Normally, when a physician notices a suspicious mass or lesion on a mammogram, he or she will request an ultrasound to explore it further. Based on those results, a biopsy may be performed to determine whether the mass is cancerous. “Unfortunately, right now, in some cases, physicians either overdiagnose or underdiagnose based on that biopsy, because with ultrasound they can only see so much,” said Lori Chmura, CEO of Dune Medical Devices. “The doctor is essentially going in blindly, trying to see what looks like the most suspicious area, and they’re trying to sample the tissue from there.” The physician will then have to send it to lab for a diagnosis.
But Dune Medical is working on a new technology called the Smart Biopsy Device that could provide physicians with very specific diagnoses in just a third of a second. It consists of miniaturized sensors mounted on the tip of the biopsy needle. "When the biopsy needle is inserted into the body, the Smart Biopsy sensor reads the physical properties of the tissue, continuously and immediately, and displays them on a screen” said Chmura. “These properties correlate to tissue types, such as invasive ductal carcinoma, ductal carcinoma in situ, fat, or fibroadenoma. The physicians can see the type of tissue they are about to sample and verify that they are taking out the right tissue sample,” she said.
The device works by detecting morphology changes that occur when there is cancer present. “All of those tissue morphology changes carry with them specific physical properties, and every physical property has its own bioelectric imprint,” said Chmura, adding that when the physical property changes, its bioelectric imprint also changes. “So we use a radiofrequency field to look at those changes, and we measure them. Those changes tell us whether it’s cancer or not cancer.”
She said that one of the challenges that they had to overcome when designing the device was to account for the accuracy to measure and differentiate between the different types of tissue, including fluid, which the device sensors are in contact with when the needle is inserted into the body. "To overcome this accuracy issue, we developed a unique calibration mechanism and process that allows accurate measurements of the physical properties and differentiation [among] all the various tissue types,” explained Chmura. “The calibration process is how we tell the sensors what to examine. And the whole concept of radiofrequency spectroscopy is the spectrum on which we want them to measure.”
“By miniaturizing those sensors and putting them on a needle, you’re ensuring that those sensors touch the tissue directly and that we’ve built a calibration to control for that extra fluid in there so that we don’t read the fluid instead of reading the actual tissue,” she continued.
Beyond diagnosing cancers, there is potential for the Smart Biopsy Device to be used in treatment, Chmura said. One application could be for cryoablation, which is freezing very small cancers. “Right now physicians need to have some kind of gauge to know where the cancer is. That’s where Smart Biopsy can be used to guide physicians to where they want to put cryo,” she said. “It could be instrumental there.”
It might also be used for delivering chemotherapy agents or radiation. Chmura said that diagnostic and therapeutic tasks potentially could all be performed within the same episode of care, which would be ideal for a patient. “With intraoperative radiation therapy, a patient could be essentially cured of their cancer in one visit to the operating room,” she said.
The Smart Biopsy Device will be first launched with CE mark in Europe within the next two years and then in the United States.