Anteris Wins German Approval to Expand Heart Valve Trial Targeting About 1,000 Patients
Key Facts
Anteris Technologies has received approval to conduct the PARADIGM study and enroll patients in Germany, expanding its global trial of the DurAVR heart valve, whose main randomized cohort targets about 1,000 patients, according to the company. The German approval covers the clinical study, while the device remains restricted to investigational use. Anteris said in a notice on its website that the valve is "not available for commercial sale." Germany was among the countries where the company had been seeking approvals to begin the study, alongside France and the Netherlands, according to an earlier update filed with the U.S. Securities and Exchange Commission. The approval is therefore part of an existing global clinical program that had already begun enrolling and treating patients outside Germany.
According to Anteris' technical description, the valve's design uses an integrated tissue structure made from a single piece, shaped to resemble a natural valve. The company says the design aims to replicate the performance of a healthy aortic valve. The device platform uses balloon expansion to deploy the valve, according to the company's technology page. Anteris describes the platform as "designed for controlled valve deployment and precise positioning." Its stated features include technology to align the valve's commissures, part of the design the company presents for the device undergoing clinical testing.
Under the study design, participants in the main randomized cohort are assigned in a 1:1 ratio to receive either the investigational valve or approved, commercially available valves, according to an Anteris statement published through GlobeNewswire. The target of about 1,000 patients applies to this cohort of the global trial. The U.S. Food and Drug Administration had approved the launch of PARADIGM under an investigational device exemption, according to a company filing with the Securities and Exchange Commission. The trial is studying the valve in patients with severe calcific aortic stenosis. The program thus combines authorization for clinical testing with a comparison of the device against commercially used valves, under the randomization specified by the company for participants.
The German expansion followed the start of patient enrollment and treatment in Denmark after regulatory approval there in October 2025, according to an Anteris filing. At U.S. sites, the first patients were enrolled and treated during May 2026, according to another company filing. A subsequent second-quarter results update said enrollment was underway in the United States, Denmark and the Netherlands. The same update reported that the company had received regulatory approvals in Canada and France. The German step adds a new location to the European regulatory pathway Anteris had been pursuing, after announced approvals included France and enrollment activity included the Netherlands.
Financially, Anteris' research and development expenses totaled $23.4 million in the second quarter of 2026, according to its filing with the U.S. Securities and Exchange Commission. The company attributed these expenses to expanding manufacturing and quality capabilities and activities related to the PARADIGM trial. Net operating cash outflow totaled $20.8 million during the three months ended June 30, 2026. Research and development spending appears in the company's update alongside progress in enrollment and regulatory approvals to expand the program. Activities Anteris cited to explain its expenses include building out device production and quality capabilities, as well as conducting the clinical study itself.
In the next phase of clinical evaluation, PARADIGM is testing non-inferiority using a composite primary endpoint, according to the study description in Anteris' filing. The endpoint includes all-cause mortality and all strokes, along with cardiovascular hospitalization. It is assessed one year after the procedure, the time specified in the study design for measuring these outcomes. On the regulatory front, the company said it expects the CE marking process to advance in parallel with the U.S. premarket approval application pathway. Parallel progress along the two pathways remains an expectation stated by Anteris, while the company continues to describe the valve as intended for investigational use only.