meet initial anticipated commercial demand Anteris included in the FTSE Russell 2000® Index Concluded the First Quarter with a cash position of $49.0m (A$78.0m) “Our focus this quarter has been on completing the substantial technical, clinical and regulatory work required to lodge our IDE application, which was successfully submitted during the period. We are also proud to have reached a major clinical milestone with over 100 patients treated with DurAVR®, the first new class of product in this space for many years – an incredible achievement which reflects the strength of our clinical program and growing physician confidence in our technology. Finally we continue to scale our field based Clinical Team, Manufacturing and Quality organizations to ensure we are able to meet the demands of the PARADIGM Trial” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations DurAVR® THV Commercialisation Update Preparations for the PARADIGM Trial The proposed DurAVR® THV global pivotal registration trial has been formally designated as the PARADIGM Trial, signifying the trial’s central role in the DurAVR® THV Clinical Development Program. PARADIGM:...

EAGAN, Minn. and BRISBANE, Australia, March 12, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the full year ended December 31, 2024, and provided a corporate update. 2024 Full Year Highlights & Recent Developments Achieved a successful U.S. Initial Public Offering (“IPO”) onto Nasdaq raising $88.8m (AUD $139.3m) before costs and commissions and excluding the underwriters option, which completed the Company’s re-domiciliation to the United States. Continued preparations to initiate the DurAVR® Transcatheter Heart Valve’s (“THV”) randomized global pivotal study (the “Pivotal Trial”) – request for Investigational Device Exemption (“IDE”) on track for submission to the U.S. Food and Drug Administration (“FDA”) in the first quarter of 2025. Generated additional positive patient data to support IDE submission for the DurAVR® THV – 86 cases treated to date. Performed first two cases of the DurAVR® THV’s European Early Feasibility Study (“EU-EFS”) at Structural Heart Copenhagen in Denmark (January 2025). Increased awareness of the DurAVR® THV system in the global medical community including multiple high profile podium presentations at key congresses such as New York Valves and the 36th TCT Conference. Finalized design optimization of the balloon-expandable ComASUR® delivery system and expanded manufacturing scale-up in Malaga, AU and Minneapolis, U.S. to support planned Pivotal Trial. Concluded 2024 with a strong cash position of $70.5m (AUD $113.3m). “This has been a transformational year for Anteris as we made advancements across all aspects of our business, which positions us well to commence the Pivotal Trial of our DurAVR® THV system in 2025.” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations DurAVR® THV Commercialization Update: Preparations for Pivotal Trial During 2024, the Company executed several key activities to facilitate obtaining approval from the FDA to commence a Pivotal Trial for the Company’s lead product, the DurAVR® THV system. The approval to commence the Pivotal Trial, if granted, requires submitting an IDE application to the FDA, which is planned...