OncoRes Medical’s system may detect cancer cells on a microscopic scale during a lumpectomy, potentially averting the need for a second breast cancer surgery.
Having breast surgery to remove a cancerous lump is traumatic enough. Learning that you’ll need another operation to remove cancer cells that the surgeon couldn’t detect the first time only adds to the worry — and the cost.
Australian startup OncoRes Medical won FDA breakthrough device designation in October 2020 for its handheld imaging device designed to identify residual cancer cells in breast tissue after the surgeon has removed a tumor but before concluding the procedure. The idea is to enable surgeons to remove all cancer on the first try, thus avoiding a second procedure.
The recently announced breakthrough designation enables OncoRes to work closely with the FDA to develop its imaging system in an expedited regulatory review process.
Breast imaging has greatly improved over the past two decades, but identifying malignant cells left inside the surgical cavity during breast-conserving surgery has remained a significant challenge. Today, patients and surgeons have to wait several days after the surgery for pathology results to reveal whether residual cancer was too close to the margins of the excised tumor. If tumor cells are found to be too close to the margins of the surgical specimen, women are left with a big decision: undergo a second breast-conserving surgery or a mastectomy.
More than 20% of patients undergoing initial breast-conserving surgery for cancer require reoperation, according to a 2019 study published in the Annals of Surgical Oncology.
The American Society of Breast Surgeons in 2015 endorsed 10 tools to lower the rate of reoperations. The study, however, found that even though the tools lowered reoperation rates among society members, the variability among surgeons was significant. The researchers called for further efforts to lower the rates more.
How OncoRes’ device works
Medtech has produced other devices to help identify residual cancer cells, but OncoRes’ device can do it quickly and on a micro-scale, according to CEO Dr. Katharine Giles. It also employs an artificial intelligence (AI) reader that enhances the evaluation to deliver 100% sensitivity and 97% specificity, Giles noted.
OncoRes’ technology combines optical coherence tomography and micro-elastography to enable real-time assessment of tissue microstructure, according to the company. The technique measures back-scattered light intensity, enabling rapid, high-resolution, 3-D imaging that can readily differentiate adipose (fatty) tissue from dense tissue. The addition of micro-elastography provides a quantitative measure of tissue stiffness that enables surgeons to distinguish healthy dense tissue from cancer better.
The combined technology, termed quantitative micro-elastography, enables the surgeon to evaluate the microarchitecture of tissue at a scale and resolution approaching histology. The technique also enables the differentiation of multiple breast cancer types, the company said.
The OncoRes probe collects the images and displays them on a console with an imaging screen similar to an ultrasound machine. It also has a disposable component, which is fit to the front of the probe.
The path so far
Dr. Christobel Saunders is a surgeon at Fiona Stanley Hospital and a professor of surgical oncology at the University of Western Australia (UWA), both in Perth. She worked with the optical engineering group at UWA for many years on precursors to OncoRes’ technology. When Brendan Kennedy came to the department as a postdoc in 2008, he brought experience in optical coherence tomography. The two worked together on the concept for years.
Meanwhile Giles, also a surgical assistant in Perth, earned an MBA and began working for a diagnostic startup. Giles entered the field of venture capital in 2006 and landed at Brandon Capital Partners, Australia’s largest venture fund, in 2012. She learned about the OncoRes technology in 2013 and described it to Medical Design & Outsourcing as “love at first sight.”
“I could just see how it was exactly what surgeons were looking for,” she said. “They were looking for more information under their control to enable better decision-making in theater and therefore, better patient outcome…
“I worked with the team for three years in terms of developing the investment case around the technology, really deeply understanding the clinical needs,” Giles added. “And then Brandon Capital put a Series A investment of $4.2 million U.S. dollars in, in late 2016.”
The company raised another $1 million USD in March 2020 and landed $6.8 million USD in grants from the Australian government.
Seeking a market in the U.S.
The team at OncoRes set their sights on the faraway U.S. market. They made connections through Brandon Capital’s Palo Alto office and entered the MedTech Innovator contest in 2019, placing second. OncoRes also won that contest’s value award as the company with the most compelling value proposition.
OncoRes’ technology presents a huge economic and patient benefit, according to MedTech Innovator CEO Paul Grand.
“This company was really one of the most likely companies to succeed,” Grand told MDO. “Just getting selected to the finals means that they not only had the promise but they had the goods. And the team is a big part of that, too.”
The OncoRes team had planned to pursue FDA 510(k) clearance but listened to the advice of the industry experts who work with MedTech Innovator contestants and decided to pursue premarket approval, the more rigorous and expensive path.
Others are working on different types of imaging technologies to scan the cavity for microscopic cancer cells during surgery, but are using tissue biopsies and different ways of detecting the cells, according to Grand.
“This kind of tool is completely different,” he said. “It doesn’t require huge capital equipment. It’s going to be more accessible because it won’t have huge costs associated with it.”
Meanwhile, OncoRes officials believe they’ll need to raise $45 million to $50 million USD over several rounds to get the company all the way through to FDA approval.
Now OncoRes’ chief medical officer, Saunders believes that if approved, the device could halve the rates of second cancer surgeries.
Said Giles: “What we’re hoping to do is be to be able to give patients and surgeons the confidence that it’s all gone. “