October 02, 2014 4:19 AM ET

Healthcare Equipment and Supplies

Company Overview of InSightec Ltd.

Company Overview

InSightec Ltd. develops and markets non-invasive surgery systems that destroy tumors inside the body without the need for open surgery. The company specializes in ExAblate, a MR guided focused ultrasound technology. It provides ExAblate O.R., a platform for treating body applications that offers research treatment options for a multitude of clinical indications, such as uterine fibroids and adenomyosis, pain palliation of bone metastases, breast cancer, prostate cancer, and various other indications; and ExAblate Neuro, a system for the treatment of essential tremor, Parkinson’s, and neuropathic pain. The company was founded in 1999 and is headquartered in Tirat Carmel, Israel with additiona...

5 Nahum Heth Street

POB 2059

Tirat Carmel,  39120

Israel

Founded in 1999

Phone:

972 4 813 1313

Fax:

972 4 813 1322

Key Executives for InSightec Ltd.

Co-Founder and Chief Executive Officer
President and Chief Commercial Officer
Chief Financial Officer and Vice President
Vice President of Operations and Quality
Vice President of Global Regulatory Affairs and CRO
Compensation as of Fiscal Year 2014.

InSightec Ltd. Key Developments

Robert Sigal Joins InSightec, Ltd. as President and Chief Commercial Officer

InSightec Ltd. announced that Robert Sigal, MD, PhD, to be joining InSightec as President and Chief Commercial Officer as of October 13, 2013. He will be responsible for all the commercial aspects of InSightec reporting to Dr. Kobi Vortman, CEO and Founder of InSightec Ltd. Robert joins InSightec from GE Healthcare where he served most recently as the General Manager of GE Healthcare France.

InSightec Ltd Receives Approval of Chinese Food and Drug Administration for ExAblate system

InSightec Ltd. announced that its ExAblate system received approval of the Chinese Food and Drug Administration (CFDA) for non-invasive treatment of uterine fibroids. Uterine fibroids are benign tumors that grow in the uterus. 20%-50% of women of childbearing age suffer from uterine fibroids. Hysterectomy, surgical removal of the uterus, is the most common form of treatment. ExAblate combines high intensity focused ultrasound waves and continuous MRI guidance and monitoring. The focused ultrasound energy is used to ablate or destroy the fibroids while the MRI images are used to plan and guide the therapy and monitor treatment outcome. ExAblate benefits are that it is incisionless, requires no hospitalization, has a high safety profile with low risk of infection and complications, and rapid recovery.

InSightec, Ltd. Receives FDA Approval to Begin its Pivotal Phase III Clinical Trial for Treatment of Essential Tremor Using ExAblate Neuro

InSightec, Ltd. announced that it has received FDA approval to begin its pivotal Phase III clinical trial for treatment of essential tremor using ExAblate(R) Neuro. This trial is intended to provide the safety and effectiveness data about the use of ExAblate(R) Neuro in order to support FDA pre-marketing approval. ExAblate Neuro uses MR guided focused ultrasound therapy to provide an incision-less treatment, through the intact skull, with no ionizing radiation. ExAblate MR guided focused ultrasound (MRgFUS) uses high intensity ultrasound waves to destroy target tissue in the brain while the patient lies in an MRI, which provides continuous visualization, plan, guidance, monitoring, and control of the treatment. The Phase III study will be a multi-center, double blinded randomized control trial, with one year followup. Patients who enroll in the trial will be randomized to either ExAblate treatment or no treatment. The first patients are expected to be enrolled in mid 2013. The trial is based on the safety and initial effectiveness results from 15 patients treated in FDA feasibility trial sponsored by the Focused Ultrasound Foundation.

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Recent Private Companies Transactions

Type
Date
Target
Private Placement
April 6, 2014
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