Latest Us Market Entry News

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Smart Parking Limited grew its ANPR sites by 17% in Q3 FY26 and increased parking breach notices by 19%, leveraging acquisitions and AI technology to expand across Europe and New Zealand.
Sophie Babbage
Sophie Babbage
13 May 2026
LTR Pharma highlights SPONTAN's 5x faster absorption and validated safety, backed by over 1,000 Australian prescriptions and strategic partnerships as it targets FDA approval and US market entry.
Ada Torres
Ada Torres
1 May 2026
Peak Processing reported its first positive EBITDA month in March 2026, driven by operational efficiencies and strong production growth. The company upgraded its Q4 production forecast and expanded key customer contracts, signaling a turning point after a challenging period.
Victor Sage
Victor Sage
29 Apr 2026
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.
Victor Sage
Victor Sage
28 Apr 2026
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.
Ada Torres
Ada Torres
28 Apr 2026
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.
Ada Torres
Ada Torres
28 Apr 2026
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.
Ada Torres
Ada Torres
27 Apr 2026
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.
Ada Torres
Ada Torres
27 Apr 2026
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.
Ada Torres
Ada Torres
21 Apr 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.
Victor Sage
Victor Sage
20 Apr 2026
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.
Ada Torres
Ada Torres
20 Apr 2026
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.
Maxwell Dee
Maxwell Dee
15 Apr 2026