OncoRes Medical has closed an AUD $27 million private funding round to advance clinical development and regulatory milestones for its Quantitative Micro-Elastography (QME) Imaging System, Elora, as the Perth-based medical device company builds toward U.S. entry and FDA approval.
The round included a cornerstone investment from Brandon Capital Partners’ BB6 Fund, alongside significant investment from Morgans, Radar Ventures, Australian and international family offices, and The Table Club network. The company said the capital will support its ongoing Australian clinical trial program, continued product development, regulatory work, and manufacturing preparation for a U.S. pivotal trial, while also enabling team expansion and early proof-of-concept work in additional cancer indications, including prostate cancer.
Elora is designed to provide real-time tumour assessment during breast-conserving surgery by enhancing a surgeon’s ability to identify and remove cancerous tissue. The device uses a probe inserted into the surgical cavity after the main specimen is excised, generating micro-scale three-dimensional maps of the scanned region’s mechanical and optical properties. Because cancerous tissue can vary in stiffness relative to healthy tissue, the company says these maps can help identify microscopic or otherwise non-palpable residual cancer within the cavity, potentially reducing the need for repeat operations.
OncoRes has opened an Australian clinical trial at six hospitals across two states: Western Australia and Victoria. The trial will recruit more than 110 breast cancer patients and marks the first time the Elora device will be used interventionally, according to the company.
The company also highlighted that Elora received FDA Breakthrough Device Designation in 2020, a status intended to support the timely development of certain medical technologies that may offer more effective treatment for life-threatening or irreversibly debilitating conditions. OncoRes said the designation supports its regulatory pathway to U.S. approval and could expedite access and reimbursement considerations following FDA approval.
As OncoRes targets regulatory approval and a U.S. commercial ramp-up, the company has added Renee Ryan to its board. Ryan is a global healthcare and medical device industry leader with decades of experience in strategic innovation, capital raising, and executive-level leadership, and is currently the co-founder and CEO of PinPrint.
In outlining the clinical need, the company pointed to repeat surgeries following breast-conserving procedures. It said limitations in today’s intraoperative technologies can lead to incomplete removal in some patients, requiring additional operations that may increase the risk of complications and impose psychological, physical, and financial burdens on patients, families, and the healthcare system.
OncoRes said Elora remains in research and development and is not yet available for sale worldwide. The company is headquartered in Perth, Western Australia, and traces its innovation to technology from the University of Western Australia, the Harry Perkins Institute, and the Western Australian Department of Health.
KEY QUOTES
“This injection of capital represents a strong endorsement of our technology and its potential to positively impact so many lives. The funding will be immediately deployed to support our Australian clinical trial, together with product development, regulatory milestones and manufacturing for our U.S. Pivotal Trial. We will also expand the team and progress proof-of-concept work for this technology in other cancer types, including prostate cancer, which is deeply exciting,” said Dr Giles. “I am energised by the scale of support we have received from Australian investors and would like to thank our existing and new investors for backing OncoRes at this important time in our development. Expanding the reach and impact of this innovative, patient-centric technology at home and abroad represents a meaningful achievement for Australia’s innovation sector at large.” “Approximately one in five women who undergo BCS are required to return to theatre for a repeat operation to remove residual tumour. These repeat operations carry a higher risk of complications and create significant psychological, physical, and financial burdens for patients, their families and the healthcare system – this is something we are working hard to change,” said Dr Giles. “We believe that all breast cancer patients deserve the opportunity to move beyond their breast cancer surgery knowing that all the cancer has been completely removed. This is an exciting milestone for an Australian company, and we are resolutely focused on taking Elora™ to Australia, the U.S., and beyond,” said Dr Katharine Giles.
Dr Katharine Giles, Chief Executive Officer, OncoRes Medical
“I’m excited to join OncoRes Medical at such a pivotal stage in the Company’s growth. This team has developed a truly groundbreaking approach to improving BCS, giving surgeons real-time insight that can reduce the burden of repeat operations for patients,” stated Ms. Ryan, Co-Founder and CEO of PinPrint, Inc. “I’ve spent my career working with innovators who reshape what’s possible in the operating room, and OncoRes stands out for both its technology and its unwavering focus on patient impact. I look forward to helping guide the company as it advances toward U.S. clinical milestones and prepares for long-term commercial expansion.”
Renee Ryan, Board Member, OncoRes Medical; Co-Founder And Chief Executive Officer, PinPrint, Inc.
