Latest Clinical Evidence News

Anteris Technologies reported solid clinical progress with 130 patients implanted with its DurAVR heart valve and is gearing up for its pivotal PARADIGM trial with 79 qualified sites worldwide. The company also strengthened its leadership with two new board members amid ongoing FDA engagement.

Neuren Pharmaceuticals has added SYNGAP1-related disorder to its NNZ-2591 development program following encouraging pre-clinical findings, targeting a rare condition with no approved treatments.

OncoSil Medical has reported a record 20% quarterly increase in dose sales and secured $8.7 million in new capital, underpinning its clinical and commercial expansion in pancreatic cancer treatment.

Aroa Biosurgery has reported its third consecutive quarter of positive net cash flow, maintaining a strong cash position and reaffirming its FY26 revenue and EBITDA guidance. The company’s Myriad product sales continue to grow, supported by new clinical evidence.

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

Pacific Edge Limited has opened a $5 million Share Purchase Plan at $0.10 per share, conditional on shareholder approval of a prior $16.1 million Placement. The capital raise aims to extend the company’s cash runway and accelerate US market adoption of its bladder cancer diagnostic tests amid Medicare non-coverage.

Pacific Edge reports steady demand for its Cxbladder cancer diagnostic tests despite losing Medicare coverage and transitioning US customers to a new test. The company is advancing clinical evidence and a $21 million capital raise to support growth and regain coverage.

Tissue Repair Limited has secured major distribution partnerships in Australia, New Zealand, and Thailand for its TR Pro+® product line, marking a pivotal shift from development to commercialisation. The company is also scaling up manufacturing and advancing regulatory approvals to support its global expansion ambitions.

Orthocell has achieved a significant milestone by recording its first US sales revenue for Remplir™, its flagship nerve repair product, shortly after FDA clearance and initial surgical use.

Orthocell Limited has reported a record FY2025 revenue of A$9.19 million, driven by strong sales of its nerve repair product Remplir™ in Australia and a promising US market launch following FDA clearance.

Argent BioPharma has begun supplying its EU-GMP cannabinoid API for drug-resistant epilepsy treatment at University Medical Centre Ljubljana, marking a key clinical and regulatory milestone in Europe.

Optiscan Imaging Ltd has commenced a landmark clinical study at Royal Melbourne Hospital, testing its cutting-edge InVue® and InForm™ devices to improve breast cancer surgery precision. The study aims to generate critical data for US FDA approval and could redefine surgical oncology workflows.