Latest Us Market Entry News

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.

Latrobe Magnesium has locked in a US$2 million non-dilutive prepayment from its US distribution partner to accelerate commissioning of its Demonstration Plant, aiming for first magnesium deliveries in late 2026.

Sultan Resources is advancing plans to list on the US OTC Markets Group, aiming to enhance liquidity and attract North American investors while pursuing strategic acquisitions.

LTR Pharma has finalised recruitment for its Phase II clinical trial of SPONTAN, a rapid-acting intranasal spray for erectile dysfunction, with initial results expected in the second quarter of 2026.

Thrive Tribe Technologies reported a $1.8 million half-year loss, driven by a major software impairment and ongoing operational challenges, while raising over $1.5 million in fresh capital to support its evolving business model.

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.

Epiminder Limited has reported a $21.7 million loss for the half-year ending December 2025, alongside a successful $125 million IPO that fuels its commercialisation of the FDA-approved Minder epilepsy monitoring device.

Imricor Medical Systems has taken a significant step toward US market entry by submitting its Advantage-MR EP Recorder/Stimulator system for FDA 510(k) clearance, aiming to enhance MRI-guided cardiac procedures.

Hydrix Limited reported $2.3 million in revenue for Q2 FY26 and secured a $2.5 million initial contract with SynCardia Systems to develop a fully implantable artificial heart, setting a positive tone for 2026.

HITIQ has made significant strides in expanding its concussion management technology, PROTEQT©, into North America and Australian retail, backed by strong research partnerships and a successful capital raise.

HeraMED has secured pivotal US commercial agreements and achieved a key Australian regulatory milestone, positioning itself for scalable growth in digital maternity care.

Iondrive Limited has marked a pivotal shift from development to commercialisation of its IONSolv™ technology, securing $4 million to target the US e-waste market and commissioning its pilot plant to refine critical minerals.