Latest Us Market Expansion News

Immuron Limited has inked an exclusive US distribution deal for PROIBS®, a European-certified medical device targeting abdominal discomfort, marking a key step in its digestive health portfolio growth.

InFocus Group Holdings has secured $450,000 in a placement to fund the commercialisation of its AI-driven Codexa sweepstakes casino platform, targeting the US market with new compliance technology and patent applications.

Imricor Medical Systems has reached a crucial milestone as the FDA accepts and closes the manufacturing module of its Premarket Approval submission, advancing its MR-guided electrophysiology devices closer to US market entry.

Titomic has raised A$16.5 million through an institutional placement priced at a 23.5% discount, aiming to scale its Huntsville facility and accelerate US growth. The company also advanced a US$10 million loan application with the Export-Import Bank and appointed aerospace veteran Jim Chilton to its board.

Vitrafy Life Sciences has secured its first US cell and gene therapy foothold by deploying its cryopreservation technology at Charter Medical's Innovation Hub, signalling a strategic expansion into a high-value biopharma segment.

Artrya has launched its AI-powered Salix® platform commercially in the US, securing three foundation health systems and raising $80 million to fuel growth. With FDA clearance for its Coronary Plaque module and a pivotal clinical study underway, the company is poised for scaling revenues amid a strong balance sheet.

RMA Global grew revenue 7% to $22.7 million in FY26, driven by US market gains and integration of Curated Social, but losses widened to $3.5 million. The company rebranded as Renowned and secured record US brokerage deals.

Orthocell posts record FY26 revenue growth driven by expanding US and international sales of its collagen medical devices, while investing ahead in manufacturing capacity and product pipeline.

AML3D Limited surged to a record $12.5 million revenue in FY26, delivering its first half-year EBITDA profit and locking in a $29 million order book driven by US Defence contracts and UK market entry.

Singular Health Group lifted revenues over fivefold to $1.43 million in FY26, driven by US commercial rollouts of its 3DICOM platform, but posted a $6.34 million loss. The company strengthened its US foothold with FDA clearance and a controlling stake in an associate.

Saluda Medical delivered FY26 revenue of US$90.2 million, beating guidance with strong US and international growth, while reporting a flat net loss of US$149.6 million amid ongoing heavy investment. The company’s FDA approval of its CAP24 paddle lead opens a new US surgical market segment.

Cyclopharm Limited posted a fifth consecutive record half-year revenue of $17.5 million, propelled by a 74% jump in US Technegas® sales and a doubling of revenue-generating US sites. New US clinical guidelines naming Technegas® as the preferred ventilation imaging agent underpin a robust growth outlook despite a wider net loss.