The Japanese Ministry of Health, Labor and Welfare Approved Exablate Neuro System for the Treatment of Essential Tremor

Tokyo and Haifa, Israel (ots/PRNewswire) - INSIGHTEC
(http://www.insightec.com/JP/), the leader in MR-guided Focused
Ultrasound (MRgFUS) therapy, announced today that the Japanese
Ministry of Health, Labor and Welfare (MHLW) has approved its
Exablate Neuro system for the non-invasive treatment of essential
tremor in patients who have not responded to medication.

Exablate Neuro uses focused ultrasound waves to precisely target and
ablate tissue deep within the brain with no incisions. The treatment
is performed under Magnetic Resonance Imaging (MRI) guidance for
real-time treatment monitoring. The approval was granted based on
data from a randomized, double-blind clinical study conducted in
eight medical centers in North America and Asia. The study
demonstrated the safety and efficacy of non-invasive thalamotomy with
Exablate Neuro.

"Results of this study show that Exablate Neuro is safe and effective
for treating essential tremor. Finding the most effective way to
manage tremor symptoms and improve the quality of life is crucial for
patients," said Professor Takaomi Taira MD, Tokyo Women's Medical
University. "Patients treated showed immediate tremor control,
allowing them to regain ability to perform daily tasks such as eating
and writing," he concluded.

"INSIGHTEC is committed to the Japanese neurosurgery market," said
Yair Bauer, Country Manager, INSIGHTEC Japan. "Following the MHLW
approval, INSIGHTEC Japan can develop its market presence and offer
essential tremor patients a non-invasive solution to improve their
quality of life," he added.

Earlier this year, Exablate Neuro was also approved by the US Food
and Drug Administration (FDA) and Health Canada for the treatment of
essential tremor. Exablate Neuro also has approvals in Europe and
Israel. Exablate Neuro is registered in Japan under the name Exablate
4000.

About Essential Tremor

Essential tremor is the most common movement disorder, affecting more
than 3 million people in Japan, and millions more worldwide. Hand
tremor is the most common symptom, but tremors can also affect the
head, arms, voice, legs, and torso. The cause of this disease is
still unknown but it has a strong hereditary attribute. Patients
often have trouble performing everyday tasks such as eating,
dressing, writing, holding objects and even speaking.

About INSIGHTEC Japan K.K.

INSIGHTEC Japan K.K. is a subsidiary of INSIGHTEC LTD. The company is
the distributor of Exablate in Japan and the regulatory market
approval holder of Exablate Neuro (Exablate 4000). Founded in 2005,
its mission is to provide non-invasive treatments for neurosurgery,
oncology and women's health indications, in order to significantly
improve the quality of life for patients in Japan. For more
information please visit: http://www.insightec.com/JP

About INSIGHTEC LTD

INSIGHTEC is the world leader in MR-guided Focused Ultrasound
(MRgFUS). The company's non-invasive therapy platforms, Exablate and
Exablate Neuro, are transforming treatment for various indications in
neurosurgery, oncology and women's health. A growing number of
renowned physicians are realizing the clinical value of MRgFUS in
more than 80 leading medical centers around the world. For more
information please visit: http://www.INSIGHTEC.com.

Media Contact:

Joanna Clark

T +44(0)20-7403-8878

insightec@rlyl.com
http://www.rlyl.com

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