CE Mark for Mirabilis system of therapeutic ultrasound technology to treat uterine fibroids.- Mirabilis Medical Inc.

Mirabilis Medical Inc., developer of advanced therapeutic ultrasound technology for non-invasive surgery, announced CE mark authorization for marketing of its system for the treatment of uterine fibroids throughout the European Union.

The Mirabilis system combines high-speed ultrasound technology with an advanced robotic system to allow treatment within minutes in a medical office setting. The Mirabilis system treats uterine fibroids non-invasively by focusing ultrasound energy into the fibroids from outside the body � no cutting is involved. The procedure is performed by a physician placing the Mirabilis device on a woman�s abdomen, locating the fibroid using built-in ultrasound imaging, and selecting the area of the fibroid to be treated. Under physician control, the system then automatically treats the fibroid using a robotic motion system. Proprietary Mirabilis technology allows typical treatments to be completed in less than ten minutes in a medical office, as opposed to several hours in a hospital for some alternatives.

Comment; Mirabilis has received FDA approval for a US clinical study. The DIANA study is intended to lead to marketing approval of the system in the United States, and is planned to be conducted at up to 12 clinical sites in the US, Canada, and Europe.