Latest Clinical Studies News

Cleo Diagnostics has successfully completed Stage 1 of the Medical Device Single Audit Program, marking a significant step toward FDA submission and global commercialisation of its ovarian cancer test.

SomnoMed reports a strong start to FY26 with 13.5% revenue growth and confirms the Clayton Sleep Institute as the first US site for its pivotal Rest Assure clinical study, backed by FDA protocol agreement.

Optiscan Imaging Ltd secured $17.75 million in a fully underwritten equity raise, fueling clinical studies and regulatory preparations for its innovative medical imaging devices. The company also reported progress in international trials and strengthened its cash position to nearly $20 million.

PYC Therapeutics has reported significant progress across its four RNA therapeutic programs targeting genetic diseases, alongside a strong cash runway supporting ongoing development.

Artrya Limited has secured FDA clearance for its Salix Coronary Plaque module and raised $80 million to fuel its U.S. commercial expansion, marking a pivotal step in its transition from development to revenue generation.

Tetratherix reports encouraging safety and stability results from its Tutelix hydrogel spacer trial, initiates stage 2 recruitment, and secures a $3.3 million government grant to boost manufacturing capacity and R&D.

Anatara Lifesciences reports steady progress in its anti-obesity pre-clinical studies with results expected by year-end, while preparing its GaRP gastrointestinal health data for publication amid ongoing commercial talks. The company also announces a key board appointment and a $1.2 million capital raise.

Lumos Diagnostics reported steady quarterly revenue with a 300% surge in product sales, driven by its flagship FebriDx® test. The company inked a landmark US$317 million exclusive U.S. distribution agreement and awaits FDA feedback on its CLIA waiver application.

Invion Limited has partnered with Protect Animal Health to explore Photosoft™, a novel photodynamic therapy, as a treatment for cancer in companion animals, targeting a booming pet cancer market.

Orthocell has raised $30 million through an institutional placement to accelerate the US commercialisation of its flagship nerve repair product Remplir and expand its regenerative medicine portfolio.

EMVision Medical Devices has received a $3 million government grant to fund a clinical study demonstrating its emu™ brain scanner's impact on accelerating stroke diagnosis in rural emergency departments.

Pacific Edge reports a 9% decline in Cxbladder test volumes amid Medicare coverage loss but gains momentum with new clinical validation and a CMS pricing boost.