Latest Clinical Studies News

EMVision has completed the first stage of a Melbourne Mobile Stroke Unit study, operating its portable brain scanner in homes, ambulances and a workplace. The small, non-diagnostic feasibility study produced strong usability results while pointing to a larger clinical validation step planned for next-generation units.

PolyNovo delivered 16.1% revenue growth and a sharp improvement in operating cash flow in FY26, despite a lower statutory profit after a prior-year tax benefit and a fire-related write-off. The ASX-listed wound-care company now expects to lodge its U.S. PMA application for NovoSorb BTM before the end of 2026.

Pacific Edge is positioning Cxbladder for a Medicare-led recovery, but the company remains loss-making with NZ$7.8 million in net cash after a difficult FY26. The investment case now turns on final US coverage, test volumes and whether the enlarged balance sheet can carry the business to scale.

Imagion Biosystems has signed nanoComposix to resume GMP-aligned manufacturing of the MagSense nanoparticle core, a move designed to support its FDA-cleared HER2 breast cancer programme without the fixed cost of an in-house facility. The agreement improves manufacturing readiness, but its value, duration and production commitments remain undisclosed.

AdAlta’s partner SHcell has gained regulatory approval to provide the BZDS1901 CAR-T therapy to advanced mesothelioma patients in China’s Hainan Boao Lecheng special access zone, marking a key milestone in real-world data collection and treatment availability.

Nexalis Therapeutics reports a 52% rise in half-year losses to $1.3 million amid funding facility cancellation and clinical trial suspensions, highlighting ongoing cash flow challenges.

Artrya has launched its AI-powered Salix® platform commercially in the US, securing three foundation health systems and raising $80 million to fuel growth. With FDA clearance for its Coronary Plaque module and a pivotal clinical study underway, the company is poised for scaling revenues amid a strong balance sheet.

Optiscan Imaging has launched a 35-patient clinical trial in the US to test its InVue™ and InForm™ platforms in head and neck cancer surgery, aiming to bolster its FDA submissions later this year.

LTR Pharma is shifting gears from clinical trials to commercial rollout, securing US partnerships for ROXUS and reporting encouraging SPONTAN Phase II data that supports FDA approval ambitions.

Argent BioPharma has secured a key FDA regulatory milestone with the establishment of an Investigational New Animal Drug (INAD) file for its CannEpil veterinary program, targeting cancer-related pain in companion animals.

PolyNovo reported a 16.1% rise in FY26 revenue to AUD 150 million, driven by strong global sales and manufacturing expansion, yet net profit fell 44% due to a significant asset write-off from an R&D centre fire and lower tax benefits.

EMVision Medical Devices has made significant strides in its emu™ bedside scanner pivotal trial and First Responder program, boosting FY26 revenue by 57% while trimming its net loss by 15%.