Elbit Imaging Ltd. Announces That INSIGHTEC's Exablate Neuro System Has Been Approved by MHLW (Japan) for the Treatment of Es...
December 19 2016 - 1:22PM
Elbit Imaging Ltd. (TASE:EMITF) (NASDAQ:EMITF)
("
Elbit" or the "
Company")
announced today that it was informed by INSIGHTEC Ltd.
("
INSIGHTEC"), that the Exablate system
(“
Exablate”) received CE Mark for treating
locally-confined prostate cancer with MR-guided Focused Ultrasound
(MRgFUS).
One of six men will be diagnosed with prostate
cancer during their lifetime. Many patients are diagnosed with
locally confined disease with low or intermediate risk for
progression. In these cases, patients may choose between monitored
waiting and an intervention. Currently available treatments
including prostatectomy, which surgically removes the entire
prostate, and radiation therapy, which demonstrates good cancer
control, however there might be impacts on potency and
continence.
The Exablate is based on INSIGHTEC’s proprietary
focused ultrasound technology. It uses focused ultrasound waves to
precisely target and ablate, or destroy, the targeted tissue in the
prostate, while avoiding adjacent structures and with no incisions.
The treatment is done under Magnetic Resonance Imaging (MRI)
guidance for high resolution visualization of the patient’s anatomy
as well as real-time temperature monitoring of the treatment area.
The treatment requires a single session, allowing patients a quick
return to normal activity.
In addition, the Company was informed by
INSIGHTEC that the Japanese Ministry of Health, Labor and Welfare
(“MHLW”) has approved its Exablate Neuro system
(“Exablate Neuro”) for the non-invasive treatment
of essential tremor in patients who do not respond to medication.
The approval was given based on data collected in a global clinical
trial conducted in eight medical centers in North America and
Asia.
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.
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 MHLW
approval was granted based on clinical data from a randomized,
double-blind, multi-center clinical study which demonstrated the
safety and efficacy of non-invasive thalamotomy with Exablate
Neuro.
At this stage, INSIGHTEC is unable to
estimate the implications of the MHLW and EU (CE) approvals on
INSIGHTEC.
The Company holds approximately 89.9% of the
share capital of Elbit Medical Technologies Ltd. (TASE:EMTC-M)
(85.6% on a fully diluted basis) which, in turn, holds
approximately 31.3% of the share capital in INSIGHTEC (26.6% on a
fully diluted basis).
About Elbit Imaging Ltd.
Elbit Imaging Ltd. operates in the following
principal fields of business: (i) Commercial centers - initiation,
construction, and sale of commercial centers and other mixed-use
property projects, predominantly in the retail sector, located in
Central and Eastern Europe. In certain circumstances and depending
on market conditions, the Group operates and manages commercial
centers prior to their sale. (ii) Hotel - operation and
management of the Radisson hotel complex in Bucharest, Romania.
(iii) Medical industries and devices - (a) research and
development, production and marketing of magnetic resonance imaging
guided focused ultrasound treatment equipment, and (b) development
of stem cell population expansion technologies and stem cell
therapy products for transplantation and regenerative medicine.
(iv) Plots in India - plots designated for sale initially
designated to residential projects.
Any forward-looking statements in our releases
include statements regarding the intent, belief or current
expectations of Elbit Imaging Ltd. and our management about our
business, financial condition, results of operations, and its
relationship with its employees and the condition of our
properties. Words such as “believe,” “expect,” “intend,” “estimate”
and similar expressions are intended to identify forward-looking
statements but are not the exclusive means of identifying such
statements. Actual results may differ materially from those
projected, expressed or implied in the forward-looking statements
as a result of various factors including, without limitation, a
change in market conditions, a decision to deploy the cash for
other business opportunities and the factors set forth in our
filings with the Securities and Exchange Commission including,
without limitation, Item 3.D of our annual report on Form 20-F for
the fiscal year ended December 31, 2015, under the caption “Risk
Factors.” Any forward-looking statements contained in our releases
speak only as of the date of such release, and we caution existing
and prospective investors not to place undue reliance on such
statements. Such forward-looking statements do not purport to be
predictions of future events or circumstances, and therefore, there
can be no assurance that any forward-looking statement contained in
our releases will prove to be accurate. We undertake no obligation
to update or revise any forward-looking statements.
For Further Information:
Company Contact
Ron Hadassi
Chairman of the Board of Directors
Tel: +972-3-608-6048
Fax: +972-3-608-6050
ron@elbitimaging.com
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