PERTH, Australia – Oncores Medical Pty Ltd. is developing a hand-held imaging tool to help surgeons differentiate between cancerous and healthy tissue in real time at the point of surgery.

Roughly 30 percent of breast cancer patients need subsequent surgeries because the surgeon didn't remove all of the cancer the first time around.

Tumors are much stiffer than the surrounding tissue, which is why women feel lumps. Oncores developed a hand-held probe like an ultrasound that provides high resolution of tissue that is stiffer. The technology allows the surgeon to distinguish the difference between normal healthy tissue and small traces of diseased tissue, allowing surgeons to remove all the diseased tissue the first time around.

The technology was developed by Oncores Chief Scientific Officer Brendan Kennedy and his team at the Harry Perkins Institute of Medical Research and the University of Western Australia.

"If we can reduce the amount of patients that need to go back for follow-up surgery, we can save the health care system a lot of money and reduce anxiety for patients," Kennedy said.

The technology combines optical coherence tomography (OCT) imaging and elastography to evaluate tissue microarchitecture at a scale and resolution comparable to histology.

OCT measures the intensity of back-scattered light, enabling high-resolution, rapid, 3D imaging. Micro-elastography measures the stiffness of tissue for diagnosing and treating disease. The combination of these technologies provides superior images and is what differentiates the technology from competitors, Oncores CEO Kath Giles told BioWorld MedTech.

Oncores was the first deal for Brandon Capital that came out of the front door of the Western Australian (WA) Department of Health, Giles said. She explained that Western Australia is the only Australian state where all the medical research institutes work under the WA Health Translation Network.

As a medical doctor who worked alongside surgeons for nearly 15 years, Giles said when she went to venture capital 12 years ago, she missed the clinical side.

"When I saw this technology, it was love at first sight," she said. "Leaving medicine was hard because I wanted to make a difference, so getting an opportunity like this, I realized I will be able to have a far greater impact on patients than I could have done on my own."

Giles has been working toward increasing exposure to WA medical innovation when she started in venture capital a decade ago. At the time, the WA Department of Health was an "impenetrable beast, with limited funding and a lot of barriers."

She co-founded the SPARK Co-Labs in Perth in 2015 to help participants understand the importance of identifying unmet medical needs and to teach them how to evolve their ideas out of the laboratory, into commercial and clinical reality.

"One of the key things we wanted to create at SPARK, was a pay-it-forward ecosystem to bring people together to educate them, inspire them and connect them."

Kennedy, lead engineer, and breast surgeon Christobel Saunders have been working together from the beginning to solve this problem, Giles said.

She discovered the Oncores technology in 2013, and it took three years of work to get it to an investable business case.

Funding for an AU$6 million (US$4.2 million) series A round over four tranches was approved in 2016 by Brandon's Medical Research Commercialization Fund. Several key questions needed to be addressed with the first tranche. First, there were a lot of other people developing technologies to solve this problem of women having to return for surgery after breast cancer.

"We wanted to know how our technology stacked up against those competitors and whether it was worth progressing further," Giles said.

Diagnostic accuracy greater than anticipated

To that end, Nedlands-based Oncores conducted a diagnostic accuracy study at Fiona Stanley Hospital with 70 patients from which 150 samples were derived. The sensitivity of the probe was around 93 percent, and specificity was more than 96 percent.

"We were hoping to get around 90 percent, so we were stoked," Giles said.

"One of the things with breast cancer is that it's been hard to relate when you see a tumor close to the edge to where that corresponds to in the patient. With the accuracy results, we feel we can out-compete on accuracy," she said.

"The probe can be used inside the cavity as opposed to just imaging the excised lump," Giles added, noting, "no one has combined these two technologies."

"As surgeons, our problem is not being able to identify the extent of a cancer at operation and thus the risk of leaving cancerous cells behind. We believe this technology has the potential to overcome this, leading to more efficient and effective surgery for the many hundreds of thousands of people who undergo cancer surgery globally each year," said Saunders, who leads the clinical development and was named WA Scientist of the Year in 2017.

The other key question was whether the images on the hand-held probe would be like those produced on a bench top unit, and the group achieved that and now has a prototype that is ready to go into the clinic in vivo in early 2019.

Trials and next milestones

With the proof-of-concept work finished, Oncores is now working with Planet Innovation to develop a final product, which should be ready to submit to the U.S. FDA in the next two years.

Oncores had an initial meeting with the FDA, and it's waiting to hear back on what regulatory pathway the company will take, but it expects to begin clinical trials early in 2019 and to submit a regulatory application by 2021.

"Surgeons have been asking for this information, and Saunders identified the need and health insurers are also looking for a solution," Giles said, noting that the technology can also be used for other cancers and has potential application in laparoscopic surgery.

"The AU$6 million series A helped answer questions of diagnostic accuracy and a better understanding of the market, and we answered those questions with AU$3 million. The remaining AU$3 million will get us through the end of 2019," Giles said. She expects to raise an AU$15 million series B round that will take Oncores through FDA approval and pivotal trials.

In December, Oncores emerged as one of two finalists from the Australian round of the international Pitch@Palance competition comprising 42 entrants, before progressing to the global finals in London. Giles pitched the company to an international audience, including the Duke of York, Prince Andrew.

"Global recognition for our technology is hugely beneficial not only for Oncores but also for Australian and Western Australian medical research. Being able to profile a WA technology in a global setting was beyond my wildest dreams," she said.