Latest Clinical Evidence News

Orthocell has achieved a significant milestone by recording its first US sales revenue for Remplir™, its flagship nerve repair product, shortly after FDA clearance and initial surgical use.

Orthocell Limited has reported a record FY2025 revenue of A$9.19 million, driven by strong sales of its nerve repair product Remplir™ in Australia and a promising US market launch following FDA clearance.

Argent BioPharma has begun supplying its EU-GMP cannabinoid API for drug-resistant epilepsy treatment at University Medical Centre Ljubljana, marking a key clinical and regulatory milestone in Europe.

Optiscan Imaging Ltd has commenced a landmark clinical study at Royal Melbourne Hospital, testing its cutting-edge InVue® and InForm™ devices to improve breast cancer surgery precision. The study aims to generate critical data for US FDA approval and could redefine surgical oncology workflows.

Microba Life Sciences has announced a $14.5 million capital raising, including a $2 million fully underwritten Securities Purchase Plan (SPP) and a $12.5 million Placement, aimed at fast-tracking commercialisation of its microbiome diagnostic tests in Australia and the UK.

PYC Therapeutics has announced promising pre-clinical results for its RNA-based drug candidate PYC-002, targeting the genetic root of Phelan-McDermid Syndrome, with clinical trials expected to begin in 2026.

Orthocell has marked a pivotal milestone with the first US surgical use of its Remplir™ nerve repair device following FDA clearance, setting the stage for commercial expansion in a $1.6 billion market.

Paradigm Biopharmaceuticals has acquired Proteobioactives, securing global rights to an oral combination therapy targeting early-stage osteoarthritis in humans and animals, complementing its injectable PPS phase 3 program.

Cleo Diagnostics has gained approval to access the prestigious PLCO biobank, a move set to strengthen its FDA submission and accelerate development of its ovarian cancer diagnostic tests.

Microba Life Sciences has raised $14.5 million to accelerate clinical adoption of its microbiome testing products, while narrowing its FY25 revenue guidance and signing a strategic UK laboratory agreement.

NeuroScientific Biopharmaceuticals reveals compelling clinical evidence supporting its StemSmart MSC therapy for severe steroid-refractory graft versus host disease, advancing its strategic acquisition plans.

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.