Biomedical company IceCure offers women a quick, scar-free and virtually painless option for freezing fibrous breast growths out of existence.
By Avigayil Kadesh
An Israeli product that gives benign breast tumors the cold shoulder is launching in US medical offices and hospitals.
Last December, the US Food and Drug Administration cleared IceSense3, a device made by IceCure Medical to vanquish fibroadenoma tumors by freezing them in a minimally invasive procedure. Two months later, the biomedical firm went public on the Tel Aviv Stock Exchange, raising $10.5 million in its initial public offering.
CEO Hezi Himelfarb explains that during an ultrasound-guided procedure, the IceSense3 probe penetrates the tumor and then destroys it cryogenically - engulfing it with ice. The entire process takes about five minutes, and the woman won't have scarring or recovery downtime. "She can get right up and go to work," he says.
Headquartered in Caesarea on the Mediterranean coast of Israel, IceCure is opening an office in the US Midwest this spring. The plan is to funnel most of its investment funds into marketing, sales and distribution in the United States, where the device is already in use at several facilities.
An improvement over existing options
"IceSense3 is not the first product in the world for this application," says Himelfarb. A similar device is made by the American company Sanarus. However, the Israeli model offers clear advantages over its competitor, he insists.
The Sanarus needle penetrates beyond the lesion since the active freezing area does not reach its tip. That limits the cases in which it can be used because of the potential for hitting healthy tissue. No such limitations hold back IceSense3, whose advanced needle technology doesn't require reaching past the tumor.
Also, says Himelfarb, the Sanarus needle, handle and tube connecting the device to the operating console all get thrown away after every procedure. With IceSense3, only the needle is disposable. This results in much lower cost and environmental impact. The handle has controls integrated into it, allowing the physician to perform the procedure solo, whereas the Sanarus device requires a second person to operate the touch screen. "Since our system is newer and the graphical user interface is more advanced, we provide the surgeon with flexibility in making decisions before and during the procedure," says Himelfarb.
Why remove a benign tumor?
Himelfarb explains that before the advent of a cryogenic solution, women with fibrous breast tumors - the majority of whom are between 17 and 30 years old - could either keep monitoring them or have them surgically removed.
Why treat it if it's benign? "I don't know any woman who wants to get up every morning and feel a lump in her breast even if she knows it was diagnosed as benign," Himelfarb answers. "It creates anxiety because it might potentially hide other tumors, and it is preferable to get rid of it."
Women can have the cryoablation procedure done in the doctor's office, private clinic or hospital breast center, freeing up operating rooms for more complicated (and profitable) procedures. It is reimbursable for half the amount of surgery, which saves money for insurers.
Best of all for patients, it is virtually painless. A local anesthetic is administered before the needle goes in, but after that the freezing itself numbs the area. "The patient feels no pain and doesn't require post-treatment of any kind," says Himelfarb. The needle is similar to the kind she would already have seen when her tumor was biopsied, he adds.
Graduate of a biotech incubator
IceCure began in 2006 as part of the Naiot Venture Accelerator in Yokneam, an incubator for IT and life science startups. Co-founded by cryogenics expert Dr. Alex Levin and businessman Didier Toubia after many consultations with physicians, IceCure developed its product based on a technology Levin had patented in 2002.
"One of our original investors is the Bridge Fund in Cleveland, Ohio, which is helping us open doors in America," says Himelfarb. The company is concentrating only on the vast US market but will also seek approval from Israel's Ministry of Health. "In the US, there is already existing reimbursement and coverage, while in other countries we'd need to invest more in clinical trials," he says.
Himelfarb is an electronics engineer who came to IceCure after 28 years in the industry with Israeli companies such as Medtronic and Remon Medical Technologies, which was sold three years ago to Boston Scientific. He says that IceCure's research and development activities in Israel are currently focused on a newer generation of IceSense as well as a future device for treating uterine fibroids.