Latest Clinical Evidence News

Aroa Biosurgery reported a 14% rise in product sales to NZ$44.6 million for the half-year ended September 2025, driven by strong growth in its Myriad portfolio. The company also posted a normalised EBITDA profit and reaffirmed its FY26 revenue and profit guidance.

Pacific Edge reports a $19.1 million net loss for the first half of FY26 amid Medicare coverage loss but positions itself for a Medicare-led recovery with strong clinical evidence and a key advisory committee meeting set for February 2026.

Orthocell Limited reports growing adoption of its Remplir™ nerve repair product in nerve-sparing prostate cancer surgeries across Australia, positioning for a significant U.S. market expansion. The company is investing in research and commercial infrastructure ahead of a medium-term U.S. launch.

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.

The FDA's removal of the black box warning on hormone replacement therapies marks a pivotal shift for Mayne Pharma, potentially unlocking new market opportunities and reshaping women’s health treatment.

Monash University has secured a $799,866 Australian Research Council grant to study brain injury thresholds using HITIQ’s PROTEQT™ instrumented mouthguards, with a $200,000 pre-order confirming commercial momentum.

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.

Imugene Limited reports an 81% overall response rate in its azer-cel CAR T-cell therapy trial for difficult lymphomas, alongside a $25 million capital raise that extends its cash runway to mid-2027.

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.

Anteris Technologies has enrolled the first patients in its pivotal PARADIGM Trial, testing the DurAVR Transcatheter Heart Valve against leading competitors in a global study.

EMVision Medical Devices has expanded its pivotal clinical trial sites, secured a $3 million government grant, and raised $14 million through placement and share purchase plan, positioning itself strongly for upcoming regulatory submissions and commercialisation.

Emyria reports strong revenue growth driven by expanded insurer-funded mental health programs, marking a significant step in national access to evidence-based PTSD and treatment-resistant depression care.