Latest Clinical Evidence News

Pacific Edge reports a 13.4% decline in test volumes for Q3 2026 but gains strategic momentum with a key Medicare advisory meeting and clinical endorsements poised to influence reimbursement policy.

Orthocell Limited has reported a record $3.2 million revenue for the December 2025 quarter, marking its seventh consecutive quarter of growth, fuelled by expanding sales of its nerve repair product Remplir in the US and other international markets.

PolyNovo reports a robust 26% increase in group sales for 1H FY26, driven by strong U.S. market expansion and a near tripling of NovoSorb MTX sales. The company also completes a new manufacturing facility, positioning itself for sustained growth.

BlinkLab Limited has secured independent scientific validation for its smartphone-based autism diagnostic technology through publication in the prestigious journal Autism Research, marking a significant milestone ahead of its FDA regulatory trial.

Clarity Pharmaceuticals’ novel diagnostic agent Cu-SAR-bisPSMA has been selected for oral presentation at the prestigious European Association of Urology Congress 2026, following promising Phase II trial results demonstrating superior detection of prostate cancer recurrence.

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.