ANTERIS TECHNOLOGIES GLOBAL Stock Price, News & Analysis

Anteris (NASDAQ: AVR) reported Q3 2025 results and a corporate update focused on advancing the PARADIGM pivotal trial and scaling manufacturing. Key regulatory milestones included FDA approval to commence U.S. recruitment announced in November 2025 and Danish Medicines Agency approval with the first PARADIGM patients treated in Denmark in October 2025. The company progressed site readiness across the U.S., Europe and Canada, advanced QMS and ISO 13485 preparation, and continued manufacturing scale-up for DurAVR THV production.

Financial highlights: net operating cash outflows $59.3M for the nine months ended Sept 30, 2025; R&D $16.8M and SG&A $5.8M for Q3; cash and cash equivalents of $9.1M at Sept 30, 2025.

Anteris (NASDAQ:AVR) announced that the U.S. Food and Drug Administration granted approval to initiate the PARADIGM global Investigational Device Exemption (IDE) clinical trial for the DurAVR® Transcatheter Heart Valve (THV) on November 3, 2025. The randomized pivotal trial will compare the DurAVR biomimetic valve to commercial TAVR devices in patients with severe calcific aortic stenosis and is intended to support a future PMA submission.

The company said U.S. patient recruitment can now begin, and noted the trial recently launched with first patients treated in Denmark. The study is co-chaired by Dr. Michael J. Reardon and Professor Stephan Windecker.

Anteris (NASDAQ: AVR) reported one-year pooled outcomes for the DurAVR® Transcatheter Heart Valve (THV) in patients with small aortic annuli (mean annulus area 396 ± 37 mm2).

Key results: EOA 2.1 ± 0.2 cm2, mean pressure gradient 8.6 ± 2.6 mmHg, no valve-related mortality and no moderate or severe paravalvular leak at one year; 30-day prosthesis-patient mismatch was 1.5% versus 11.2%–35.3% for current devices. The pooled cohort included 65 small-annulus patients from EMBARK and a US early feasibility study; >100 patients have been implanted overall. Results will be evaluated further in the randomized PARADIGM pivotal trial (NCT07194265).

Anteris Technologies (NASDAQ: AVR) announced on October 27, 2025 that the first patients were enrolled and successfully treated in the global pivotal PARADIGM Trial evaluating the DurAVR® Transcatheter Heart Valve (THV) for severe calcific aortic stenosis.

The initial procedures were performed at Rigshospitalet, Copenhagen by Prof. Dr. Ole De Backer. The head-to-head study will randomize patients across surgical risk groups and builds on an existing clinical dataset of 130 patients previously treated with DurAVR® (including de novo, valve-in-valve, and bicuspid anatomies). Anteris plans near-term expansion of PARADIGM into the United States, Europe and Canada to accelerate enrollment and evidence generation toward commercialization.

Anteris Technologies (NASDAQ: AVR) announced that one-year clinical outcomes for the DurAVR® Transcatheter Heart Valve (THV) will be presented at TCT 2025 on October 27, 2025 at 2:27pm GMT-7 in the Innovation Theater, Moscone Center, San Francisco.

The oral presentation, titled “The DurAVR® Biomimetic TAVR System in Patients with Small Aortic Annuli (Anteris): One-Year Clinical and Hemodynamic Outcomes,” summarizes outcomes in over 100 patients with symptomatic severe aortic stenosis and small aortic annuli (annulus area 396 ± 37 mm2). The company said the outcomes to date are encouraging and will be further evaluated in the global pivotal PARADIGM Trial, a prospective randomized controlled trial comparing DurAVR THV to commercially available TAVRs for safety and effectiveness.

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.