HAIFA, Israel (March 12, 2007)—InSightec Ltd. announced today that Canada’s healthcare regulatory body, Health Canada, has granted regulatory approval to the company’s ExAblate Magnetic Resonance-guided Focused Ultrasound (MRgFUS) incisionless surgery system for the treatment of symptomatic uterine fibroids.
"We’re very pleased that the Canadian government has approved ExAblate, the only non-invasive treatment option for women suffering from the painful, symptoms of uterine fibroids,” said Jacob Vortman, PhD, President and Chief Executive Officer of InSightec. “This approval expands access to this revolutionary incisionless surgery technology and offers Canadian women an alternative to hysterectomy and other invasive surgeries to treat this condition. Instead of lengthy hospitalizations and weeks of recovery time, the outpatient ExAblate procedure allows women to return home after treatment and get back to normal activities with their families and jobs within two days.”
ExAblate uses MR guided Focused Ultrasound which 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 non-invasively.
ExAblate was approved by the U.S. Food and Drug Administration (FDA) in October 2004 and to date over 2,500 women have been treated worldwide for symptomatic uterine fibroids.
“Non-invasive therapy with ExAblate has the potential to dramatically change the way surgery is conducted” said David Gianfelice, MD, lead researcher. “We are delighted that Canadian women suffering from uterine fibroids will now have access to this technology.”
Doctors from the Mount Sinai Hospital and University Health Network (UHN) Joint Department of Medical Imaging in Toronto, Ontario are conducting clinical studies on uterine fibroids, pain palliation of patients suffering from advanced bone metastases and breast tumors using the ExAblate.
The ExAblate is the first 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.
InSightec Ltd. is a privately held company owned by Elbit Medical Imaging (EMI), General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 135 employees and has invested more than $100 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to: http://www.insightec.com/
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