GE Healthcare -
Approved for Sale in Australia and Taiwan.
--Women in Asian Pacific to be offered non-invasive treatment for uterine fibroids--
HAIFA, Israel, June 21, 2006 – InSightec announced today it has been awarded regulatory approval by the Australian and Taiwanese governments for commercial distribution of the ExAblate® 2000 magnetic resonance guided focused ultrasound (MRgFUS) incisionless surgery system for the treatment of uterine fibroids.
"The approvals in Australia and Taiwan will expand access to this revolutionary incisionless surgery technology in these important markets in Asia and the Pacific,” said Jacob Vortman, PhD, President and Chief Executive Officer of InSightec. “The ExAblate system is a breakthrough technology that has the potential to benefit millions of women around the world who are seeking a non-invasive alternative to surgery to deal with their uterine fibroid symptoms.”
MRgFUS combines Magnetic Resonance Imaging (MRI) to visualize tissue in the body, plan and monitor the treatment and outcome in real time and high-intensity focused ultrasound energy to thermally ablate (destroy) tissue such as tumors.
ExAblate 2000 is the only MRgFUS system approved by the U.S. Food and Drug Administration as a non-invasive, outpatient procedure to treat uterine fibroids. It also has the European CE mark ISO 13485 and ISO 9001. Over 1800 women have been treated worldwide for symptomatic uterine fibroids.
The company has begun clinical trials to study the technology’s use in other indications including breast, bone, liver and brain tumors.
About ExAblate 2000
The ExAblate 2000 is the first U.S. Food and Drug Administration (FDA) approved system to use the breakthrough MRgFUS technology that combines MRI – to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome – and high intensity focused ultrasound to thermally ablate uterine fibroid tissue. MR thermal feedback, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is fully treated and surrounding tissue is spared. ExAblate received FDA approval for the treatment of symptomatic uterine fibroids in October 2004. ExAblate has been recognized for its innovation and potential to serve mankind and has been awarded the 2004 European Union’s Information Society Technologies grand prize, The Wall Street Journal’s 2004 Technology Innovation Awards, and Advanced Imaging’s 2005 Solutions of the Year.
Uterine fibroids are benign growths in the uterus that up to 30% of women of childbearing age. Symptomatic women suffer from extensive and prolonged menstrual bleeding, anemia, pain, pressure and often infertility. Existing treatment options include hysterectomy, myomectomy and uterine artery embolization and are invasive, involving hospitalization and several weeks of recovery time. ExAblate is an outpatient procedure and patients return home the same day and to work within one to two days.
