Latest Clinical Studies News

Optiscan Imaging Ltd has entered a five-year exclusive collaboration with Long Grove Pharmaceuticals to jointly develop new clinical applications for the fluorescein drug AK-FLOUR®, supporting US clinical trials and FDA regulatory submissions for Optiscan’s InVue® surgical device.

Neurizon Therapeutics reveals that its lead drug candidate NUZ-001 and its metabolite effectively penetrate the blood-brain barrier and reverse pathological protein aggregation linked to ALS, marking a critical step forward in neurodegenerative disease treatment.

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

Lumos Diagnostics has enrolled 500 patients in its FebriDx CLIA waiver clinical study, unlocking a significant milestone payment from BARDA and moving closer to FDA approval that could open a US$1 billion market.

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.

Opyl Limited has secured strategic collaborations with two leading contract research organisations, integrating its AI-driven TrialKey platform into cardiovascular, oncology, and rare disease clinical trials to enhance trial design and accelerate commercial growth.

Cleo Diagnostics unveils a pioneering blood test for early ovarian cancer detection, boasting superior accuracy to existing methods and targeting a significant U.S. market opportunity.

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.