Latest Reimbursement News

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

OncoSil Medical reported a 60% year-on-year increase in dose sales in Q3 FY26, boosted by expanding treatment centres and advancing clinical trials, while cost-cutting and a new manufacturing facility aim to underpin growth.

Emyria reported $1.2 million revenue for Q1 2026 driven by insurer-funded clinics and expanded its Empax network across multiple states. It launched a Global Partnership Program targeting international drug sponsors, leveraging its clinical infrastructure amid growing global interest in psychedelic therapies.

Proteomics International is pivoting from research to disciplined commercial execution of its proteomics-based diagnostic tests, focusing on distributor partnerships and reimbursement pathways in Australia and the US.

European Resources has more than doubled its Korsnäs rare earth resource following a successful drilling program and metallurgical advances, underpinning a $3.4 million capital raise to fund further development.

IperionX has transitioned its Virginia titanium operations to continuous 24/7 production, ramping proprietary HAMR™ titanium powder output to 4.2 metric tons in March and targeting 200 tons per annum by the end of 2026. Alongside manufacturing capacity expansions and strong U.S. Department of War backing, the company advances its critical minerals project in Tennessee.

Imricor Medical Systems updates its SEC Form 10 with minor SEC-driven revisions as it pushes forward with FDA clearances and clinical trials, reporting a $25.3 million net loss in 2025 amid early-stage commercialisation.

Diatreme Resources reported a $745,000 net loss for FY 2025 but strengthened its financial footing through asset sales and an IPO stake. The company’s Northern Silica Project and Cyclone Zircon Project showed significant technical progress, while a major Cape Flattery asset sale aims to streamline operations and unlock funding.

Macallum New Energy has successfully listed on the ASX and raised A$7.4 million to fund exploration in the Northern Perth Basin. The company is progressing a 66% complete Barberton 3D seismic survey and preparing a Condor 2D survey, positioning itself amid renewed regional drilling activity.

EBR Systems secures Priority Review from Australia's TGA for its wireless cardiac pacing system, fast-tracking regulatory approval and expanding access for heart failure patients. This follows strong US commercial momentum after FDA approval.

Phoslock Environmental Technologies reported a stable sales volume and improved cash flow compared to last year, while ramping up production after reopening its Chinese factory. The company is advancing R&D on a new lanthanum product and faces ongoing legal challenges with mediation set for June.

BCAL Diagnostics has expanded its Avantect cancer blood tests nationally through major pathology networks, generating $88,000 in Q3 revenue from 91 tests. The company also submitted an initial Medicare reimbursement application for pancreatic cancer detection and is preparing to launch an enhanced BREASTESTplus 2.0 test in early 2027.