Anteris scales for pivotal PARADIGM Trial, plunging R&D investment into clinical activities

During the March quarter, Australian structural heart valve company Anteris Technologies Global Corp was busy ramping up investment in its global pivotal trial for the DurAVR® transcatheter heart valve (THV) system.

In the resource-intensive phase of the clinical cycle, the company reported a net loss of US$21.9 million for the quarter, up 36% on the prior corresponding period.

Focus on technical, clinical and regulatory work

“Our focus this quarter has been on completing the substantial technical, clinical and regulatory work required to lodge our IDE application, which was successfully submitted during the period,” vice chair and CEO Wayne Paterson said.

“We are also proud to have reached a major clinical milestone with over 100 patients treated with DurAVR®, the first new class of product in this space for many years – an incredible achievement which reflects the strength of our clinical program and growing physician confidence in our technology.

“Finally we continue to scale our field based clinical team, manufacturing and quality organisations to ensure we are able to meet the demands of the PARADIGM Trial.”

The first quarter was marked by the submission of an Investigational Device Exemption (IDE) to the US Food and Drug Administration (FDA) for the planned PARADIGM Trial – a global, head-to-head study comparing the DurAVR® system to current market-leading transcatheter aortic valve replacement (TAVR) devices.

In preparation, Anteris expanded its clinical specialist team and contracted with centres across the US, Canada and Europe.

It also scaled its global manufacturing footprint to triple 2024 capacity, establishing new ISO-qualified clean room facilities and diversifying its supply chain across the US and Australia.

One hundred patients treated

Anteris also surpassed a major clinical milestone during the period, with 100 patients treated using the DurAVR® THV.

These included de novo aortic stenosis patients and those undergoing valve-in-valve procedures.

Of these, 65 patients completed the primary 30-day safety and efficacy endpoint, delivering results the company described as clinically relevant and significantly differentiated from existing therapies.

Further reinforcing its progress, one-year clinical data from the DurAVR® program presented at a leading structural heart conference highlighted sustained hemodynamic performance and a strong safety profile.

Key metrics included an effective orifice area of 2.1 ± 0.2 cm² and no reports of prosthesis-patient mismatch in small annuli patients – a common complication in commercial valve therapies.

Revenue for the quarter fell to US$0.6 million, down from US$0.8 million, primarily due to softer demand for tissue products.

R&D costs up

Research and development expenditure rose 42% to US$16.5 million, driven by scale-up and clinical trial preparation, while selling, general and administrative costs fell 13% to US$5.7 million.

Anteris closed the quarter with a cash balance of US$49.0 million (A$78.0 million) and was added to the FTSE Russell 2000® Index in March 2025, reflecting its growing presence in the US small-cap equity market.

The company expects to commence the PARADIGM Trial in the third quarter of 2025, pending FDA approval of its IDE application.