Latest Us Commercialisation News

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.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

LTR Pharma has locked in Strive Specialties as its exclusive US pharmacy fulfilment partner for ROXUS, marking a critical step towards commercial launch in the US erectile dysfunction market.

LTR Pharma has secured a binding US telehealth commercialisation framework for its intranasal erectile dysfunction treatment ROXUS, committing to at least 150,000 prescriptions in the first year and granting exclusivity to Shed Holdings' platform.

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.

INOVIQ Limited is on track to complete its EXO-OC™ ovarian cancer screening study by mid-2026 and is accelerating its CAR-exosome therapy program, supported by a strong cash position of A$11.9 million.

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.

Orthocell has swiftly converted regulatory approval into clinical use with the first Remplir™ surgery completed in a US Department of Defense hospital, marking a key step in its US commercial expansion.