Latest Us Commercialisation News

Lumos Diagnostics has increased live FebriDx sites to 215 and moved two additional top 100 US urgent care groups into network rollout across more than 40 sites. Two further health-system-owned groups are validating the test across more than 45 sites, but the announcement does not disclose contract values or guaranteed purchase volumes.

Epiminder Limited reported a $42.7 million loss for FY26, driven by clinical trial and product development costs following a $125 million IPO. The company progresses its FDA-approved Minder implantable EEG monitor with a pivotal US trial and next-gen device on track for 2028 launch.

LTR Pharma reports a 93% response rate in men seeking convenience and spontaneity with SPONTAN, alongside a 64% response in post-prostatectomy patients, highlighting potential for its rapid-onset intranasal ED treatment in challenging populations.

Metallium Limited has appointed key board members and executives to strengthen governance and operational capacity as it advances its Flash Joule Heating technology towards commercialisation in the US.

PainChek lifted implemented ARR by 5.9% to $4.46 million and secured its first US commercial contracts under a major Sabra REIT agreement, boosting customer receipts 27% in the June quarter.

AFT Pharmaceuticals has received tentative US FDA approval for its Scomara cream to treat Facial Angiofibromas in Tuberous Sclerosis, but US commercialisation is postponed until 2029 due to orphan drug exclusivity. The approval bolsters regulatory prospects in other key markets where AFT anticipates competitive advantages.

LTR Pharma has locked in a comprehensive commercial agreement with Strive Pharmacy, cementing its manufacturing and fulfilment infrastructure for the upcoming US launch of ROXUS®.

LTR Pharma has formalised its US commercialisation strategy by signing a definitive agreement with telehealth leader Shed, targeting at least 150,000 ROXUS units in the first year through digital men’s health platforms.

Orthocell Ltd delivered a standout FY26 with 44% revenue growth to A$13.2 million, powered by accelerating US sales of its nerve repair product Remplir and a robust cash position supporting further expansion.

Orthocell Limited has posted record revenue for FY2026, driven by strong sales growth of Remplir™ and Striate+™ products in Australia, the US, and new international markets, supported by a robust $44.1 million cash position.

Echo IQ has locked in a binding Heads of Agreement with Pro Medicus for a strategic A$20 million investment and a US commercial partnership to accelerate adoption of its AI-powered cardiac diagnostic platform.

LTR Pharma has confirmed it disclosed a binding US commercialisation agreement for ROXUS promptly after signing, responding to ASX scrutiny over pre-announcement trading activity.