Anteris Technologies Global Corp. has secured regulatory clearance from the Danish Medicines Agency to begin the DurAVR Transcatheter Heart Valve (THV) global pivotal trial in patients with severe calcific aortic stenosis (i.e., the PARADIGM Trial). Patient recruitment at Danish centers is currently underway.

“Receiving initial approval in Europe is an important milestone as it signals the launch of the global PARADIGM Trial. This study has been designed with experts and is attracting significant interest from clinicians globally, reflecting the potential for DurAVR to transform care for patients with aortic stenosis,” Anteris Chief Medical Officer Chris Meduri, M.D., said.

With the first regulatory clearance secured, Anteris is positioned to drive the global PARADIGM Trial by adding further countries and sites in the near term, with planned expansion in the United States, Europe, and Canada. Management believes strong enthusiasm from investigators is expected to translate into efficient recruitment and timely study advancement.

“The PARADIGM Trial enables us to bring promising new technology to patients across all surgical risk groups, building on the growing body of evidence supporting the DurAVR THV’s favorable hemodynamic performance. We look forward to contributing meaningful data which could support both PMA* and CE Mark approvals,” stated Dr. Michael Reardon and professor Stephan Windecker, PARADIGM study co-chairs.

PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices.

“The PARADIGM trial is a multi center global study which, if successful, will result in multiple approvals and labels for the DurAVR THV. This is a watershed moment in the company’s life cycle and marks the beginning of the commercialization planning phase as we march towards global approvals,” Anteris Technologies Vice Chairman/CEO Wayne Paterson commented. “Anteris is excited to be able to allow access to an increasing pool of patients globally who will benefit from this life saving technology. The commencement of this trial reflects the commitment and work of our Anteris team, as well as our physician and scientific advisors. The company would like to express its gratitude to the physicians, patients and shareholders who have been fundamental in developing this important new therapy.”

In parallel, an Investigational Device Exemption (IDE) application remains under review by the U.S. Food and Drug Administration (FDA). Anteris continues to expect FDA approval in the near term, which will allow the company to select U.S. sites for the PARADIGM trial, pending Institutional Review Board approval.

The PARADIGM Trial is a prospective randomized controlled trial (RCT) to evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enroll approximately 1,000 patients in the ‘All Comers Randomized Cohort’ with one to one patient randomization who will receive either the DurAVR THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure.

Anteris Technologies Global Corp. is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients.

Anteris’ lead product, the DurAVR Transcatheter Heart Valve (THV), was designed in partnership with interventional cardiologists and cardiac surgeons to treat aortic stenosis—a potentially life-threatening condition resulting from aortic valve narrowing. The balloon-expandable DurAVR THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR THV is made using a single piece of molded ADAPT tissue, Anteris’ patented anti-calcification tissue technology. The FDA-cleared ADAPT tissue has been used clinically for more than 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR THV System is comprised of the DurAVR valve, the ADAPT tissue, and the balloon-expandable ComASUR Delivery System.

* A Premarket Approval (PMA) application requires a high level of clinical evidence to demonstrate reasonable assurance of safety and effectiveness for the intended use. Randomized controlled trials are generally considered Level 1 evidence, the highest level for determining the effectiveness of interventions in evidence-based medicine given RCTs minimize bias and allow a clear comparison between treatment groups.