Replies to post #1666 on Elbit Imaging Ltd (EMITF)

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Elbit Imaging Ltd. Announces FDA Approval Extension of Insightec's Exablate Neuro for Treatment of Essential Tremor


TEL AVIV, ISREAL / ACCESSWIRE / April 24, 2017 / Elbit Imaging Ltd. (EMITF.TA) (EMITF) ("Elbit" or the "Company") announced today, in furtherance to the announcements dated on October 22, 2015 and July 12, 2016, that it was informed by INSIGHTEC Ltd. ("INSIGHTEC"), that the FDA has extended its approval of Exablate Neuro system for a non-invasive treatment of essential tremor in patients who have not responded to medication and now it's including the usage on 1.5 Tesla MRI systems (the FDA approval which was announced on July 12, 2016, was given for the usage of the Exablate Neuro on 3 Tesla magnet strength MRI systems). The above-mentioned extension is expected to expend the product's markets of which Exablate Neuro is applicable for.

Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under MRI guidance for real time treatment monitoring.

Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom, but tremors can also affect the head, arms, voice, legs, and torso. For these patients, performing everyday tasks presents a challenge and impacts their quality of life.

The Company holds approximately 89.9% of the share capital of Elbit Medical Technologies Ltd. (TASE:EMTC-M) (85.8% 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).

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INSIGHTEC Receives FDA Approval for Exablate Neuro for 1.5T MRI in the Treatment of Essential Tremor

HAIFA, Israel, May 9, 2017 /PRNewswire/ --

INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS), announced today that the FDA has approved its Exablate Neuro (Model 4000) system for use with 1.5T MRI in the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication.

Exablate Neuro uses focused ultrasound waves to target and ablate the Vim nucleus of the thalamus with no surgical incisions or implants. The treatment is done under MRI guidance for real-time treatment monitoring. In July 2016, INSIGHTEC received FDA approval for the Exablate Neuro for use with 3.0T MRI systems. This approval for a new MR head coil significantly opens new potential markets for INSIGHTEC'S Exablate Neuro as 1.5T systems are the most common MRI systems in use today.

Essential tremor is the most common movement disorder, affecting more than 42 million people worldwide. For patients suffering from essential tremor, performing everyday tasks presents a challenge and impacts their quality of life.

"Being able to bring MR-guided focused ultrasound to hospitals that have 1.5T MRIs will enable more essential tremor patients to have access to this non-invasive treatment option using INSIGHTEC's ground-breaking technology," stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.

To read more about the Exablate Neuro, please visit: http://www.insightec.com/us/clinical/neurosurgery

About INSIGHTEC

INSIGHTEC is the world leader and innovator of MR-guided Focused Ultrasound (MRgFUS). The company's non-invasive therapy platforms, Exablate and Exablate Neuro, are proven technology based on sound clinical evidence for treating essential tremor, painful bone metastases and uterine fibroids. The company is dedicated to improving patient lives by collaborating with physicians, medical institutions, academic researchers and regulatory bodies around the world. For more information, please visit: http://www.insightec.com .

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SOURCE INSIGHTEC