Latest Clinical Evidence News

Anteris Technologies has gained U.S. Medicare reimbursement eligibility for its pivotal PARADIGM Trial, clearing a key hurdle for clinical site activation and accelerating its transcatheter heart valve study.

Biome Australia’s Activated Probiotics brand surpasses one million boxes sold in Australia, approaches top pharmacy ranking, and launches nationally in Canada, setting the stage for FY26 profitability.

Radiopharm Theranostics has finished enrolling patients in its U.S. Phase 2b trial of RAD 101 for brain metastases imaging, reporting promising interim data showing 90% concordance with MRI. The company aims to launch a pivotal Phase 3 trial following a full data readout in June 2026.

Pacific Edge reported a 2.7% increase in test volumes for Q4 2026 despite operational challenges, supported by growing momentum toward Medicare coverage and expanded commercial payer adoption in the US and Asia Pacific.

EBR Systems has reported a significant increase in commercial implantations of its WiSE System in Q1 2026, more than doubling case volumes from the previous quarter and projecting preliminary revenue between US$2.25 million and US$2.36 million.

Cleo Diagnostics has completed blood sample collection for its pivotal U.S. clinical trial, advancing its Pre-Surgical Ovarian Cancer Test closer to FDA submission.

Aroa Biosurgery has completed its Symphony randomised controlled trial, demonstrating improved healing rates for diabetic foot ulcers compared to standard care. The preliminary results pave the way for clinical adoption and potential US reimbursement.

EBR Systems marked a pivotal transition in 2025 with FDA approval of its WiSE CRT System and the initiation of U.S. commercial implants, generating $1.6 million in revenue. Despite this progress, the company reported a net loss of $48.8 million and completed a significant capital raise to support ongoing growth.

A new clinical study from Sichuan University confirms that TruScreen’s AI-enabled cervical cancer screening combined with high-risk HPV testing outperforms traditional cytology methods, reinforcing its global potential.

Anteris Technologies Global Corp. posted a $94.2 million loss for 2025 amid a 29% revenue decline, while progressing its pivotal DurAVR THV clinical trial and securing $320 million in early 2026 financings.

OncoSil Medical has reported record dose sales and cash receipts in the first half of FY26, supported by encouraging clinical trial results and expanded European market penetration.

A recent expert panel convened by Novitas has strongly endorsed Pacific Edge’s urine-based Cxbladder tests for hematuria evaluation, recommending Medicare coverage based on robust clinical evidence and patient care benefits.