Israel’s Dune Medical Devices has developed an instrument to help women with breast cancer avoid undergoing dreaded follow-up surgery to remove residual cancer cells after a tumor is removed. The device is already being used by surgeons on patients in more than 100 hospitals in the US and in Israeli medical centers.
When women undergo lumpectomies to remove breast cancers, the cancerous tissue is then sent to labs to ensure that the margins surrounding the tumor are clear of cancerous cells, so that the patients are truly cancer-free. Unfortunately, statistics show that when lab results are released, after a process that can take several weeks, one in four women is asked to return for re-excision — secondary surgery — if the tumors tested reveal that the margins are not clear, indicating some cancer cells remain in the patient’s body.
“We have developed the only technology in the world that has a commercial product that allows surgeons in operating rooms, in real time, to check the margins of the tumor, identify cancerous tissue and decide on the spot if more tissue needs to be removed or not,” Gal Aharonowitz, general manager in charge of Israeli operations, told The Times of Israel in a phone interview.
Clinical trials show that the company’s MarginProbe device reduces the need for re-excision by 51 percent, if it is used during the initial procedure, Aharonowitz said. Commercial use of the product has shown a drop of as much as 80% in the need for repeat surgery, he said.
The device consists of a hand-held gadget — a single-use probe that looks like a large pen or ultrasound instrument — and a console. After the tumor is removed, while the patient is still on the operating table, the surgeon uses the probe to check the margins of the just-removed tissue. Sensors on the probe send signals to the tissue, and a signal, both visual and acoustic, gets reflected back, which is then classified as either positive, indicating there are still cancerous cells on the margins, or negative, giving the all-clear to close up the patient.
The radio-frequency spectroscopy technology used by the probe measures the electrical properties of the cells and can distinguish cancer cells from healthy ones within a second, said Aharonowitz.
The product got FDA approval at the end of 2012 and started marketing in the US in 2013. It has also received the necessary regulatory approvals from European authorities.
The company is now seeking to increase the use of the device in the US and in Israel, and to expand the applications of the technologies to other cancers, like prostate, lung and liver cancers, he said.
“We are already working on these new applications — more specifically on a smart biopsy device that will allow surgeons or radiologists to identify and take the right tissue sample out. We expect this to be available in the market in the near term,” Aharonowitz said. Dune received a 3 million euros grant through the EC Horizon 2020 award in 2016 to expedite development of the biopsy device, he said.
The product is being used by more than 100 hospitals in the US, including Mt. Sinai Hospital in Manhattan, Einstein Medical Center in Philadelphia and UC Irvine Health in California, and 12 in Israel. It has been used commercially on some 10,000 patients, said Aharonowitz.
Dune Medical is in talks with the Israeli Health Ministry to get the probe recognized as standard care in Israel, a step that would allow hospitals to be reimbursed for its use. At the moment, said Ramit Harpaz, in charge of marketing the product in Israel for Dune, the lack of reimbursement is hindering the device’s adoption.
“None of the large hospitals use it, because it is not part of the standard of care,” she said. “We bring objectivity to procedures that were based mostly upon clinical judgment until now.” Hospitals that use the technology include Assuta Hospital in Ramat HaHayal, Tel Aviv, Barzilai Hospital in Ashkelon, Shaare Zedek Medical Center in Jerusalem, and the Kaplan Medical Center in Rehovot.
Use of each probe costs around $1,000 in the US, said Aharonowitz — significantly lower than the outlay incurred by insurers when a patient needs to undergo additional surgery, he said. According to a recent article in The Wall Street Journal, re-excisions for lumpectomy procedures range in price from $9,000 to $16,000.
Dr. Tanir Allweis, a breast surgeon and medical director at the Sarah Markowitz Breast Health Center at Kaplan Medical Center in Rehovot, has been using MarginProbe on some 100 patients a year and finds it “very, very user-friendly.”
Allweis, who also took part in Dune Medical’s clinical trials for the product, says it has reduced her re-excision rates by some 50%.
“A conservative approach,” the cost, and some hesitancy regarding the false positives the instrument sometimes gives — requiring surgeons to remove further tissue from the patient even when pathological results later show it was actually clear — could be preventing more widespread adoption of the gadget, she said.
“But false positives are a small price to pay for the improvement in the re-operation rate,” she said. “The trade-off is worth it.”
According to US nonprofit Breastcancer.org, about one in eight women will develop invasive breast cancer over the course of her lifetime. In 2017 some 255,180 new cases of invasive breast cancer are expected to be diagnosed in women in the US. About 40,610 women in the US are expected to die in 2017 from breast cancer, though death rates have been decreasing since 1989.
Dr. Alice Police, a breast cancer surgeon at UC Irvine Health, does about 300 surgeries a year and has been a surgeon for about 26 years. She participated in Dune’s US clinical trial.
“I think it is the biggest advancement in breast cancer surgery in a generation,” she said in a video testimonial on the company’s website. “When we have to tell a patient that they need a second surgery because the margins aren’t clear from the first surgery, it is just devastating for the patient psychologically.”
Using the probe at the time of the surgery gives immediate reassurance to the surgeon and is “very simple and easy to use,” Police said.
Dune Medical Devices was founded by Dr. Dan Hashimshony, a physicist, in 2002 and has been funded by VCs and private investors.
“I like to carry around a list of difficult questions that are worth solving and the margins issue was one of them. It took a while, but we did it,” Hashimshony said in a phone interview. “The next challenge for Dune will be to bring to the market a generic version of the product that will work in almost every solid tumor removal procedure.”