- Anteris Technologies (AVR, Financial) reports Q1 2025 net sales of $0.6M, a 27% YoY decrease.
- Net loss increased 36% YoY to $21.9M, while R&D expenses rose 42% to $16.5M.
- Successful submission of IDE for PARADIGM Trial to FDA; trial expected to start Q3 2025.
Anteris Technologies (AVR) has announced its financial results for the first quarter of 2025 alongside key corporate updates. The company reported net sales of $0.6 million, reflecting a 27% decrease year-over-year primarily due to diminished demand for its tissue products. Additionally, the company faced a net loss of $21.9 million, which marks a 36% increase from the previous year.
Research and development expenses saw a notable increase of 42%, amounting to $16.5 million. This rise is largely attributed to the company’s efforts to scale up its manufacturing capabilities and prepare for the planned PARADIGM Trial.
Anteris successfully submitted an Investigational Device Exemption (IDE) application to the FDA for the DurAVR® THV's pivotal PARADIGM Trial. This crucial submission positions the company to potentially commence the trial in the third quarter of 2025, pending FDA approval.
A significant clinical milestone was achieved, with over 100 patients treated using the DurAVR® THV system. The one-year clinical data demonstrated favorable hemodynamics with an Effective Orifice Area of 2.1 cm², a Mean Pressure Gradient of 8.6 mmHg, and importantly, no valve-related mortality.
On the manufacturing front, Anteris announced an expansion of its global capacity, increasing it to at least three times the levels of 2024. The production will be moving to new ISO Qualified Clean Room facilities, and the ADAPT® tissue will now be sourced from both the U.S. and Australia to mitigate supply chain risks. The company concluded the quarter maintaining a strong cash position of $49.0 million.
Furthermore, Anteris has been included in the FTSE Russell 2000® Index, which is a significant milestone increasing its market visibility and reflecting its growth trajectory in the medical devices sector.
