Latest Commercial Rollout News

EBR Systems plans to file a Changes Being Effected PMA supplement in the fourth quarter to make echo-induced pacing risks and their mitigations more prominent on WiSE System labelling. The FDA has aligned with the proposed path, but the filing and final labelling changes are still ahead.

CurveBeam AI has secured FDA 510(k) clearance for CT-based bone mineral density measurement, establishing the first regulatory step towards a potential new SaaS offering. The more commercially significant HiRise weight-bearing application still requires a separate clearance.

Proteomics International has begun a controlled release of two Promarker diagnostic tests through Healius in Western Australia and the Northern Territory. National commercial sales are targeted for Q2 FY27, but uptake and revenue remain difficult to estimate at this early stage.

Peppermint Innovation has shifted from building its Philippines payments platform to commercialising it, but the FY26 report shows the business remains loss-making, balance-sheet constrained and dependent on future funding. The company reported A$217,720 in revenue, a A$2.40 million net loss and negative net assets of A$578,233.

EBR Systems has secured ISO 13485 certification for its new Santa Clara manufacturing site, paving the way for a 500% increase in WiSE System production pending FDA approval expected by year-end.

Peppermint Innovation Limited posted a $2.4 million net loss for FY26 as it shifted from platform development to commercial execution in the Philippines, achieving key regulatory milestones and securing strategic investment.

Streamplay Studio Limited surged past $13 million in revenue for FY26, driven by a full year of Noodlecake Studios' contribution, while trimming its net loss by 15%.

Wide Open Agriculture cut its loss to $3.64 million in FY2026 as it pivots from owning manufacturing to a capital-light contract model, while securing global commercial traction for its lupin-based ingredients.

Nexsen Limited (ASX:NXN) reported a 30% rise in net loss to $6.55 million for FY26, driven by ongoing investment in its Group B Streptococcus rapid diagnostic and Asia-Pacific growth initiatives following its October 2025 IPO.

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.

HITIQ Limited posted a 21% drop in revenue to $1.59 million and reduced its net loss by 15% to $6.1 million for FY26, advancing commercialisation of its concussion management platform PROTEQT™ despite ongoing funding pressures and regulatory hurdles.

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.