Latest Market Entry News

TrivarX has secured positive feedback from the FDA on its pivotal trial design for MEB-001, an AI-driven algorithm targeting major depressive episode screening via sleep study data. The company is advancing site collaborations to launch a large-scale US trial.

Chemist Warehouse Group has delivered a standout first half in FY25, reporting record sales growth and a significant expansion in EBIT margins, driven by new store openings and international expansion.

OncoSil Medical has achieved a key regulatory milestone with MDR certification from BSI, removing post-market restrictions and streamlining its commercial operations across Europe. This approval also paves the way for renewed efforts to enter the Australian market.

Bioxyne Limited has reported a remarkable 77% jump in revenue for Q2 FY2025, alongside positive operating cash flow, as it prepares to expand manufacturing capacity and enter new international markets.

Zeotech Limited has secured a strategic MOU with Holcim Australia to advance its AusPozz™ low-carbon concrete product, alongside promising methane reduction results and a newly granted Japanese patent.

Sarytogan Graphite Limited has successfully produced premium ductile cast iron using its Micro80C graphite, positioning itself to capture a high-margin segment amid growing domestic demand.

EMVision Medical Devices reports strong progress in clinical trials for its emu™ Bedside Scanner, backed by robust cash reserves and strategic non-dilutive funding. The company is poised to commence pivotal FDA validation trials, marking a key step toward commercialisation.

Zelira Therapeutics has received a fourth funding tranche, bringing total investment to US$3.25 million to support FDA clinical trials of its HOPE® 1 cannabinoid medicine targeting irritability in autism spectrum disorder and Phelan-McDermid Syndrome.

Memphasys Limited marks a pivotal quarter with the completion of clinical trials for its Felix™ System, strategic market expansions in Greater China and the Middle East, and a successful capital raise to fuel growth.

Cardiex Limited has commenced U.S. deliveries of its CONNEQT Pulse arterial health monitor alongside the launch of its companion CONNEQT App, marking a pivotal expansion into the American digital health market.

Rhythm Biosciences reported a strong December quarter, securing a $3.2 million R&D tax incentive and completing a strategic acquisition of Genetype assets, positioning the company for commercial expansion in cancer diagnostics.

EZZ Life Science Holdings delivered a robust Q2 FY25 with a 16.6% increase in customer receipts and a 308% jump in operating cash flows, while gearing up for US market entry and expanding its global footprint.