Anteris Raises A$35 Million in Funding for DurAVR TAVR Device, Commences EFS

February 16, 2023—Anteris Technologies Ltd recently announced the completion of a A$35 million (approximately US$24.1 million) equity fundraising. The company stated that the funding will be primarily used for the clinical development of the DurAVR aortic valve for the treatment of aortic stenosis and general working capital purposes. The DurAVR is a balloon-expandable, three-dimensional, single-piece aortic valve that is shaped to mimic the native human valve.

Also noted in the announcement, Anteris will commence its United States early feasibility study (EFS) of the DurAVR. The study will enroll 15 aortic stenosis patients across seven transcatheter aortic valve replacement (TAVR) Centers of Excellence in early Q2 2023 and will report interim and final 30-day data in Q3 2023. This trial will also report 3-month data in Q4 2023 and then proceed to its 12-month safety and efficacy milestone for Q2 2024. The EFS, which was previously announced in November of 2022, will evaluate the safety and feasibility of the DurAVR device in the treatment of patients with symptomatic severe native aortic stenosis.

Additionally, in the first half of 2023, the company plans to report 12-month data from the second cohort of patients (n = 8) from its 13-patient pilot study from outside the United States. These data will build upon the successful 12-month data that was already reported for the first cohort of patients (n = 5). With these 12-month data and the 30-day and 3-month data from the United States EFS study, Anteris plans to approach the FDA to finalize the design of their premarket authorization trial of United States approval of DurAVR.