Breakthrough imaging technology targets better breast cancer surgery

OncoRes Medical is developing world-leading technology to improve the surgical removal of cancers and outcomes for patients and their families. Support from AusIndustry, through the Cooperative Research Centres Project (CRC-P) Grants has been critical to developing this technology in Australia.

OncoRes Medical CEO Dr Kath Giles says the company has created a handheld probe that surgeons can use while operating to identify cancerous tissue. “The probe is able to go inside the surgical cavity,” explains Dr Giles.

“It uses a quantitative micro-elastography (QME) Imaging System to create microscale maps of tissue stiffness. Cancerous tissue is stiffer than healthy tissue. These tissue maps then allow the surgeon to identify the cancerous tissue and remove it entirely,” she says.

The technology itself came about through a collaboration between Professor Christobel Saunders AO and Associate Professor Brendan Kennedy in Western Australia.

Professor Saunders is a world-leading surgical oncologist who specialises in breast cancer surgery and research. Associate Professor Kennedy is a leading biomedical engineer at the University of Western Australia (UWA) who developed a new imaging technology he thought could help identify cancerous cells.

Cancerous tissue is hard to detect by normal visual clues such as colour or visible texture. Despite the stiffer texture of this tissue, it can also be hard to detect by touch alone. But this is how surgeons currently decide whether they have removed the entire tumour or not.

Dr Giles says the current technique is very much reliant on the surgeon and the sensitivity of their touch. When cancerous tissue is missed, patients may need one or more follow-up surgeries. This can affect their recovery and comes with significant physical, psychological and financial burdens for patients and their families.

Among women, breast cancer is the most common cancer diagnosed and the second most common cause of death from cancer. In the US alone more than 325,000 women are diagnosed each year. Most will elect to have breast-conserving surgery. But up to 35% may need additional operations to remove cancerous tissue that was missed in the first operation. (In Australia, the repeat surgery rate is estimated at 30%.)?

“When we started the company eight years ago, building a medical device company in Western Australia for global export would have seemed a crazy idea. Now, that is a real possibility.”?

Dr Giles is a co-founder of OncoRes Medical with Professor Saunders and Professor Kennedy. She came to the start-up through her work with the venture capital firm Brandon Capital, which committed $6 million over three years to establish the business in Perth in 2016.

In its first two years, OncoRes Medical verified in the laboratory that the imaging technology was 96% accurate in identifying cancerous tissue. It also had proof of concept that the imaging technology could be fitted into a probe for use inside the body.?

“The ripple effect of the CRC-P, for the academics as well as for the business – it’s huge.”

The business received a three-year $3 million CRC-P Grant in 2018 which released the second $3 million of Brandon Capital’s investment.

“The CRC-P grant enabled us to iterate the initial design of the handheld probe to a point where it could actually be used inside a patient,” Dr Giles says.

“The grant helped us meet the governance and ethics requirements to use the probe within patients. And it co-funded a clinical study with 21 patients at the Fiona Stanley Hospital in Perth. We used the probe inside the surgical cavity and showed that we can produce QME images.”

In 2019, based on these promising results, OncoRes Medical became the first Australian company accepted into the global MedTech Innovator program. Advice from the program led to a new strategy to tap into the US market. It successfully applied for, and was awarded, ‘Breakthrough Device’ designation from the US Food & Drug Administration (FDA).

Dr Giles says the designation will expedite access to the US market. It could also expedite insurance coverage for the cost of using the technology. All of this gave the company confidence to start building its team. In 2018, when the CRC-P Grant was awarded, OncoRes Medical had two staff members. Now in 2022 it has 17 staff members, and this is expected to grow to at least 23 by the end of the year.

“We have created a specialist product development team and we’re now doing development in-house instead of at UWA. We have completely re-engineered the probe,” Dr Giles says.

“We have started to develop the quality management systems and processes needed for approval through the FDA in the US and Therapeutic Goods Administration (TGA) in Australia. And we’re about to start new clinical trials in Perth.”

In 2022 OncoRes Medical was awarded a second $3 million CRC-P Grant that will run until 2025. This will advance the imaging probe through to TGA approval.

The company has also raised an additional $10 million of investment funding, almost entirely from Australian investors. This includes over $4M of funding from the Commonwealth-supported Medical Research Commercialisation Fund – Biomedical Translation Fund (BTF).

Dr Giles believes the government support has helped to attract local investors, rather than forcing the company to seek investment overseas. She says the US dominates investment in biomedical technologies.

More money from international investors might have forced the company into relocating to the US. But she says its founders remain committed to building the business in Australia.

“When we started the company eight years ago, building a medical device company in Western Australia for global export would have seemed a crazy idea. Now, that is a real possibility.”?

“It wouldn’t be happening in Australia without the support from the Australian Government and various AusIndustry programs.”

In addition to the CRC-P Grants, the company has received the R&D Tax Incentive. Dr Giles says this has significantly extended the value of investment capital.

OncoRes Medical has also used the AusIndustry Entrepreneurs’ Programme Business Evaluation Service and received a $20,000 Growth Grant. This provided advice and help to develop the company’s market strategy in the US.

In the next 12 months, the company will be looking for new premises to establish its manufacturing operations. Dr Giles says it will be crucial to transition from the laboratory to commercial manufacture in a cost-competitive way.

“We’ve shown that we can manufacture locally, with our current devices. If we can manufacture here and export our product, then we can create so many more jobs for skilled workers, and income for Australia.”

In all of this work, Dr Giles highlights the important role the CRC-P Grants play in providing a bridge between the commercial and academic worlds.

She says academics get kudos and advancement from publishing their research and from grants. But working on commercial projects often involves periods of ‘silence’ in their careers, as confidentiality considerations kick in. This can make it hard to step off the academic pathway and then hop back on.

“With the CRC-P Grants, the engineering team at UWA gets huge kudos and it helps the researchers with their career trajectory,” Dr Giles says. “It makes working on commercial projects more valuable.

“Associate Professor Brendan Kennedy, our leading founder, now has a start-up company under his belt. He has gone on to co-develop a new course in bioengineering at UWA, which has produced its first graduates.

“The research team at UWA funded by the CRC-P has included up to 11 people at its peak. We’ve employed several of these at various times. Some are still with us,” she says.

“The ripple effect of the CRC-P, for the academics as well as for the business – it’s huge.”

About Cooperative Research Centres

Cooperative Research Centres (CRC) Grants provide funding for medium to long-term, industry-led research collaborations.

CRC Grants are part of the CRC Program. The CRC Program supports industry, research and the community in 2 ways:

• CRC Grants – support medium to long term industry-led collaborative research, for up to 10 years.
• CRC Projects (CRC-P) grants – support short term, industry-led collaborative research, for up to 3 years.

CRC Grants provide funding for collaborations to solve industry identified problems.

Find out about CRC grants and how to help improve your competitiveness, productivity and sustainability.