Latest Regulatory Submissions News

EMVision Medical Devices has begun a pivotal aeromedical study with the Royal Flying Doctor Service to test its portable First Responder brain scanner in remote emergency settings. The trial aims to validate device usability and workflow integration ahead of commercial rollout.

Zelira Therapeutics has received a $1.07 million cash refund under Australia’s R&D Tax Incentive Scheme, reinforcing its funding for ongoing clinical trials and product development. The company has also repaid a prior loan advanced against this claim, positioning it for continued growth in cannabinoid-based medicines.

Mesoblast has achieved a landmark FDA approval for RYONCIL, the first allogeneic mesenchymal stromal cell therapy, driving strong commercial momentum and advancing a robust pipeline targeting inflammatory diseases.

Anteris Technologies has gained FDA approval to start patient recruitment in the US for its pivotal PARADIGM Trial, following initial European regulatory success. The company advances manufacturing and clinical readiness as it pushes toward key regulatory milestones.

Optiscan Imaging has entered a three-year strategic collaboration with Australian Clinical Labs to validate and deploy its InForm™ digital pathology platform, aiming to transform diagnostic workflows with real-time tissue analysis.

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.

Avecho Biotechnology advances its pivotal Phase III CBD insomnia trial with 160 patients dosed and secures $2.5 million to accelerate manufacturing and regulatory efforts ahead of a 2026 interim analysis.

Nexsen Limited has successfully completed an $8 million IPO and ASX listing, while advancing its kidney diagnostic tests and initiating clinical trials for its GBS Rapid Sensor targeting expedited FDA approval.

Micro-X Ltd has secured its largest-ever $3.3 million Rover Plus order from Malaysia’s Ministry of Health and is progressing critical Head CT imaging trials, supported by a $4.4 million government grant.

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.

Alterity Therapeutics reports strengthened efficacy signals for ATH434 in Multiple System Atrophy and secures a robust cash position to fuel upcoming Phase 3 trials.

BPH Energy’s September quarter report highlights pivotal developments across its investees, from a critical judicial review in offshore petroleum to breakthroughs in AI medical devices and clean hydrogen production.