Latest Us Market Entry News

AnteoTech has signed a binding Term Sheet with US-based Black Diamond Structures to jointly develop and commercialise an advanced battery additive combining their proprietary technologies, targeting improved lithium-ion battery anodes with higher silicon content.

PainChek has completed its final FDA submission for the PainChek Adult App, targeting the US long-term care market with a potential $100 million annual opportunity. A regulatory decision is expected within 75 days, setting the stage for rapid commercialisation.

Lumos Diagnostics has inked a landmark six-year exclusive distribution agreement with PHASE Scientific for its FebriDx® rapid diagnostic test in the US, potentially unlocking nearly half a billion Australian dollars in revenue contingent on FDA approval.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Orthocell Limited has reported a record FY2025 revenue of A$9.19 million, driven by strong sales of its nerve repair product Remplir™ in Australia and a promising US market launch following FDA clearance.

Terragen Holdings has been granted a US patent for its microbial feed supplements, reinforcing its position in the animal probiotics market and supporting plans for US market entry.

LTR Pharma has successfully completed the extractables study for its intranasal erectile dysfunction spray SPONTAN, confirming safety compliance and initiating the next phase of leachables testing to support FDA approval.

Proteomics International has launched PromarkerD, a pioneering blood test that predicts diabetic kidney disease years before symptoms, marking its entry into the vast US healthcare market.

Singular Health Group has inked a $1.3 million contract with Provider Network Solutions to deploy its 3DICOM imaging platform across key US states, backed by an $8 million capital raise to fuel national expansion.

Adveritas Limited reports a record 61% increase in annualised recurring revenue, driven by strong gains in sports betting and new product launches, while preparing for a strategic expansion into North America.

Smart Parking Limited reports robust H1 FY25 growth driven by a strategic US acquisition and expanding global footprint, underpinned by proprietary AI technology.

Orthocell has rapidly expanded its US distributor network for Remplir™, surpassing its target ahead of schedule and positioning itself for imminent sales in the $1.6 billion nerve repair market.