OncoRes Medical – Novel Diagnostic Imaging System Aims To Identify Residual Cancer During Surgery
Pictured: left, OncoRes Medical prototype probe.
Surgeons will often plan a cancer removal informed by Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) images. However, once surgery begins, most often, they are required to identify and assess cancerous tissue based on their anatomical knowledge, visual differences in tissue structure and importantly, their sense of touch. Cancerous tissue has an elasticity difference compared to surrounding normal tissue, and during surgery this is assessed by the surgeon with their sense of touch, through one or more pairs of surgical gloves which dampens their sense of touch significantly.
Breast cancer is the most prevalent form of cancer worldwide, with around 2.3 million people diagnosed with the disease in 20191. In Australia, breast cancer is the most diagnosed cancer with 20,428 women receiving a diagnosis in 20222, and in females aged between 30 and 59, breast cancer has the highest mortality rate of all cancers3.
Most women with breast cancer have breast conserving surgery (BCS) (a lumpectomy), rather than a mastectomy which have equivalent survival rates, but BCS is less invasive, minimises recovery time and preserves the appearance and function of the breast. However, due to the limitations of technologies available to oncology surgeons today, the cancer will not be completely removed in many of these patients, committing one in five to a repeat operation. Lacking an intraoperative tool, surgeons must rely on their sense of touch to ensure that the entire tumour has been removed and as a result, cancer is often left behind.
A 2017 report found that repeated BCS surgeries cost an additional $16,072 per patient4. Scaled globally, this billion-dollar burden on healthcare systems as well as the immeasurable and significant time, cost and distress for patients and families can be reduced with improved outcomes from the first surgical intervention.
Novel diagnostic imaging system to increase complete clearance of cancer
Consequently, Perth-based medical device company OncoRes Medical is developing a novel diagnostic imaging system to increase the opportunity for complete clearance of cancer during breast conserving surgery.
As a BioMedTech Horizons (BMTH) program funding recipient, OncoRes Medical proposed to develop proof of concept for a novel technology platform capable of detecting changes in tissue elasticity that are characteristic of cancerous tissues. This, in turn, translates a surgeon's sense of touch into a microscale image, which will improve the likelihood of complete cancer clearance during the initial surgery and reduce complication rates.
The goals of the BMTH project were to understand the market opportunity for the company’s novel technologies and implement a clinical benchtop device suitable for use on clinical breast cancer surgery specimens, integrate the sensor into a handheld probe form factor suitable for use by a surgeon, and conduct a pilot study on lumpectomy specimens and compare results to pathology.
During the project, OncoRes Medical achieved its objectives, progressing its novel, early-stage technology platform to technology proof of concept and defining additional market opportunities and use cases.
Pictured: The BMTH program team visited the OncoRes Medical team on-site in Perth during the development of its novel diagnostic imaging system for cancer.
The team demonstrated proof of concept of its technology by applying benchtop implementation of Stereoscopic Optical Palpation (SOP) imaging, achieving visualisation of microscale stiffness to depths greater than 1 mm in excised breast cancer tissue. The ex vivo benchtop SOP study demonstrated the diagnostic accuracy of SOP images for the detection of cancer within 1 mm of the margins of excised breast tissue specimens, with assessments validated through complimentary histological examination.
The team also achieved proof of technical product feasibility and incorporated the technology into a handheld SOP device intended to be operated by surgeons during breast conserving surgery.
Surgeon engagement and use of early-stage prototypes carried out during the project provided important information to inform user requirements and product specifications. Feedback informed development decisions taken during this project to progress the development of the handheld prototype device.
Datasets, detailed analyses, opportunities and the US market
Sourcing of a highly valuable burden of illness (BOI) dataset from US-based hospitals proved critical in informing the product development and commercialisation path. Detailed analyses were performed to understand the size and accessibility of the US breast conserving surgery market and competitor activity in breast cancer surgical imaging technologies. Recognising significant opportunity from the BOI dataset, some changes in the commercial and technical direction of the BMTH program were made.
Surgeon interviews conducted during the project, enabled the identification of expansion opportunities into other solid cancers. These opportunities were further investigated using the BOI dataset, accessed as part of the BMTH project. Clinical protocols for proof-of-concept studies in additional cancer indications were drafted as part of the project rescoping to realise greater commercial opportunity. Through the BMTH program, OncoRes was able to scope these market opportunities more fully than would otherwise be possible and develop commercialisation plans for these, and positions OncoRes in the broader cancer surgery market.
Major achievements were reached encompassing commercial and technical aspects of the project, advancing product development towards market, and progressing from Technology Readiness Level (TRL) 2 to 4.
The new SOP platform technology is complementary to OncoRes Medical’s existing and more advanced Quantitative Micro-Elastography (QME) technologies and may enable the company to present a pipeline of products that best meet the needs of specific clinical-use cases.
Further funding & validation of the system's potential
Since commencing the BMTH project, OncoRes Medical has secured $22.5 million in funding to support the development of its QME Imaging System, which the company’s CEO and Managing Director, Dr Katharine Giles, has said is validation of the system’s potential to improve outcomes in breast conserving surgery.
“At OncoRes Medical we believe that all women deserve the opportunity to move beyond their initial breast cancer surgery knowing that all of the cancer has been removed, the first time,” she said.
“Continued support of our technology has helped us progress through the path from a university research project to a standalone company with FDA breakthrough device designation. This continued support takes us closer to providing a game-changing solution for cancer surgeons, so we can bring these benefits to the people at the centre of our mission, patients.”
1. Union for International Cancer Control, GLOBOCAN 2020.
2. Cancer Australia Breast Cancer Statistics.
3. Australian Institute of Health and Welfare; Cancer Data in Australia 2022.