Latest Us Commercialisation News

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.

Imricor Medical Systems has submitted its NorthStar Mapping System for FDA pediatric label expansion, aiming to accelerate adoption in over 250 US children’s hospitals and broaden its commercial footprint.

Artrya Limited reported a 44% increase in its half-year loss to $10.7 million as it transitioned from development to commercial operations in the US, securing FDA clearance and signing three foundation customers. An $80 million capital raise underpins its ambitious US expansion and ongoing product development.

4DMedical Limited has responded to ASX queries over its announcements of commercial agreements with leading US academic medical centres, clarifying its disclosure approach and denying ramping allegations ahead of a $150 million capital raise.

4DMedical Limited has raised AU$150 million to accelerate the commercial rollout of its FDA-cleared CT, VQ lung imaging technology in the US, leveraging a strategic partnership with Philips. This funding aims to expand adoption across major medical centres and government healthcare programs.

4DMedical Limited has raised $150 million through a well-supported institutional placement to accelerate the commercialisation of its innovative lung imaging product CT – VQ™ in the US market. The capital raise comes with minimal dilution and increased insider confidence.