Replies to post #1763 on Elbit Imaging Ltd (EMITF)

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Elbit Imaging Ltd. Announces The Taiwanese Food And Drug Administration (TFDA) Approved Insightec's Exablate Neuro For The Treatment Of Essential Tremor

TEL AVIV, ISRAEL / ACCESSWIRE / November 24, 2017 / Elbit Imaging Ltd. (TASE, NASDAQ: EMITF) ("Elbit" or the "Company") announced today, that Insightec Ltd. ("Insightec") informed that the Taiwanese Food and Drug Administration (TFDA) has approved its Exablate Neuro system for the treatment of essential tremor in patients who do not respond to medication.

Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions. The treatment is done under Magnetic Resonance Imaging (MRI) guidance which provides real-time imaging and temperature monitoring. Due to its non-invasive nature, the treatment carries minimal risk of surgical complications such as infections or bleeding. The treatment is performed in a single session with no anesthesia, allowing patients to experience immediate tremor improvement.

The approval was 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 Exablate Neuro.

The Company holds approximately 89.64% of the share capital of Elbit Medical Technologies Ltd. (TASE: EMTC-M) (86.64% on a fully diluted basis) which, in turn, holds approximately 31% of the share capital in Insightec (25% on a fully diluted basis).

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FDA Approves First Study of INSIGHTEC's Exablate Neuro to Open the Blood-Brain Barrier in Glioblastoma Patients

HAIFA, Israel, November 27, 2017 /PRNewswire/ --

INSIGHTEC, the world leader of MR-guided Focused Ultrasound announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a study to evaluate the safety and feasibility of the Exablate Neuro for disrupting the blood brain barrier (BBB) in patients with Glioblastoma.

The blood brain barrier restricts the passage of substances from the bloodstream into the brain, protecting it from toxins. This barrier also prevents the effective delivery of agents, such as medications from reaching their target.

In the current trial, the research team will inject a commonly used sonographic microbubble solution into the bloodstream of a patient with a malignant brain tumor. Ultrasound waves will then be delivered to oscillate the microbubbles causing temporary disruption of the blood brain barrier. The trial will include up to 15 subjects with suspected glioblastoma who are scheduled to undergo tumor resection. The Principal Investigator is Graeme F. Woodworth, MD, FACS, Associate Professor of Neurosurgery and Director of The Brain Tumor Treatment & Research Center at the University of Maryland School of Medicine, and Attending Neurosurgeon at the University of Maryland Medical Center in Baltimore, Maryland.

"Clinical research is critical for pushing the boundaries of MR-guided focused ultrasound technology," said Maurice R. Ferré MD, INSIGHTEC's CEO and Chairman of the Board. "INSIGHTEC continues to collaborate with leading researchers to trial new clinical applications that may have significant impact where it matters most - patient lives."

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Insightec Signed An Agreement With An Investor Who Will Invest Up To USD150 Million In Insightec


TEL AVIV, ISRAEL / ACCESSWIRE / December 14, 2017 / Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today that InSightec Ltd. ("Insightec"), has signed a Share Purchase Agreement with Koch Disruptive Technologies (a subsidiary of Koch Industries, Inc.) ("Koch Disruptive Technologies"), pursuant to which Koch Disruptive Technologies together with other investors (the "Additional Investors") will invest in Insightec a total amount of between US$75 million and US$150 million, in consideration for the issuance of a new series of preferred stock of Insightec (the "Transaction").
The main terms of the Transaction are as follows:
At the initial closing of the Transaction, Koch Disruptive Technologies shall purchase new Series E Preferred Shares of Insightec (the "Preferred Stock") in consideration for a total amount of USD75 million. The Preferred Stock will represent, immediately following the issuance, approximately 17% of the outstanding share capital (14% on a fully-diluted basis) of Insightec. The initial closing is scheduled to be held, subject to fulfillment of all conditions precedent described in Section 6 below, no later than January 31, 2018.
The transaction documents grant Koch Disruptive Technologies and the Additional Investors (some of which are existing shareholders of Insightec) the right to invest in additional closings (to be held by no later than January 31, 2018) an additional amount of up to USD75 million in consideration for the issuance of additional Preferred Stock, provided that Koch Disruptive Technologies will hold at least 66% of the Preferred Stock after each closing.
The Transaction reflects a pre-money valuation for Insightec of approximately USD460 million (on a fully-diluted basis).
Holders of Preferred Stock shall have preferred rights in the event of a dividend distribution and certain material events as set forth in the transaction documents.
The transaction documents also set forth the rights of Koch Disruptive Technologies and other major shareholders of Insightec (in an amended Securityholders Agreement and amended Articles of Association), including, that following the consummation of the Transaction, Insightec's board of directors shall consist of a maximum of nine (9) board members. Each of the four major shareholders in Insightec (including Elbit Medical) will be entitled to appoint one director for as long as each of them holds at least 5% of the outstanding share capital of Insightec. The directors appointed by three of the major shareholders (including the one appointed by Elbit Medical) may together appoint up to four (4) additional directors. The CEO of Insightec will also serve as the director.
The completion of the Transaction is subject to the terms and conditions stipulated in the transaction documents, including the approvals of the shareholders' meetings of Insightec. Elbit Medical has undertaken to support the Transaction in Insightec's shareholders' meetings.
Following the consummation of the Transaction, Elbit Medical will hold approximately 26% (22% on a fully-diluted basis) of Insightec's share capital, assuming a total investment of US $75 million, and 22% (19% on a fully-diluted basis) in the event of an investment of the total amount of US $150 million.