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FDA APPROVES
ExAblate(R) 2000 SYSTEM AS NON-INVASIVE SURGERY FOR UTERINE
FIBROIDS
-New outpatient procedure significantly reduces symptoms and
improves quality of life for women with symptomatic uterine
fibroids
-First FDA approval for MR guided Focused Ultrasound System-
October 22, 2004
Haifa, Israel - InSightec, today reported that
the U.S. Food and Drug Administration (FDA) has awarded pre-market
approval (PMA) to the Company's ExAblate® 2000 system for
the non-invasive surgery of symptomatic uterine fibroids. Elbit
Medical Imaging Ltd. (NASDAQ: EMITF) is the major shareholder
in InSightec.
According to the U.S. National Institutes of Health, at least
25 percent of women suffer from uterine fibroids. As many as 77
percent of women may actually have the condition, but may be unaware
of it because they exhibit few or no symptoms. Symptoms of uterine
fibroids include heavy bleeding or painful periods, bleeding between
periods, pressure on the lower abdomen, frequent urination (resulting
from fibroid pressure on the bladder), pain during sex, and lower
back pain. Until today, treatment options for uterine fibroids
included invasive and minimally invasive procedures such as hysterectomy,
myomectomy or uterine artery embolization (UAE). Hormonal therapy,
the only non-invasive surgery available, offers only temporary
relief of symptoms, and fibroids frequently grow back once therapy
is terminated.
"Many women with fibroids continue to suffer with their symptoms
rather than undergo treatment out of concern for the side effects
of existing therapies. ExAblate 2000 gives women an important
new choice to help reduce the symptoms of uterine fibroids," said
Elizabeth A. Stewart, MD, Brigham and Women's Hospital and co-principal
lead investigator.
Dr. Jacob Vortman, PhD, President and CEO of InSightec, said,
"Today's approval marks an historic event for InSightec and underscores
the importance of imaging technologies not only as diagnostic
tools, but also as therapeutic treatment enablers for a growing
range of diseases. By bringing together world experts in gynecology,
ultrasound and magnetic resonance imaging, we have helped to commercialize
the first non-invasive surgery for uterine fibroids that has
the potential to provide significant relief of disease symptoms.
InSightec is committed to using focused ultrasound surgery and
innovative MR imaging to advance the care of patients with serious
diseases, and we are exploring the potential application of the
ExAblate system in other diseases such as breast, liver, bone
and brain cancer."
About the ExAblate® 2000 System
The ExAblate System integrates focused ultrasound thermal ablation
with GE Healthcare's MR imaging capabilities to provide a non-invasive
method for destroying (ablating) targeted tissue. General Electric
Capital Equity Holdings, Inc., a division of General Electric
Company (NYSE: GE), is an equity shareholder in InSightec.
During this outpatient procedure the patient
lies inside the MRI scanner. The MRI scanner provides 3-dimensional
images of the fibroid and surrounding tissue, enabling precise
guidance of the ultrasound waves to the target tissue. Highly
focused ultrasound waves are directed into the body, and at the
focal point, the ultrasound waves raise the temperature of the
tissue, leading to its destruction. The thermal imaging capabilities
of the MRI scanner provide real-time feedback on the temperature
achieved at the target tissue during treatment, helping to ensure
therapy outcome control.
"Our partnership with InSightec demonstrates
our company's commitment to partner and invest in innovative technologies
that benefit both doctors and patients," said Joe Hogan, President
and CEO, GE Healthcare Technologies. "What's most gratifying about
GE's contribution to the ExAblate 2000 system is knowing millions
of women around the world afflicted with fibroids will now have
an opportunity to treat their symptoms non-surgically."
The ExAblate is the first focused ultrasound thermal ablation
system approved by the FDA and is also the first focused ultrasound
surgery system using Magnetic Resonance (MR) guidance approved
by the FDA, providing an alternative treatment option for women
with uterine fibroids, the most common non-cancerous tumor in
women of childbearing age.
The device received the European CE mark and
ISO 9001 and is commercially available in Israel, Europe, and
Asia. The ExAblate System was awarded the 2004 European Information
Society Technologies grand prize for innovation and potential
to serve mankind. Around the world over 700 women have been treated
with ExAblate 2000.
Clare Tempany, M.D., Brigham and Women's Hospital, and co-principal
investigator said, "ExAblate 2000 provides a major advance
in image guided therapy, significantly increasing our ability
to both identify the precise target and treatment location as
well as directly monitor the treatment effect and outcome."
Other treatment modalities for uterine fibroids, including hysterectomy
and myomectomy, are conducted as in-patient procedures usually
requiring a hospital stay. Hysterectomy is the most common surgical
procedure for uterine fibroids and the NIH estimates that more
than 200,000 women undergo hysterectomy each year as a treatment
for uterine fibroids. According to the Society of Interventional
Radiology, hysterectomy requires a 3-4 day hospital stay and a
recovery time of approximately six weeks; myomectomy also requires
a hospital stay of several days and a recovery time of two to
four weeks; and UAE requires a day of hospitalization and a week
of recovery time. According to a RAND report, direct costs alone
associated with treating uterine fibroids are more than $1 billion
annually. As an outpatient procedure, the ExAblate procedure has
the potential to be a more cost effective therapy compared with
current invasive surgery strategies.
Pivotal Trial Results
The FDA approval to market ExAblate followed a multi-national
trial conducted in 109 women with symptomatic uterine fibroids
at seven medical centers around the world. After 6 months 70.6
percent of the women reported a significant improvement in fibroid
related symptoms. The study compared the results of ExAblate treatment
with total abdominal hysterectomy. Patients treated with the ExAblate
missed 1.4 working days, on average compared to an average of
18 days for the hysterectomy group. They returned to normal activity
in less than 3 days, compared to 17 days for the hysterectomy
group. Adverse events, while rare, included minor skin burns,
and a few instances of nerve injury, all of which resolved within
one year.
Availability of ExAblate 2000 for the Treatment of Uterine
Fibroids
ExAblate 2000 is only compatible with General Electric Healthcare's
SIGNA 1.5 Tesla Magnetic Resonance systems. Currently, seven major
medical centers in the United States are equipped with the ExAblate
2000 System:
- Brigham and Women's Hospital in Boston
- The Johns Hopkins Hospital in Baltimore
- Mayo Clinic in Rochester, MN
- University MRI in Boca Raton
- Tower Beverly Radiology - Radnet in Beverly Hills, CA
- Virtua Health in Marlton, NJ
- The Lahey Clinic in Boston, MA
Physicians, patients or hospital administrators interested in
learning more about ExAblate 2000 for the treatment of symptomatic
uterine fibroids may call 1-866-EXABLATE. Patient information
is also available on www.uterine-fibroids.org.
About InSightec:
InSightec Image Guided Treatment Ltd. is a privately held company
owned by Elbit Medical Imaging (EMI), General Electric, private
investors, 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 80 employees and has invested
more than $60 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: www.insightec.com.
About EMI:
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' 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 Commission.
About GE Healthcare:
GE Healthcare provides transformational medical technologies that
will shape a new age of patient care. GE Healthcare's expertise
in medical imaging and information technologies, medical diagnostics,
patient monitoring systems, disease research, drug discovery and
biopharmaceuticals is dedicated to detecting disease earlier and
tailoring treatment for individual patients. GE Healthcare offers
a broad range of services to improve productivity in healthcare
and enable healthcare providers to better diagnose, treat and
manage patients with conditions such as cancer, Alzheimer's and
cardiovascular diseases.
GE Healthcare is a $14 billion unit of General Electric Company
(NYSE: GE) that is headquartered in the United Kingdom. Worldwide,
GE Healthcare employs more than 42,500 people committed to serving
healthcare professionals and their patients in more than 100 countries.
For more information about GE Healthcare, visit our Web site at
http://www.gehealthcare.com/.
Video News Release Contents:
- Soundbites
- Kristen Larsen - ExAblate® 2000 Patient
- Dr. Clare Tempany, Associate Professor of Radiology;
Director, Clinical MRI, Brigham and Women's Hospital
- Dr. Elizabeth Stewart. Clinical Director, Center for
Uterine Fibroids., Brigham and Women's Hospital
- B-roll Includes
- Patient in garden
- MR Screenshots
- Focused Ultrasound animation
- Patient on ExAblate table
Satellite coordinates and feed times:
- Galaxy 3 (c-band) Transponder 2
- Downlink 3740 (V) Audio 6.2 and 6.8
- Monday, October 25, 2004 --- 2:30-2:45 PM ET
- Tuesday, October 26, 2004 --- 10:00-10:25 AM ET
For media inquiries, contact:
Laura Yoshida
Lazar Partners Ltd
Tel: (212) 867-1762
Email: lyoshida@lazarpartners.com |
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