Anteris’ DurAVR Valve Shows Promise for Challenging Aortic Stenosis Cases

NEW YORK, NY – November 17, 2025 – Anteris Technologies presented compelling 30-day clinical data from its DurAVR transcatheter heart valve (THV) at the PCR London Valves conference, showcasing promising results for patients with a challenging condition: aortic stenosis with small aortic annuli. The data, simultaneously published in EuroIntervention, suggest the DurAVR valve could offer a significant improvement in valve performance and patient outcomes, potentially disrupting a rapidly growing market.

Addressing a Critical Need in Aortic Stenosis

Aortic stenosis, a narrowing of the aortic valve, affects millions worldwide and often requires intervention. Transcatheter Aortic Valve Replacement (TAVR) has become a standard treatment option, offering a less invasive alternative to open-heart surgery. However, patients with small aortic annuli – the ring of tissue surrounding the aortic valve – present a unique challenge. These patients are at higher risk of prosthesis-patient mismatch (PPM), a condition where the implanted valve is too small, leading to reduced blood flow and poorer outcomes.

“Finding a valve that fits properly and functions optimally in patients with small annuli is a constant struggle,” said one cardiologist familiar with the challenges of TAVR. “Existing valves often lead to significant pressure gradients and increased risk of complications.”

The DurAVR valve is designed to address this critical need. Its biomimetic design, coupled with the company’s proprietary ADAPT tissue technology, aims to replicate the performance of a natural aortic valve and minimize the risk of PPM. The recent clinical data presented at PCR London Valves offers encouraging evidence supporting this approach.

Promising Clinical Data and Technological Innovation

The data showcased results from 100 patients with small aortic annuli (average area 404 ± 37mm²). The DurAVR valve demonstrated a large effective orifice area (EOA) of 2.2 ± 0.3 cm² and a single-digit mean pressure gradient (MPG) of 8.2 ± 3.1 mmHg. Crucially, the study reported a remarkably low PPM rate of just 3.0%, significantly lower than rates reported for some existing commercial devices, which can range from 11.2% to 35.3%.

“These results are particularly noteworthy given the challenges associated with treating patients with small annuli,” commented a structural heart specialist. “A low PPM rate translates to improved hemodynamics and potentially better long-term outcomes.”

The DurAVR valve’s innovative design incorporates the ADAPT tissue, a next-generation bioscaffold that claims to be free of DNA and glutaraldehyde. The tissue is designed to resist calcification – a major cause of structural valve deterioration – potentially extending the valve’s lifespan and reducing the need for re-intervention. The company states the tissue has been clinically used for over 10 years and distributed for use in over 55,000 patients worldwide.

Market Dynamics and Future Prospects

The global TAVR market is experiencing rapid growth, driven by an aging population and increasing adoption of minimally invasive procedures. Projected to reach $17.58 billion by 2032, the market is currently dominated by Edwards Lifesciences and Medtronic. Anteris Technologies is positioning itself as a potential disruptor, focusing on a specific niche – patients with small aortic annuli – where unmet needs remain.

“The TAVR market is competitive, but there’s still room for innovation,” explained an industry analyst. “A valve that can consistently deliver superior hemodynamics and reduce complications, especially in challenging cases, will have a strong appeal.”

Anteris is currently enrolling patients in the PARADIGM trial, a global, randomized controlled trial designed to evaluate the safety and effectiveness of the DurAVR valve compared to commercially available TAVRs. The trial, which includes an ‘All Comers Randomized Cohort’ of up to 1054 patients, is expected to provide further evidence supporting the valve’s performance and durability. The company recently completed a U.S. IPO onto Nasdaq, raising $79.6 million to support these efforts. While the company reported a net loss of $76.0 million for the full year ended December 31, 2024, it maintains a strong cash position of $70.5 million.

While still early in its commercial journey, Anteris Technologies’ DurAVR valve appears to be a promising innovation in the field of structural heart disease. With its focus on addressing the specific needs of patients with small aortic annuli, the company is poised to potentially capture a significant share of this growing market.