ANTERIS TECHNOLOGIES GLOBAL Stock Price, News & Analysis

Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a structural heart company in the medical instruments and supplies industry focused on restoring healthy heart function through science-driven cardiac devices. According to the company’s public disclosures, Anteris is dedicated to designing, developing and commercializing medical devices for patients with structural heart disease, with a particular emphasis on aortic valve pathology.

The company describes itself as a global structural heart business that was founded in Australia and has a significant presence in Minneapolis in the United States. Its common stock trades on the Nasdaq Global Market, and its CHESS Depositary Interests (CDIs) trade on the Australian Securities Exchange, both under the symbol AVR. Anteris positions its work around multidisciplinary expertise, stating that its team of professionals focuses on restorative solutions for structural heart disease patients.

Core business focus

Anteris’ lead product is the DurAVR® Transcatheter Heart Valve (THV) System, which the company states was designed in collaboration or partnership with leading interventional cardiologists and cardiac surgeons to treat aortic stenosis, a potentially life‑threatening condition resulting from narrowing of the aortic valve. Aortic stenosis reduces or blocks blood flow through the aortic valve and, as described in the company’s SEC registration statement, is one of the most serious valvular heart diseases.

The DurAVR THV is described as a balloon‑expandable, biomimetic valve shaped to mimic the performance of a healthy human aortic valve and intended to replicate normal aortic blood flow. The company highlights that this biomimetic design is central to its approach to restoring more physiologic flow patterns in patients with severe calcific aortic stenosis, including those with small aortic annuli.

DurAVR THV System and ADAPT® tissue

In its filings and news releases, Anteris explains that the DurAVR THV System consists of three key components:

• The DurAVR valve, a single‑piece biomimetic heart valve.
• ADAPT® tissue, the company’s patented anti‑calcification tissue technology used to create the valve leaflets.
• The ComASUR® balloon‑expandable Delivery System, developed in consultation with physicians to deploy the valve.

The company describes ADAPT tissue as a proprietary tissue‑enhancing technology designed to reengineer xenograft tissue into a pure, single‑piece collagen bioscaffold. According to the S‑1 registration statement, ADAPT tissue has been clinically demonstrated to be calcium free for up to 10 years post‑procedure in published clinical work and has been distributed for use in over 55,000 patients globally in other indications. Anteris also notes that ADAPT tissue is FDA‑cleared.

The ComASUR Delivery System is described as balloon expandable and designed to provide precise alignment with the heart’s native commissures to support accurate placement of the DurAVR THV. Across its disclosures, the company emphasizes the combination of balloon‑expandable deployment characteristics with a hemodynamic profile that its clinical data associates with physiologic, laminar flow.

Clinical development and structural heart focus

Based on company statements in SEC filings and press releases, Anteris is focused on generating clinical evidence for DurAVR THV in patients with symptomatic severe aortic stenosis, including those with small aortic annuli and complex anatomies. The company reports that, as of a referenced point in its S‑1, a total of 130 patients had been treated worldwide with DurAVR THV in early feasibility and related studies.

Anteris’ news releases describe pooled analyses and outcomes from ongoing studies such as the EMBARK Study and early feasibility studies in the United States and Europe. These reports include 30‑day and one‑year outcomes in severe aortic stenosis patients with small aortic annuli, noting single‑digit mean gradients, large effective orifice areas, no moderate or severe paravalvular leak, and no valve‑related mortality in the cohorts reported. The company also highlights low rates of prosthesis‑patient mismatch in these small annulus populations compared with ranges cited from external trials of current commercial devices.

The PARADIGM Trial

A central element of Anteris’ clinical strategy is the PARADIGM Trial, which the company describes as a global, prospective randomized controlled trial (RCT) conducted under an Investigational Device Exemption (IDE). According to multiple press releases and related Form 8‑K filings, PARADIGM is designed to evaluate the safety and effectiveness of DurAVR THV compared to commercially available transcatheter aortic valve replacement (TAVR) devices in patients with severe calcific aortic stenosis.

The company states that PARADIGM will enroll approximately 1,000 patients in an “All Comers Randomized Cohort” across the United States, Europe and Canada, with 1:1 randomization between DurAVR THV and approved TAVR devices. The primary endpoint is described as a composite of all‑cause mortality, all stroke and cardiovascular hospitalization at one year post‑procedure, with the trial designed to assess non‑inferiority. Anteris indicates that the trial is intended to provide the level of evidence required to support a Premarket Approval (PMA) application to the U.S. Food and Drug Administration and to progress CE Mark approval in parallel.

Company announcements report key milestones for PARADIGM, including first European regulatory clearance from the Danish Medicines Agency, first patients enrolled and treated in Denmark, and FDA approval to initiate the global IDE trial with U.S. recruitment subject to Institutional Review Board approval.

Geographic footprint and listings

In its public materials, Anteris notes that it was founded in Australia and maintains its principal executive offices in Toowong, Queensland, Australia. The company also states that it has a significant presence in Minneapolis in the United States. Earlier descriptions from market data providers reference operations in the United States, Germany, Australia, Switzerland and Sweden, and the company’s more recent news flow confirms active clinical and regulatory activities across the United States, Europe and Canada.

The S‑1 registration statement and related filings confirm that Anteris Technologies Global Corp. is incorporated in Delaware, with its common stock listed on the Nasdaq Global Market under the symbol AVR and its CDIs listed on the Australian Securities Exchange under the same symbol. The company identifies itself as an emerging growth company and a smaller reporting company under U.S. securities regulations.

Capital markets and corporate governance

Recent Form 8‑K filings describe capital raising and corporate governance events. The company reports entering into subscription agreements and confirmation letters for a combined offering of common stock and CHESS Depositary Interests, each accompanied by five‑year warrants, resulting in gross proceeds described in the filings. Anteris has also filed a shelf registration statement on Form S‑1 to register shares of common stock for resale by selling stockholders, including shares underlying warrants and CDIs.

Proxy materials filed on Schedule 14A outline the agenda for the company’s 2025 Annual Meeting of Stockholders, including the election of directors, ratification of the independent registered public accounting firm, and approval of various grants of restricted stock units and option adjustments under company incentive plans. The company also discloses the timing and procedures for stockholder and CDI holder participation in meetings and voting.

Position within healthcare and medical devices

Within the healthcare sector, Anteris is classified in the medical instruments and supplies industry, with a specific focus on structural heart interventions. Its disclosures emphasize aortic valve disease and transcatheter heart valve technology rather than a broad device portfolio. The company’s narrative centers on measurable hemodynamic performance, biomimetic valve design, anti‑calcification tissue technology and randomized clinical evidence as key elements of its approach to treating severe aortic stenosis.

FAQs about Anteris Technologies Global Corp. (AVR)

• What does Anteris Technologies Global Corp. do?
  Anteris Technologies Global Corp. is a structural heart company that designs, develops and aims to commercialize medical devices to restore healthy heart function, with a primary focus on treating severe aortic stenosis using its DurAVR Transcatheter Heart Valve System.
• What is the DurAVR® Transcatheter Heart Valve (THV)?
  DurAVR THV is the company’s lead product, a balloon‑expandable, biomimetic transcatheter aortic valve designed to mimic the performance of a healthy human aortic valve and to replicate normal aortic blood flow in patients with severe aortic stenosis.
• What is ADAPT® tissue and how is it used by Anteris?
  ADAPT tissue is Anteris’ patented anti‑calcification tissue technology used to create the DurAVR valve leaflets as a single‑piece collagen bioscaffold. The company states that ADAPT tissue is FDA‑cleared, has been used clinically for over 10 years and has been distributed for use in more than 55,000 patients worldwide in other indications.
• What is the ComASUR® Delivery System?
  The ComASUR Delivery System is a balloon‑expandable transcatheter delivery platform developed in consultation with physicians to deploy the DurAVR THV. Anteris describes it as designed to provide precise alignment with the heart’s native commissures to support accurate valve placement.
• What is the PARADIGM Trial?
  The PARADIGM Trial is a global prospective randomized controlled trial intended to compare the safety and effectiveness of DurAVR THV with commercially available TAVR devices in patients with severe calcific aortic stenosis. It is structured as an IDE trial and is designed to support a future PMA submission to the U.S. FDA and CE Mark approval.
• Which markets does Anteris target for its clinical programs?
  Company announcements describe clinical and regulatory activities for DurAVR THV in the United States, Europe and Canada, including regulatory clearance in Denmark, FDA IDE approval for PARADIGM and plans to expand trial sites across these regions.
• Where is Anteris Technologies Global Corp. based?
  Anteris reports that it was founded in Australia and maintains principal executive offices in Toowong, Queensland, Australia, with a significant presence in Minneapolis in the United States.
• On which exchanges does AVR trade?
  Anteris’ common stock trades on the Nasdaq Global Market under the symbol AVR, and its CHESS Depositary Interests trade on the Australian Securities Exchange under the same symbol.
• How does Anteris describe its clinical results with DurAVR THV?
  In pooled analyses from early feasibility and related studies, the company reports single‑digit mean gradients, large effective orifice areas, no moderate or severe paravalvular leak, no valve‑related mortality and low prosthesis‑patient mismatch in severe aortic stenosis patients with small aortic annuli.
• Is Anteris considered an emerging growth company?
  In its S‑1 registration statement, Anteris identifies itself as an emerging growth company and a smaller reporting company under U.S. securities regulations.