Western Australian medtech company OncoRes Medical is preparing to begin a US clinical trial of its handheld cancer imaging device ELORA in 2027, ahead of seeking regulatory approval from the US Food and Drug Administration (FDA).
The company, which has received support from the Australian Government’s Medical Research Future Fund (MRFF), has also been nominated for the 2026 Prix Galien USA Awards in the Best Startup category.
OncoRes Medical’s technology is designed to help surgeons identify cancerous tissue in real time during operations, potentially reducing the need for repeat surgery.
The handheld device uses quantitative micro-elastography (QME), an imaging technique developed by researchers at the University of Western Australia, including breast surgeon Professor Christobel Saunders AO and engineer Professor Brendan Kennedy.
QME uses light waves to measure differences in tissue stiffness under gentle compression, producing images that help distinguish cancerous tissue from healthy tissue.
The technology is intended to provide surgeons with information about whether cancerous tissue remains in the patient during an operation, rather than relying solely on examination of tissue that has already been removed.
Professor Saunders said that in breast-conserving surgery, around 20 to 30 per cent of women undergo repeat surgery to remove remaining cancerous tissue.
“The reality is it’s often difficult at the time of surgery to know you’ve removed all the tumour, even with imaging of the removed specimen,” Professor Saunders said.
The research team spent a decade developing the technology before establishing OncoRes Medical to commercialise it.
The company has since developed a handheld QME probe connected to a workstation monitor for use in operating theatres.
Professor Saunders said the researchers had found they could distinguish cancerous tissue from healthy tissue with high accuracy, although the announcement did not provide specific performance figures.
OncoRes Medical is also investigating how QME could be incorporated into minimally invasive procedures, including robotic surgery, where surgeons cannot rely on their sense of touch to identify tissue differences.
The company hopes this could extend the technology’s application beyond breast cancer surgery.
OncoRes Medical CEO Dr Katharine Giles said the company’s immediate priority was bringing ELORA to market. According to the Department of Health, a pivotal US clinical trial is planned to begin in 2027, followed by a submission to the FDA for market approval.
“Surgery is constantly evolving in the quest for better outcomes. To be a sustainable Australian-based business it’s important to have a pipeline of products in development.
“Having the minimally invasive product line underway is future proofing our company,” Dr Giles said.
The company is one of three Australian women-led organisations nominated for the 2026 Prix Galien USA Awards, alongside digital health commercialisation organisation ANDHealth and children’s digital mental health company Gheorg.
The winners are due to be announced in New York on 29 October.
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