Latest Reimbursement News

Control Bionics has secured a key regulatory milestone with its NeuroNode device now eligible for reimbursement under Germany’s statutory health insurance, paving the way for expanded European distribution.

Botanix Pharmaceuticals reports a surge in Sofdra sales driving revenue to $16.5 million, yet the company records a $33.2 million loss amid expanded marketing and operational costs. A $45 million capital raise aims to support growth and supply chain improvements.

PainChek Limited reported a half-year loss of AUD 4.7 million but achieved a major regulatory milestone with FDA clearance for its Adult App, unlocking significant US market opportunities. The company also completed a share consolidation and raised capital to support growth.

Lumos Diagnostics reported a 74% increase in its half-year loss to US$4.88 million, despite strong progress with its FebriDx diagnostic test and a landmark US distribution agreement. The company awaits a critical FDA decision that could unlock significant revenue growth.

4DMedical Limited’s half-year report reveals rapid commercial traction following FDA clearance of its CT:VQ™ imaging technology, alongside a $150 million institutional placement that bolsters its cash reserves for global expansion.

Mesoblast Limited reported its first commercial sales of FDA-approved Ryoncil, generating $48.7 million in net product sales for the half-year ended December 31, 2025, while reducing its net loss by 16%. The company also secured a $125 million five-year credit facility, restructuring its debt to support ongoing commercialization and development.

DorsaVi Limited reported a steep increase in its half-year loss to $3.6 million, driven by declining revenues and a sharp rise in operating costs, despite raising over $5 million in fresh capital.

Emyria Limited has reported a significant 136% increase in revenue to $1.55 million for the half-year ended December 2025, driven by its expanding Empax clinic network and insurer-funded treatments across Australia. Despite this growth, the company posted a $2.37 million net loss, reflecting investments in scaling operations and infrastructure.

Native Mineral Resources (NMR) has validated historic high-grade gold mineralisation at the Podosky deposit in Queensland, advancing its Ravenswood JV mining ambitions. Early drilling results reveal significant shallow intercepts, supporting fast-tracked resource estimation and mine planning.

Artrya Limited reported a 44% increase in its half-year loss to $10.7 million as it transitioned from development to commercial operations in the US, securing FDA clearance and signing three foundation customers. An $80 million capital raise underpins its ambitious US expansion and ongoing product development.

Cyclopharm Limited reported a 17% revenue increase to a record $32.3 million in 2025, powered by a 226% surge in US Technegas sales. The company is accelerating its US rollout with plans for up to 300 installations in 2026, while advancing clinical trials beyond pulmonary embolism.

Cleo Diagnostics reported a 53% drop in revenues and a slight increase in net loss to $1.98 million for H1 2025, while progressing its pivotal FDA clinical trial for an ovarian cancer blood test with strong regulatory and commercial milestones.