Latest Structural Heart News

Anteris Technologies has gained shareholder approval for an ASX waiver allowing flexible capital raising and updated its PARADIGM trial timeline, now set to begin patient enrolment in Q4 2025 after addressing FDA requests.

Anteris Technologies reported solid clinical progress with 130 patients implanted with its DurAVR heart valve and is gearing up for its pivotal PARADIGM trial with 79 qualified sites worldwide. The company also strengthened its leadership with two new board members amid ongoing FDA engagement.

Anteris Technologies has submitted its FDA Investigational Device Exemption for the pivotal PARADIGM Trial of its DurAVR heart valve and marked a milestone of 100 patients treated, while expanding manufacturing capacity amid rising R&D costs.

Anteris Technologies Global Corp. reported a $21.9 million net loss for Q1 2025, driven by increased R&D spending as it scales manufacturing and prepares pivotal trials for its DurAVR Transcatheter Heart Valve. The company’s recent $80 million IPO proceeds are being deployed to support these efforts and repay debt.

Anteris Technologies Global Corp. has filed an amended 10-K to disclose comprehensive governance, executive pay, and related party transactions for fiscal 2024, completing its annual SEC reporting obligations.

Echo IQ Limited marked a pivotal quarter with FDA clearance for EchoSolv AS, strategic US partnerships, and a clear path toward reimbursement and broader commercialisation.

Echo IQ has secured a $1.26 million refund under the Australian Government's R&D Tax Incentive, reinforcing its commitment to AI-driven solutions for structural heart disease detection.