GAITHERSBURG, Md., June 4 /PRNewswire-FirstCall/ -- InSightec Ltd., a
majority owned subsidiary of Elbit Medical Imaging Ltd. (Nasdaq: EMITF), today
reported that the Obstetrics and Gynecology Devices Panel of the U.S. Food and
Drug Administration (FDA) has recommended the Company's ExAblate(R) 2000
System for the non-invasive treatment of uterine fibroids for approval, with
post-approval conditions. The ExAblate System is the first Magnetic Resonance
guided Focused Ultrasound Surgery (MRgFUS) system to be reviewed by the panel
and recommended for FDA approval.
The ExAblate System is intended to provide a non-invasive alternative to
current treatments for symptomatic uterine fibroids, which include
hysterectomy, myomectomy, uterine artery embolization, and drug therapy.
Uterine fibroids are the most common reason for surgery among women of
reproductive age, after caesarean section. Approximately 200,000 women in the
United States currently undergo hysterectomy each year for the treatment of
Dr. Jacob Vortman, President and Chief Executive Officer of InSightec,
said, "We are pleased with the recommendation for approval and look forward to
working closely with the FDA on the specific conditions for approval. 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. Although the concept
of focused ultrasound has been researched for over 60 years, this is the first
time an implementation of this technology has been recommended for FDA
The panel recommendation was based on the results of a multicenter,
controlled clinical study that was performed at centers in the United States,
Europe, and Israel, including Brigham and Women's Hospital, the Mayo Clinic,
and Johns Hopkins Hospital in the US, St. Mary's Hospital in London, Charite
Hospital in Berlin, and Sheba Medical Center and Hadassah Hospital in Israel.
The primary endpoint of the study was to ensure improvement in uterine fibroid
symptom severity, as measured using a patient treatment outcome questionnaire,
and ensure safety of the device.
"Upon approval, women will have a significant alternative for a very
common, debilitating condition. We are delighted to have participated in this
ground-breaking study and hope that this will stimulate further research for
fibroids," said Elizabeth A. Stewart, M.D., Brigham and Women's Hospital and
Co-principal investigator Clare Tempany-Afdhal, M.D., Brigham and Women's
Hospital stated, "The novel combination of Focused Ultrasound and Magnetic
Resonance guidance provides a unique image-guided therapy that has the
potential to be used for many other applications."
Post-approval conditions recommended by the FDA panel were related to the
development of training material and labeling.
The ExAblate System attaches to a standard 1.5 Tesla MRI system used in
many hospitals. During this outpatient procedure the patient lies inside the
MRI scanner and highly focused ultrasound waves, which non-invasively ablate
the uterine fibroid(s), are emitted into the body. The device received the
European CE mark in 2002 and is currently commercially available in Israel,
Europe, and Japan.
InSightec Ltd. is privately held company owned by Elbit Medical Imaging,
General Electric, private investors, and employees. It was founded in 1999 to
develop the promising MR guided Focused Ultrasound technology. Headquartered
near Haifa, Israel, the company has over 80 employees and has invested more
than $50 million in research, development, and clinical investigations. Its US
headquarters are located in Dallas, Texas. ExAblate was awarded the 2004 grand
prize of the IST (Information Society Technology) of the European Union for
innovation and potential to serve mankind. For more information, please go
to: http://www.insightec.com .
EMI is a subsidiary of Europe Israel (M.M.S.) Ltd. and focuses on four
main fields of operations: Commercial and Entertainment Malls through its
subsidiary Plaza Centers; the Hotel segment through its subsidiary Elscint
Ltd.; image guided treatment through InSightec; and venture capital
investments in the biotechnology and communication business.
Any forward looking statements with respect to EMI's business, financial
condition and results of operations included in this release are subject to
risks and uncertainties that could cause actual results to differ materially
from those contemplated in such forward looking statements, including, but not
limited to, product demand, pricing, market acceptance, changing economic
conditions, risks in product and technology development and the effect of
EMI's accounting policies, as well as certain other risk factors which are
detailed from time to time in EMI's filings with the Securities and Exchange
SOURCE InSightec Ltd.