Latest Clinical Studies News

Lumos Diagnostics has secured a significant follow-on contract with Aptatek Biosciences to push forward the development of an innovative in-home monitoring device for Phenylketonuria (PKU), a rare genetic disorder. This next phase aims to bring the FDA Breakthrough Device-designated PheCheck™ closer to clinical trials and commercial readiness.

Lumos Diagnostics, backed by BARDA, is set to begin a pivotal pediatric clinical study to extend the use of its rapid respiratory infection test, FebriDx, to children aged 2–12 in U.S. CLIA-waived settings, potentially unlocking a $1 billion market.

Orthocell Ltd reported a record $9.23 million revenue for FY25, driven by strong sales of its nerve repair and dental products, alongside securing US FDA clearance for its flagship nerve repair device Remplir. The company is poised for accelerated growth as it expands its global commercial footprint.

BCAL Diagnostics has launched its first commercial breast cancer diagnostic test, BREASTESTplus™, in Australia, marking a key milestone despite a $7.24 million loss for FY2025. The company is also advancing its US operations with a new subsidiary and clinical trials underway.

Next Science Limited reported a 7% revenue decline and a 20% reduction in net loss for H1 2025, alongside a major $50 million asset sale agreement with OSARTIS GmbH. The transaction, approved by shareholders, signals a strategic pivot for the biofilm-focused medical device company.

EMVision Medical Devices reported a sharp increase in FY25 losses alongside a 51% revenue drop, yet marked significant progress in clinical trials for its innovative brain scanners and secured $8 million in government grants to fuel commercialisation.

SomnoMed delivered a strong FY25 performance with revenue climbing 22% to $111.5 million and EBITDA turning positive at $9.2 million, boosted by operational improvements and FDA clearance of its Rest Assure device. The company projects further growth in FY26 with expanded manufacturing and ongoing innovation.

Imagion Biosystems reported a $1.66 million loss for the half-year ending June 2025 while progressing its MagSense® HER2 Imaging Agent towards a Phase 2 FDA trial and securing $3.5 million in new funding.

Optiscan Imaging Limited has launched a $17.75 million fully underwritten entitlement offer to fund clinical trials, regulatory approvals, and product development. Peters Investments underwrites the offer, potentially increasing its stake to nearly 39%.

Optiscan Imaging Ltd has launched a fully underwritten $17.75 million entitlement offer to fund clinical trials and regulatory clearances for its medical devices, marking a pivotal step in its transition to a commercial medical device manufacturer.

Microba Life Sciences reported a 30% increase in revenue to $15.7 million for FY25, driven by strong growth in its core microbiome diagnostic products and successful UK market expansion. Despite narrowing its net loss to $14.9 million, the company is focused on scaling diagnostics adoption and achieving break-even in FY26.

Neurizon Therapeutics reported a $16.6 million loss for FY2025 amid significant progress in its lead neurodegenerative therapy NUZ-001, including regulatory milestones and a global licensing deal. The company is poised to enter a pivotal ALS clinical trial pending FDA clearance.