Latest Us Market Entry News

Terra Critical Minerals (ASX, T92) broadens its critical minerals portfolio with new US initiatives and promising exploration in New South Wales and Canada. The company also pursues a US OTC listing to tap North American capital.

PainChek Ltd has achieved a pivotal FDA De Novo clearance for its AI-driven Adult pain assessment app, unlocking the US market and driving its annual recurring revenue to $5.6 million. The company also launched its Infant app, targeting a vast global market of pre-verbal children.

EZZ Life Science Holdings reported a 25% drop in Q1 receipts, driven by seasonal softness and campaign timing, while accelerating its US market entry and launching three new health supplements.

LTR Pharma has made significant strides towards its US market debut with ROXUS, bolstered by expert appointments and peer-reviewed clinical data validating its rapid-onset ED treatments.

Microba Life Sciences reports robust Q1 FY26 growth in microbiome diagnostics, introduces workflow-enhancing features, and prepares for key therapeutic deal catalysts by year-end.

AnteoTech Ltd reports strong quarterly progress with a key US joint development agreement, significant manufacturing scale-up, and expanded market access in South Korea, underpinning its 2025 commercialisation strategy.

HyTerra Limited has begun trading on the US OTCQB Venture Market, opening doors to American investors and supporting its strategic expansion in the burgeoning geologic hydrogen sector.

Orthocell has boosted its investment in Marine Biomedical to secure exclusive global distribution rights for PearlBone™, an innovative bone substitute nearing FDA approval, enhancing its regenerative medicine portfolio.

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.