Anteris Technologies Global Corp. develops structural heart medical devices for aortic valve disease, with its lead product, the DurAVR® Transcatheter Heart Valve, designed for patients with aortic stenosis. News about AVR commonly centers on the DurAVR THV System, the ADAPT® anti-calcification tissue technology, the ComASUR® Delivery System and the company’s work in transcatheter aortic valve replacement.
Company updates also cover the PARADIGM global pivotal trial, including clinical enrollment, U.S. reimbursement under Medicare coverage for TAVR procedures, regulatory and clinical strategy, manufacturing expansion, capital raises, strategic investment activity, financial results and healthcare investor conference presentations. The company is listed on Nasdaq and ASX under the symbol AVR.
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.