Latest Clinical Evidence News

Cleo Diagnostics has entered the critical Analytical Validation phase for its ovarian cancer blood test, progressing toward an FDA 510(k) submission targeted for the first half of 2027. The company also secured a U.S. reimbursement pathway to support early market entry post-clearance, backed by a cash balance of A$6.2 million.

Artrya is advancing its commercial footprint in the US with two health systems now generating revenue and FDA clearance for its Salix Coronary Flow module expected in H2 2026.

Adherium Limited has posted a fourth consecutive quarter of record remote patient monitoring revenue, driven by growing device activations and strong clinical evidence from the iCARE study, positioning the company for expanded value-based care contracts in the US.

Biome Australia (ASX: BIO) edged close to breakeven in FY26, driven by $1.8 million in international sales across four markets and a 68% gross margin. The company is set to launch onshore manufacturing and a digital health platform to accelerate growth.

Adherium reports a near tenfold surge in recurring revenue from remote patient monitoring and clinical evidence supporting significant cost reductions in respiratory care.

PolyNovo has delivered solid FY26 revenue growth of 16.1%, driven by commercial sales expansion and improved manufacturing output, while progressing insurance recovery from its R&D centre fire.

Optiscan Imaging has kicked off a US clinical trial with Mayo Clinic to test its InVue and InForm devices in breast conserving surgery, aiming to generate data for FDA 510(k) submissions and validate a new surgical-pathology workflow.

Entropy Neurodynamics has expanded its global intellectual property portfolio with a South African patent for psilocybin-based fibromyalgia treatment, covering broad therapeutic methods and extending protection to 2043.

Neurotech International has secured FDA clearance for its Investigational New Drug application for NTI164, enabling clinical development in the US and advancing its global registration and commercialisation plans.

Pacific Edge edges closer to Medicare reimbursement for its bladder cancer tests while its Asia Pacific operations show rising test volumes and improved margins, signaling a path toward profitability.

Cleo Diagnostics (ASX:COV) has entered the analytical validation phase for its ovarian cancer test, progressing toward an FDA 510(k) submission expected in early 2027.

Island Pharmaceuticals is progressing its broad-spectrum antiviral Galidesivir amid a severe Ebola outbreak, securing government approvals in Uganda and outlining a dual clinical and regulatory development pathway targeting multiple deadly filoviruses.