Israel's Icecure Gets US FDA To Expand To Treat Tumours In Liver, Kidney Besides Breast Tumors
Medical, an Israel based company said that it received US regulatory approval to expand the use of its cryoablation
technology to treat benign and cancerous tumors
in livers and kidneys.
's treatment platform uses special needles to inject liquid nitrogen to freeze and destroy tumors
without the need for surgery.
had initially focused on breast tumors,
but now the US Food and Drug Administration (FDA) approved new uses, such as against tumors
in the kidney, liver and in the fields of neurology and ear, nose and throat, the company said.
The FDA also approved its new MultySense system that has three probes, it said. Its earlier system had one needle.
Chief Executive Eyal Shamir told Thailand Medical
news via a phone interview, "This machine will allow us to treat bigger tumors
or a few different tumors
at the same time of treatment. Also we have a new system that is slated to be launched at the end of 2020.”
Medical develops and markets minimally invasive cryoablation
therapies for women's health and the general oncology
market. The company's proprietary IceSense3 and ProSense systems provide minimally invasive, in-office definitive treatment for symptomatic tumors
in various organs.
The minimally invasive cryoablation
procedure is done under ultrasound or CT imaging to guide a small probe (thin hollow needle) into the tumor.
The system then uses extremely cold temperatures to ablate the targeted tumor
in situ. The cryoablation
procedure is a safe and effective treatment option that can be performed quickly in a doctor's office.
has US FDA and CE approval for broad benign and malignant indications. The company's ProSense is available in the United States, Europe, Hong Kong, Thailand, Singapore, Central America, and South America. The company is also undergoing the regulatory process in China with the CFDA as well as other Asian and South American countries.
It is currently participating in several clinical studies for the treatment of lung, kidney, and breast cancer
(under clinical studies in the United States and Japan).