Galvanised by results from its DurAVR™ transcatheter heart valve’s first-in-human study, Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has presented its findings at the 2023 EuroPCR meeting.
The biotech stock published early safety and feasibility data in EuroPCR’s official EuroIntervention journal, showcasing how DurAVR can restore near-normal blood flow dynamics and maintain significant haemodynamic performance for up to a year.
Anteris’ first-in-class biomimetic aortic valve boasts an exceptional safety record, with no cases of mortality, disabling stroke, life-threatening bleeding, or myocardial infarction reported during any follow-up visits in the early study.
These promising initial results will soon be further validated in an FDA-approved early feasibility study.
Study says …
As published in EuroIntervention, Anteris’ first-in-human study recruited 13 patients with symptomatic severe aortic stenosis, each of whom received the DurAVR implant without any device-related complications.
Favourable haemodynamic results were observed at six months, while results were sustained at one year in patients who completed the one-year follow-up at the time the paper was submitted.
In parallel to the publication, Dr Susheel Kodali presented an expanded first-in-human data set — incorporating post-procedural data for another seven patients — during a scientific session at EuroPCR 2023.
Dr Kodali said: “In the short-term, the haemodynamics are amazing, and that’s one of the things I’m excited about…when you look at 3D echo, the leaflets really open to the frame edge, and that’s different than what we see with other valves.”
Technically speaking, the post-procedure haemodynamics reveal the average effective orifice area increased by 307% from baseline — an indicator of a patient’s increased long-term survival and exercise capacity.
The findings also indicate that a mean pressure gradient reduced by 84% across the valve from baseline.
Anteris chief medical officer Dr Chris Meduri was also upbeat about the early findings, noting there was more data to come as the company continues its studies.
“Preliminary results from the first-in-human study with DurAVR demonstrate a good safety profile with promising haemodynamic performance sustained at one year and restoration of near-normal flow dynamics.
“The results are encouraging, and we look forward to validating the data as we study more patients.”