Financial & Business

Breast Cancer Detection Development Firm Attracts $27M in Funding

OncoRes Medical's imaging tool earned FDA Breakthrough Device Designation in 2020.

By: Michael Barbella

Managing Editor

OncoRes Medical has closed a $27 million private funding round to progress clinical development and regulatory milestones for its Quantitative Micro-Elastography (QME) Imaging System, Elora.

The funding round included a cornerstone investment from Brandon Capital Partners’ BB6 Fund; significant investment from Morgans; Radar Ventures; Australian and international family offices, and The Table Club network.

“I am energized 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,” OncoRes Medical CEO Dr. Katharine Giles stated.

Elora provides real-time tumor assessment to help surgeons more accurately identify and remove cancerous tissue—an approach that could substantially improve outcomes in breast-conserving surgery (BCS) and reduce repeat operations for breast cancer patients. This technology enhances the surgeon’s sense of touch, enabling real-time, high-resolution intraoperative tumor cavity assessment.

The Company has opened an Australian clinical trial across six different hospitals and two states. The trial will recruit more than 110 breast cancer patients and marks the first time the Elora device will be used interventionally.

Elora received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation in 2020, which supports the timely development of technologies that can potentially provide more effective treatment of life-threatening or irreversibly debilitating health conditions. The designation will also support Elora’s expedited approval and reimbursement coverage upon its FDA approval.

“This injection of capital represents a strong endorsement of our technology and its potential to positively impact so many lives,” Dr. Giles said. “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.”

As part of the company’s targeted runway to U.S. regulatory approval and commercial ramp-up in the U.S. market, OncoRes recently welcomed new board member Renee Ryan. She is a respected leader in the global healthcare and medical device industries, with decades of experience supporting strategic innovation, capital raising, and executive-level leadership.

“I’m excited to join OncoRes Medical at such a pivotal stage in the company’s growth. This team has developed a groundbreaking approach to improving BCS, giving surgeons real-time insight that can reduce the burden of repeat operations for patients,” commented 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.”

Breast cancer remains the most common cancer among women and is the second most common cause of death from cancer in American women. In the United States alone, more than 370,000 women and men will be diagnosed with breast cancer this year. Most of those women will choose to undergo BCS in preference to mastectomy to surgically excise the tumor and preserve the appearance and function of their breast. However, due to the limitations of technologies available to oncology surgeons today, the cancer will not be completely removed in many of those patients.

“Approximately one in five women who undergo BCS are required to return to theatre for a repeat operation to remove residual tumor. 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,” Dr. Giles said.

Cancerous tissue is well known to vary in stiffness from healthy tissue. Following the excision of the main specimen during BCS, the Elora probe is applied within the breast cavity, and a micro-scale three-dimensional map of the mechanical and optical properties of the scanned region is generated. These micro-scale maps of tissue stiffness offer surgeons a mechanical and optical imaging method for assessing breast tissue for the presence of microscopic or otherwise non-palpable cancerous tissue remaining inside the breast cavity. By facilitating the identification of residual cancerous tissue within the cavity, Elora enables the surgeon to perform a more complete removal of cancerous tissue during the surgery.

“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,” Dr. Giles concluded.

OncoRes Medical is a medical device company headquartered in Perth, Australia. The team is dedicated to eliminating the physical, psychological, and economic burdens associated with repeat operations following breast-conserving surgery (BCS). OncoRes Medical is developing a hand-held, real-time, intraoperative imaging device (Elora) to improve the detection of residual tumor in the surgical cavity. This innovation is based on technology from the University of Western Australia, Harry Perkins Institute, and Western Australian Department of Health. The Elora device is not yet available for sale anywhere in the world.

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