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.