Quantcast
Last updated on April 17, 2014 at 17:30 EDT

ExAblate Receives Approval of Chinese Food and Drug Administration

July 29, 2013

TIRAT CARMEL, Israel, July 29, 2013 /PRNewswire/ –

Non-invasive MR guided Focused Ultrasound treatment now available for

millions of Chinese women suffering from uterine fibroids

InSightec Ltd, the leader in MR guided Focused Ultrasound therapy, announced that its
ExAblate system received approval of the Chinese Food and Drug Administration (CFDA) for
non-invasive treatment of uterine fibroids.

Uterine fibroids are benign tumors that grow in the uterus. 20-50% of women of
childbearing age suffer from uterine fibroids. Hysterectomy, surgical removal of the
uterus, is the most common form of treatment.

ExAblate combines high intensity focused ultrasound waves and continuous MRI guidance
and monitoring. The focused ultrasound energy is used to ablate or destroy the fibroids
while the MRI images are used to plan and guide the therapy and monitor treatment outcome.

ExAblate benefits are that it is incisionless, requires no hospitalization, has a high
safety profile with low risk of infection and complications, and rapid recovery.

ExAblate received approval by the United States FDA in 2004 and is the only MR guided
Focused Ultrasound system to have both FDA and CFDA approval. Thousands of women have been
treated with the system around the world. Dr. Kobi Vortman, CEO and founder of InSightec
said, “We are extremely proud to have received CFDA approval for ExAblate which is another
vote of confidence in ExAblate’s high safety profile and excellent outcomes.”

The CFDA approval was based on data published from clinical trials conducted at Peking
Union Medical College Hospital and China Medical University First Hospital.

“In our clinical study we found that patients who underwent ExAblate treatment were
able to return home within few hours and to normal life within one or two day. It is a
safe and effective way to treat women with symptomatic fibroids and should be offered as a
non-invasive treatment option.” said Prof. Jin Zhengyu, the lead investigator.

————————————————————————————–

About InSightec

InSightec [http://www.insightec.com ] Ltd. is privately held by Elbit Imaging, General
Electric, and MediTech Advisors. Founded in 1999 InSightec developed ExAblate to transform
MRI-guided Focused Ultrasound (MRgFUS) into a clinically viable technology. ExAblate has
won several awards for innovation and its potential to help mankind including The Wall
Street Journal Technology Innovation Awards and the European Union’s IST grand prize. TIME
magazine recently named Focused Ultrasound as “one of 50 best inventions.” For more
information please visit: http://www.insightec.com.

        Media Contact:
        Lynn Golumbic
        lynng@insightec.com
        Tel: +972-4-8131309

SOURCE InSightec Ltd


Source: PR Newswire