Latest Clinical Studies News

Nova Eye Medical reported a 20% year-on-year revenue increase in Q1 FY26, reaffirming its FY26 sales guidance and targeting breakeven EBITDA by June 2026 amid cautious commercial expansion.

ReNerve Limited is scaling up its clinical trial for the NervAlign® Nerve Cuff following promising interim results that show significant pain reduction in nerve repair patients. The expanded study aims to solidify evidence for broader regulatory approval and market adoption.

Anteris Technologies has secured FDA approval to commence its pivotal PARADIGM clinical trial, testing its innovative DurAVR Transcatheter Heart Valve against established devices in patients with severe aortic stenosis.

Argent BioPharma has secured a transformative acquisition of AusCann’s core assets, bolstering its drug delivery technology and manufacturing capabilities ahead of a planned U.S. listing. The company also reported key clinical milestones and refinancing moves in its September 2025 quarterly update.

Neurizon Therapeutics has secured FDA clearance to resume clinical trials for its lead ALS drug candidate NUZ-001 and strengthened its balance sheet with a $5.2 million capital raise. The company is now poised to enter the pivotal HEALEY ALS Platform Trial, marking a significant step forward in its neurodegenerative disease program.

Nova Eye Medical reported a robust 32% increase in global sales excluding China for Q1 FY26 and secured regulatory approval for its iTrack™ Advance device in China, setting the stage for expanded market penetration.

Biotron Limited has advanced its Hepatitis B antiviral program while preparing to acquire Sedarex Limited, backed by a $2.5 million capital raise. The move signals a strategic expansion into safer anaesthetics alongside ongoing R&D progress.

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.