Latest Asx Healthcare News

CurveBeam AI has secured its strongest first-quarter HiRise sales result, gained China regulatory clearance and raised A$7.35 million to fund the next stage of commercialisation. The progress comes alongside lower customer receipts and a reported 4.3 quarters of cash runway.

ReNerve has received supportive FDA feedback on the preclinical and testing pathway for its NervAlign Nerve Guide Matrix. The guidance sharpens the route towards a US submission, but does not amount to clearance and leaves the submission timetable open.

Cleo Diagnostics has moved its pre-surgical ovarian cancer test into formal Analytical Validation, a key regulatory step before its planned FDA 510(k) submission in the first half of 2027. The three-batch program is expected to take about three months, but no validation results have yet been reported.

LTR Pharma has completed the final Phase II pharmacokinetic report for SPONTAN, confirming a median 10-minute time to peak concentration against 60 minutes for an oral vardenafil tablet. The result completes the FDA-aligned dataset ahead of planned US submission work, although efficacy in erectile dysfunction patients remains to be tested.

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.

Entropy Neurodynamics reported that all six patients in Cohort 1 of its Phase 2 BED trial maintained clinically meaningful improvement 12 weeks after two TRP-8803 infusions. Three patients experienced no binge-eating episodes during the 84-day follow-up, although the results come from a small, open-label study without a control group.

Optiscan Imaging has reached the halfway recruitment milestone in its first in-human breast cancer study, advancing its regulatory and commercial ambitions with promising clinical data and expanded trial sites.

EVE Health Group has appointed Ben Rohr as CEO, shifting Damian Wood to focus on regulatory and clinical affairs, aiming to sharpen commercial execution amid ongoing product rollouts.

Inoviq Ltd's trading suspension has been lifted following new disclosures, but the ASX continues to investigate the company's compliance with listing rules.