Board Change • Jun 20
Less than half of directors are independent Following the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Non-Executive Director Gregory Moss was the last independent director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Ankündigung • Jun 09
Anteris Technologies Global Corp. Receives French Regulatory Clearance for Duravr Transcatheter Heart Valve Global Pivotal Trial Anteris Technologies Global Corp. had received full regulatory clearance from the French National Agency for Medicines and Health Products Safety (ANSM) for the DurAVR Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic stenosis (the PARADIGM Trial). This authorization marks a significant milestone in the Company’s clinical and regulatory strategy and enables patient recruitment to commence at centers in France. The Company continues to advance its global clinical strategy, with ongoing site activations and patient enrollment across the United States and Europe. The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR Transcatheter Heart Valve 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. Anteris’ lead product, the DurAVR THV, was designed in collaboration with interventional cardiologists and cardiac surgeons to treat aortic stenosis – a 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. Ankündigung • May 23
Anteris Technologies Global Corp. has filed a Follow-on Equity Offering in the amount of $250 million. Anteris Technologies Global Corp. has filed a Follow-on Equity Offering in the amount of $250 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Ankündigung • May 14
Anteris Technologies Global Corp. Appoint Board of Director Anteris Technologies Global Corp. announced the appointment of Ms. Susan Knight and Mr. Stephen Denaro to serve on the Board of Directors. Ms. Knight will serve as a Class I Director, with a term expiring at the Company's 2028 annual meeting of stockholders and will serve on the Audit and Risk Committee of the Board. Mr. Denaro will serve as a Class II Director, with a term expiring at the Company’s 2026 annual meeting of stockholders. Ms. Knight most recently served as the Board Chair of Surmodics Inc., a medical device provider, a position she held from 2015 until November 2025. She has served on corporate boards of directors since 2008 and has broad audit committee experience, including serving as committee chair at Surmodics Inc., Greater Metropolitan Housing Corporation and Plato Learning. During her professional career, Ms. Knight was the Senior Vice President and Chief Financial Officer of MTS Systems Corporation from 2011 to 2014 and its Chief Financial Officer from 2001 to 2011. Prior to MTS Systems Corporation, Ms. Knight was the Vice President of Finance of the Home and Building Control Business of Honeywell Inc. from 1994 to 2001. She also held various other management and executive financial positions during her 24-year career at Honeywell Inc. Ms. Knight earned a BSBA in Accounting from Creighton University. Mr. Denaro rejoins the Board with deep knowledge of the Company and its strategic priorities. Together these appointments reinforce the Company’s governance and strategic capabilities as it advances its global clinical and commercial objectives towards the anticipated U.S. and EMA licensure of the DurAVR THV for patients with aortic stenosis. Ankündigung • May 06
Anteris Technologies Global Corp. Announces First U.S. Patients Treated in Global Pivotal Paradigm Trial Anteris Technologies Global Corp. announced that the first patients in the United States have been enrolled and successfully treated in the DurAVR Transcatheter Heart Valve (THV) global pivotal trial for patients with severe calcific aortic stenosis (the PARADIGM Trial). The procedures were performed at Montefiore Medical Center, New York, United States. 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 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. 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. Ankündigung • Apr 29
Anteris Technologies Global Corp. Secures Cms Reimbursement Eligibility for Paradigm Trial Anteris Technologies Global Corp. announced it has secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services (CMS) national coverage policy. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32. The CMS framework operates under a Coverage with Evidence Development (CED) model, enabling reimbursement with clinical evidence generation in 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. 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. Ankündigung • Jan 22
Anteris Technologies Global Corp. has completed a Follow-on Equity Offering in the amount of $200.000002 million. Anteris Technologies Global Corp. has completed a Follow-on Equity Offering in the amount of $200.000002 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 34,782,609
Price\Range: $5.75
Discount Per Security: $0.29325 Ankündigung • Dec 15
Anteris Technologies Global Corp. Announces Resignation of Stephen Denaro from the Board of Directors Anteris Technologies Global Corp. announced on December 14, 2025, Mr. Stephen Denaro resigned from the Board of Directors (the "Board") of Anteris Technologies Global Corp. (the "Company") and as a Class II director with immediate effect. The resignation from the Board was not due to any disagreement with the Company or its management with respect to any matter relating to the Company's operations, policies or practices. Mr. Denaro will continue to serve as the corporate secretary of Anteris Technologies Pty Ltd. ("ATPL") and as a member of the Board of Directors of ATPL and the Company's other Australian subsidiaries. Ankündigung • Nov 18
Anteris Technologies Global Corp. Presents Data from 100 DurAVR®? THV Patients at PCR London Valves Anteris Technologies Global Corp. released 30-day clinical outcomes for the DurAVR®? THV in one hundred severe aortic stenosis patients with small aortic annuli (aortic annulus area 404 +- 37mm2). TheDurAVR®? THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality, with 97% freedom from moderate or severe paravalvulvular leak (PPM) in a cohort of small annuli patients similar to the one reported in the SMART Trial1. 30-day Results Highlights for 100 DurAVR®?THV Patients: DurAVR®? TH V delivered a favorable hemodynamic profile with a large EOA of 2.2 +- 0.3 cm2 and a single digit mean pressure gradient (MPG) of 8.2 +- 3.1 mmHg. At 30-days, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalVular leak (PVL). Prosthesis-patient mismatch was just 3.0% compared with 11.2% to 35.3% for current commercial devices, highlighting a meaningful reduction in a key predictor of valve failure and disease progression. Hahn RT, Pibarot P. Prosthesis-patient mismatch in transcatheter and surgical aortic valve replacement. Ankündigung • Nov 06
Anteris Technologies Global Corp. has completed a Follow-on Equity Offering in the amount of AUD 20.91048 million. Anteris Technologies Global Corp. has completed a Follow-on Equity Offering in the amount of AUD 20.91048 million.
Security Name: CHESS Depositary Interests
Security Type: Depositary Receipt (Common Stock)
Securities Offered: 2,788,064
Price\Range: AUD 7.5
Discount Per Security: AUD 0.45
Security Features: Attached Warrants
Transaction Features: Regulation S; Subsequent Direct Listing Ankündigung • Nov 04
FDA Approves Anteris Technologies Global Corp.'s DurAVR®? THV Global Pivotal Trial Anteris Technologies Global Corp. announced it has received U.S. Food and Drug Administration (FDA) approval to initiate PARADIGM, its global Investigational Device Exemption (IDE) clinical trial which is designed to evaluate the DurAVR®? Transcatheter Heart Valve (THV) in patients with severe calcific aortic stenosis and to support a future PMA submission. The PARADIGM Trial is co-chaired by Dr. Michael J. Reardon, Allison Family Distinguished Chair of Cardiovascular Research and Professor of Cardiothoracic Surgery at the Houston Methodist Hospital, Texas and Professor Stephan Windecker, Chairman of the Department of Cardiology at Bern University Hospital, Switzerland. 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 enroll approximately 1000 patients across the Unites 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 trials is designed to provide the robust clinical evidence required to support an application to the FDA for Premarket Approval in the United States, with CE Mark approval anticipated to progress in parallel to the PMA. 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 minimize bias and allow a clear comparison between treatment groups. Ankündigung • Oct 29
Anteris Technologies Global Corp. Announces One-Year Clinical Outcomes for the DurAVR Transcatheter Heart Valve Anteris Technologies Global Corp. announced one-year clinical outcomes for the DurAVR®? Transcatheter Heart Valve (THV) in symptomatic severe aortic stenosis patients with small aortic annulus area 396 + 37 mm2). The DurAVR®? THV System demonstrated single digit mean gradients and large effective orifice areas (EOAs), no moderate or severe paravalvular leaks and no valve related mortality at one year, with low prosthesis-patient mismatch at 30 days. One-year Results Highlights: DurAVR®?THV delivered a favorable hemodynamic profile sustained to one-year, with an EOA of 2.1 + 0.2 cm2 and a mean pressure gradient (MPG) of 8.6 + 2.6 mmHg. At one-year, clinical safety outcomes were positive with no valve related mortality and no moderate or severe paravalVular leak (PVL). At 30-days, prosthesis-patient mismatch was just 1.5%, compared with 11.2% to 35.3%1 for current commercial devices, highlighting a meaningful reduction in a key predictor of valve failure and disease progression. The pooled cohort included 65 patients with small aortic Annuli implanted with the DurAVR®? TH V from the ongoing EBARK Study and US Early Feasibility Study (EFS). The encouraging clinical outcomes observed to date in over 100 patients implanted with the DurAVR™? THV will be further validated in the Company's recently initiated global pivotal trial (the "PARADIGM Trial"). The PARADIGM Trial (ClinicalTrials.gov ID NCT07194265) is a prospective, randomized controlled trial (RCT) which will evaluate the safety and effectiveness of theDurAVR®? THV compared to commercially available transcatheter aortic valve replacements (TAVRs) in the treatment of severe aortic stenosis. Prosthesis-patient mismatch (PPM) happens when a prosthetic valve, after being implanted, doesn't have a large enough opening (EOA) to accommodate the patient's blood flow needs, based on their body size. The result is higher than expected gradients. PPM affects a significant proportion of transcatheter aortic valves (TAVR) patients, particularly patients with a small aortic annulus and has been associated with impaired long-term survival following surgical aortic valve replacement (SAVR). Ankündigung • Oct 16
Anteris Technologies Global Corp., Annual General Meeting, Dec 03, 2025 Anteris Technologies Global Corp., Annual General Meeting, Dec 03, 2025. Ankündigung • Oct 15
Anteris Technologies Global Corp. Receives First European Regulatory Clearance to Commence DurAVR® THV Global Pivotal Trial Anteris Technologies Global Corp. announced it has received regulatory clearance from the Danish Medicines Agency to initiate the DurAVR® Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic stenosis (the "PARADIGM Trial"). Patient recruitment at Danish centers is expected to begin in fourth quarter 2025. With the first regulatory clearance secured, Anteris is positioned to drive the global PARADIGM Trial through the addition of further countries and sites in the near term, with planned expansion across the United States, Europe and Canada. In parallel, an Investigational Device Exemption (IDE) application remains under review by the U.S. Food and Drug Administation (FDA). Anteris continues to expect FDA approval in the near term, which will allow initiation of study sites in the PARADIGM Trial in the United States, pending Institutional Review Board (IRB) approval. 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 aoric valve replacements (TAVRs). The planned expansion across other geographies includes additional cohorts. 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 minimize bias and allow a clear comparison between treatment groups. Ankündigung • Jun 10
Anteris Technologies Global Corp. Announces Board Changes Anteris Technologies Global Corp. announced the appointments of Mr. David Roberts and Mr. Gregory Moss to its board of directors. The Company also announced the resignation of Dr. Wenyi Gu from the Board upon completion of his term as an Australia-based non-executive director. Mr. David Roberts is currently President of LeMaitre Vascular Inc., a position he has held since 2007. He joined LeMaitre in 1997 as Vice President of Business Development and was promoted to Chief Financial Officer in 2000. Prior to LeMaitre, Mr. Roberts served as Vice President of Development for BUCA Inc. from 1994 to 1997, and prior to that as Associate of HarbourVest Partners from 1992 to 1994. Mr. Roberts received a Bachelor of Arts in Business Economics and History from Brown University and a Master of Business Administration from the Stanford University Graduate School of Business. Mr. Roberts serves as a director of LeMaitre Vascular Inc., Lexington Medical Inc. and Parasole Restaurant Holdings Inc. Mr. Gregory Moss serves as Chief Business and Legal Officer, as well as Corporate Secretary and Chief Compliance Officer of Evommune Inc. Prior to Evommune, Mr. Moss served as Executive Vice President, General Counsel, and Corporate Secretary, Chief Compliance Officer at Kadmon, a Sanofi Company, where he led legal, compliance, and business development operations, culminating in Kadmon’s $1.9 billion acquisition in 2021. Prior to joining Kadmon in 2012, Mr. Moss served as a solicitor in the corporate risk department of a large Australian law firm and as an associate at a boutique law firm and hedge fund in New York, where he focused on complex litigation and event-driven outcomes. Mr. Moss currently serves on the board of Vitls Inc. Mr. Moss earned a BA and an LLB from Macquarie University, Australia, and is a member of the Bar Associations of New York, USA, and New South Wales, Australia, with admissions before the Supreme Court of the United States of America; Southern District of New York; Supreme Court of New South Wales, Australia; and High Court of Australia. Mr. Roberts and Mr. Moss will help guide Anteris through its next phase of growth, with the upcoming global pivotal PARADIGM study in third quarter 2025 towards the ultimate U.S. and EMA licensure of the DurAVRTHV for patients with aortic stenosis. Ankündigung • Mar 31
Anteris Technologies Global Corp. Announces 100 Patients Treated with DurAVR THV Anteris Technologies Global Corp. announced a significant milestone in their mission to restore heart valve patients to healthy function. Their first in class, biomimetic DurAVR. Transcatheter Heart Valve has now been used to treat over 100 patients worldwide, marking a major achievement in their goal to revolutionize cardiac care in patients affected by severe aortic stenosis. Highlights: Over 100 patients successfully treated with the DurAVR THV, including de novo (first time) aortic stenosis cases, valve-in-valve patients and complex anatomies such as bicuspid aortic valve patients. 65 patients have successfully completed the primary endpoint measures of safety and efficacy, including hemodynamic benefit at 30-days post implant. One-year efficacy data on 37 aortic stenosis patients continues to validate the exceptional hemodynamic performance, with sustained large effective orifice areas and low mean pressure gradients. Excellent safety profile demonstrated at one-year, with no valve or cardiovascular related mortality. Range of valve sizes used to accommodate a broad patient population. The Company remains on track to commence the DurAVR THV Pivotal Trial in the third quarter of 2025, pending U.S. Food and Drug Administration approval. Ankündigung • Mar 21
Anteris Technologies Global Corp. Reports One-Year Patient Outcomes for DurAVR®? THV Anteris Technologies Global Corp. announced one-year results for patients treated with its proprietary, balloon expandable, DurAVR®? Transcatheter Heart Valve (THV) System. One-year Results Highlights: DurAVR®? THV demonstrated a favorable hemodynamic profile sustained to one-year, with 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. At one-year, clinical safety outcomes show positive results with no valve or cardiovascular related mortality and importantly no prosthesis-patient mismatch (PPM) reported in these small annuli patients (aortic annulus area 395.80 + 37.26mm2). Current commercial devices have demonstrated rates between 11.2% to 35.3% PPM1, a predictor of valve failure and disease progression. Sixty-five (65) patients have completed the primary endpoint measure at 30 days (pre previously reported as rolling cohorts at multiple medical conferences through 2023-2024). The DurAVR®? TH V System continues to demonstrate a consistent safety and efficacy profile, with high implant success across the clinical program. The one-year data builds on the existing body of clinical evidence and will be included in the planned Investigational Device Exemption (IDE) submission to the U.S. FDA to seek approval to conduct the DurAVR®? THR®? THV randomized, global pivotal study. Ankündigung • Mar 06
Anteris Technologies Global Corp. Appoints David St Denis as President and as a Class II Director of the Board Anteris Technologies Global Corp. advised that on 6 March 2025 the Board of Directors (the "Board") appointed David St Denis as the Company's President and as a Class II director of the Board, effective immediately. As a non-independent director, Mr. St Denis will not serve on any committees of the Board. Mr. St Denis, 56, has served as Chief Operating Officer of the Company since July 2017 and the Chief Executive Officer of v2vmedtech, inc. since April 2023. Mr. St Denis also served as Chief Financial Officer of v2vmedtech from April 2023 to September 2023. Prior to his appointment as Chief Operating Officer of the Company, Mr. St Denis served as Head of Commercial Operations for Europe and Canada at Merck since 2013, and prior to that served as Head of Operations for Emerging Markets at Merck since 2008. In addition, Mr. St Denis had held multiple leadership roles at Millennium Pharmaceuticals, Inc, now Takeda Pharmaceutical Company, from 1996 to 2006, and provided strategic consulting services to such company from 2006 to 2008. Mr. St Denis has a Bachelor of Science from the University of Connecticut, a Master of Arts from Boston University and an MBA in Global Management and International Marketing from Babson College--Franklin W. Olin Graduate School of Business. There are no arrangements or understandings between Mr. St Denis and any other persons pursuant to which Mr. St Denis was named as President of the Company or a director of the Board. There are no family relationships between Mr. St Denis and any director or executive officer of the Company. Mr. St Denis has no direct or indirect material interest in any transaction or proposed transaction required to be reported under Item 404(a) of Regulation S-K under the Securities Exchange Act of 1934, as amended. In connection with his previous appointment as Chief Operating Officer, the Company entered into its standard form of indemnification agreement for directors and officers with Mr. St Denis, which requires the Company to indemnify him against certain liabilities that may arise as a result of his status or service as a director or officer. Ankündigung • Dec 27
Anteris Technologies Ltd. Ordinary Shares to Be Deleted from OTC Equity Anteris Technologies Ltd. Ordinary Shares will be deleted from OTC Equity effective December 27, 2024, due to CUSIP Suspended. Ankündigung • Dec 14
Anteris Technologies Global Corp. has completed an IPO in the amount of $88.8 million. Anteris Technologies Global Corp. has completed an IPO in the amount of $88.8 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 14,800,000
Price\Range: $6
Discount Per Security: $0.42
Transaction Features: Sponsor Backed Offering