From pathway to proof

A next-generation hydrogel condom designed for enhanced feel and hypoallergenic performance underwent a Phase 1 pilot with 35 couples. Results confirmed safety, efficacy, and strong user preference—setting up larger trials and scaled manufacturing.

The first multicentre randomised trial for aspiration thrombectomy proved an advanced catheter system could match—and in some cases exceed—stent retriever outcomes. With 89% delivery success, superior revascularisation, and zero haemorrhage events, it earned FDA 510(k) clearance.

A handheld spectroscopy device using AI and elastic scattering spectroscopy achieved ~96% sensitivity across major skin cancers. Trials spanning urban and rural centres halved missed cancers and led to FDA De Novo and CE Mark approvals.

A new electrophoretic system offered a faster, safer alternative to conventional sperm selection. In a multicentre pivotal trial, it outperformed Density Gradient Centrifugation, matched Swim-Up, and showed no adverse events—supporting CE Mark submission.

An innovative repositionable mitral valve system underwent early feasibility trials in Australia before scaling to a global pivotal study. Results showed durable valve function, improved survival, and quality of life—culminating in CE Mark (2020) and FDA approval (2025).

Pregnant women in their third trimester experienced better sleep and less pain using a specialised maternity airbed tested in a Mobius-run pilot trial. The study validated safety, comfort, and efficacy—proving a non-invasive way to ease late-pregnancy discomfort.

A closed-loop spinal cord stimulation device was tested across multiple sites in Australia, demonstrating over 80% patient improvement and 82% opioid reduction. The evidence secured CE Mark and FDA approvals, helping thousands reclaim their lives.