The Israeli med-tech company IceCure Medical has reported “very promising” early results in clinical trials of its innovative breast cancer treatment, which relies on a liquid nitrogen technology to freeze tumors and destroy abnormal tissue.
The firm is nearing completion of a major clinical trial in hospitals across the United States where it has already treated hundreds of women.
“The US market for breast cancer treatment is our unique value proposition,” Eyal Shamir, CEO of IceCure Medical, told The Media Line.
“Mid-next year, we are going to present the interim result of our Ice3 trial, which has 206 patients in 19 hospitals,” he added. “The current results are pretty promising.”
Founded in 2006, IceCure is headquartered in the coastal city of Caesarea.
The innovative process of using extreme cold to destroy tissue is known as cryoablation therapy.
IceCure’s ProSense system, which features a hollow needle, relies on liquid nitrogen to help it quickly reach a temperature of -170°C(-274 F), according to the company. Once cold, the needle is inserted directly into a tumor to kill the abnormal tissue.
“We are basically covering the tissue with an ice ball,” Tlalit Bussi Tel-Tzure, vice president of business development and global marketing at IceCure, explained to The Media Line during a recent demonstration.
“No tissue can survive such a low temperature,” she explained. “Once the tissue is dead, it will dissolve in the body in a natural process and be absorbed in the body in a couple of weeks.”
One of the primary benefits of cryoablation therapy is that it is a minimally invasive procedure that can be carried out either at a doctor’s office or an outpatient facility, with no general anesthesia needed.
With regard to breast cancer, the process takes less than an hour and does not change the appearance of the breast, unlike traditional surgeries, such as lumpectomies.
Cryoablation has been used to treat various types of cancers, including bone, cervical, kidney, liver and lung cancer. However, because the technology is still very new, Bussi Tel-Tzure says it will take time for medical professionals to widely adopt it.
“Especially when we treat cancer, we have to complete five years of follow-up in order to conclude that it is a safe and effective solution,” she noted. “But based on the information we have from Japan and other parts in the world, we can say that the results are very promising.”
Despite the COVID-19 pandemic, IceCure has continued to expand into new markets, having last week received regulatory approval in both Taiwan and Russia. The company is already active in several countries throughout Europe, as well as in Mexico.
IceCure is not the only firm studying the effects of cryoablation on breast cancer. California-based Sanarus Technologies is conducting a clinical trial in the US, known as the FROST Trial.
IceCure has already received clearance from the US Food and Drug Administration to treat kidney and liver cancers with the technology. It is hoping to receive federal approval for use against breast cancer soon.
The Ice3 trial so far has focused on early stages of malignant tumors in low-risk candidates.
“Our main vision is to become the gold standard in breast cancer treatment,” Shamir said. “Most of the cases where you have good early detection are small tumors, considered early stage, and the only treatment available today is surgery.”
Breast cancer is the most common cancer for women (excluding non-melanoma skin cancers), with over two million cases diagnosed worldwide each year, according to the World Cancer Research Fund. In fact, an estimated 1 in 8 American women will develop the disease.
“The importance of early screening is crucial when it comes to breast cancer, and given the fact that October is Breast Cancer Awareness Month, we want to increase awareness to do early screening,” Bussi Tel-Tzure stressed.
“The sooner the screening or the diagnosis is done, the sooner the tumor will be discovered and the more efficient our treatment will be,” she said.
Dr. Richard E. Fine is director of education and research at the Margaret West Comprehensive Breast Center in the US state of Tennessee. He has been performing breast surgery since 1988 and is the principal investigator for the Ice3 Trial, and calls the initial results “very encouraging.”
While it cannot replace all forms of treatment, Fine believes cryoablation can transform the lives of millions of women.
“We’re not removing any volume from the breast, so the cosmetic result is very nice. Patients go back to pretty much normal activity,” he told The Media Line.
“This could have a major impact,” he continued. “It lets patients go back to work, to their home, their family, and will actually decrease costs.”
Fine notes that more and more women have been postponing doctor’s visits and mammograms in recent months out of fear of contracting COVID-19, something he calls a mistake.
“We do not want to delay the early detection of breast cancer, so we very much encourage women to have their mammograms,” he emphasized.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.