Latest Reimbursement News

Pacific Edge’s draft Medicare Local Coverage Determination for its Cxbladder bladder cancer tests marks a pivotal step toward unlocking a $10.2 billion global market. Despite FY26 setbacks, the company is poised for growth with improved reimbursement prospects and strategic cost management.

Artrya Limited marked its first full year of US commercial operations with a $25.18 million loss, driven by regulatory clearances, customer contracts, and an $80 million capital raise.

ImpediMed has secured FDA 510(k) clearance for its SOZO Digital Health Platform to assess sarcopenia risk, marking it as the only FDA-cleared bioimpedance spectroscopy solution for this clinical application. This clearance enables clinicians to non-invasively monitor muscle loss in cancer and chronic disease patients, potentially improving treatment outcomes.

CSL Limited’s FY2026 results reveal modest revenue growth offset by a multibillion-dollar statutory loss driven by restructuring and impairments, alongside a maintained dividend and a strategic focus on sustainable growth.

OncoSil Medical has won FDA Humanitarian Device Exemption approval for its OncoSil™ device to treat distal cholangiocarcinoma, opening a US market estimated at A$80 million annually.

ResMed Inc. posted a 10% rise in fiscal 2026 revenue to $5.65 billion, bolstered by the acquisition of Noctrix Health and an agreement to sell its MatrixCare business. The company continues to invest in AI-powered digital health solutions amid ongoing patent litigation and a shifting regulatory landscape.

Sarama Resources has offloaded its Cosmo and Mt Venn gold projects to Riedel Resources, securing a substantial equity stake while progressing a US$242 million arbitration claim against Burkina Faso.

Lunnon Metals has completed mining at its Lady Herial gold open pit ahead of schedule, delivering a record month in July and generating $35 million pre-tax free cash flow to date.

Anteris Technologies posted a $51.7 million loss in H1 2026 amid ramped-up R&D and clinical trial activity, supported by a $320 million capital raise and Medicare reimbursement for its DurAVR heart valve trial.

EBR Systems marked a commercial milestone with over 100 WiSE CRT implants and secured purchasing agreements with three major US healthcare networks. The company is progressing toward Medicare coverage and scaling manufacturing, supported by a near-complete A$150 million capital raise.

AVITA Medical posted robust Q2 2026 results with 18% revenue growth, driven by RECELL and supported by Cohealyx and PermeaDerm, and now expects to reach cash flow breakeven by year-end.

Dimerix CEO Dr Nina Webster detailed the company’s geographic and product diversification at the Bioshares Summit, spotlighting the commercial potential of DMX-200 and the newly acquired Phase 2 asset DMX-652 targeting acute kidney injury.