MINNEAPOLIS & BRISBANE, May 13, 2025—Anteris Technologies Global Corp. announced its first-quarter 2025 results, revealing significant progress across clinical development, regulatory preparation and manufacturing expansion for the company’s flagship DurAVR® Transcatheter Heart Valve (THV) program. During the quarter, Anteris submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration for its global pivotal PARADIGM Trial, achieved the clinical milestone of 100 patients successfully treated, reported one-year outcomes demonstrating sustained hemodynamic advantages, and advanced preparation of global trial infrastructure. These developments underscore the company’s growing role in next-generation valve technologies designed to restore physiologic blood flow in patients with aortic stenosis.
Science Significance
The scientific significance of the first-quarter achievements centers on the strong performance of the DurAVR® THV, a biomimetic, balloon-expandable prosthetic heart valve made from a single molded piece of ADAPT® anti-calcification tissue. The device is engineered to replicate native aortic valve function, with clinical data showing a sustained Effective Orifice Area of 2.1 cm², a mean pressure gradient of 8.6 mmHg, and a Doppler Velocity Index of 0.58 at one year—metrics that surpass many commercial TAVR systems. Importantly, the technology demonstrated no prosthesis-patient mismatch (PPM) in small annuli patients, a complication frequently associated with conventional valves and a key predictor of accelerated valve deterioration. The treatment of over 110 patients, including those with complex anatomies and valve-in-valve needs, strengthens the scientific foundation supporting DurAVR® THV’s physiologic design and its potential to shift the standard of care for structural heart interventions.
Regulatory Significance
Regulatorily, the submission of the IDE application marks a central milestone enabling Anteris to initiate the PARADIGM Trial, a pivotal global randomized study comparing DurAVR® THV directly against leading commercial valves. The trial is designed to generate the robust Level 1 evidence necessary to support a future Premarket Approval (PMA) application in the United States, with parallel preparation for CE Mark authorization in Europe. The proposed design includes randomization to either DurAVR® or commercial comparators (SAPIEN or Evolut devices), with a separate registry planned for valve-in-valve (ViV) patients. Regulatory authorities will rely on these data to assess safety, hemodynamic performance and long-term durability. An approved IDE would allow the investigational device’s use across U.S., Canadian and European centers, with Anteris’ growing Clinical Specialist Team positioned to support proper device use, protocol adherence and high-quality data capture—key requirements within a GxP-aligned trial environment.
Business Significance
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From a business perspective, Anteris’ first-quarter progress reflects disciplined investment into manufacturing expansion, trial readiness and global operations. The company is scaling all production—including the DurAVR® valve, ComASUR® Delivery System, E-sheath and crimper—into new ISO-qualified cleanroom facilities, increasing capacity to three times 2024 levels. This preparation is essential for both the PARADIGM Trial and anticipated initial commercial demand. Financially, Anteris ended the quarter with $49 million in cash, supported by post-IPO green-shoe exercise proceeds and inclusion in the FTSE Russell 2000® Index, strengthening visibility among institutional investors. While the company reported increased R&D expenses associated with trial and manufacturing scale-up, these investments align with its strategy to transition from clinical validation to pivotal execution, positioning Anteris for long-term growth in the rapidly expanding structural heart market.
Patients’ Significance
For patients with severe aortic stenosis, especially those with small annuli or previous valve replacements, the continued development of DurAVR® THV represents a meaningful advancement in treatment options. The device’s ability to mimic natural valve behavior and maintain excellent hemodynamics at one year suggests potential benefits in terms of symptom relief, exercise tolerance and long-term valve durability. The absence of prosthesis-patient mismatch in small annuli patients addresses a critical unmet need, as PPM can accelerate disease progression and increase the likelihood of reintervention. The planned PARADIGM Trial will further clarify the device’s impact on patient outcomes while expanding access to a next-generation valve system engineered for physiologic blood-flow restoration.
Policy Significance
At a policy level, Anteris’ progress aligns with global initiatives aimed at promoting innovation in cardiovascular medical devices, advancing evidence-based evaluation standards and encouraging equitable access to breakthrough technologies. The company’s IDE submission supports FDA goals of strengthening oversight of high-risk device trials, while its commitment to multi-regional enrollment reflects alignment with harmonized regulatory frameworks across the U.S., Europe and Canada. The expansion of ISO-compliant manufacturing reinforces policy priorities around quality systems, supply chain resilience and scalable production capacity. As structural heart interventions continue to grow in prevalence, the PARADIGM Trial may help shape future regulatory expectations for biomimetic, tissue-engineered valve platforms.
The first-quarter 2025 results highlight Anteris’ momentum across science, regulation, manufacturing and clinical operations, underscoring its emergence as a key innovator in the structural heart field. With the IDE submitted, manufacturing capacity expanding and pivotal-trial readiness advancing, the company is strategically positioned to elevate standards in aortic stenosis care through its DurAVR® THV platform. As the PARADIGM Trial approaches launch, Anteris is entering a transformative phase that could redefine valve replacement therapy for patients worldwide.
Source: Anteris Technologies Ltd press release
