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Investor releaseQuarter not tagged2026-08-11Anteris Technologies Announces Results for the Second Quarter of 2026
GlobeNewswire
Anteris Technologies Announces Results for the Second Quarter of 2026
MINNEAPOLIS and BRISBANE, Australia, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended June 30, 2026, and provided a corporate update. Q2 2026 Highlights Secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services (CMS) national coverage policy, enabling reimbursement for eligible procedures at U.S. sites. Initiated U.S. recruitment in the PARADIGM Trial, with the first U.S. patients enrolled and treated in May 2026. Expanded the PARADIGM Trial, with active recruitment underway in the U.S., Denmark and the Netherlands, and obtained regulatory clearance in Canada and France. Appointed Ms. Susan Knight and Mr. Stephen Denaro to the Board of Directors, broadening governance, financial and public company leadership as the Company advances the DurAVR® THV toward commercialization. Presented clinical and scientific progress at New York Valves 2026, including a symposium, innovation session feature, and pre-recorded live case presentation highlighting clinical experience with the DurAVR® THV. The symposium recording is available on the Company’s website under the News section. “Q2 marked an important period of execution for Anteris as we advanced the PARADIGM Trial across clinical, regulatory and reimbursement milestones. During the quarter, we secured U.S. Medicare reimbursement for eligible procedures, initiated U.S. recruitment in the PARADIGM Trial, expanded active recruitment across key geographies and showcased growing clinical experience with DurAVR® at New York Valves, a leading structural heart conference. These achievements, together with the continued strengthening of our Board, support our progress toward commercialization and our commitment to improving outcomes for patients with severe aortic stenosis,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations During the quarter, we continued to advance execution of the global pivotal PARADIGM Trial across active European sites and commenced patient enrollment in the United States. Clinical centers are progressing throug…Read full documentShow less
MINNEAPOLIS and BRISBANE, Australia, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended June 30, 2026, and provided a corporate update. Q2 2026 Highlights Secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services (CMS) national coverage policy, enabling reimbursement for eligible procedures at U.S. sites. Initiated U.S. recruitment in the PARADIGM Trial, with the first U.S. patients enrolled and treated in May 2026. Expanded the PARADIGM Trial, with active recruitment underway in the U.S., Denmark and the Netherlands, and obtained regulatory clearance in Canada and France. Appointed Ms. Susan Knight and Mr. Stephen Denaro to the Board of Directors, broadening governance, financial and public company leadership as the Company advances the DurAVR® THV toward commercialization. Presented clinical and scientific progress at New York Valves 2026, including a symposium, innovation session feature, and pre-recorded live case presentation highlighting clinical experience with the DurAVR® THV. The symposium recording is available on the Company’s website under the News section. “Q2 marked an important period of execution for Anteris as we advanced the PARADIGM Trial across clinical, regulatory and reimbursement milestones. During the quarter, we secured U.S. Medicare reimbursement for eligible procedures, initiated U.S. recruitment in the PARADIGM Trial, expanded active recruitment across key geographies and showcased growing clinical experience with DurAVR® at New York Valves, a leading structural heart conference. These achievements, together with the continued strengthening of our Board, support our progress toward commercialization and our commitment to improving outcomes for patients with severe aortic stenosis,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations During the quarter, we continued to advance execution of the global pivotal PARADIGM Trial across active European sites and commenced patient enrollment in the United States. Clinical centers are progressing through key start-up milestones, including ethics and regulatory approvals, site initiation visits and investigator training, alongside patient screening and enrollment at activated sites. This includes selected Australian sites, which are progressing through initial start-up documentation, with activation and patient recruitment to follow subject to ethics committee approval at each site. In the United States, the CMS coverage determination represented a key execution milestone for the PARADIGM Trial, providing the reimbursement framework required to support patient enrollment and broader 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. With this reimbursement framework now in place, we expect U.S. site activation and patient recruitment activities to continue advancing as additional centers begin contributing to trial execution. Financial Results The financial results for Anteris for the quarter ended June 30, 2026, are presented below. All amounts in $ refer to U.S. dollars. The Company’s net operating cash outflows for the three months ended June 30, 2026 were $20.8 million, primarily attributable to clinical, regulatory and manufacturing requirements to support the PARADIGM Trial. Operating expenditures reflected the phased execution of the clinical program during the quarter, including the timing of U.S. site activation activities following receipt of the CMS coverage determination in April 2026. R&D expenses of $23.4 million were driven by the scaling of manufacturing and quality capabilities, including process development and validation activities and expanded headcount, together with PARADIGM trial related activities, including clinical costs associated with patient enrollment and the scaling of our field-based clinical team. These costs were partly offset by reduced DurAVR® THV product research costs. Please see the detailed financial information contained in Anteris’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2026. About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve (“THV”) compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enroll approximately 1,000 patients in the ‘All Comers Randomized Cohort' with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. 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. For further information, please refer to ClinicalTrials.gov NCT07194265. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements, including, but not limited to, statements regarding the PARADIGM Trial, CMS reimbursement eligibility, clinical development timelines and potential commercialization. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Actual future events may vary from these forward-looking statements and readers are cautioned not to put undue reliance on forward-looking statements. Other than as required by law, Anteris gives no representation or guarantee that the occurrence of any of the events or circumstances expressed or implied in these statements will occur. In addition, except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information:
Investor releaseQuarter not tagged2026-08-11Anteris Technologies advances PARADIGM Trial in June quarter as US patient recruitment gets underway
Proactive
Anteris Technologies advances PARADIGM Trial in June quarter as US patient recruitment gets underway
Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) made progress on its pivotal PARADIGM Trial during the June quarter, enrolling and treating its first US patients after securing Medicare reimbursement eligibility for qualifying procedures. The company also expanded recruitment across international sites, with patients now being recruited in the US, Denmark and the Netherlands, while regulatory clearance was secured in Canada and France. Anteris is developing its DurAVR® Transcatheter Heart Valve (THV) as a treatment for aortic stenosis, with the PARADIGM study representing the pivotal clinical program supporting its path toward potential commercialisation. A key milestone was securing reimbursement eligibility for the PARADIGM Trial under a US Centers for Medicare & Medicaid Services (CMS) national coverage policy. Eligible procedures carried out at participating US study sites are now covered under the Transcatheter Aortic Valve Replacement National Coverage Determination, providing the reimbursement framework required to support patient enrolment and broader site participation. US recruitment commenced during the quarter, with the first patients enrolled and treated in May 2026. Clinical centres are progressing through start-up activities including ethics and regulatory approvals, site initiation visits and investigator training, as well as screening and enrolment at activated sites. Selected Australian centres are also completing initial start-up documentation ahead of activation and recruitment, subject to ethics committee approval. Anteris also presented clinical and scientific progress with DurAVR at the New York Valves 2026 conference and appointed Susan Knight and Stephen Denaro to its board during the period. The PARADIGM Trial is a prospective randomised controlled study comparing the safety and effectiveness of DurAVR THV against commercially available transcatheter aortic valve replacements. Around 1,000 patients are expected to participate in the trial's All Comers Randomized Cohort, with patients assigned on a 1:1 basis to either DurAVR or an approved commercially available THV. The trial will assess non-inferiority using a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalisation at 1 year following the procedure. Anteris recorded net operating cash outflows of US$20.8 million for the 3 months to June 3…Read full documentShow less
Anteris Technologies Pty Ltd (ASX:AVR, NASDAQ:AVR) made progress on its pivotal PARADIGM Trial during the June quarter, enrolling and treating its first US patients after securing Medicare reimbursement eligibility for qualifying procedures. The company also expanded recruitment across international sites, with patients now being recruited in the US, Denmark and the Netherlands, while regulatory clearance was secured in Canada and France. Anteris is developing its DurAVR® Transcatheter Heart Valve (THV) as a treatment for aortic stenosis, with the PARADIGM study representing the pivotal clinical program supporting its path toward potential commercialisation. A key milestone was securing reimbursement eligibility for the PARADIGM Trial under a US Centers for Medicare & Medicaid Services (CMS) national coverage policy. Eligible procedures carried out at participating US study sites are now covered under the Transcatheter Aortic Valve Replacement National Coverage Determination, providing the reimbursement framework required to support patient enrolment and broader site participation. US recruitment commenced during the quarter, with the first patients enrolled and treated in May 2026. Clinical centres are progressing through start-up activities including ethics and regulatory approvals, site initiation visits and investigator training, as well as screening and enrolment at activated sites. Selected Australian centres are also completing initial start-up documentation ahead of activation and recruitment, subject to ethics committee approval. Anteris also presented clinical and scientific progress with DurAVR at the New York Valves 2026 conference and appointed Susan Knight and Stephen Denaro to its board during the period. The PARADIGM Trial is a prospective randomised controlled study comparing the safety and effectiveness of DurAVR THV against commercially available transcatheter aortic valve replacements. Around 1,000 patients are expected to participate in the trial's All Comers Randomized Cohort, with patients assigned on a 1:1 basis to either DurAVR or an approved commercially available THV. The trial will assess non-inferiority using a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalisation at 1 year following the procedure. Anteris recorded net operating cash outflows of US$20.8 million for the 3 months to June 30, primarily related to clinical, regulatory and manufacturing requirements for PARADIGM. Research and development expenses totalled US$23.4 million, reflecting increased manufacturing and quality capabilities, process development and validation work, additional headcount and costs associated with patient enrolment and expansion of its field-based clinical team. These expenses were partly offset by lower DurAVR product research costs. Anteris expects US site activation and patient recruitment to continue progressing as additional centres join the PARADIGM Trial. Anteris Technologies is a global healthcare company developing medical devices for structural heart disease. Its lead product, DurAVR THV, is a balloon-expandable transcatheter heart valve designed to treat aortic stenosis. The valve is shaped to mimic the function of a healthy human aortic valve and uses Anteris' ADAPT® anti-calcification tissue technology. The DurAVR system comprises the valve, ADAPT tissue and the balloon-expandable ComASUR® Delivery System.
Investor releaseQuarter not tagged2026-05-13Anteris Announces Results for the First Quarter of 2026
GlobeNewswire
Anteris Announces Results for the First Quarter of 2026
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…Read full documentShow less
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 contribute to trial execution. Financial Results The financial results for Anteris for the quarter ended March 31, 2026, are presented below. All amounts in $ refer to U.S. dollars. The Company’s net operating cash outflows for the three months ended March 31, 2026, were $28.7 million, attributable to clinical, regulatory and manufacturing requirements to support the PARADIGM Trial. This clinical focus is reflected in the Company’s operating expenditures, with R&D expenses of $17.5 million driven by the upscaling of manufacturing and quality capabilities, including process design and validation activities and the expansion of headcount, and activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients and the scaling of our field-based clinical team. These were partly offset by reduced DurAVR® THV product research costs. Anteris refers to the detailed financial information contained in its Form 10-Q filing including the Management Discussion & Analysis and the Risks. ENDS About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve (“THV”) compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enrol approximately 1,000 patients in the ‘All Comers Randomized Cohort' with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. 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. For further information, please refer to ClinicalTrials.gov NCT07194265. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements, including statements regarding the expectation that achievement of CMS coverage will facilitate U.S. site activation, accelerating operational momentum across participating centers, and the PARADIGM Trial. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information:
Investor releaseQuarter not tagged2026-02-27Anteris Reports 2025 Financial Results and Provides Corporate Update
GlobeNewswire
Anteris Reports 2025 Financial Results and Provides Corporate Update
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…Read full documentShow less
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; advancing clinical evidence, strengthening our balance sheet, and building sustainable long-term value,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. 2025 Financial Results The financial results for Anteris for the year ended December 31, 2025, are presented below. The Company’s net operating cash outflows for the year ended December 31, 2025, were $77.8 million, in line with the increase in clinical, regulatory and manufacturing requirements to support the PARADIGM Trial. Reflecting this clinical focus, the key areas of the Company’s operating expenditures for the year ended December 31, 2025, were as follows: R&D expenses were $69.1 million and included the upscaling of manufacturing and quality capabilities, including process design and validation activities, an increase in R&D headcount, PARADIGM Trial preparatory activities, including clinical costs associated with the enrolment of additional patients and the scaling of our field-based clinical team, and expansion of our medical affairs activities, partially offset by lower DurAVR® THV product research costs as we shifted our focus to clinical, regulatory and manufacturing activities ahead of the PARADIGM Trial. Selling, general and administrative expenses were $26.1 million. Anteris refers to the detailed financial information contained in its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, including the discussion under the headings “Item 1A. Risk Factors” and “Item 7. Management’s Discussion & Analysis of Financial Condition and Results of Operations.” About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (“TAVRs”). This head-to-head study will enroll approximately 1000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. 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. The PARADIGM Trial is actively recruiting with the first patients enrolled and implanted during the fourth quarter of 2025. For further information, please refer to ClinicalTrials.gov NCT07194265. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (“THV”), was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information:
Investor releaseQuarter not tagged2025-11-13Anteris Announces Results for the Third Quarter of 2025
GlobeNewswire
Anteris Announces Results for the Third Quarter of 2025
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…Read full documentShow less
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 secured in Denmark in October 2025. In parallel, cross-functional teams completed site and operational readiness activities, namely investigator training, study material preparation, and logistical set up, ahead of anticipated enrolment and pending receipt of regulatory clearance and Institutional Review Board (IRB) approval. The first PARADIGM patients were enrolled and treated in Denmark following regulatory approval from the Danish Medicines Agency in October 2025. The Company continued strengthening its operational infrastructure during the quarter, advancing quality management system (QMS) buildout to support upcoming clinical activities and future ISO 13485 certification. Key quality procedures and standard operating documents were released to establish the framework for a mature, compliant system and to mitigate audit risk. In parallel, manufacturing scale-up activities progressed, including cross-training of inspection personnel, expansion of clean room capacity, and ongoing process development initiatives for projected DurAVR® THV demand. The financial results for Anteris for the quarter ended September 30, 2025, are reviewed below. All amounts in $ refer to U.S. dollars. The Company’s net operating cash outflows for the nine months ended September 30, 2025, were $59.3 million, in line with the increase in clinical, regulatory and manufacturing requirements to support the PARADIGM Trial. Reflecting this clinical focus, the key areas of the Company’s operating expenditure for the three months ended September 30, 2025, were as follows: R&D expenses were $16.8 million. The key activities undertaken were the preparatory activities linked to the PARADIGM Trial, including regulatory work regarding the IDE and extensive engagement with planned investigators at clinical trial sites by the Clinical Specialist Team, who work directly with physicians in the Cath Lab to support appropriate use of the device and procedural success. Additionally, there were further costs associated with upscaling of manufacturing capabilities, including completion of design validation processes and documentation, and continued portfolio development aimed at driving long-term growth beyond the current products. Selling, general and administrative expenses were $5.8 million. The Company held $9.1 million of cash and cash equivalents as of September 30, 2025. Anteris refers to the detailed Financial Information contained in its Form 10-Q filing including the Management Discussion & Analysis and the Risks. About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enrol approximately 1,000 patients across the United States, Europe and Canada in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. 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. The PARADIGM Trial is designed to provide the robust clinical evidence required to support an application to the FDA for Premarket Approval (PMA) in the United States, with CE Mark approval anticipated to progress in parallel to the PMA. For further information about the PARADIGM Trial, please refer to ClinicalTrials.gov (ClinicalTrials.gov ID NCT07194265). *Subject to Institutional Review Board (IRB) approval About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts, including the objectives of, plans for and size of Anteris’ studies and trials. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information:
Investor releaseQuarter not tagged2025-08-13Anteris Technologies Global Second Quarter 2025 Earnings: Revenues Beat Expectations, EPS Lags
Simply Wall St.
Anteris Technologies Global Second Quarter 2025 Earnings: Revenues Beat Expectations, EPS Lags
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.
Investor releaseQuarter not tagged2025-08-12Anteris Announces Results for the Second Quarter of 2025
GlobeNewswire
Anteris Announces Results for the Second Quarter of 2025
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…Read full documentShow less
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 the body of clinical evidence with the DurAVR® THV System. At the end of the Second Quarter, there were 130 patients successfully implanted with the DurAVR® THV in rolling cohorts since start of clinical development, with 49 of these patients treated in the first half of 2025 and 21 in 2Q 2025. These additional patients continue to support the strong clinical benefits of our new class of biomimetic TAVR over current commercially available TAVR platforms. Activities supporting the launch of the PARADIGM Trial Over the Second Quarter, the Anteris team made considerable progress strengthening its clinical infrastructure and manufacturing capabilities in preparation for the Trial. A key focus was the qualification of trial sites, including feasibility assessments to confirm each site’s access to a suitable aortic stenosis patient population and their capacity to conduct the Trial to the highest standards. Preparatory activities, including site contracting with planned centers across the U.S., Europe and Canada, are well advanced, with 79 sites now qualified to participate. In May, Anteris hosted a European Investigator Meeting for the PARADIGM Trial to facilitate operational alignment of qualified sites across the European investigator network, with participation from principal investigators at leading sites in Denmark, France, Germany, the Netherlands and Switzerland. In June, Anteris hosted a Global Investigator Meeting to formally initiate activities for the PARADIGM Trial ahead of anticipated regulatory clearance. Dr. Michael J. Reardon and Professor Stephan Windecker were confirmed as the Co-Chairs of the Trial during the meeting, held in conjunction with New York Valves. These physicians provide significant clinical and trial experience in interventional cardiology and TAVR. Ongoing collaborative work with the U.S. Food and Drug Administration (FDA) to progress the Investigational Device Exemption (IDE) application has been a major focus this Quarter, in addition to proactively scaling the manufacturing of all key products to meet the anticipated inventory demands of the upcoming PARADIGM Trial. Corporate matters - Board appointments On 10 June, Anteris appointed two seasoned executives, David Roberts and Gregory Moss, to its Board of Directors. Mr. Roberts brings extensive operational leadership experience, and Mr. Moss offers expertise in legal and corporate governance. These appointments are strategic steps to bolster the Company's leadership as it advances its clinical and commercial objectives. Second Quarter 2025 Financial Results The financial results for Anteris for the quarter ended June 30, 2025 are reviewed below. All amounts in $ refer to US dollars. The Company’s net operating cash outflows for the six months ended June 30, 2025 were $41.0 million, in line with the increase in clinical, regulatory and manufacturing requirements to support the PARADIGM Trial. Reflecting this clinical focus, the key areas of the Company’s operating expenditure for the three months ended June 30, 2025 were as follows: R&D expenses were $16.3 million. The key activities undertaken were the preparatory activities linked to the PARADIGM Trial, including regulatory work regarding the IDE, extensive engagement with planned investigators at clinical trial sites and the Global Investigator Meeting. Additionally, there were clinical costs associated with the enrollment of additional DurAVR® patients and further upscaling of manufacturing capabilities. Selling, general and administrative expenses were $5.0 million. The Company held $28.4 million of cash and cash equivalents as of June 30, 2025. Anteris refers to the detailed Financial Information contained in its Form 10-Q filing including the Management Discussion & Analysis and the Risks. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercialising cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of moulded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts, including the objectives of and plans for Anteris’ studies and trials, the timing of the PARADIGM Trial, the goals of the expansion of the global manufacturing capacity and the sourcing of ADAPT® tissue for the DurAVR® THV in the future. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, neither ATL or Anteris assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. Authorization and Additional information This announcement was authorized for release by the Board of Directors. For more information:
Investor releaseQuarter not tagged2025-05-14Anteris Announces Results for the First Quarter of 2025
GlobeNewswire
Anteris Announces Results for the First Quarter of 2025
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 Pro…Read full documentShow less
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: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices An IDE application for the PARADIGM Trial was submitted to the U.S. Food and Drug Administration (FDA) during the First Quarter. An approved IDE allows the investigational device (the DurAVR® THV) to be used in a clinical study to collect safety and effectiveness data. The PARADIGM Trial is designed to provide the robust clinical evidence required to support an application to the FDA for Premarket Approval (“PMA”*) in the United States, with CE Mark approval anticipated to progress in parallel to the PMA. The Company remains on track to commence the PARADIGM Trial in the third quarter of 2025, pending FDA approval of the IDE. The naming of the PARADIGM Trial reflects both the paradigm-shifting hemodynamic performance observed to date in over 110 patients treated with the DurAVR® THV and the trial’s head-to-head, comparative design. It is proposed that patients will be randomized 1:1 to either the DurAVR® treatment arm or to a commercially available device in the control arm (SAPIEN or Evolut series THV). Patients with an existing failed surgical valve, needing valve-in-valve (“ViV”) TAVR are proposed to be enrolled in a separate parallel registry. This is intended to support the Company’s plans for the ViV market opportunity. Scale up activities for the PARADIGM Trial The Company continues to develop infrastructure to support the PARADIGM Trial including building out the global Clinical Specialist Team to provide on-site expert clinical support in addition to working with its Contract Research Organisation to engage with planned centers and investigators in the U.S., Canada and Europe. These teams will provide oversight and guidance to site based clinical staff to ensure appropriate use of the DurAVR® THV System, high-quality data collection and adherence to regulatory and protocol requirements throughout the PARADIGM Trial. These preparatory steps are intended to increase the speed of enrolment following IDE approval. Clinical Milestone – 100 patients successfully treated with the DurAVR® THV During the First Quarter, Anteris achieved a major clinical milestone when the 100th patient was successfully treated with the DurAVR® THV System. This marks a significant achievement for Anteris and its goal to restore heart valve patients to healthy function. The patients included de novo (first time) aortic stenosis cases, some with complex anatomies such as bicuspid aortic valve patients. Additionally, a cohort of ViV patients were treated—these are patients who underwent a previous surgical or transcatheter aortic valve replacement procedure (SAVR or TAVR) and subsequently experienced failure of their bioprosthetic aortic valve. At the end of the First Quarter, 65 of the 100 patients treated with the DurAVR® THV, had successfully completed the primary endpoint measures of safety and efficacy including hemodynamic benefit at 30-days post implant. These results are both clinically relevant and significantly differentiated to current therapies available to aortic stenosis patients. Clinical Data – One-year patient outcomes for DurAVR® THV patients Anteris released one-year clinical data for patients treated with the DurAVR® THV, as a late breaking clinical trial podium presentation by Rishi Puri, M.D. PhD, at the Sydney Valves structural heart conference in March 2025. The one-year data, which was included in the IDE submission to the FDA, demonstrated a consistent safety and efficacy profile, with high implant success across the clinical program. Highlights from the one-year data include: Favorable hemodynamics sustained to one-year: DurAVR® THV demonstrated an Effective Orifice Area (EOA) of 2.1 + 0.2 cm2, a Mean Pressure Gradient (MPG) of 8.6 + 2.6 mmHg and Doppler Velocity Index (DVI) of 0.58. Strong safety profile at one year: No valve or cardiovascular related mortality. Importantly, there was no prosthesis-patient mismatch (PPM) reported in small annuli patients with aortic annulus area of 395.80 + 37.26 mm2, while current commercial devices have rates between 11.2% to 35.3% PPM1, a predictor of valve failure and disease progression. The clinical presentation is available on the Company’s website. Expansion of global manufacturing capacity During the First Quarter, the Anteris team continued to expand global manufacturing capacity to scale for the PARADIGM Trial. All production (DurAVR® THV, ComASUR® Delivery System, crimper, E-sheath) are being scaled into new ISO Qualified Clean Room facilities, increasing manufacturing capacity to at least three times the 2024 capacity levels. The transition to the new facilities aims for a reliable and scaled inventory supply to support the anticipated commencement of the PARADIGM Trial. In addition, the gold-standard ADAPT® tissue for the DurAVR® THV will be sourced from both the U.S. and Australia moving forward to mitigate supply chain risks. This progress reflects the strategic deployment of capital into infrastructure that supports operational readiness and long-term growth capacity for clinical and commercial success. First Quarter 2025 Financial Results The financial results for Anteris for the quarter ended March 31, 2025 compared to March 31, 2024 are reviewed below. All amounts in $ refer to US dollars. Net sales during the three months ended March 31, 2025 were $0.6 million, a decrease of $0.2 million (27%), compared to $0.8 million for the same period in the prior year, primarily due to lower demand for tissue products in 2025. Loss after Income Tax was $21.9 million for the three months ended March 31, 2025, an increase of $5.8 million (36%) compared to $16.2 million for the same period in the prior year. R&D expenses during the three months ended March 31, 2025 were $16.5 million, an increase of $4.9 million (42%) compared to $11.6 million for the same period in the prior year. This is primarily due to $3.5 million relating to the upscaling of manufacturing capabilities including process design and validation activities and the expansion of headcount and $1.5 million relating to preparatory activities linked to the PARADIGM Trial, including clinical costs associated with the enrollment of additional patients; Selling, general and administrative expenses during the three months ended March 31, 2025 were $5.7 million, a decrease of $0.8 million (13%) compared to $6.5 million for the same period in the prior year, primarily due to a reduction of $1.2 million relating to costs incurred in the first quarter of 2024 associated with the plans to re-domicile, list on Nasdaq and conduct our initial public offering, partly offset by a $0.8 million increase in legal, tax and compliance costs linked to dual listing requirements and other operational matters. There was also a decline in share based payment expense of $0.5 million. Anteris refers to the detailed Financial Information contained in its Form 10-Q filing, including the Management Discussion & Analysis and the risks described therein. Corporate and Financing Activities In January 2025, TD Cowen, Barclays and Cantor, the Underwriters to the December 2024 US IPO, partially exercised the green shoe option granted by Anteris. This green shoe option was in respect of 78,481 shares of Common Stock at the purchase price of US$6.00 per share, less underwriting discounts and commissions, to raise a further $0.47 million. During the First Quarter, Anteris was included as one of seven IPO additions to the FTSE Russell 2000® Index, effective as of March 24, 2025. The FTSE Russell 2000® Index measures the performance of the small-cap segment of the US equity market. The FTSE Russell® 2000 Index is a subset of the Russell 3000® Index which is designed to represent approximately 98% of the investable US equity market. 1 Herrmann HC, Mehran R, Blackman DJ, Bailey S, Möllmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Wood DA, Bleiziffer S, Ramlawi B, Gada H, Petronio AS, Resor CD, Merhi W, Garcia Del Blanco B, Attizzani GF, Batchelor WB, Gillam LD, Guerrero M, Rogers T, Rovin JD, Szerlip M, Whisenant B, Deeb GM, Grubb KJ, Padang R, Fan MT, Althouse AD, Tchétché D; SMART Trial Investigators. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971. doi: 10.1056/NEJMoa2312573. Epub 2024 Apr 7. PMID: 38587261. *A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs mimimize bias and allow a clear comparison between treatment groups. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts, including the objectives of and plans for Anteris’ studies and trials, the timing of the PARADIGM Trial, the goals of the expansion of the global manufacturing capacity and the sourcing of ADAPT® tissue for the DurAVR® THV in the future. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. Authorisation and Additional information This announcement was authorised for release by the Board of Directors.
Investor releaseQuarter not tagged2025-03-13Anteris Reports 2024 Financial Results and Provides Corporate Update
GlobeNewswire
Anteris Reports 2024 Financial Results and Provides Corporate Update
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, whi…Read full documentShow less
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 for the first quarter of 2025. Multiple pre-submission meetings with the FDA occurred covering topics such as reviewing the Pivotal Trial’s clinical plan and statistical rationale. Other key preparatory activities included life cycle testing, test method creation and validation, human factors validation testing with physicians, sterilization and shipping validation, and simulated use testing. Expanded clinical experience During 2024, Anteris advanced preparations for the DurAVR® THV’s planned EU-EFS. The first two cases were performed in January 2025 at Structural Heart Copenhagen in Denmark by Dr Ole De Backer. Excellent outcomes were achieved in a native aortic valve stenosis and a degenerated surgical valve. The EU-EFS is planned to be carried out in Denmark, Sweden, the Netherlands, France and Germany, enrolling up to 40 patients, to provide both Valve-in-Valve (“ViV”) data in a controlled setting as well as generate further feasibility and safety data in patients with severe aortic stenosis. The objective of these EU-EFS implants is to build awareness, understanding and experience with the DurAVR® THV system. Clinical data presented at major medical conferences Over the course of 2024, the Company attended several key industry conferences to promote awareness among clinicians of the DurAVR® THV system as a potential new treatment paradigm for aortic stenosis. These activities included podium presentations at Cardiovascular Research Technologies or CRT (March 2024), Sydney Valves (March 2024), Society for Cardiovascular Angiography & Interventions or SCAI (May 2024), Euro PCR (May 2024), New York Valves (June 2024), the 36th Annual Transcatheter Cardiovascular Therapeutics or TCT Conference (October 2024) and London Valves (Nov 2024). Data presented during the year included US-EFS 30-day results, First-in-Human (“FIH”) 1-year results demonstrating sustained hemodynamic performance, ViV data and a post-transcatheter aortic valve replacement (“TAVR”) cardiac magnetic resonance (“CMR”) imaging study demonstrating restoration of laminar flow and early left ventricular reverse remodelling following treatment with the DurAVR® THV. Scaled up manufacturing to support Pivotal Trial During 2024, the Company’s team continued design optimizations to the DurAVR® THV system to optimise the procedure, support ease of use and lower manufacturing costs. Additionally, manufacturing scale-up progressed at both the Malaga, AU and Minneapolis, U.S. manufacturing facilities as well as outsourced suppliers of the key components and delivery system. Additionally, Anteris engaged a Contract Research Organisation and bolstered in-house resources to support planned requirements to initiate and manage the Pivotal Trial. About the DurAVR® THV Pivotal Trial This prospective Pivotal Trial is anticipated to be the first all-risk, head-to-head TAVR registration trial to date. The Pivotal Trial is expected to include up to 80 sites across the U.S. and other key markets with an estimated 1,000 to 1,200 patients having severe, calcific aortic stenosis, and subject to customary study exclusions. The Pivotal Trial will be on a 1:1 randomised basis with patients receiving either the DurAVR® THV or TAVR using a commercially available and approved THV from the SAPIEN series (Edwards Life Sciences) or the Evolut series (Medtronic). This is intended to generate the widest possible patient population from the Pivotal Trial, enabling direct comparison with existing therapy and support a claim to the FDA of non-inferiority of the DurAVR® THV. Patients with a failed surgical bio-prosthesis needing ViV TAVR will be enrolled in a separate parallel registry. This is intended to support the Company’s plans for the ViV market opportunity. To date, 86 patients have been implanted with the DurAVR® THV with an expanding dataset over one year and overall promising performance across several haemodynamic measures. 2024 Financial Results The financial results for Anteris for the year ended December 31, 2024 are reviewed below. All amounts in $ refer to U.S. dollars. Net Sales for 2024 were $2.7 million Net Loss after Income Tax for 2024 was $76.0 million Closing cash balance at December 31, 2024 was $70.5 million In 2024, Net Sales were $2.7 million relating to sales of our tissue products. In line with contractual arrangements, the manufacture of products for LeMaitre ceased in January 2025. In 2024, the Net Loss after Income Tax of $76.0 million was driven by the operating expenses principally related to research and development to support the planned launch of the Pivotal Trial in 2025 and increased selling, general and administrative expenses which includes the re-domiciliation, Nasdaq listing and the U.S. IPO. Anteris refers to the detailed Financial Information contained in its Form 10-K filing including the Management Discussion & Analysis and the Risks. Corporate and Financing Activities In October 2024, Anteris entered an AUD $25.0 million secured convertible note facility (the Bridging Facility) with Obsidian Global Partners, LLC (“Obsidian”) to provide funding, primarily for the period prior to the U.S. IPO. In total AUD $7.5 million was drawn down under the Bridging Facility. The Bridging Facility was repaid in full in December 2024 from the proceeds of the U.S. IPO. This facility was subsequently terminated in February 2025. In December 2024, Anteris completed its U.S IPO, through the offering of 14,800,000 shares of common stock (the “Common Stock”) in the U.S. at a price of $6.00 per share (the “Offering”) raising $79.6 million after costs and commissions. Anteris Common Stock were then listed on the Nasdaq Global Market from 13 December 2024 and on 17 December 2024, Anteris listed its CHESS Depositary Interests (CDIs) on a 1 CDI-for-1 share of Common Stock basis, on the ASX. In January 2025, TD Cowen, Barclays and Cantor (the “IPO Underwriters”) partially exercised the underwriters’ option to purchase additional shares granted by Anteris in respect of 78,481 shares of Common Stock at the purchase price of $6.00 per share, less underwriting discounts and commissions, to raise a further $0.4 million. About Anteris® Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, U.S., Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (“THV”), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV system is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® delivery system. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ registration statement filed on 10 December 2024 with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, neither ATL or Anteris assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. Authorisation and Additional information This announcement was authorised for release on the ASX by the Board of Directors. For more information:

