Latest Clinical Evidence News

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.

Cochlear Limited reports steady FY25 financials alongside the launch of its innovative Nucleus Nexa cochlear implant system, setting the stage for projected double-digit profit growth in FY26.

Aroa Biosurgery delivered a robust September quarter with strong cash flow and record sales of its Myriad product, while reaffirming its FY26 revenue and EBITDA guidance. The company also highlighted a promising US Medicare reimbursement proposal for its Symphony product.

PYC Therapeutics has reported encouraging pre-clinical results for its RNA therapy candidate PYC-002 targeting Phelan-McDermid Syndrome, supporting plans to enter human trials in 2026. The data demonstrate safety, brain distribution, and gene expression restoration in key disease regions.