Welcome to our dedicated page for ANTERIS TECHNOLOGIES GLOBAL news (Ticker: AVR), a resource for investors and traders seeking the latest updates and insights on ANTERIS TECHNOLOGIES GLOBAL stock.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) generates news primarily around its structural heart programs, clinical data and capital markets activities. As a company focused on medical instruments and supplies for structural heart disease, its announcements center on the development of the DurAVR Transcatheter Heart Valve (THV) System and related regulatory and trial milestones.
Investors following AVR news will see regular updates on clinical outcomes for DurAVR THV in patients with severe aortic stenosis, including small aortic annulus cohorts. Recent releases have detailed 30‑day and one‑year results from pooled analyses of patients treated in the EMBARK Study and early feasibility studies in the United States and Europe, highlighting hemodynamic performance, effective orifice areas, paravalvular leak rates, valve‑related mortality and prosthesis‑patient mismatch metrics.
News coverage also tracks the progress of the PARADIGM Trial, Anteris’ global prospective randomized controlled trial comparing DurAVR THV with commercially available TAVR devices. Key items include first European regulatory clearance from the Danish Medicines Agency, first patients enrolled and treated in Denmark, and U.S. FDA approval of the Investigational Device Exemption to initiate the trial, with recruitment in the United States subject to Institutional Review Board approval.
Beyond clinical data, Anteris issues updates on quarterly financial results, cash flows and operating expenditure linked to regulatory work, trial preparation and manufacturing scale‑up for DurAVR THV. Additional news items cover capital raising transactions involving common stock, CHESS Depositary Interests and warrants, as well as corporate governance events such as special meetings and the annual meeting of stockholders.
For readers tracking AVR, this news stream offers insight into the pace of clinical development, regulatory interactions, trial execution and financing activities that shape the company’s structural heart strategy.
Anteris (NASDAQ: AVR) received regulatory clearance from the Danish Medicines Agency to start the global pivotal PARADIGM Trial of the DurAVR® transcatheter heart valve for severe calcific aortic stenosis, announced on October 15, 2025.
Patient recruitment at Danish centers is expected to begin in 4Q 2025, with planned expansion across the United States, Europe and Canada. An IDE remains under review by the U.S. FDA, and U.S. sites will begin once IDE and IRB approvals are obtained. Management cites trial design aimed to support future PMA and CE Mark approvals.
Anteris Technologies Global Corp. (NASDAQ: AVR) announced the adjournment of its Special Meeting of Stockholders due to lack of required quorum. The meeting has been rescheduled for September 29, 2025, at 8:00 a.m. Central time.
The virtual meeting will be held via webcast, maintaining the original record date of August 11, 2025. Stockholders who haven't voted can still do so, with proxy submissions due by September 28, 2025, at 11:59 p.m. Eastern time for online/telephone votes, and September 26, 2025 for mail-in proxies. CDI holders must submit voting instructions by September 25, 2025, at 5:00 p.m. Central time.
Anteris Technologies Global Corp. (NASDAQ: AVR) has announced the postponement of its Special Meeting of Stockholders from September 11 to September 18, 2025. The virtual meeting will be held at 5:00 p.m. Central time via live webcast.
The postponement aims to provide stockholders additional time to vote on proposals outlined in the Company's August 18 Proxy Statement. The record date remains August 11, 2025. Previously cast votes will remain valid unless changed. The Board unanimously recommends voting FOR the proposals.
Stockholders can vote via Internet or telephone until September 17, while CDI holders must submit their Voting Instruction Forms by September 16. All relevant materials are available on the SEC website and the company's investor relations page.
Anteris Technologies Global Corp. (NASDAQ: AVR) has announced the postponement of its Special Meeting of Stockholders from September 4, 2025, to September 11, 2025, at 5:00 p.m. Central time. The meeting will be held virtually via webcast at www.virtualshareholdermeeting.com/AVR2025SM.
The Record Date remains unchanged at August 11, 2025. The postponement aims to provide stockholders additional time to vote on the proposals outlined in the Company's Proxy Statement filed on August 18, 2025. The Board of Directors unanimously recommends voting FOR all proposals.
Previously cast votes will remain valid unless changed. Stockholders can submit new votes via Internet or telephone by September 10, 2025, while CDI holders must submit voting instructions by September 9, 2025.
Anteris Technologies (NASDAQ: AVR) has reported its Q2 2025 financial results and corporate updates, highlighting significant progress in its DurAVR® THV (transcatheter heart valve) program. The company has successfully treated 130 patients with DurAVR® since clinical development began, including 21 patients in Q2 2025.
Key developments include the world's first "double DurAVR®" implant for both mitral and aortic valve positions, and advancement of the global PARADIGM Trial with 79 qualified clinical sites. The company appointed Dr. Michael J. Reardon and Professor Stephan Windecker as Trial Co-Chairs and added two new board members. Financial results show net operating cash outflows of $41.0 million for H1 2025, with $28.4 million in cash as of June 30, 2025.
Anteris Technologies (NASDAQ/ASX: AVR) has announced a significant milestone with over 100 patients worldwide now treated using their DurAVR® Transcatheter Heart Valve (THV) for severe aortic stenosis. The treatment includes first-time cases, valve-in-valve patients, and complex bicuspid aortic valve cases.
Key clinical outcomes include:
- 65 patients completed primary endpoint measures showing safety and efficacy at 30 days
- 37 patients reached one-year follow-up, demonstrating sustained large effective orifice areas and low mean pressure gradients
- No valve or cardiovascular-related mortality reported at one-year
The company plans to commence the DurAVR® THV Pivotal Trial in Q3 2025, pending FDA approval. This trial will be an all-risk, head-to-head registration study, marking a significant step in the company's development of what they describe as the first new class of product in this space in many years.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) announced one-year results for its DurAVR® Transcatheter Heart Valve (THV) System at Sydney Valves on March 21, 2025. The data demonstrates sustained favorable hemodynamic performance with an Effective Orifice Area (EOA) of 2.1 + 0.2 cm2, a Mean Pressure Gradient of 8.6 + 2.6 mmHg, and Doppler Velocity Index of 0.58.
Key highlights include:
- No valve or cardiovascular-related mortality at one year
- Zero prosthesis-patient mismatch (PPM) in small annuli patients
- 65 patients completed the primary endpoint measure at 30 days
The results are particularly significant as current commercial devices show PPM rates between 11.2% to 35.3%. The company plans to include this data in their upcoming FDA Investigational Device Exemption submission for the DurAVR® THV randomized, global pivotal study.
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) reported its 2024 financial results and corporate updates. Key highlights include a successful U.S. IPO raising $88.8M and preparations for the DurAVR® Transcatheter Heart Valve's global pivotal study. The company completed 86 patient cases and initiated European Early Feasibility Study in Denmark.
Financial results show net sales of $2.7M and a net loss of $76.0M for 2024, ending with a cash position of $70.5M. The planned pivotal trial will be an all-risk, head-to-head TAVR registration trial involving 80 sites and 1,000-1,200 patients with severe calcific aortic stenosis.
The company advanced manufacturing scale-up in Malaga and Minneapolis facilities, presented clinical data at major conferences, and plans to submit an IDE application to FDA in Q1 2025.
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