Latest Clinical Evidence News

Orthocell has reached a significant milestone with 100 units of its nerve repair product Remplir™ sold in the US, signaling accelerating adoption in a $1.6 billion market. The company’s strategic medical education and distributor network are driving momentum ahead of further hospital approvals.

Orthocell has lodged a regulatory application to distribute its nerve repair product Remplir™ across the EU and UK, aiming to tap into a $750 million market with approval expected by Q3 2026.

Proteomics International's PromarkerD blood test shows clinically meaningful accuracy in predicting diabetic kidney disease among Aboriginal Australians, matching performance in non-Indigenous populations. This advancement offers a promising tool for early intervention in a high-risk group.

Immuron Limited reports topline results from a Uniformed Services University trial of a third-party ETEC product that missed its primary endpoint, reaffirming commitment to its established Travelan dosing ahead of FDA discussions.

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.