Latest Us Market Entry News

Adveritas Limited has reported a record annualised recurring revenue of $12.2 million for the September 2025 quarter, driven by strong affiliate momentum and initial commercialisation of its Meta integration. The company is advancing its US expansion with a robust trial pipeline and expects significant contract conversions in the coming quarter.

PainChek Limited has confirmed FDA De Novo classification for its PainChek Adult App, promptly disclosing the material regulatory milestone to the ASX and signalling a significant step towards US market entry.

Compumedics has secured a $2.15 million placement to fast-track commercialisation of its Somfit D device following early FDA approval, positioning the company for significant growth in the US home sleep testing market.

The Calmer Co. has secured $700,000 in the first tranche of a $1.4 million convertible note raise, welcoming US distributor Applied Food Sciences as a strategic investor to fuel its expanding wholesale presence.

AnteoTech has formalized a joint development and sales agreement with US-based Black Diamond Structures to co-develop an advanced battery product targeting high silicon lithium-ion anodes in the US market.

ReNerve Ltd has launched its Empliq product range, marking its entry into the dermal and amniotic tissue repair markets with first sales already recorded and a US launch planned.

Althea Group Holdings has secured $2.55 million through a share placement to fuel expansion of its Canadian THC beverage manufacturing arm, Peak Processing, as it targets growth in both Canadian and US markets.

Talga Group has signed a strategic cooperation agreement with United Catalyst Corporation, marking its entry into the US battery anode market and setting the stage for new graphite recycling and anode production facilities in South Carolina.

Pure Hydrogen Corporation has signed a Letter of Intent with California's GTS Group to supply hydrogen-powered heavy vehicles, marking a strategic push into the North American market.

4DMedical Limited reported a 56% jump in FY2025 operating revenue driven by SaaS growth, while narrowing its net loss to $30.1 million. The company also secured $13.9 million in capital and a $10 million funding facility to accelerate product commercialisation.

LTR Pharma’s FY25 results reveal a transformative year highlighted by SPONTAN’s rapid absorption and strategic partnerships that pave the way for US market entry.

LTR Pharma Limited (ASX, LTP) reported significant progress in FY25, advancing its novel intranasal treatments for erectile dysfunction and expanding its commercial footprint in Australia and the US. The company secured key partnerships and capital raises, positioning itself for regulatory milestones and global market entry.