Icecure Medical Ltd. reported that the U.S. FDA has granted marketing authorization to Icecure's de novo application for the Prosense cryoablation system for the local treatment of breast cancer in patients 70 years of age or older with biologically low-risk tumors. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment.

Early-stage breast cancer patients in the U.S. may soon be able to access another treatment regime based on the result of a Nov. 7 FDA advisory committee for the Prosense cryoablation system by Icecure Medical Ltd. The advisory committee voted 9-5 that the benefits of Prosense outweigh the risks, although the FDA has yet to decide on the application.

Icecure Medical Ltd.’s Prosense system demonstrated a 100% success rate in destroying breast cancer tumors that were less than or equal to 25 millimeters, according to a study published in the British Journal of Radiology.

Icecure Medical Ltd. submitted data to the U.S. FDA seeking de novo marketing authorization for its Prosense system to treat patients with early stage T1 invasive breast cancer in combination with adjuvant hormone therapy. Prosense is a minimally invasive cryoablation technology that freezes and destroys tumors, both malignant and benign.

The U.S. FDA granted Edap Tms SA breakthrough device designation for its Focal One system to treat deep infiltrating rectal endometriosis. The company believes that the Focal One high intensity focused ultrasound technology can offer relief to the thousands of women suffering from the debilitating condition.

Cryoablation technology firm Icecure Medical Ltd. raised $6 million (₪20.7 million) in an oversubscribed equity offering. The Caesarea, Israel-based company (TASE:ICCM) plans to use the funds for continued expansion of operations in the U.S., Europe and Asia.