Latest Clinical Studies News

Lumos Diagnostics has reached 50% recruitment of bacterial positive patients in its pivotal FebriDx CLIA waiver clinical study, setting the stage for a planned FDA submission in late 2025 and unlocking a substantial US market opportunity.

TruScreen Group Limited forecasts a robust 64% increase in FY26 sales, driven by strategic market expansions and new distribution agreements. The company’s AI-enabled cervical cancer screening technology is gaining traction across emerging markets.

TruScreen Group Limited has announced a NZ$3 million capital raise to fund strategic growth initiatives across Asia and Africa, alongside repaying existing debt. The raise includes a placement and share purchase plan with free attaching options, signaling confidence in its expanding cervical cancer screening programs.

4DMedical has submitted its CT:VQ lung imaging technology for FDA clearance, aiming to disrupt the $1 billion US nuclear lung scan market with a non-nuclear, lower-cost alternative. Clinical studies show CT:VQ matches or exceeds existing nuclear imaging in accuracy and patient experience.

TruScreen Group Limited reported a 19% revenue decline in FY2025 due to delayed rollouts in key emerging markets but anticipates a strong rebound with FY2026 sales forecast to exceed NZ$2.8 million.

EBR Systems has announced a fully underwritten A$55.9 million capital raise alongside a Security Purchase Plan to fund the commercial rollout of its FDA-approved WiSE CRT System, targeting a US$3.6 billion market opportunity in cardiac resynchronization therapy.

Microba Life Sciences reveals breakthrough data showing its MetaPanel™ test detects elusive gastrointestinal pathogens in 20% of chronic cases, enabling targeted treatment and complete symptom resolution.

Rhythm Biosciences’ subsidiary Genetype has landed a pivotal 12-month contract with the University of Melbourne to provide advanced breast cancer risk assessments, marking a significant step in personalised cancer screening.

Microba Life Sciences reveals preliminary data from over 4,600 MetaXplore GI Plus tests showing significant clinical findings in the majority of patients, with two-thirds reporting symptom improvements following test-guided care.

Cleo Diagnostics has completed alpha testing of its ovarian cancer pre-surgical triage assay kits, confirming robust performance and differentiation between benign and malignant disease. The company now moves forward to assay optimisation and manufacturing scale-up, edging closer to FDA submission and commercial launch.

AVITA Medical reported a strong first quarter with revenues up 67% to $18.5 million, driven by expanded commercial sales and new product introductions. Despite a narrower net loss, the company faces ongoing challenges from revenue covenants and macroeconomic pressures.

Anatara Lifesciences reports mixed results from its Phase II GaRP-IBS trial, missing the primary efficacy target but showing significant improvements in anxiety and patient-reported relief, while advancing its anti-obesity pre-clinical program.