Latest Us Market Entry News

Janus Electric has begun generating export revenue in the US while expanding its electric truck fleet to 28 vehicles and significantly improving its cash position through a $1.4 million R&D tax refund and a $2.75 million finance facility.

LTR Pharma has wrapped up recruitment for its SPONTAN Phase II pharmacokinetic study, with interim results expected soon to bolster FDA approval efforts. Meanwhile, US commercial talks for ROXUS advance cautiously under the FDA 503(a) personalised medicine pathway.

Echo IQ has taken a major step in its US expansion by deploying its AI-powered EchoSolv AS software at Mount Sinai Health System, one of America’s leading cardiovascular centres. This marks a key milestone in integrating AI into routine cardiology workflows at scale.

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.

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

Starpharma has secured FDA alignment on the clinical development plan for its DEP® HER2 radiotherapy candidate, paving the way for a first-in-human phase 1 study in advanced HER2-positive cancers scheduled for H2 2026.

AnteoTech (ASX: ADO) pushed forward its advanced battery and life sciences technologies in the March 2026 quarter, achieving key product validations and expanding its sales pipeline to record levels. The company ended the period with A$3.3 million cash and no debt following a recent A$3.5 million capital raise.

Orthocell’s Q1 FY26 revenue hits $3.2 million, buoyed by growing US sales of its Remplir nerve repair device and a robust $48 million cash position supporting global expansion.

Omnia Metals has made a decisive entry into the US critical minerals market by acquiring the Stibnite Ridge antimony and silver project and staking the Radix rare earth and gallium project in Montana, backed by a $1.5 million capital raise.

PainChek has secured a landmark agreement with Sabra Health Care REIT to deploy its AI-powered pain assessment across up to 20,000 beds in North America, marking a pivotal step in its US expansion.

Harvest Technology Group has secured independent validation of its Nodestream platform's strong fit within the US defence sector, highlighting a clear pathway for market entry focused on bandwidth-constrained communications.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.