InSightec Submits Pre Market Application (PMA) for FDA Approval of ExAblate for Treatment of Painful Bone Metastases

TIRAT CARMEL, Israel, January 24, 2012 /PRNewswire/ –

InSightec Ltd, the leader in MR guided Focused Ultrasound therapy, announced that it
has submitted a premarket approval application (PMA) to the U.S. Food and Drug
Administration (FDA) for its ExAblate treatment of pain palliation of bone metastases.
[http://www.bone-pain-palliation.co.uk ] ExAblate uses MR guided focused ultrasound
(MRgFUS) to treat the pain caused by bone metastases non-invasively and without ionizing
radiation.

Over sixty percent of cancer patients suffer from painful bone metastases. Of these
thirty percent will not respond to radiation therapy. ExAblate was investigated as an
option for these patients. The PMA submission was based on a two arm randomized controlled
trial [http://clinicaltrials.gov/ct2/show/NCT00656305?term=exablate&rank=10 ] comparing
patients undergoing ExAblate’s MR guided focused ultrasound for palliation of painful bone
metastases [http://www.insightec.com/BoneMets-ClinicalTrials.html ] with patients
undergoing a sham, (no) treatment. Patients who had no response to the sham treatment were
later allowed to undergo an ExAblate treatment. The FDA also granted an expedited review
process for the PMA submission.

“Today’s announcement is a significant milestone: our second medical indication
submitted for FDA approval and the first PMA for oncology ” said Dr. Kobi Vortman,
President and CEO of InSightec. “This represents our continued commitment to bring MRgFUS
into broad clinical use.”

ExAblate combines high intensity focused ultrasound to thermally ablate tumors and
continuous MRI to visualize the anatomy, plan treatment and monitor treatment outcomes in
real time.

ExAblate is the only MRgFUS system with FDA approval, granted in 2004 for uterine
fibroids. It also received European CE marking for uterine fibroids, bone metastases, and
adenomyosis. Clinical trials are ongoing for brain disorders, including essential tremor
and Parkinson’s disease, and prostate cancer.

About InSightec

InSightec Ltd. is privately held by Elbit Imaging, General Electric, MediTech
Advisors, 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 130 employees and has invested more
than $150 million in research, development, and clinical investigations. ExAblate has won
several awards for innovation and its potential to help mankind including the Wall St.
Journal Technology Innovation Award and the European Union’s IST grand prize. Time
Magazine recently included it among the 50 best inventions. ExAblate was presented at
TEDMED 2011 [http://www.insightec.com/tedmed.html ] in San Diego, Ca.

Websites: http://www.insightec.com; http://www.bone-pain-palliation.co.uk

About Focused Ultrasound Foundation

The Focused Ultrasound Foundation [http://www.fusfoundation.org ] is dedicated to
improving the lives of millions of people with serious medical disorders by accelerating
the development and adoption of focused ultrasound — an amazing, early-stage, noninvasive
therapeutic technology that has the potential to revolutionize surgery, radiation therapy
and drug delivery and to transform the treatment of many life-threatening and disabling
conditions.

http://www.fusfoundation.org

        Media Contact:
        Lynn Golumbic
        +1866-835-0437 x309
        +972(4)813-1309
        lynng@insightec.com

SOURCE InSightec Ltd