Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF, FRA:DDF) is a step closer to its proposed US transcatheter aortic valve replacement (TAVR) clinical trial, following the completion of a pre-clinical trial in sheep.
The company reported on Tuesday that it had successfully completed its final chronic animal study required for the US Food and Drug Administration (FDA) early feasibility study (EFS) submission on the TAVR clinical trial.
This pre-clinical trial aimed to assess the performance of Anteris’ DurAVR™ heart valve replacement, which, when coupled with the company’s ADAPT® technology, has the potential to deliver a more durable heart valve that delivers better hemodynamics performance.
Early findings promising
Initial findings from the pre-clinical study have been promising, with the DurAVR™ transcatheter heart valve having fully functioning leaflets and haemodynamics resulting in zero mortalities within the study, while the DurAVR™ valve functioned well for the study’s duration.
Anteris said the early review of the data was consistent with observations from previous studies; once formal analysis is complete, it will be submitted to the FDA in the final dossier seeking approval to commence the first in-human TAVR study.
Company progress
Anteris is well-funded, having recently issued 1.125 million new ordinary shares to sophisticated investors at $8 per share to raise $9 million in fresh capital.
The company plans to use proceeds from the placement in meeting the working capital requirements of DurAVR™, the company’s 3D single-piece aortic valve for the treatment of aortic stenosis.
Prior to that, an animal study testing the viability of the company’s ADAPT® tissue technology treated conduits in the carotid artery, with conduits showing no evidence of calcification, as indicated by histopathology.
In addition, there were no visible signs of inflammation, specifically in the intimal or medial layers of the conduits and the grafts also showed the presence of a partial neo-intimal layer, likely indicating surface remodelling of the vessels.
- Daniel Paproth