Latest Clinical Evidence News

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.

PolyNovo Limited reported a robust 25.2% increase in half-year revenue to A$75 million, driven by strong U.S. sales and product growth, despite a near break-even net profit impacted by a manufacturing slowdown and a fire at its R&D lab.

Medical Developments International (MVP) reported an 8% revenue increase driven by strong Penthrox growth, despite a slight EBIT loss impacted by foreign exchange. The company advances pediatric approvals and targets further volume gains.

Orthocell has secured a $3 million R&D tax refund, lifting its cash reserves to nearly $50 million and reinforcing its financial strength as it pushes commercialisation of its nerve repair product Remplir™ across key global markets.

Emyria has secured expanded funding from Medibank to support its Treatment-Resistant Depression and PTSD programs at a new clinic in Victoria, marking a significant step in its national mental health care rollout.

Cochlear Limited reported a modest 1% rise in sales but a 9% fall in underlying net profit for the half year ended December 2025, as the rollout of its innovative Nucleus Nexa System faced longer-than-expected regulatory and contract hurdles. The company anticipates a robust second half driven by broader product availability and service growth.