Medical device pioneer Anteris Technologies Global Corp released its full year financial results for 2024, which looked back on a year in which the company re-domiciled to the US and made its debut on the Nasdaq.
Year of US debut
Anteris’ Nasdaq IPO raised $88.8 million (A$139.3 million) before costs and commissions and excluding the underwriters’ option – this step finalised the company’s re-domiciliation process.
In the meantime, Anteris continued preparations to initiate the DurAVR® Transcatheter Heart Valve’s (THV) randomised global pivotal study.
The approval to commence the pivotal study is contingent upon submitting an Investigational Device Exemption (IDE) to the US Food and Drug Administration (FDA), which is planned for the first quarter of 2025.
On track for FDA meeting
Multiple pre-submission meetings with the FDA occurred covering topics such as reviewing the trial’s clinical plan and statistical rationale.
Other key preparatory activities included life cycle testing, test method creation and validation, human factors validation testing with physicians, sterilisation and shipping validation, along with simulated use testing.
The company has generated additional positive patient data to support IDE submission for the DurAVR® THV, with 86 cases treated to date.
Over in Europe, the first two cases of the DurAVR® THV’s European Early Feasibility Study (EU-EFS) were conducted at Structural Heart Copenhagen in Denmark in January of this year.
Anteris is promoting increased awareness of the DurAVR® THV system in the global medical community including through multiple high profile podium presentations at key congresses such as New York Valves and the 36th TCT Conference.
Design optimisation finalised
During the year the company also finalised design optimisation of the balloon-expandable ComASUR® delivery system and expanded manufacturing scale-up in Malaga, AU and Minneapolis, US to support the planned pivotal trial.
And the company’s cash position is strong – it concluded the year with $70.5 million (A$113.3 million) in the bank.
“This has been a transformational year for Anteris as we made advancements across all aspects of our business, which positions us well to commence the Pivotal Trial of our DurAVR® THV system in 2025,” vice chair and CEO Wayne Paterson said.