Anteris Advances DurAVR Trial with FDA Submission, Hits 100 Patients Treated
Anteris Technologies has submitted its FDA Investigational Device Exemption for the pivotal PARADIGM Trial of its DurAVR heart valve and marked a milestone of 100 patients treated, while expanding manufacturing capacity amid rising R&D costs.
- FDA IDE application submitted for DurAVR pivotal PARADIGM Trial
- 100 patients successfully treated with DurAVR Transcatheter Heart Valve
- One-year clinical data shows sustained favorable outcomes and safety
- Manufacturing capacity tripled to support upcoming trial and demand
- Q1 2025 loss increased 36% due to R&D and trial preparation expenses
Clinical and Regulatory Progress
Anteris Technologies Global Corp. has taken a significant step forward in its quest to revolutionize treatment for aortic stenosis with the submission of an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration. This submission paves the way for the company’s global pivotal clinical trial, dubbed the PARADIGM Trial, which aims to rigorously evaluate the safety and effectiveness of its DurAVR Transcatheter Heart Valve (THV).
The PARADIGM Trial is designed as a randomized, head-to-head comparison against established commercial devices, reflecting Anteris’ confidence in the biomimetic DurAVR valve’s potential to set a new standard in heart valve replacement therapy. Pending FDA approval, the trial is expected to commence in the third quarter of 2025, with enrollment planned across the U.S., Canada, and Europe.
Clinical Milestones and Data Highlights
During the first quarter, Anteris celebrated a key clinical milestone by successfully treating its 100th patient with the DurAVR THV. This cohort includes both first-time aortic stenosis patients and those requiring valve-in-valve procedures, demonstrating the device’s versatility across complex anatomies.
One-year clinical data presented at a major structural heart conference underscored the valve’s promising profile, showing sustained favorable hemodynamic performance and a strong safety record. Notably, there were no valve-related mortalities or prosthesis-patient mismatch cases, a complication that can predict valve failure and is seen at significant rates with current commercial devices.
Manufacturing Scale-Up and Operational Readiness
To support the upcoming trial and anticipated commercial demand, Anteris has expanded its manufacturing capacity threefold by transitioning production into new ISO-qualified clean room facilities. This strategic move also includes sourcing the proprietary ADAPT tissue from multiple locations to mitigate supply chain risks, reflecting a robust approach to operational scalability.
Financial Overview and Market Position
Financially, the company reported a 27% decline in net sales to $0.6 million for the quarter, attributed primarily to reduced demand for tissue products. Meanwhile, losses after tax increased by 36% to $21.9 million, driven by higher research and development expenses linked to manufacturing scale-up and clinical trial preparations.
Despite these short-term financial pressures, Anteris’ inclusion in the FTSE Russell 2000 Index signals growing recognition in the investment community, positioning the company among notable small-cap players in the U.S. equity market.
Bottom Line?
As Anteris prepares to launch its pivotal trial, investors will watch closely for FDA approval and early enrollment progress to gauge the DurAVR valve’s commercial and clinical trajectory.
Questions in the middle?
- When will the FDA grant approval to commence the PARADIGM Trial?
- How will the DurAVR valve’s clinical outcomes compare to established competitors in the trial?
- What are the company’s plans to address the current decline in tissue product sales?
