Latest Clinical Evidence News

Pacific Edge edges closer to a Medicare breakthrough with a draft Local Coverage Determination proposing coverage for its Cxbladder Triage and Triage Plus tests, potentially unlocking reimbursement for over 66 million US patients.

Pacific Edge launches a NZ$6 million retail share offer at NZ$0.17 per share following a NZ$25.4 million institutional placement, aiming to strengthen its balance sheet and support Medicare reimbursement efforts for its bladder cancer diagnostics.

Pacific Edge has raised NZ$25.4 million through an oversubscribed placement priced at NZ$0.17 per share, aiming to bolster operations, support Medicare re-coverage efforts, and advance its bladder cancer diagnostic tests.

EBR Systems accelerated its U.S. commercial rollout of the WiSE CRT System in Q1 2026 with implant volumes more than doubling and revenue hitting US$2.4 million. The company also secured a key regulatory milestone in Australia with TGA Priority Review, yet losses deepened and cash burn intensified, raising fresh questions about its funding runway.

Pacific Edge is raising NZ$24 million to shore up its finances and support a crucial Medicare re-coverage bid following a steep revenue drop after losing Medicare reimbursement for its bladder cancer test. The company eyes a draft Medicare policy by September 2026 as a potential turning point.

ImpediMed has secured A$15.2 million through a two-tranche placement and share purchase plan, alongside A$5 million in cost reductions, aiming for operating cashflow breakeven by H2 FY28.

Microba Life Sciences reported a 99% year-on-year surge in core testing revenue for Q3 FY26, propelled by strong test volume growth and new clinic contracts in Australia and the UK. The company is advancing a major product release and negotiating a significant corporate transaction to bolster its financial position.

Anteris Technologies has gained U.S. Medicare reimbursement eligibility for its pivotal PARADIGM Trial, clearing a key hurdle for clinical site activation and accelerating its transcatheter heart valve study.

Biome Australia’s Activated Probiotics brand surpasses one million boxes sold in Australia, approaches top pharmacy ranking, and launches nationally in Canada, setting the stage for FY26 profitability.

Radiopharm Theranostics has finished enrolling patients in its U.S. Phase 2b trial of RAD 101 for brain metastases imaging, reporting promising interim data showing 90% concordance with MRI. The company aims to launch a pivotal Phase 3 trial following a full data readout in June 2026.

Pacific Edge reported a 2.7% increase in test volumes for Q4 2026 despite operational challenges, supported by growing momentum toward Medicare coverage and expanded commercial payer adoption in the US and Asia Pacific.

EBR Systems has reported a significant increase in commercial implantations of its WiSE System in Q1 2026, more than doubling case volumes from the previous quarter and projecting preliminary revenue between US$2.25 million and US$2.36 million.