Breast cancer is the most common cancer among women globally, with 2.3 million women diagnosed annually[1]. For those undergoing breast-conserving surgery (BCS), success hinges on removing all cancerous tissue during the first procedure. Yet, up to 35 per cent of patients face the physical and emotional toll of repeat surgeries due to residual cancer being left behind.
A significant challenge surgeons face is ensuring “clear margins” – that no microscopic cancer is left behind at the edge of the removed tissue. Currently, finding these margins relies on the surgeon’s sense of touch, a highly subjective approach with limited precision. Outcomes are only confirmed by post-operative pathology, in the week after surgery. This limitation most often results in a higher risk of cancer recurrence, costly repeat surgeries, significant delays in commencing post-surgery cancer treatments, and emotional stress for patients and their families.
Perth-based medical technology company, OncoRes Medical, is tackling this critical issue head-on by developing an innovative imaging system designed to give surgeons real-time, microscopic feedback directly in the operating theatre.
A better way of imaging cancer in real time
OncoRes’s proprietary Quantitative Micro-Elastography (QME) imaging system combines micro-elastography with optical coherence tomography.[2] By combining these techniques, the system can produce high-resolution cross-sectional images of tissue micro-architecture such as cancer tissue margins, surpassing the capabilities of existing intraoperative tools like ultrasound or specimen radiography. Most importantly, this vital information is available to surgeons in real-time, using a device conveniently operated by hand within the operating room, enabling them to make faster, more informed decisions.
Since its founding in 2016, OncoRes has had impressive traction in advancing its technology from concept to clinic. The company has secured multiple successful funding rounds, alongside receiving Australian government grants from the CRC-P, Modern Manufacturing Initiative and WA State Investment Attraction Fund. OncoRes was also awarded funding from MTPConnect’s BioMedTech Horizons (BMTH) accelerator program, to support the pre-clinical development of its device.
The company conducted first-in-human clinical trials in WA and demonstrated early clinical feasibility of the QME imaging System, and the device was granted Breakthrough Device Designation by the US Food and Drug Administration in October 2020.
Reflecting on the company’s progress, Deputy Chief Medical Officer, Dr Bridget Ryan, says one of OncoRes’s strongest advantages is the workplace culture the firm has created.
“I’m a big fan of the concept of ‘psychological safety’ – the capacity to ask questions of seniors, in a supportive environment, without fear of retribution,” she said.
“This kind of culture is embraced and encouraged, which is a testament to the company’s leadership and managers, for leading by example. We have a common goal to improve patient outcomes, and that’s pretty awesome.”
CTCM accelerator support prompts nationwide clinical trial and opens regulatory pathways
Building on its momentum, OncoRes received $1.5 million in funding from MTPConnect’s Clinical Translation and Commercialisation Medtech (CTCM) accelerator program, enabling the company to complete its first nationwide, multi-centre clinical trial with support from CTCM Program Partner, the Medical Device Partnering Program.
The “OPTICS” pilot trial aimed to establish the device’s safety profile and demonstrate seamless integration into surgical workflows. This involved shipping the devices across the country, and training surgeons, theatre nurses and sterilisation staff to use the imaging system.
The device successfully met its primary safety endpoints and allowed OncoRes to prepare a robust technical file for regulatory and market approval from authorities such as the TGA and the FDA, once pivotal trial data is available.
Chief Operating Officer Dr. Simon Graindorge said: “For us, producing great data and understanding it deeply, is one of our superpowers. The better our data, the more we can learn from it, and the more we can help the surgeons achieve better outcomes for their patients.”
The funding also supported the implementation of the company’s Quality Management System, ensuring it is well-equipped for future manufacturing processes.
During the clinical trial, OncoRes built strong relationships with clinicians, with many surgeons showing deep interest in the QME Imaging System and expressing eagerness to be involved in future trials. The company also actively engaged with the broader community, gathering feedback on patient preferences and attitudes, while observing real-world scenarios involving breast cancer and breast conserving surgery firsthand.
This engagement is crucial in providing OncoRes valuable insights into the needs of both surgeons and patients, identifying gaps in the market, and enabling the development of their technology to optimise outcomes for patient and end-users.
MTPConnect’s CTCM program also enabled OncoRes to upskill its existing team in conducting medical device clinical trials. OncoRes staff received subsidised ISO13485 training and participated in multiple networking events hosted by MTPConnect and the CTCM program, fostering valuable industry connections. This funding also allowed the company to grow its team, including bringing on a dedicated project manager to support regulatory submissions. This strategic addition increased the capabilities within the company and was instrumental in finalising a TGA dossier.
Building a future of world-class medtech in WA
OncoRes has successfully advanced its device from a Technology Readiness Level (TRL) of 5 at the start of the project to TRL 7 by its conclusion.
The company has not only demonstrated its potential to improve the success rate of cancer surgery, but has also made a considerable impact to Australia’s Medtech sector, particularly in Western Australia. By conducting all manufacturing at its Nedlands facility, the company is creating high-value jobs in engineering, clinical research, and manufacturing, and helping to retain and attract specialised talent to the state. OncoRes’s workforce has grown to over 40 professionals from diverse industry sectors. Fostering good relationships with local and Australian based suppliers, the company is proud to say that their device is truly Australian-made.
Following the completion of its CTCM project, OncoRes secured a $2.5 million CUREator+ grant from Brandon BioCatalyst.
OncoRes is well-prepared to launch large-scale pivotal clinical trials necessary for regulatory approval of the device and to scale up manufacturing efforts, marking a significant step forward in their commercialisation journey.