A WA-developed imaging device that can reduce the number of repeat surgeries for breast cancer patients has received a major accreditation from the US Food and Drug Administration.
A WA-developed imaging device that can reduce the number of repeat surgeries for breast cancer patients has received a major accreditation from the US Food and Drug Administration, which will fast-track its development.
Based in Perth, OncoRes Medical has developed a handheld device, called a quantitative micro-elastography (QME) imaging system, to assist surgeons in accurately identifying and removing cancerous tissue.
The QME system has now been included in the FDA's Breakthrough Device program, which supports the development of technologies that have the potential for more effective treatment of life-threatening or irreversibly debilitating diseases and conditions.
While noting a preference for breast-conserving surgeries (BCS) over mastectomies among patients, OncoRes said its QME device could substantially improve BCS outcomes and reduce the number of repeat operations.
OncoRes medical chief executive Katharine Giles said one in five women in the US who undergo breast-conserving surgeries are required to return to theatre.
“These repeat operations carry a higher risk of complications and create significant physical, psychological and financial burdens for patients, their families and the healthcare system – this is something we are working hard to change,” Dr Giles said.
She said OncoRes’ QME imaging device intensified a surgeon’s sense of touch and enabled a real-time, high-resolution intraoperative assessment of the tumour cavity.
“We know that facilitating detailed assessments in-cavity may improve surgical accuracy and support complete tumour removal, the first time,” Dr Giles said.
“Breakthrough Device Designation from the FDA is a strong endorsement of our technology and its potential to change, even save, lives.
“It provides a more efficient regulatory and reimbursement pathway in the US, ensuring earliest possible surgeon and patient access to the clinical and economic benefits of this world-class innovation.”
OncoRes chief medical officer Christobel Saunders said the QME imaging system was a vital, game-changing tool for breast cancer surgeons.
“The improved surgical accuracy facilitated by the system will get us closer to a world where patients and their families will no longer have to endure the physical, psychological and financial burdens of repeat operations,” Professor Saunders said.
OncoRes’s QME imaging system was developed in collaboration with the University of Western Australia, the Harry Perkins Institute of Medical Research, and the Department of Health.
The FDA accreditation follows $150,000 in state government funding awarded to OncoRes in January.
Ms Giles said some of the funding would be used to enhance the company's R&D capability and collaboration with local researchers, surgeons, clinicians, suppliers, and manufacturers.