Latest Healthcare News

Lumos Diagnostics has secured a significant follow-on contract with Aptatek Biosciences to push forward the development of an innovative in-home monitoring device for Phenylketonuria (PKU), a rare genetic disorder. This next phase aims to bring the FDA Breakthrough Device-designated PheCheck™ closer to clinical trials and commercial readiness.

Lumos Diagnostics, backed by BARDA, is set to begin a pivotal pediatric clinical study to extend the use of its rapid respiratory infection test, FebriDx, to children aged 2–12 in U.S. CLIA-waived settings, potentially unlocking a $1 billion market.

Imricor Medical Systems has taken a significant step toward U.S. market entry by submitting its Vision-MR Diagnostic Catheter for FDA 510(k) approval, complementing its recent NorthStar system filing. These moves aim to establish a fully integrated MRI-guided cardiac ablation platform.

Osteopore Limited has established OsteoRx, a new special purpose vehicle, with an initial AUD 0.5 million investment to accelerate breakthroughs in cellular regenerative medicine. This strategic move integrates a controlling stake in US-based RxCell Inc, expanding Osteopore’s footprint in the fast-growing stem cell market.

4DMedical Limited has secured FDA clearance for CT – VQ™, the first non-contrast CT-based ventilation-perfusion imaging technology, promising to transform lung diagnostics by replacing traditional nuclear scans.

Recce Pharmaceuticals reported a 21% increase in net loss to $21.4 million for FY2025, driven by intensified R&D spending. The company secured key regulatory approvals for Phase 3 trials of its lead anti-infective gel and bolstered its financial position with significant capital raises and grants.

Opthea Limited reported a 26% reduction in net loss for FY2025 despite discontinuing its wet AMD drug after failed Phase III trials. The company settled its Development Funding Agreement with investors, securing liquidity and planning a strategic pivot.

Botanix Pharmaceuticals posted a sharp revenue increase driven by its new hyperhidrosis treatment Sofdra, yet reported a substantial net loss reflecting heavy investment in commercialisation. The company’s strong cash position underpins its path to profitability.

Holista Colltech reports a sharp 70% reduction in net loss and an 8.6% revenue rise, driven by strong supplements sales and a landmark collagen partnership with Regenerex Pharma.

Vectus Biosystems has posted a 58% drop in revenue and a 24% reduction in operating loss for FY2025, but its net equity has swung into negative territory.

Argent BioPharma reported a net loss of A$17.84 million for FY2025, reflecting a strategic pivot towards core drug development and clinical advancement. The company secured key EU approvals and raised significant capital to support its neuro-immune modulatory pipeline.

Wellnex Life reported a strong 40.4% revenue increase to $23.6 million in FY25, alongside a 57% improvement in normalised EBITDA loss, signaling progress despite ongoing investment costs.