IceCure tests its freeze technology on malignant breast tumours

* IceCure in-office procedure costs half that of surgery

* Clinical trials for malignant tumours in 20 U.S. hospitals

TEL AVIV, Oct 1 (Reuters) - IceCure Medical Inc, whose technology destroys benign breast tumours by freezing them, is starting trials in the United States to test the product’s effectiveness on malignant breast tumours, its chief executive said.

The technology - cryoablation - has existed for decades to treat organs such as prostate, liver and kidney instead of surgery. The older technology requires the procedure to be done in an operating room usually under general anaesthesia.

“We decided to do two things. Since we are using a newer technology we moved it from the operating room to the doctor’s office,” CEO Hezi Himelfarb told Reuters. “Second, we looked for new areas ... not crowded with competition with high demand.”

IceCure’s device, the IceSense3, needs six minutes to kill a 3 cm tumour, compared with 45 minutes for the older technology.

Nearly 400 women in the United States have undergone the procedure to remove benign tumours called breast fibroadenomas. Using local anaesthesia, a needle is inserted into the tumour at minus 170 degrees Celsius, creating an ice ball that kills the tumour. The dead tissue is absorbed by the immune system.

The procedure costs $2,500, half that of surgery, and is covered by several insurers such as United Healthcare.

The company’s U.S. Food and Drug Administration approval includes use of the IceSense3 in malignant tumours but there is not yet enough clinical data to prove it is effective.

“We are starting a clinical study in the U.S. for treatment in breast cancer tumours up to 1.5 cm in up to 200 patients in 20 hospitals,” Himelfarb said.

“Because of the huge interest in breast cancer treatments, we have been approached by many institutions that want to be involved and are willing to pay most of the expenses for the study,” he said, without elaborating.

IceCure, which estimates the U.S. market for fibroadenomas is worth $800 million a year, is also looking at other indications such as lung tumours and uterine fibroids.

Israeli insurer Migdal is the largest shareholder in IceCure, with more than 16 percent. IceCure raised more than $10 million in a Tel Aviv public offering in 2011.

In the second quarter, IceCure started selling the systems after lending them out for free for the last 2.5 years, having charged only for needles. This change boosted sales in the second quarter to $350,000, similar to its sales in all of 2013.

“We expect to continue to grow our sales on an annual basis,” Himelfarb said. (Reporting by Tova Cohen; Editing by Steven Scheer)